MuscleView 2.0
K251682Springbok, Inc. (dba Springbok Analytics) · cleared 2025-09-09 · product code LNH · Radiology
Premarket evidence — what FDA accepted
source quote (p.6)
“MuscleView 2.0 is a software-only medical device which performs automatic segmentation of musculoskeletal structures.”
source quote (p.6)
“The software utilizes a locked artificial intelligence/machine learning (AI/ML) algorithm to identify and segment anatomical structures for quantitative analysis.”
source quote (p.6)
“The software utilizes a locked artificial intelligence/machine learning (AI/ML) algorithm to identify and segment anatomical structures for quantitative analysis. The model behavior is locked and deterministic.”
source quote (p.1)
“FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP). The submission includes a Predetermined Change Control Plan which details the procedure for retraining AI/ML algorithms or adding data to the Virtual Control Groups in order to improve performance without negatively impacting the safety or efficacy of the device. A Predetermined Change Control Plan (PCCP) has been developed in accordance with the FDA Guidance "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions" (issued December 4, 2024). Modifications to the MuscleView AI/ML models will be made in accordance with the PCCP summarized below:”
source quote (p.9)
“MuscleView 2.0 has been tested in alignment with the FDA's guidance on software functions ("Content of Premarket Submissions for Device Software Functions”, June 14, 2023) and cybersecurity ("Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions”, September 27, 2023). It has successfully met the predetermined acceptance criteria for the following tests: ... Cybersecurity Testing”
Validation studies (1)
Retrospective clinical
n=319 patients · 19 site(s)
endpoints: dice similarity coefficient (DSC); volume difference (VDt)
Reported performance (1 observation)
source quote (p.11)
“Table 1: The 95% confidence intervale for the ROIs in Al settings 1-3 for the DICE (DSC) metric.”
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
- recall_reason_pattern
Software/algorithm-related recall in product code LNH (Philips North America, initiated 2026-04-14): "The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction " Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98779
- recall_reason_pattern
Software/algorithm-related recall in product code LNH (Philips North America, initiated 2025-12-03): "The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS)." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98111
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).