MuscleView

K241331

Springbok, Inc. · cleared 2024-10-01 · product code LNH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.6)

“MuscleView is a software only product that uses a machine learning-based approach for the automatic segmentation of musculoskeletal structures from MRI.”

Algorithmmachine learning-based approach, specifically convolutional neural networks (CNNs)

source quote (p.6)

“MuscleView is a software only product that uses a machine learning-based approach for the automatic segmentation of musculoskeletal structures from MRI. ... A library of already contoured expert cases is utilized to train the machine learning algorithms, specifically convolutional neural networks (CNNs) perform automated segmentation.”

Adaptive (vs locked)No

source quote (p.6)

“The segmentation & 3D model viewer module handles training data and algorithms to obtain the pre-trained models and algorithms to update models.”

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

n=148 cases · 19 site(s)

endpoints: dice similarity coefficient (DSC) below interobserver variability; volume difference (VDt) below interobserver variability

Reported performance (3 observations)

diceas written: “Dice Similarity Coefficient (DSC) for adductor brevis (Healthy)”stated without valueCI 0.962 -0.965

source quote (p.13)

“adductor brevis 0.962 -0.965”

diceas written: “Dice Similarity Coefficient (DSC) for gluteus maximus (Healthy)”stated without valueCI 0.993-0.994

source quote (p.13)

“gluteus maximus 0.993-0.994”

diceas written: “Dice Similarity Coefficient (DSC) for pelvis (Healthy)”stated without valueCI 0.978-0.981

source quote (p.13)

“pelvis 0.978-0.981”

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

100

recalls in product code, 24mo

510

MAUDE reports in code, 12mo

+5%

vs code's own 3-yr baseline

drift signals on this device

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).