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The VEPTR/VEPTR II device is indicated for skeletally immature patients with severe, progressive spinal deformities and/or three dimensional deformity of the thorax associated with or at risk of Thoracic Insufficiency Syndrome (TIS). TIS is defined as the inability of the thorax to support normal respiration or lung growth. This would include patients with progressive congenital, neuromuscular, idiopathic, or syndromic scoliosis.

In children with or at risk of developing Thoracic Insufficiency Syndrome, the natural course of lung development is arrested due to constriction by the thorax. The VEPTR/VEPTR II devices mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow.

The VEPTR devices are attached perpendicularly to the subject's natural ribs and lumbar vertebra or pelvis. This mechanically stabilizes the chest wall and enlarges the thorax to improve respiration and lung growth. Once the VEPTR/VEPTR II device is in place, its design allows for expansion, anatomic distraction, and replacement of component parts through less invasive surgery.

The VEPTR/VEPTR II devices allow assembly in a number of different configurations. All of these configurations are required to accommodate the wide variety of anatomical deformities encountered by the clinician in treating patients with or at risk of developing Thoracic Insufficiency Syndrome.

This document is a 510(k) Premarket Notification for the DePuy Synthes Spine Vertical Expandable Prosthetic Titanium Rib (VEPTR/VEPTR II) device. It is a medical device submission, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance in the way a diagnostic AI/ML device submission would.

Therefore, the requested information elements related to AI/ML device performance, ground truth, expert adjudication, sample sizes for training/test sets, and MRMC studies are not applicable to this document. This submission relates to a physical orthopedic implant, not a diagnostic algorithm.

Here's a breakdown of the applicable information:

1. A table of acceptance criteria and the reported device performance:

Since this is a submission for a physical implant demonstrating substantial equivalence, "acceptance criteria" are not defined as specific performance metrics like sensitivity/specificity for an AI/ML diagnostic. Instead, the submission relies on comparison to predicate devices and mechanical testing standards.

2. Sample sized used for the test set and the data provenance:

• Test Set (for clinical evaluation of safety and effectiveness): The submission references the results of the HDE (H030009) post-market follow-up. The specific sample size for this HDE is not provided in this document summary.
• Data Provenance: The HDE (H030009) is a Humanitarian Device Exemption, typically involving devices for rare conditions. This indicates a clinical study with human subjects, likely multi-center, but the specific country of origin and retrospective/prospective nature are not detailed in this summary. HDEs are inherently prospective post-market follow-ups to gather data on probable benefit and safety.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

Not applicable. This is not an AI/ML device where "ground truth" is established by experts for diagnostic performance. Clinical outcomes and safety were evaluated in the HDE study.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. This is not an AI/ML device with a human-labeled test set requiring adjudication. Clinical trial data typically has pre-defined endpoints and evaluation criteria.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is a physical orthopedic implant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical orthopedic implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The closest equivalent to "ground truth" here would be clinical outcomes data from the HDE post-market follow-up, which would involve patient data reflecting safety and probable benefit in treating Thoracic Insufficiency Syndrome.

8. The sample size for the training set:

Not applicable. This is a physical orthopedic implant, not an AI/ML model.

9. How the ground truth for the training set was established:

Not applicable. This is a physical orthopedic implant, not an AI/ML model.

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