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The PASS Anterior Spinal System is an anterolateral screw fixation system intended to provide immobilization and stabilization of spinal segments from T4 to L5 in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic and lumbar spine:

• Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
• · Traumatism (ex: fracture, dislocation)
• · Tumor
• · Spinal deformation such as scoliosis or kyphosis
• · Failed previous fusion (Pseudoarthrosis)

The Medicrea PASS Anterior Spinal System consists of screws, rods, plates, staples, connection and locking devices. It can be used for single or multiple level fixations, with one or two rods. This system has been developed to accommodate a left or right anterior approach. The implants are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ISO 5832-3 specifications and ASTM F136 specifications.

This is a 510(k) premarket notification for a medical device called the "PASS Anterior Spinal System." It is a spinal intervertebral body fixation orthosis. The document focuses on demonstrating substantial equivalence to previously marketed predicate devices rather than providing detailed acceptance criteria and a study to prove performance in the context of an AI/machine learning device.

Therefore, most of the requested information for an AI/ML device's acceptance criteria and study proving performance is not applicable to this document.

However, I can extract what is provided regarding non-clinical testing and the overall conclusion.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a mechanical spinal implant, the "acceptance criteria" are based on mechanical performance tests, and "reported device performance" refers to the device passing these tests.

Note: The document states "The following tests were conducted according to ASTM F1717," implying successful completion and meeting relevant standards for spinal implants. However, specific numerical acceptance thresholds or results (e.g., "device withstood X N-m," or "deformation less than Y mm") are not provided in this summary.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not applicable in the context of an AI/ML test set. For mechanical testing, the "sample size" would refer to the number of devices tested. This information is not explicitly stated in the summary, but typically multiple units are tested per configuration to ensure reproducibility and statistical significance.
• Data Provenance: Not applicable for AI/ML specific data provenance. The testing is non-clinical, done in a laboratory environment according to ASTM F1717.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a mechanical device, not an AI/ML device requiring expert ground truth for image interpretation or diagnosis.

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

Not applicable. Adjudication methods are relevant for clinical studies or AI/ML evaluations, not mechanical testing.

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 mechanical spinal implant, not an AI-assisted diagnostic tool.

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

Not applicable. This is a mechanical spinal implant.

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

For the mechanical tests, the "ground truth" would be the engineering specifications and performance standards defined by ASTM F1717 for spinal implant constructs. The device's ability to withstand certain loads and cycles without failure or exceeding deformation limits constitutes meeting the "ground truth" for mechanical integrity.

8. The sample size for the training set

Not applicable. There is no AI/ML training set for this mechanical device.

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

Not applicable. There is no AI/ML training set for this mechanical device.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as per the provided document):

The provided document describes a Non-Clinical Test Summary which details mechanical testing performed according to ASTM F1717. These tests included:

• Static testing in a load to failure mode in axial compression bending.
• Static testing in a load to failure mode in torsion.
• Cyclical axial compression bending testing.

The conclusion drawn from these tests is that "The PASS Anterior Spinal System is substantially equivalent to the predicate devices in terms of indications for use, design, material, and function." This implies that the device successfully met the mechanical performance requirements defined by the ASTM standard, thereby demonstrating its safety and effectiveness comparable to existing, legally marketed devices.

No clinical studies were performed as the substantial equivalence was established through design, material comparison, and non-clinical mechanical testing, which is common for spinal fixation systems.

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