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The PASS Spinal System consists of pedicle screws, rods, nuts and crosslink members utilized to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

As a pedicle screw system, the PASS Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The subjects of this Special 510(k) submission are the addition of rod-plate components for the PASS Spinal System (K001024). All components are manufactured from titanium alloy (Ti-6AI-4V) that conforms to ASTM F136.

The rod-plates are similar to the rods as they consist of a short rod segment that has enlarged portions at the ends with holes to attach directly to the screws with hemispherical nuts rather than connecting the rod to the screw via a clamp. The proximal end is circular is shape with a circular hole, while the distal end is oval in shape with an oval opening that allows vertical variability of the distal screw placement. These components are offered in two versions (two or three holes) for one or two level instrumentation, each being available in two sizes, small and large. Rod-plates are present to match the lumbar lordosis.

Here's an analysis of the provided text regarding the acceptance criteria and study for the device:

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

Explanation: The document explicitly states, "The Food and Drug Administration have established no performance standards applicable to pedicle screw spinal systems. However, static and fatigue compression testing of the PASS Spinal System was performed according to ASTM F1717-96." This indicates that the chosen acceptance criteria were specific engineering tests to demonstrate the mechanical integrity of the device, aligned with an established standard for spinal implant testing. The reported performance is simply that these tests were conducted as per the standard. There is no pass/fail metric or numerical result provided in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified. The document only mentions "static and fatigue compression testing of the PASS Spinal System," but does not provide details on the number of devices tested.
• Data Provenance: The document does not provide information on the country of origin of the data or whether the study was retrospective or prospective. Given that this is a 510(k) submission for mechanical components, the "data" would refer to laboratory test results.

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)

This section is not applicable to this device. This 510(k) pertains to a mechanical medical device (spinal system components), not an AI or diagnostic imaging device that requires interpretation by human experts to establish ground truth from medical images or clinical data. The "ground truth" here is the physical performance of the device under specific mechanical loads.

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

This section is not applicable to this device. Adjudication methods are typically used in studies involving human interpretation or clinical endpoints where there might be disagreement among experts. For mechanical testing, the results are typically quantitative measurements that do not require adjudication.

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

This section is not applicable to this device. MRMC studies are relevant for diagnostic or AI-assisted interpretation devices, not for a mechanical spinal implant.

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

This section is not applicable to this device. This is a mechanical implant, not an algorithm.

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

The "ground truth" in this context is the mechanical performance of the device as measured by standardized engineering tests. Specifically, the performance under static and fatigue compression loading conditions, as defined and evaluated by ASTM F1717-96.

8. The sample size for the training set

This section is not applicable to this device. This is a mechanical implant, not an AI or machine learning model that requires a training set.

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

This section is not applicable to this device. As it's not an AI/ML device, there is no training set or ground truth established for one.

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