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The PASS 2 Spinal System consists of pedicle screws, rods, nuts and clamps members utilized to provide immobilization 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, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

As a pedicle screw system, the PASS 2 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 PASS 2 Spinal System consists of pedicle screws, rods, nuts and clamps. It can be used for single or multiple level fixations. All components are manufactured from titanium alloy (Ti-6Al-4V) that conforms to ASTM F136.

The provided text is a 510(k) summary for the PASS 2 Spinal System, which is a pedicle screw spinal system. This document focuses on demonstrating substantial equivalence to legally marketed predicate devices through mechanical testing, rather than a clinical study involving human patients. Therefore, many of the requested fields related to clinical study design (e.g., sample size for test set, expert qualifications, adjudication methods, MRMC studies, training set details) are not applicable.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

Sample Size: Not specified for the mechanical testing. The testing was likely conducted on a sufficient number of device components to meet ASTM F1717 requirements.

Data Provenance: The data is from mechanical testing, not clinical data from patients. The specific lab or country where the testing was performed is not stated.

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

Not applicable. This was a mechanical testing study, not a study requiring expert clinical assessment for ground truth. The "ground truth" was established by the specified ASTM F1717 standard for mechanical integrity.

4. Adjudication method for the test set

Not applicable. This was a mechanical testing study, not a study requiring expert adjudication of clinical findings.

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 device is a pedicle screw spinal system, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study is not relevant.

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

Not applicable. This device is a medical implant, not an algorithm.

7. The type of ground truth used

The "ground truth" for demonstrating the device's performance was compliance with the ASTM F1717 standard, which outlines mechanical testing procedures for spinal implant constructs.

8. The sample size for the training set

Not applicable. This device is a pedicle screw spinal system, not a machine learning model requiring a training set.

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

Not applicable. This device is a pedicle screw spinal system, not a machine learning model.

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