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The S-LOK™ PSS System is intended 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 (pseudoarthrosis).

The S-LOK™ PSS System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra 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. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis, and/or lordosis); spinal tumor; pseudoarthrosis; and failed previous fusion.

The S-LOK™ PSS System is a top-loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, cross links, locking cap screws and hooks. All of the components are available in a variety of sizes to match more closely the patient's anatomy.

Here's an analysis of the provided text regarding the S-LOK™ PSS Pedicle Screw System's acceptance criteria and studies:

Acceptance Criteria and Device Performance

Study Details

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

   • The document mentions a "cadaver study" but does not specify the sample size (number of cadavers or specific test subjects).
   • The provenance of the data (country of origin, retrospective/prospective) is not specified.

2. 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 information is not provided in the document. The studies conducted are mechanical and biomechanical, not clinical studies involving expert interpretation for ground truth.

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

   • Not applicable. The studies are mechanical/biomechanical, not involving human adjudication of results.

4. 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:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a pedicle screw system, not an AI diagnostic tool.

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

   • No, a standalone (algorithm-only) performance study was not done. The device is a physical medical implant, not an algorithm.

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

   • For the mechanical tests (Static axial gripping, Static flexion/extension moment), the ground truth is derived from the established ASTM F1798 standard and comparison to the predicate device's performance under similar testing conditions.
   • For the cadaver study, the ground truth would be based on biomechanical measurements and observations of the system's performance within the cadaveric spine, again likely in comparison to the predicate device.

7. The sample size for the training set:

   • Not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set.

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

   • Not applicable, as there is no training set for this type of device.

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