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When used as a posterior, noncervical pedicle screw system, the VertiFlex™ Spinal Screw 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 of the thoracic, lumbar, and sacral spine:

• Degenerative disc disease (DDD) as defined by back pain of discogenic origin . with degeneration of the disc confirmed by patient history and radiographic studies;
• Severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra; .
• Degenerative spondylolisthesis; .
• Trauma (i.e., fracture or dislocation); .
• . Spinal stenosis;
• Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); ●
• Tumor: .
• Pseudoarthrosis; and/or .
• Failed previous fusion. .

The VertiFlex™ Spinal Screw System is a posterior, non-cervical instrumentation system consisting of both pedicle screws and rigid connecting rods. Screws are of polyaxial or monoaxial (fixed) top-loading design, are composed of titanium alloy, and are available in a range of diameters and lengths to accommodate physiological requirements. The rods are composed of titanium, and are available in both straight and curved (pre-lordosed) styles, and in a range of lengths to accommodate both single-level and multiple levels procedures. The System may be implanted by either conventional surgical methods, or via minimally-invasive/percutaneous techniques. Manual instrumentation for implantation of the System is available for both conventional and minimally-invasive procedures. Screws, rods, and instruments are offered non-sterile.

The provided document is a 510(k) summary for a medical device called the "VertiFlex™ Spinal Screw System." It describes the device, its intended use, and substantial equivalence to predicate devices, but it does not contain acceptance criteria or a study proving the device meets those criteria, especially in the context of an AI/algorithm-based device as implied by your detailed questions.

This 510(k) pertains to a physical implantable device (pedicle screws) and its regulatory review for market clearance based on substantial equivalence to existing devices, not an AI or software as a medical device (SaMD). Therefore, many of your specific questions related to AI/algorithm performance metrics, training sets, expert ground truth, MRMC studies, and standalone performance are not applicable to the information contained in this document.

Here's an analysis based on the provided text, highlighting what is present and what is absent:

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

• Not Applicable / Not Provided. The document does not define specific performance acceptance criteria in terms of quantitative metrics for a device (like sensitivity, specificity, accuracy, etc.) nor does it report performance against such criteria. This is a physical implant device, and its performance is assessed via non-clinical tests (mechanical/material properties) and comparison to predicate devices, not AI performance metrics.

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

• Not Applicable / Not Provided. No "test set" in the context of an algorithm's performance is mentioned. The document refers to "non-clinical tests" in accordance with standards like ASTM F1717-04 for spinal implant constructs in a vertebrectomy model. This implies mechanical testing of the physical device, not data analysis on a patient dataset. Therefore, there's no information on sample size for an algorithm test set, data provenance, or whether it was retrospective/prospective.

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 / Not Provided. As there is no algorithm requiring a "ground truth" to be established for a test set, there is no mention of experts or their qualifications in this context. The "truth" for a mechanical implant typically comes from engineering standards and physical measurements.

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

• Not Applicable / Not Provided. An adjudication method is used when multiple human readers disagree on ground truth. Since no human readers or ground truth establishment for a test set are mentioned, no adjudication method is applicable or described.

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

• No, not done. The document explicitly states: "No clinical testing was conducted to support this submission." Therefore, no MRMC study, AI assistance, or effect size is reported.

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

• No, not done. This device is a physical medical implant, not an algorithm. Standalone algorithm performance is not applicable.

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

• Not Applicable. For this physical device, "ground truth" would relate to its material properties and mechanical performance meeting engineering specifications and standards (e.g., ASTM F1717-04), rather than clinical outcomes or diagnostic accuracy. The document focuses on demonstrating "substantial equivalence" of the device's design, materials, and performance to predicate pedicle screw systems through non-clinical tests.

8. The sample size for the training set

• Not Applicable / Not Provided. There is no algorithm, and thus no training set or associated sample size for training data.

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

• Not Applicable / Not Provided. No training set means no method for establishing its ground truth is described.

Summary of what the document does provide regarding device performance:

The document states that non-clinical tests, including those conducted in accordance with recognized standards like ASTM F1717-04, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, "have demonstrated the substantial equivalence of the subject device to commercially-available predicate devices in terms of performance."

This implies a comparison of the mechanical and structural performance of the VertiFlex™ Spinal Screw System against the performance of predicate devices, adhering to industry-accepted testing standards. The "acceptance criteria" here are effectively met by demonstrating that the VertiFlex™ system performs comparably to the predicate devices under these standardized non-clinical tests. However, the exact numerical results or specific pass/fail thresholds from these tests are not detailed in this summary.

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