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The REVOLVE™ Stabilization System, when used as a posterior pedicle 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 or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.

In addition, the REVOLVE™ Stabilization System is intended for treatment of 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 lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.

The REVOLVE™ Stabilization System consists of rods, polyaxial screws, locking caps, t-connectors, and associated manual surgical instruments. Screws and rods are available in a variety of sizes to accommodate individual patient anatomy. Implant components can be rigidly locked into a variety of configurations for the individual patient and surgical condition. REVERE® locking caps are used to connect screws to the rod.

The most common use of this screw and rod system in the posterior thoracolumbar and sacral spine is two rods, each positioned and attached lateral to the spinous process via pedicle screws.

Screws attach to the rods using a locking cap with an inner set screw. The size and number of screws are dependent on the length and location of the rod. Screws are inserted into a pedicle of the thoracolumbar and/or sacral spine.

T-connectors are modular components designed to connect the two rods of a construct and act as a structural cross member. The rod-clamping set screws secure the t-connectors to the rods. Additional set screws secure the adjustable cross members at the desired length. REVERE® t-connectors may be used with 5.5mm REVOLVE™ rods.

REVOLVE™ implants are composed of titanium alloy, as specified in ASTM F136 and F1295.

The acceptance criteria for the REVOLVE™ Stabilization System are not explicitly stated in the provided text. Instead, the submission focuses on demonstrating "substantial equivalence" to a predicate device (REVERE® Stabilization System K061202) based on technical characteristics, performance, and intended use. The primary method for proving this equivalence is through mechanical testing.

Here's an analysis of the provided information, addressing your specific points:

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

The document does not provide a table with specific, quantitative acceptance criteria for the REVOLVE™ Stabilization System. Instead, it states that "Mechanical testing in accordance with the 'Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s', May 3, 2004 is presented." This implies that the device's performance was compared to the standards and benchmarks outlined in that FDA guidance document, rather than a predefined set of internal acceptance criteria explicitly listed here.

Thus, we can infer the acceptance criteria are implicitly those set by the FDA guidance for spinal systems, and the reported device performance is that it met these criteria, allowing for a finding of substantial equivalence.

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

The document focuses on mechanical testing, not clinical studies with patient data. Therefore, there is no sample size for a "test set" in the context of patient data, nor is there information about data provenance (country of origin, retrospective/prospective).

For mechanical testing, the "sample size" would refer to the number of implants or constructs tested. This information is not provided in the excerpt.

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 question is not applicable. The submission relies on mechanical testing against regulatory guidance, not expert consensus on clinical cases. Therefore, no experts were used to establish ground truth in this context.

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

This question is not applicable as there was no clinical test set requiring adjudication. The assessment of mechanical testing likely involves laboratory procedures and comparison to established engineering standards, rather than expert 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

No MRMC comparative effectiveness study was done. This device is a medical implant, not an AI-powered diagnostic or assistive tool.

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

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

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

The "ground truth" for the device's performance is the standards and benchmarks for spinal system mechanical performance as defined by the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004. This guidance likely references specific ASTM or ISO standards for testing spinal implants (e.g., fatigue strength, static strength).

8. The sample size for the training set

This question is not applicable. There is no AI or machine learning component to this device, so there is no "training set."

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

This question is not applicable as there is no training set for an AI/ML model.

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