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The REVERE® 6.35 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 REVERE® 6.35 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 illum with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.

When used as a posterior non-pedicle screw fixation system, the REVERE® 6.35 Stabilization System is intended for the treatment of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scollosis, kyphosis, and/or lordosis, Scheuermann's disease), fracture, pseudarthrosis, tumor resection, and/or failed previous fusion. Overall levels of fixation are T1-sacrum/ilium.

When used as an anterolateral thoracolumbar system, the REVERE® 6.35 Stabilization System is intended for anterolateral screw (with or without staple) fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis), fracture or dislocation of the thoracolumbar spine, pseudoarthrosis, tumor resection, and/or failed previous fusion. Levels of screw fixation are T8-L5.

The REVERE® Stabilization System consists of rods, hooks, monoaxial screws, uniplanar screws, polyaxial screws, reduction screws, locking caps, t-connectors, staples, connectors, and associated manual surgical instruments. Screws and rods are available in a variety of sizes to accommodate individual patient anatomy. REVERE® implants mate with 5.5mm diameter rods; REVERE® 6.35 implants mate with 6.35mm diameter rods. Implant components can be rigidly locked into a variety of configurations for the individual patient and surgical condition. Polyaxial screws, hooks, and t-connectors are intended for posterior use only. Staples are intended for anterior use only. Rods and monoaxial screws may be used anteriorly or posteriorly. Locking caps are used to connect screws or hooks to the rod.

The most common use of this screw, hook, 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 and/or lamina, pedicle or transverse process hooks.

The most common use of this screw, hook, and rod system in the anterior thoracolumbar spine is one rod, positioned and attached to the vertebral bodies via monoaxial screws through an appropriate size staple.

Screws and hooks 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. The type and number of hooks are also dependent on the location in the spine needing correction and/or stabilization. Hooks are attached to the laminae. pedicles, or transverse process of the posterior 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. T-connectors from the PROTEX® system may be used with 6.5mm, 6.0mm or 5.5mm rod systems. REVERE® tconnectors may only be used with 5.5mm rods; REVERE® 6.35 t-connectors may only be used with 6.35mm rods. Additional connectors may be used to connect two rods, and are also secured using set screws.

The REVERE® rods are composed of titanium alloy, commercially pure titanium, or stainless steel, as specified in ASTM F136, F1295, F67, and F138. All other REVERE® implants are composed of titanium alloy or stainless steel, as specified in ASTM F136, F1295, and F138. Due to the risk of galvanic corrosion following implantation, stainless steel implants should not be connected to titanium or titanium alloy implants.

This document is a 510(k) summary for a medical device called the REVERE® 6.35 Stabilization System. It focuses on demonstrating substantial equivalence to a predicate device through mechanical testing, not a clinical study involving human or AI performance. Therefore, many of the requested criteria are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a separate "test set" in the context of clinical data. The mechanical testing would have involved a sample of the physical device components. The specific number of components tested for each mechanical test is not provided in this summary.
• Data Provenance: The data is from mechanical testing of the REVERE® 6.35 Stabilization System and its predicate devices. This is not human clinical data, so country of origin and retrospective/prospective classification are not applicable in this context.

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

• Not applicable. This is not a study requiring expert clinical ground truth. The "ground truth" here is compliance with established mechanical testing standards and comparison to a predicate device's performance.

4. Adjudication method for the test set

• Not applicable. No human adjudication is mentioned for the mechanical testing results.

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. This is a 510(k) summary for a spinal stabilization system, not an AI-powered diagnostic or interpretive device. An MRMC study is not relevant to this type of device.

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

• No. This is not an algorithm or AI device.

7. The type of ground truth used

• For the purpose of substantial equivalence, the "ground truth" used is the mechanical performance characteristics required by the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s" and the established performance of the predicate REVERE® Stabilization System implants. This is based on engineering and material science standards, not clinical outcomes, pathology, or expert consensus in a diagnostic sense.

8. The sample size for the training set

• Not applicable. This device does not involve a "training set" in the context of AI or machine learning.

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

• Not applicable. Given that this is a 510(k) for a physical implant system, there is no "training set" or corresponding ground truth establishment process in the AI/ML sense.

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