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The REVERE 4.5 Stabilization System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is indicated for skeletally mature patients (including small stature) and pediatric patients. These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), turnor, stenosis, and failed previous fusion (pseudoarthrosis).

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the REVERE® 4.5 Stabilization System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The REVERE® 4.5 Stabilization System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

In order to achieve additional levels of fixation in skeletally mature patients, the REVERE® 4.5 Stabilization System rods may be connected to the REVERE® Stabilization System (5.5mm or 6.35mm rod) or ELLIPSE® Occipito-Cervico-Thoracic Spinal System (3.5mm rod) using corresponding connectors. Refer to the REVERE® or ELLIPSE® system package insert for instructions and indications of use.

The REVERE® 4.5 Stabilization System consists of rods, hooks, monoaxial screws, Uniplanar screws, polyaxial screws, reduction screws, locking caps, tconnectors, head offset connectors, trans-iliac connectors, staples, and associated manual surgical instruments. Screws are available in a variety of sizes to accommodate individual patient anatomy. REVERE® 4.5 implants mate with 4.5mm 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 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 and trans iliac connectors.

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. REVERE® 4.5 t-connectors may only be used with 4.5mm diameter rods. Additional connectors may be used to connect two rods, and are also secured using set screws.

REVERE 4.5 Stabilization System S-rods and unit rods are specifically excluded for use in adolescent idiopathic scoliosis patients.

The rods are composed of titanium alloy, commercially pure titanium, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F136. F1295, F1472, F67, F1537 and F138. All other REVERE® 4.5 implants are composed of titanium alloy or stainless steel, as specified in ASTM F136, F1295. F67 and F138. Due to the risk of galvanic corrosion following implantation. stainless steel implants should not be connected to titanium, titanium alloy, or cobalt chromium-molybdenum alloy implants.

This is a medical device 510(k) summary for the REVERE® 4.5 Stabilization System, a spinal fixation device. The document describes the device, its intended use, and the basis for its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets those criteria in the way a diagnostic AI/ML device submission would.

The "Performance Data" section indicates: "Mechanical testing (static and dynamic compression, and static torsional) was conducted in accordance with ASTM F1717 and, the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004, Performance data demonstrate substantial equivalence to the predicate device."

This means the device's physical and mechanical properties were tested to specific engineering standards to show it performs comparably to existing, approved devices. However, this is not a clinical study involving human patients or ground truth establishment in the context of diagnostic performance (e.g., sensitivity, specificity, accuracy).

Therefore, I cannot provide the requested information in the format you've outlined because the provided document does not pertain to acceptance criteria and a study proving device performance in the context of an AI/ML diagnostic device.

Here's why the requested information cannot be extracted:

• Acceptance Criteria & Reported Device Performance: These typically refer to diagnostic metrics (e.g., sensitivity, specificity, AUC) for AI/ML devices. The REVERE® 4.5 system is a physical implant, and its performance is assessed via mechanical testing against engineering standards (ASTM F1717). The document states "Performance data demonstrate substantial equivalence to the predicate device," but does not provide specific numerical outcomes against acceptance criteria for diagnostic accuracy.
• Sample Size (Test Set) & Data Provenance: Not applicable. This device does not use a "test set" of medical images or patient data for diagnostic classification.
• Number of Experts & Qualifications for Ground Truth: Not applicable. Ground truth as typically defined for AI/ML diagnostic devices (e.g., expert consensus on images or pathology results) is not relevant for a spinal implant's mechanical testing.
• Adjudication Method: Not applicable.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This is for diagnostic performance comparison.
• Standalone Performance: Not applicable. This device is a physical implant, not a standalone diagnostic algorithm.
• Type of Ground Truth: Mechanical testing against ASTM standards is the "ground truth" for its physical performance.
• Sample Size (Training Set): Not applicable. This is not an AI/ML device that uses a training set.
• How Ground Truth for Training Set Was Established: Not applicable.

In summary, the provided document describes a traditional medical device (a spinal stabilization system) and its regulatory clearance process, which relies on demonstrating mechanical performance and substantial equivalence to legally marketed predicate devices, rather than clinical diagnostic performance metrics or AI/ML model validation.

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