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The REVERE® 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, spinal tumor, pseudoarthrosis and failed previous fusion.

In addition, the REVERE® 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.

When used as a posterior non-pedicle screw fixation system, the REVERE® 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. scoliosis, and/or lordosis, Scheuermann's disease). fracture, pseudarthrosis, turnor resection, and/or failed previous fusion. Overall levels of fixation are T1-sacrum/ilium.

When used as an anterolateral thoracolumbar system, the REVERE® Stabilization System is intended for anterolateral screw (with or without staples or staple plates) 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, and/or lordosis), fracture or dislocation of the thoracolumbar spine, pseudoarthrosis, turnor 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, tconnectors, offset housing clamps, head offset connectors, trans-illiac connectors, sacral and sacral-iliac plates, staples and staple plates, 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 and staple plates 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, trans-iliac connectors and sacral-iliac plates.

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® t-connectors may only be used with 5.5mm rods; REVERE® 6.35 tconnectors may only be used with 6.35mm rods. Additional connectors may be used to connect two rods, and are also secured using set screws.

REVERE® hooks and t-connectors, and 5.5mm or 6.35mm diameter rods may be used with the BEACON® Stabilization System.

REVERE® screws and locking caps may be used with the TRANSITION® Stabilization System. Specifically, REVERE® polyaxial (solid, cannulated and dual outer diameter) screws and monoaxial screws 6.5mm diameter and larger, and 35mm length and longer, may be used with the TRANSITION® implant assemblies.

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® implants are composed of titanium alloy, stainless steel, and cobalt chromium molybdenum alloy, as specified in ASTM F136, F1295, F138, and F1537. The screws are available with hydroxyapatite (HA) coating, as specified in ASTM F1185. Due to the risk of galvanic corrosion following implantation, stainless steel implants should not be connected to titanium, titanium allov, or cobalt chromiummolybdenum.

The provided 510(k) summary for the REVERE® Stabilization System focuses on biomechanical performance of the device, rather than a clinical study involving human readers or AI. Therefore, most of the requested information regarding acceptance criteria and studies that prove the device meets these criteria in a medical image analysis context (like expert consensus, MRMC studies, training/test sets, etc.) is not applicable.

However, I can extract the relevant information from the provided document regarding the device's performance assessment.

Here's a breakdown based on the document:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document does not specify a "sample size" in terms of cases or patients. Instead, it refers to mechanical testing. For mechanical testing, the "samples" would be the physical devices or components tested. The number of devices or components tested is not explicitly stated.
• Data Provenance: Not applicable in the context of clinical data. The tests are laboratory-based mechanical tests.

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

• Not applicable. This device is a physical implant, and its performance is evaluated via mechanical testing against established engineering standards, not through expert clinical consensus on images or outcomes.

4. Adjudication method for the test set:

• Not applicable. This is not a clinical study requiring adjudication of expert opinions. Mechanical tests have objective pass/fail criteria based on measured physical properties.

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, a MRMC comparative effectiveness study was not done. This device is a spinal implant, not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not relevant.

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

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• The "ground truth" for this device's performance is defined by established engineering standards and guidance documents (ASTM F1717 and "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s"). The "truth" is that the device must meet or exceed the biomechanical properties (e.g., strength, stiffness, resistance to pull-out) specified by these standards.

8. The sample size for the training set:

• Not applicable. This is a physical device, and "training set" doesn't apply in the context of mechanical testing. Development of the device would involve engineering design and iterative testing, but not a "training set" as understood in machine learning.

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

• Not applicable.

In summary, the provided document describes the mechanical performance evaluation of additional components for an already cleared spinal stabilization system. The acceptance criteria are essentially compliance with specific ASTM standards and FDA guidance for spinal systems. The "study" proving this compliance is the mechanical testing itself, which demonstrated "substantial equivalence" to predicate devices by meeting or exceeding their performance under these standards. The context of your questions (AI, expert readers, clinical data, ground truth for image analysis) does not align with the type of device and accompanying evidentiary information provided in this 510(k) summary.

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The REVERE® 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® 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® 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. scoliosis, kyphosis, and/or lordosis, Scheuermann's disease), fracture, pseudoarthrosis, tumor resection, and/or failed previous fusion. Overall levels of fixation are T1-sacrum/ilium.

When used as an anterolateral thoracolumbar system, the REVERE® Stabilization System is intended for anterolateral screw (with or without staples or staple plates) 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, offset housing clamps, head offset connectors, trans-iliac connectors, sacral and sacral-iliac plates, staples and staple plates, and associated manual surgical instruments. Screws and rods are available in a variety of sizes to accommodate individual patient anatomy. REVERE® 5.5 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 and staple plates 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, transiliac connectors and sacral-iliac plates.

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.

REVERE® hooks and t-connectors, and 5.5mm or 6.35mm diameter rods may be used with the BEACON® Stabilization System.

REVERE® screws and locking caps may be used with the TRANSITION® Stabilization System. Specifically, REVERE® polyaxial (solid, cannulated and dual outer diameter) screws and monoaxial screws 6.5mm diameter and larger, and 35mm length and larger, may be used with the TRANSITION® implant assemblies.

The rods are composed of titanium allov, commercially pure titanium, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F136, F1295, F1472, F67, F1537 and F138. All other REVERE® implants are composed of titanium alloy or stainless steel, as specified in ASTM F136, F1295, and F138. The screws are available with or without hydroxyapatite (HA) coating, as specified in ASTM F1185. Due to the risk of galvanic corrosion following implantation, stainless steel implants should not be connected to titanium, titanium allov, or cobalt chromium-molybdenum.

The provided text is a 510(k) Summary for the REVERE® Stabilization System and primarily focuses on regulatory clearance for additional implants (specialty rods, HA coated screws, closed head screws, and washers). It describes the device, its intended use, and indicates that its technological characteristics are similar to predicate devices. Crucially, the "Performance Data" section states:

"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 is a submission for a spinal implant system, not an AI/ML powered medical device. Therefore, many of the requested categories (such as sample sizes for test/training sets, expert ground truth establishment, MRMC studies, standalone performance, etc.) are not applicable to this type of regulatory submission. The "acceptance criteria" here are based on meeting established mechanical performance standards for spinal fixation systems and demonstrating substantial equivalence to pre-existing, legally marketed devices.

Here's the breakdown based on the provided document, addressing the relevant points and noting the non-applicability of others:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide specific numerical values for the acceptance criteria or the test results. It states that testing was conducted according to specific ASTM standards and FDA guidance, and that the device data demonstrated substantial equivalence.

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

• Not applicable (N/A). This is a mechanical device submission. Performance is assessed through mechanical testing (in vitro), not clinical data or human-derived test sets in the context of AI/ML.

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

• Not applicable (N/A). Ground truth in the context of AI/ML performance evaluation (e.g., image interpretation) is not relevant for this mechanical device. Mechanical testing relies on standardized protocols and material science principles.

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

• Not applicable (N/A). Adjudication methods are relevant for subjective human interpretations, typically in diagnostic evaluations involving AI. This is a mechanical device.

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

• Not applicable (N/A). MRMC studies are used for evaluating diagnostic performance, often with AI assistance for human readers. This device is a surgical implant.

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

• Not applicable (N/A). This refers to AI algorithm performance. The REVERE® Stabilization System is a physical implant.

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

• N/A (for AI/ML context). In the context of mechanical testing for a spinal implant, the "ground truth" would be the established mechanical properties required by standards (e.g., ASTM F1717 for static and dynamic loading) and the performance characteristics of predicate devices. The device's performance data is compared against these established benchmarks.

8. The sample size for the training set

• Not applicable (N/A). There is no "training set" in the context of a mechanical device submission like this.

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

• Not applicable (N/A). As there is no training set, this question is not relevant.

Ask a specific question about this device

The REVERE® 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® 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® 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. scoliosis, kyphosis, and/or lordosis, Scheuermann's disease), fracture, pseudoarthrosis, tumor resection, and/or failed previous fusion. Overall levels of fixation are T1-sacrum/ilium.

When used as an anterolateral thoracolumbar system, the REVERE® 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, offset housing clamps, REVERE® head offset connectors, trans iliac connectors, staples, 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.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. 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.

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

Here's a breakdown of the requested information based on the provided text for the K093294 510(k) summary for REVERE® Additional Implants.

Important Note: This 510(k) summary (K093294) primarily focuses on establishing substantial equivalence to existing predicate devices through mechanical testing. It does not describe a clinical study in the typical sense of evaluating AI performance or human reader effectiveness. Therefore, many of the requested fields related to clinical studies, AI performance, ground truth, and expert evaluation will be marked as "Not Applicable" or "Not Provided" because this type of submission doesn't involve those elements for this device.

Acceptance Criteria and Device Performance

Study Details (as applicable to a 510(k) for a medical device without AI)

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

   • Sample Size for Test Set: Not applicable in the context of a clinical test set for AI. The "test set" here refers to the mechanical testing performed on the device components. The specific number of devices or configurations tested is not provided in this summary but would be detailed in the full 510(k) submission as per the referenced guidance document.
   • Data Provenance: Not applicable in terms of country of origin or retrospective/prospective for a mechanical testing study. The testing would have been conducted by Globus Medical Inc. or a contracted lab.

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):

   • Not applicable. This submission relies on mechanical and material standards, not expert-derived ground truth for clinical outcomes or image interpretation.

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

   • Not applicable. This type of adjudication is for clinical or image interpretation studies, not mechanical testing.

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. This is a spinal implant, not an AI-powered diagnostic device.

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

   • No, a standalone algorithm performance study was not done. This is a medical device, not an algorithm.

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

   • For mechanical testing, the "ground truth" is adherence to established engineering standards (e.g., ASTM standards) and meeting predetermined pass/fail criteria derived from these standards and the predicate device's performance. There is no biological "ground truth" involved in the summary provided.

7. The sample size for the training set:

   • Not applicable. There is no AI training set for this device.

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

   • Not applicable. There is no AI training set for this device.

Ask a specific question about this device

The REVERE™ Stabilization System, when used as posterior pedicle screw systems, are 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™ Stabilization Systems are 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.

When used as posterior non-pedicle screw fixation systems, the REVERE™ Stabilization Systems are 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. scoliosis, 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 anterolateral thoracolumbar systems, the REVERE™ Stabilization Systems are 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 Systems consist of a variety of shapes and sizes of rods, hooks, monoaxial screws, polyaxial screws, locking caps, tconnectors, staples, and associated manual surgical instruments. Implant components can be rigidly locked into a variety of configurations for the individual patient and surgical condition. Polyaxial screws, hooks, and tconnectors 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 rods are composed of titanium alloy, commercially pure titanium, or stainless steel, as specified in ASTM F136, F1295, F67, and F138. All other implants are composed of titanium alloy or stainless steel, as specified in ASTM F136, F1295, and F138.

The REVERE™ Stabilization System did not provide a typical "acceptance criteria" table as one might find for a diagnostic device. The provided document is a 510(k) summary for a medical device (spinal stabilization system), and regulatory submissions for such devices typically focus on demonstrating substantial equivalence to a legally marketed predicate device through mechanical testing, rather than reporting performance against a set of predefined clinical accuracy metrics.

Therefore, the "acceptance criteria" here are implied by the performance of the predicate devices and the mechanical testing standards for spinal systems. The "reported device performance" refers to the fact that the REVERE™ system met these implied criteria through its mechanical testing.

Here's the breakdown based on the provided text, and where information is not explicitly stated in the context of typical AI/diagnostic device studies, it will be noted as "Not applicable" or "Not specified."

Acceptance Criteria and Device Performance for REVERE™ Stabilization System

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable. For a spinal stabilization system, "test sets" in the context of diagnostic AI algorithms are not relevant. The device undergoes mechanical testing based on specified standards, which involves a specific number of devices/components tested under simulated physiological conditions. The document does not specify the number of units tested in the mechanical assessment but references the governing guidance document.
• Data Provenance: Not applicable in the context of clinical patient data. The "data" here refers to the results of mechanical testing performed on the device components. The location of these tests is not specified in the summary but would typically occur in a controlled laboratory environment.

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

• Not applicable. This device is a mechanical implant, not a diagnostic tool requiring expert interpretation of results. The "ground truth" for mechanical testing is established by engineering standards and validated testing methodologies.

4. Adjudication method for the test set

• Not applicable. Adjudication methods (like 2+1, 3+1 consensus) are used for resolving disagreements among human experts in interpreting diagnostic data. This is not relevant for mechanical testing.

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

• Not applicable. This is not an AI-assisted diagnostic device, and therefore MRMC studies comparing human readers with and without AI assistance are not relevant.

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

• Not applicable. This is a physical medical implant, not a software algorithm.

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

• The "ground truth" for this device's performance is established by engineering standards and validated mechanical testing protocols. This involves evaluating the strength, fatigue resistance, and other mechanical properties of the device components under various loads as defined by the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s."

8. The sample size for the training set

• Not applicable. The concept of a "training set" is for machine learning models. For a physical device, the "training" involves engineering design, material selection, and manufacturing processes, with iterative testing. The document does not provide a "sample size" for this developmental stage.

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

• Not applicable. As above, this concept refers to machine learning. The "ground truth" for design and development in medical device manufacturing is based on established biomechanical principles, material science, and prior knowledge from existing predicate devices. Successful mechanical testing (as mentioned in section 7) confirms that the design meets the required performance standards.

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