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The Zimmer Virage® OCT Spinal Fixation System is intended to provide immobilization of spinal segments as an adjunct into fosion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1-C7) and the thoracic spine from T1-T3; traumatic spinal fractures and/or traumatic dislocations; instability of deformity; failed previous fusions (e.g., pseudoarthorsis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Zimmer Virage® OCT Spinal Fixation System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advance stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, The Zimmer Virage® OCT Spinal Fixation System may be connected to the Instinct Java and Sequoia Spinal Systems offered by Zimmer Spine, using rod connectors and transition rods. Refer to the Instinct Java and Sequoia Spinal System package insert for a list of the system specific indications of use.

The titanium SONGER® Spinal Cable System to be used with the Zimmer Virage® OCT Spinal Fixation System allows for cable attachment to the posterior cervical or thoracic spine.

The Zimmer Spine Virage® OCT Spinal Fixation System is a posterior system intended for the Occipital-Cervical-Thoracic Spine (Occiput-T3). The system consists of a variety of rods, anchors, screws and connectors to build a spinal construct as necessary for the individual patient. The system also includes the instruments necessary for inserting and securing the implants. The implants are intended to be removed after solid fusion has occurred.

The Virage System implants are fabricated from medical grade titanium alloy or medical grade cobalt chromium allov. Implants made from medical grade titanium, medical grade titanium allov. and medical grade cobalt chromium may be used together. Never use titanium, titanium alloy, and/or cobalt chromium with stainless steel in the same construct. All implants are single use only and should not be reused under any circumstances.

The modification is to increase the torque limit used with the Virage® OCT Spinal Fixation System.

The provided text is a 510(k) summary for a medical device called the Zimmer Virage® OCT Spinal Fixation System. It describes the device's indications for use, general description, and claims of substantial equivalence to a predicate device. However, it does not provide detailed information about specific acceptance criteria, comprehensive study designs, or detailed performance data typically associated with a medical device study (such as accuracy, sensitivity, or specificity values).

Here's an analysis based on the provided text, highlighting what is present and what is missing concerning your request:

1. Table of acceptance criteria and reported device performance:

The document states that "Performance mechanical testing was conducted to confirm that the Zimmer Spine Virage® OCT Spinal Fixation System performs as intended and that the fundamental scientific technology remains unchanged from the predicate and referenced devices." It also mentions that the device "demonstrates that the device performs as well as or better than the primary predicate."

However, it does not provide a specific table of acceptance criteria or quantitative performance metrics (e.g., minimum torque values, fatigue life cycles, pull-out strength, etc.) with corresponding reported device performance values. The statement is a general claim of performance.

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

The document mentions "Performance mechanical testing" and "non-clinical tests performed were based on ASTM F2706 and ASTM F1717." However, it does not specify the sample size for these tests or the data provenance (e.g., country of origin, retrospective/prospective). Mechanical testing typically involves material and component testing, not patient data.

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

This information is not applicable to the type of device and study described. This is a spinal fixation system, and the studies mentioned are mechanical performance tests, not studies requiring expert interpretation of clinical data in the same way an AI diagnostic device would.

4. Adjudication method for the test set:

This information is not applicable for the reasons stated in point 3. Mechanical testing results are objective measurements (e.g., force, displacement, cycles to failure), not subjective interpretations requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable. The device is a spinal fixation system, not an AI-assisted diagnostic tool. Therefore, an MRMC study and AI improvement metrics are not relevant to this submission.

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

This information is not applicable for the reasons stated in point 5.

7. The type of ground truth used:

For mechanical performance testing, the "ground truth" would be established by the test standards themselves (ASTM F2706 and ASTM F1717) and the physical properties and behavior of the device components under various loads. It's not "expert consensus," "pathology," or "outcomes data" in the clinical sense. It's engineering specifications and observed mechanical responses.

8. The sample size for the training set:

This information is not applicable as there is no mention of an algorithm or an AI component requiring a training set. The study described is mechanical performance testing of a physical medical device.

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

This information is not applicable for the reasons stated in point 8.

In summary, the provided text is a regulatory submission for a physical medical device (spinal fixation system) and focuses on demonstrating substantial equivalence through mechanical testing, not on clinical performance or AI algorithm validation. Therefore, many of the requested data points, which are typically relevant for AI/diagnostic device studies, are not present or applicable.

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The Nu Vasive® VuePoint® II OCT System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The VuePoint II OCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the VuePoint II OCT System may be connected to the Nu Vasive® SpheRx® Spinal System, Precept® Spinal System, Armada® Spinal System and Reline™ System via the rod to rod connectors or transition rods.

The NuVasive VuePoint II OCT System consists of screws, hooks, rods, offset connectors, set screws, cross connectors, occipital plates and associated general instruments. Implant components are available in a variety sizes and can be rigidly locked into a variety of configurations to suit the individual pathology and anatomical conditions of the patient. The scope of this submission includes indications for the use of bone screws in the cervical (C1-C7) and thoracic (T1 to T3) spine.

The information provided does not describe a study that uses AI or machine learning, nor does it include many of the requested details such as specific acceptance criteria or performance metrics for such a device. The device described is the NuVasive® VuePoint® II OCT System, which is a spinal fixation system intended for immobilization and stabilization of spinal segments. The document is a 510(k) summary for FDA clearance, focusing on demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing.

Here's an attempt to answer the questions based on the provided text, acknowledging where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document focuses on substantial equivalence based on material composition, design, labeling, and function, rather than specific numerical acceptance criteria for performance against a defined metric (which would typically be found for an AI/ML device's accuracy, sensitivity, specificity, etc.). The performance described is primarily non-clinical mechanical testing.

2. Sample Size Used for the Test Set and Data Provenance

This information is not applicable in the context of this 510(k) summary for a physical medical device. The "test set" here refers to the actual physical devices (implants and instruments) that were subjected to non-clinical mechanical testing. The document does not specify the number of devices tested for each mechanical test. Data provenance in this context would refer to the testing facility and methodology, which aligns with ASTM standards rather than patient data. The document does reference a "review of published literature" to support the use of bone screws in the cervical and upper thoracic spine, but this is not a "test set" for the device's performance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable. For a physical device like a spinal fixation system, ground truth is established through engineering and material science standards (e.g., ASTM standards) and direct measurement of mechanical properties, not through expert consensus on diagnostic interpretations.

4. Adjudication Method for the Test Set

Not applicable. As described above, the "test set" refers to mechanical testing of the physical device, not a diagnostic or interpretative task requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. The NuVasive® VuePoint® II OCT System is a physical spinal fixation device, not a diagnostic or AI-assisted system that would involve human readers interpreting images.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

Not applicable. This device is not an algorithm or AI system.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is established through physical measurements and adherence to recognized mechanical testing standards (e.g., ASTM F2706, ASTM F1717, ASTM F1798). The results of these tests demonstrate that the device met specified engineering benchmarks for strength, stability, and integrity, which are considered "ground truth" for its mechanical properties.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML product and does not have a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable.

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The VuePoint® OCT System is intended to promote fusion of the cervical spine and occipito-thoracic junction (Occiput-T3), and is indicated for: (1) Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) Degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) Fracture/Dislocation, (4) Spinal Stenosis, (5) Atlantoaxial fracture with instability, (6) Occipitocervical dislocation, (7) Spinal tumor and/or (8) Revision of previous cervical spine surgery.

The occipital bone screws are limited to occipital fixation only.

The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

The VuePoint OCT System can also be linked to the NuVasive SpheRx Spinal System via the rod to rod connectors or transition rods.

The NuVasive VuePoint OCT System consists of a variety of shapes and sizes of screws, rods, offset connectors, set screws, and cross connectors which can be rigidly locked in a variety of configurations to accommodate patient anatomy.

Here's a breakdown of the acceptance criteria and study information for the NuVasive® VuePoint® OCT System based on the provided 510(k) summary:

This device did not involve AI or algorithms; it is a spinal fixation system. Therefore, many of the requested categories related to AI performance, ground truth establishment, expert adjudication, MRMC studies, and training sets are not applicable. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on demonstrating substantial equivalence to predicate devices through biomechanical testing.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify the exact sample sizes (number of constructs or test specimens) used for each biomechanical test.
• Data Provenance: Not applicable in the context of clinical data. The tests are nonclinical (laboratory-based biomechanical tests) performed to demonstrate mechanical equivalence. Country of origin for data is not specified, but the submission is to the U.S. FDA, implying adherence to U.S. recognized standards. The study is nonclinical (in-vitro testing).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not applicable. This device is a spinal fixation appliance, and the "ground truth" for its performance is established by standardized biomechanical tests demonstrating its physical and mechanical properties, not by human expert opinion or clinical outcomes in the traditional sense. The "ground truth" is adherence to established engineering standards for strength and durability.

4. Adjudication Method for the Test Set

• Not applicable. There was no human adjudication of "cases" or "ground truth" as this was a nonclinical biomechanical study. The adjudication is against the performance of predicate devices and relevant ASTM standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No. This is not an AI-powered device. It is a physical spinal implant system. Therefore, MRMC studies and AI assistance are not relevant.

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

• Nonclinical Biomechanical Performance. The "ground truth" for this device's performance is its ability to meet or exceed the biomechanical performance (static and dynamic torsion, compression, interconnection strength) of legally marketed predicate devices, as measured by established ASTM (American Society for Testing and Materials) standards.

8. The Sample Size for the Training Set

• Not applicable. This non-AI device does not have a "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. This non-AI device does not have a "training set" or "ground truth" established for training in the context of machine learning.

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