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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 Virage OCT Spinal Fixation 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-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 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 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 Virage OCT Spinal Fixation System allows for cable attachment to the posterior cervical or thoracic spine.

The Zimmer Spine Virage® OCT Spinal Fixation 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 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 alloy, and medical grade cobalt chromium may be used together. Never use 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.

This document is a 510(k) summary for the "Virage OCT Spinal Fixation System," a medical device. It does not describe a study involving algorithms, AI, or human readers. Instead, it focuses on demonstrating substantial equivalence to a predicate device through mechanical testing, sterilization, and biocompatibility assessments. Therefore, I cannot provide information for most of your requested points, as they are related to studies on AI/algorithm performance.

However, I can extract the information related to performance testing and acceptance criteria as described in the document.

1. Table of Acceptance Criteria and Reported Device Performance

Summary of the study conducted to prove the device meets acceptance criteria:

The study was a series of non-clinical, mechanical performance tests, along with assessments for sterilization and biocompatibility.

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

• Sample Size: The document does not specify the exact number of units or samples used for each test (e.g., how many open rod connectors were tested for axial gripping). It states "Performance mechanical testing concluded the Virage open rod connector performed as intended."
• Data Provenance: Not applicable as this is not a study involving human data or retrospective/prospective clinical data. The tests are laboratory-based mechanical testing and material assessments.

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

This information is not applicable. The "ground truth" in this context is defined by the standards (ASTM F1798, ASTM F1717) themselves and the predefined pass/fail criteria within those standards for mechanical performance, and established methods for assessing sterilization and biocompatibility. There are no "experts" establishing ground truth in the sense of medical diagnosis or interpretation for this type of device submission.

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

This is not applicable as there is no human interpretation or subjective assessment being adjudicated. The tests are objective mechanical and material 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:

This is not applicable. The document describes a spinal fixation system, not an AI or imaging device with readers.

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

This is not applicable. The device is a physical spinal implant system, not an algorithm.

7. The type of ground truth used:

The "ground truth" for the performance testing was based on:

• Engineering standards and recognized test methodologies (ASTM F1798 for axial and torsional gripping, ASTM F1717 for static torsion, static and dynamic compression bending).
• Established scientific principles and regulatory requirements for sterilization and biocompatibility.

8. The sample size for the training set:

This is not applicable. There is no concept of a "training set" for this type of mechanical and material performance testing of a physical medical device.

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

This is not applicable. The concept of "ground truth for a training set" is relevant to machine learning or AI models, which are not involved in this device's submission.

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When intended to promote fusion of the occipitocervical spine, cervical spine and the thoracic spine, (Occiput -T3), the Virage OCT Spinal Fixation System is indicated for the following:

Degenerative disc disease (DDD) (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.

Occipitocervical Plate/Rod/Occipital Screws/Hooks

Occipitocervical plate, rods, occipital screws, and hooks are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the occipitocervical junction and the cervical spine. When used to treat occipitocervical and cervical conditions, the occipital screws are limited to occipital fixation only. The occipital screws are not intended for the cervical spine.

Hooks and Rods

Hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Thoracic Screws

The use of thoracic screws is limited to placement in T1-T3 for anchoring the construct only. The thoracic screws are not intended to be placed in the cervical spine.

Rod Connectors

The Virage OCT Spinal Fixation System can also be linked to the Instinct Java and Sequoia Spinal Systems offered by Zimmer Spine using rod connectors and transition rods.

The titanium SONGER® Spinal Cable System to be used with the 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, transverse connectors, screws, and polyaxial screws to achieve an implant construct as necessary for the individual case. The system also includes the instruments necessary for inserting and securing the implants. The implant system is intended to be removed after solid fusion has occurred.

The Virage System implants are fabricated from medical grade titanium alloy and medical grade cobalt chromium alloy. Implants made from medical grade titanium. medical grade titanium alloy, 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. Refer to the product label to determine if instrumentation is intended for single use.

The Zimmer Spine Virage OCT Spinal Fixation System is a medical device, not an AI/ML product, so the provided document does not contain information on acceptance criteria for AI algorithms, or studies related to AI/ML performance.

However, based on the provided text, I can extract information related to the device's mechanical performance acceptance criteria and the study that proves the device meets those criteria:

Device Acceptance Criteria and Performance

Study Details for Mechanical Performance

Since the device is a medical implant and not an AI/ML system, the following questions are not applicable in their original context related to AI/ML studies. However, I will address them in the context of the mechanical testing study where possible.

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

  • The document states "Worst case constructs of the occipito-cervical portion of the Virage System were tested per ASTM F2706. Worst case constructs of the thoracic portion of the Virage System were tested per ASTM F1717. Select components were also tested per ASTM F1798."
  • The exact sample size (number of constructs or components tested) is not specified in the provided text.
  • Data provenance is not explicitly mentioned, but the tests were conducted according to ASTM (American Society for Testing and Materials) standards, which are internationally recognized. This is a prospective test in the sense that the testing was performed specifically to demonstrate mechanical performance for this 510(k) submission.

• 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 (N/A) to mechanical testing. The "ground truth" for mechanical testing is defined by the objective pass/fail criteria outlined in the ASTM standards (F2706, F1717, F1798), not by expert human interpretation.

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

  • This is N/A for mechanical testing. Adjudication methods are typically used for subjective assessments or when multiple human reviewers are involved. Mechanical tests have objective pass/fail criteria.

• 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

  • This is N/A as this is a mechanical medical device, not an AI/ML product. No human readers or AI assistance are involved in evaluating its mechanical effectiveness.

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

  • This is N/A as this is a mechanical medical device. There is no algorithm to test in a standalone manner.

• The type of ground truth used (expert concensus, pathology, outcomes data, etc)

  • For the mechanical testing, the "ground truth" is the objective pass/fail criteria defined by the relevant ASTM standards (F2706, F1717, F1798). These standards establish the expected mechanical performance (e.g., fatigue strength, static strength) that the device must meet.

• The sample size for the training set

  • This is N/A as this is a mechanical medical device. There is no AI model requiring a training set.

• How the ground truth for the training set was established

  • This is N/A as this is a mechanical medical device. There is no AI model requiring a training set or ground truth establishment for training.

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