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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 Vitality® Spinal Fixation System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (TI-S2/iium), posterior hook fixation (TI-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent 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. scolosis, Scheuermann's Disease), tumor, stenoss, pseudoarthrosis and/or failed previous fusion. When used as an adjunct to fusion, the Vitality Spinal Fixation System is intended to be used with autograft and/or allograft.

In addition the Vitality® Spinal Fixation System is intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the LS-S1 vertebra in skeletally mature patients receiving fusionenous bone graft, having implants attached to the lumbosacral spine and or ilium with removal of the implant after attainment of a solid fission. Levels of pedicle screw fixation for these patients are L3sacrum/ilium.

When used for posterior non-cervical pediatic patients, the Vitality® System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Vitality® System is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The use of the Vitality Spinal Fixation System in skeletally mature patients may include the fixation of the Instinct® JavaTM Spinal Fixation System hooks, Apex Spinal System hooks, or fixation of the Universal Clamp® Spinal Fixation System to the rods of the Vitality Spinal Fixation System. The Vitality Spinal Fixation System may also be used in skeletally immature patients when connected with the Universal Clamp® Spinal Fixation System.

In order to achieve additional levels of fixation in skeletally mature patients, the Vitality Spinal Fixation System may be comected to the Virage® OCT Spinal Fixation System and the Instinct® JavaTM Spinal Fixation System offered by Zimmer Spine, using rod connectors.

The Vitality Spinal Fixation System is a thoracolumbar and sacroiliac fixation system designed to aid in the surgical correction of several types of spinal conditions. The system consists of a variety of spinal rods, pedicle screws, and connectors intended only to provide temporary stabilization during the development of a solid fusion of the spine with bone graft. The system can be rigidly locked into a variety of configurations, with each construct being customized to the patient's anatomy. All implants are single use only and should not be reused under any circumstances. The implant system is intended to be removed after solid fusion has occurred.

The system also includes instrumentation for insertion, securing and removal of the implants. All implants are made from medical grade titanium alloy; select rods are also available in medical grade cobalt chromium alloy.

The provided text is a 510(k) summary for the Vitality® Spinal Fixation System. It focuses on demonstrating substantial equivalence to predicate devices, rather than detailing a specific study proving the device meets acceptance criteria in terms of clinical performance or diagnostic accuracy. Instead, the "acceptance criteria" discussed here refer to a set of non-clinical, mechanical performance standards.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the testing was conducted "appropriately to design controls; i.e. ASTM Standards," and that the device components "were assessed and tested appropriately to design controls." It does not provide specific numerical results or direct comparisons against pre-defined numerical acceptance criteria for each test. Instead, the conclusion is based on an overall assertion of substantial equivalence to predicate devices based on the type of testing performed and the "same mechanical and functional scientific technology."

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

• Test Set Sample Size: Not applicable in the traditional sense for a clinical study. The "test set" here refers to the physical Vitality® Spinal Fixation System implants that underwent mechanical bench testing. The specific number of implants tested per condition is not provided.
• Data Provenance: The tests are non-clinical bench tests, meaning they were conducted in a laboratory setting. There is no information on the country of origin of the data or whether it was retrospective or prospective, as these terms typically apply to clinical data.

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

Not applicable. For mechanical bench testing, "ground truth" is established by adherence to standardized ASTM testing protocols and engineering principles, not by expert medical consensus.

4. Adjudication method for the test set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used in clinical studies to resolve discrepancies in expert opinions for ground truth establishment. This is a non-clinical, mechanical testing scenario.

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 a 510(k) submission for a spinal fixation system, not an AI/CADe device that involves human readers or diagnostic interpretation.

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

Not applicable. This device is a physical spinal implant, not a software algorithm.

7. The type of ground truth used

For the mechanical performance, the "ground truth" is defined by the ASTM standards (ASTM F1717 for Static Torsion, Static and Dynamic Compression Bending, and ASTM F1798 for axial and torsional grip strength). The performance of the device components is compared against the expected performance based on these established engineering standards and, implicitly, against the performance of predicate devices that also comply with these standards.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model that requires a training set.

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

Not applicable (see point 8).

Summary of the Study:

The "study" described in the 510(k) summary is a set of non-clinical bench tests designed to assess the mechanical integrity and performance of the Vitality® Spinal Fixation System implants. These tests were conducted according to established ASTM standards (F1717 and F1798).

The primary purpose of these mechanical performance tests was to demonstrate that the new device has "the same mechanical and functional scientific technology" and "substantially equivalent performance characteristics" to previously cleared predicate devices. The document concludes that the Vitality® Spinal Fixation System is substantially equivalent based on these non-clinical tests and shared technological characteristics, rather than reporting on clinical outcomes or diagnostic accuracy.

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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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