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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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When intended to promote fusion of the cervical spine, (C1-T3), the Endius Minit Posterior Cervical and Upper Thoracic Fixation System is indicated for the following: 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.

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

Screws/Connectors: The use of screws is limited to placement in the TI-T3 in treating thoracic conditions only. Screws are not intended to be placed in the cervical spine.

Axial and Offset Rod Connectors: The Minit Posterior Cervical and Upper Thoracic Fixation System can also be linked to the TiTLE 2 System offered by Endius Inc. using the Axial Rod Connectors, Dual Rod Connectors and the Tri Screw Dual Rod Connectors.

When intended to promote fusion of the cervical spine and the thoracic spine, (Cl-T3), the NexLink Spinal Fixation System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, failed previous fusion and/or tumors.

Hooks and rods are also intended to provide stabilization following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (Cl-T3) spine. The use of multiaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. The multiaxial screws are not intended to be placed in the cervical spine.

The NexLink OCT Occipital Cervical Plating System is intended to provide stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) for the following indications: degenerative disease (neck pain of discogenic origin with degeneration of the disk as confirmed by patient history and radiological studies), spondylolisthesis, spinal stenosis, fracture/dislocation, atlantoaxial fracture with instability, occipito-cervical dislocation, revision of previous cervical spine fusion surgery and tumors.

The Cancellous and Cortical Bone Screws (3.5mm and 4mm diameters; 6mm-20mm threaded lengths) are used with the NexLink OCT Occipital Cervical Plating System to allow for occipital fixation and limited to occipital fixation only. The 4mm Cannulated Side Loading Closed Screws are limited to placement in the upper thoracic spine (T1-T3) for additional stabilization of the cervical spine for the indications specified above.

When intended for pedicle screw fixation from T1-S1, the Sequoia 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, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor and failed previous fusion.

When used as a pedicle screw system placed between L3 and S1, the indications include Grade 3 or Grade 4 spondylolisthesis, when utilizing autologous bone graft, when affixed to the posterior lumbosacral spine, and intended to be removed after the solid fusion is established.

When intended for non-pedicle, posterior screw fixation of the non-cervical spine (T1-S1), the indications are idiopathic scoliosis, neuromuscular scoliosis with associated paralysis or spasticity, scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele, spinal fractures (acute reduction or late deformity), degenerative disc disease (back pain of discogenic origin with degenerative of the disc confirmed by history and radiographic studies), tumor, spondylolisthesis, spinal stenosis and failed previous fusion.

After solid fusion occurs, these devices serve no functional purpose and should be removed. In most cases, removal is indicated because the implants are not intended to transfer or support forces developed during normal activities. Any decision to remove the device must be made by the physician and the patient, taking into consideration the patient's general medical condition and the potential risk to the patient of a second surgical procedure.

The ST360° Spinal Fixation System is intended for posterior, non-cervical pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion. Pedicle screw fixation is limited to skeletally mature patients.

When used as a sacral screw system, the ST360° Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined as chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic, deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal fusion. When used for this indication, screws of the ST360° Spinal Fixation System are intended for the sacral iliac attachment only. Transverse connectors of the system are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use for sacral screw fixation of this system are T1 to the sacrum.

The TiTLE 2 Polyaxial Spinal System is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.

The TiTLE 2 Polyaxial Spinal System is a Pedicle Screw System intended to provide immobilization 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 spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

The TiTLE 2 Polyaxial Spinal System is also indicated for pedicle screw fixation for severe spondylolisthesis (grades 3 and 4) at L5-S1, in skeletally mature patients, when autogenous bone graft is used, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1.

In addition, TiTLE 2 Polyaxial Spinal System, when not used with pedicle screws, is indicated for sacral screw fixation from T1 to the illum/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease, (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis, and kyphosis), tumor, fracture, and previous failed fusion surgery.

The TiTLE 2 Polyaxial Spinal System can also be linked to the Minit® Posterior Cervical and Upper Thoracic Fixation System.

The Zimmer Spine Pedicle Screw-Rod System implants include pedicle, polyaxial or fixed screws of varying diameters and lengths, rods of varying lengths, hooks (anchors) in varying designs and fixed and adjustable transverse connectors (cross-links). These implants are manufactured from medical grade Ti-Al-4V ELI titanium alloy and or commercially pure titanium. The system(s) are provided to the end-user Non-Sterile. Implants and instrumentation are provided clean and must be sterilized prior to use by the end-user. The system(s) implants are designed for single-use only. The purpose of this submission was to demonstrate through testing and engineering analyses that the subject devices can be labeled as MR Conditional.

This document is a 510(k) Pre-Market Notification from Zimmer Spine, Inc. to the FDA. The purpose of this submission is not to introduce a new device or a new algorithm, but rather to update the product-specific package inserts (IFU) with MRI Conditional language only for existing pedicle screw-rod systems. Therefore, the traditional acceptance criteria and study design for a new medical device would not apply in the same way.

The "study" conducted here is a series of performance tests to demonstrate the MRI compatibility of the existing devices.

Here's a breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

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

• Sample Size: The document does not specify the exact number of individual screws and rods tested from each system. It states "Magnetic Resonance Imaging (MRI) testing of screws and rods contained in the Zimmer Spine Pedicle Screw-Rod Systems were assessed and tested appropriately." This implies representative samples of the various components were used.
• Data Provenance: The testing was likely conducted in a controlled laboratory environment by Zimmer Spine or a contracted test facility in the USA (given the submitter's location in Minneapolis, Minnesota, USA, and submission to the FDA). The tests themselves are prospective in nature, as they involve actively conducting measurements on physical devices.

3. 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 is not applicable to this submission. The "ground truth" in this context is established by adherence to recognized ASTM standards for MRI compatibility testing, which are objective, quantifiable measurements. There is no subjective expert interpretation of output data in the same way there would be for image analysis or clinical diagnosis.

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

Not applicable. This type of testing involves objective physical measurements according to standardized protocols, not subjective expert review or adjudication.

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 submission is for MRI compatibility of hardware (pedicle screw-rod systems), not an AI device or a diagnostic tool that involves human readers.

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

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

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

The "ground truth" for this performance testing is defined by the objective pass/fail criteria established within the referenced ASTM standards (ASTM F2052, ASTM F2119, ASTM F2182, ASTM F2213). These standards provide quantitative thresholds for magnetic field interactions (displacement, torque, heating) and qualitative assessments of image artifact.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning device. The testing involved physical devices.

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

Not applicable.

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The inViZia® Anterior Cervical Plate System is designed for anterior interbody screw fixation of the cervical spine at levels C2-T1. The inViZia® Anterior Cervical Plate System is in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis or scoliosis), pseudoarthrosis and/or failed previous fusions. WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

The SC-AcuFix® Ant-Cert Dynamic Anterior Cervical Plate System is in the temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion inpatients with instability caused by the following: degenerative disc disease (as defined by neck pain of discogenic origin with denegation of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, deformity (i.e. scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions.

The Spinal Concepts Inc. (SCI) Anterior Cervical Plate System is in the temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion inpatients with instability caused by the following: degenerative disc disease (as defined by neck pain of discogenic origin with denegation of the disc confirmed by patient history and radies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, kyphosis, lordosis, lordosis), pseudarthrosis, and failed previous fusions.

The SC-AcuFix® Thinline Anterior Cervical Plate System is indicated for use in the temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion inpatients with instability caused by the following: degenerative disc disease (as defined by neck pain of discogenic origin with denegation of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e. scoliosis, lordosis), pseudarthrosis, and failed previous fusions.

The Trinica® Anterior Lumbar Plate System is interal or anterolateral surgical approach above the bifuration of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels. This system is indicated in the treatment of lumbar or lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthrosis, scoliosis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous fusion.

The Trinica® and Trinica® Select Anterior Cervical Plate System is interior interbody screw fixation of the cervical spine at level C2-T1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degeneratived by neck pain of discogenc origin confirmed by patient history and radiographic studies), trauma (including fractures), turnors, deformity (defined as kyphosis, or scoliosis), pseudoarthrosis and/or failed previous fusions. WARNING: These devices are not approved for screw attachments (pedicles) of the cervical, thoracic, or lumbar spine.

The V2F Anterior Fixation System is indicated for use via the lateral or anterolateral surgical in the treatment of thoracc and thoracolumbar (TI-L5) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.

The Zimmer Spine Anterior Cervical and Lumbar Plate Systems are intended to provide stabilization of the spine during the development of a solid spinal fusion in patients per the system(s) indications at various spinal levels. The Zimmer Spine Anterior Cervical and Lumbar Plate Systems consist of plates, bone screws and instruments necessary to implant the specific system. Bone screws are secured to the plate through locking caps and/or a Secure Ring® mechanism. The plates are available in various sizes and lengths and the bone screws are available in various diameters and lengths. The subject devices are temporary implants to be implanted per the indications for use and/or the instructions of the surgical technique guide(s). These subject implants are intended to be removed after solid fusion has occurred. The Zimmer Spine Anterior Cervical and Lumbar Plate implants (plates and bone screws) are manufactured from medical grade Ti-6Al-4V ELI titanium alloy. The system's instrumentation is manufactured from one (or more) of the following medical/surgical grade materials: stainless steel, plastic, aluminum, and silicone. The subject implants are provided non-sterile and must be sterilized by the enduser/healthcare facility prior to use. The subject implants are designed for single-use only. The system's instrumentation is provided to the end-user/healthcare facility clean but not sterile. The end-user/healthcare facility ensures through cleaning and sterilization of instrumentation before use and the instrumentation may be reused. Selective plate systems contain drill bits and/or fixation pins that are provided to the end-user sterile and designed for single-use.

This document describes a 510(k) premarket notification for several Zimmer Spine Anterior Cervical and Lumbar Plate Systems. The purpose of this submission is not to introduce a new device or change the design/performance of existing devices, but solely to update the product-specific package inserts (Instructions for Use - IFU) with MRI Conditional language. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are related to MRI compatibility, rather than the primary biomechanical function of the implants.

Here's an analysis based on the provided text, addressing your points:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria here are implicitly meeting the standards for MRI compatibility for passive implants. The reported performance is that the devices were tested according to these standards and found to be MRI Conditional.

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

• Sample Size: The document does not specify the exact number of devices (plates and screws) tested for each MRI compatibility standard. It refers to "Plate implants contained in the Zimmer Spine Anterior Cervical and Lumbar Plate Systems were assessed and tested." This suggests representative samples were used for each type of implant.
• Data Provenance: Not explicitly stated, but typically, such testing is conducted in controlled laboratory environments in the country of manufacturing or a certified testing facility. The context is a US FDA submission, so the testing would have been to US-recognized standards. The testing is prospective in nature, as it's a specific set of tests performed on the physical devices for this submission.

3. 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 to this submission. The "ground truth" here is the physical interaction of the medical devices with magnetic fields, measured by engineering and physics principles, not by expert interpretation of clinical data or images. The standards (ASTM) themselves define the methodology and acceptable limits, which are established by relevant technical experts in the field of MRI safety and medical devices.

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

Not applicable. This is not a clinical study involving human assessment of outcomes or images. The results of the MRI compatibility tests are objective measurements against defined ASTM standards.

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 submission is for MRI conditional labeling updates for orthopedic spinal implants, not for an AI/CAD device.

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

Not applicable. This submission is for MRI conditional labeling updates for orthopedic spinal implants, not for an AI/CAD device.

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

The "ground truth" used for this submission is based on scientific and engineering principles outlined in the referenced ASTM standards for MRI compatibility testing. These standards define the acceptable limits for magnetically induced displacement, torque, heating, and image artifact generation for passive medical implants.

8. The sample size for the training set

Not applicable. This submission is for MRI conditional labeling updates for existing devices, not for a device developed using a training/test set methodology (e.g., AI/ML).

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

Not applicable. See point 8.

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When used as a vertebral body replacement device, the InFix System is intended for use in the thoracic and/or lumbar spine (T3-L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial vertebrectorny procedures) due to tumor or trauma (i.e., fracture). The InFix System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The InFix intended to be used with bone graft.

When used as an intervertebral body fusion device, the InFix System is indicated for use with autogenous bone graft at one or two contiguous levels in the lumbosacral region (12-S1) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at involved level may be treated with the device. Patients should be skeletally mature and six months of non-operative treatment. When used as an intervertebral body fusion device, the InFix implant is intended to be used with supplemental fixation.

For both of the indications listed above, the InFix implant is intended to be implanted via an open anterior approach.

The Ardis Interbody System is indicated for use with autogenous bone graft as an intervertebral body fusion device at one or two contiguous levels in the lumbosacral region (12-S1) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at involved level may be treated with the device. Patients should be skeletally mature and have had six months of non- operative treatment.

The Ardis Interbody System is implanted using a posterior or transforaminal approach and is intended to be used singly or in pairs with supplemental fixation.

The BAK/C implant is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. BAK/C implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C-3 to C-7 disc levels using autograft bone.

The BAK device is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels form L2-S1. These DDD patients may also have up to Grade I spondylolisthesis at the involved levels(s). BAK devices are to be implanted via an open anterior or posterior approach. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

Standard BAK devices and BAK/Proximity devices are to be implanted via an open anterior or posterior approach. BP/Lordotic devices are to be implanted via an open anterior approach.

All BAK devices are also indicated for lapantation at the L4-L5 and L5-S1 levels for the same clinical indications described above.

Cadence and TraXis are vertebral body replacement devices that are intended for use in the thoracic and/or thoracolumbar spine (T3-LS) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebres) due to tumor or trauma (i.e., fracture). These devices are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. These devices are intended to be used with bone graff.

The Zimmer Spine Interbody Fusion and Vertebral Body Replacement Device Systems are intended for use in the cervical, thoracic and/or lumbar spine to mitigate and/or replace the disc space. The interbody fusion devices are intended for use with autogenous bone graft in patient with degenerative disc disease (DDD); defined as discogenic back pain and degeneration of the disc space. The vertebral body replacement (VBR) devices are intended to replace a collapsed, damaged or unstable vertebral body. VBR devices are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column in the absence of fusion for a prolonged period.

The subject devices are to be implanted by either an anterior approach or a posterior approach or a transforaminal approach per the indications for use and/or the instructions of the surgical technique quide(s). The BAK devices are also indicated for laparoscopic implantation, per the device indications for use.

The Zimmer Spine Interbody Fusion and Vertebral Body Replacement Device System implants are manufactured from medical grade Ti-6AI-4V ELI titanium alloy or Polyether ether ketone (PEEK) OPTIMA with tantalum markers. The InFix system allows for the use of an optional Endcap made from Ultra High Molecular Weight Polyethylene (UHMWPE).

System(s) with instrumentation, the instruments are manufactured from one (or more) of the following materials: Surgical Grade Stainless Steel, Aluminum, Silicone Rubber, Radel, AITiN PVD coating, TiN PVD Coating, Nylon.

The subject implants are provided terminally sterilized with the exception of the InFix System, which is provided Non-Sterile. The InFix System must be sterilized by the end-user/healthcare facility prior to use. The subject implants are designed for single-use only. The System(s) instrumentation is provided to the end-user/healthcare facility clean but not sterile. The end-user/healthcare facility ensures through cleaning and sterilization of instrumentation before use.

This document is a 510(k) premarket notification for several spinal implant devices, primarily focused on updating product specific package inserts with MRI Conditional language. Therefore, the "acceptance criteria" and "device performance" discussed relate to MRI compatibility, rather than clinical efficacy or diagnostic accuracy.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

• Magnetically Induced Displacement Force (ASTM F2052)
• MR Image Artifacts (ASTM F2119)
• Radio Frequency Induced Heating Near Passive Implants (ASTM F2182)
• Magnetically Induced Torque (ASTM F2213)

While specific numerical acceptance criteria are not explicitly stated in this document (e.g., maximum displacement, artifact size limits, temperature rise limits), the implication is that the devices passed these tests to qualify for MRI Conditional labeling. The underlying acceptance would be that the forces, heating, and artifacts generated during an MRI scan at specified field strengths would not pose an unacceptable risk to the patient and would allow for diagnostically acceptable imaging if properly managed according to the labeling. | Summary of Performance Testing:
Magnetic Resonance Imaging (MRI) testing of interbody fusion and VBR devices contained in the Zimmer Spine Interbody Fusion and Vertebral Body Replacement Device Systems were assessed and tested appropriately to design controls and the following ASTM Standards:

• ASTM F2052: 2006 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
• ASTM F2119: 2007 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
• ASTM F2182: 11a* Standard Test Method of Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging
• ASTM F2213: 2006 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment

The document asserts that these tests were conducted to support the update of product-specific package inserts (IFU) with MRI Conditional language. This indicates that the devices performed within the acceptable limits of these standards to be deemed "MRI Conditional." |

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

The document does not specify the sample size for the MRI compatibility tests. It refers to "interbody fusion and VBR devices contained in the Zimmer Spine Interbody Fusion and Vertebral Body Replacement Device Systems," implying that representative samples of the various devices (Ardis, BAK, InFix, TraXis, etc.) were tested.

Data provenance (e.g., country of origin, retrospective/prospective) is not mentioned as this type of testing is typically controlled laboratory testing of the devices themselves, not patient data.

3. 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 type of information is not applicable to the performance testing described. MRI compatibility testing involves standardized physical measurements in a laboratory setting, not expert interpretation of clinical data to establish a "ground truth."

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

Not applicable. This testing is based on objective physical measurements according to ASTM standards, not subjective assessments requiring adjudication.

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 document is a 510(k) submission for spinal implants, specifically addressing MRI compatibility, not an AI-based diagnostic tool.

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

Not applicable. This document does not describe an algorithm or AI.

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

Not applicable. For MRI compatibility testing, the "ground truth" is adherence to the physical and safety limits defined by the ASTM standards and regulatory requirements for MRI Conditional labeling.

8. The sample size for the training set

Not applicable. There is no training set mentioned as this is not an AI/machine learning device.

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

Not applicable. There is no training set.

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The Universal Clamp Spinal Fixation System is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:

1. Spinal trauma surgery, used in sublaminar or facet wiring techniques;

2. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis and spondylolisthesis;

3. Spinal degenerative surgery, as an adjunct to spinal fusions.

The Universal Clamp System may also be used in conjunction with other medical grade implants made of similar metals whenever "wiring" may help secure the attachment of the other implants.

The Universal Clamp Spinal Fixation System consists of a woven band with a stiff guiding section at one end and metal buckles at the other end, implantable grade metal clamps that mate with 4.5mm - 6.35mm diameter rods, and an implantable grade metal locking screw that tightens the clamp over the band securing it to the connecting rod.

Implants made from implantable grade titanium, implantable grade titanium alloy, and implantable grade cobalt chromium may be used together. Due to the risk of galvanic corrosion, never use titanium alloy, and/or cobalt chromium with stainless steel in the same construct. All implants are provided sterile and are single use only; the implants should not be re-used or re-sterilized under any circumstances.

This document is a 510(k) premarket notification for the Universal Clamp Spinal Fixation System. It confirms that the device is substantially equivalent to legally marketed predicate devices.

1. A table of acceptance criteria and the reported device performance

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

The document does not specify the exact sample size for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It broadly states that "Performance testing (static axial pushdown, static axial rotation, static axial tension, and dynamic tension) was conducted to in accordance with ASTM F1798."

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 device is a spinal fixation system, and its performance is evaluated through mechanical testing, not through expert-reviewed diagnostic image interpretation or similar processes that would require establishing a ground truth based on expert consensus.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving human interpretation or subjective assessments, not for mechanical performance testing of an implantable 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

An MRMC comparative effectiveness study was not done. This device is a mechanical implant, not an AI-assisted diagnostic tool or an imaging device directly involving human readers.

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

This information is not applicable. The device is a mechanical implant, not an algorithm, so the concept of standalone algorithm performance does not apply.

7. The type of ground truth used

The ground truth for evaluating the device's performance was established through mechanical testing standards, specifically ASTM F1798. This standard likely defines specific parameters, test methods, and pass/fail criteria for spinal fixation systems.

8. The sample size for the training set

This information is not applicable. The Universal Clamp Spinal Fixation System is a mechanical implant, not a machine learning or AI-based device that would require a training set.

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

This information is not applicable, as there is no training set for this type of device.

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When Optio-C Anterior Cervical Plate is used with structural allograft it is intended for one-level anterior screw fixation of the cervical spine (C2-T1). The implant has been designed for use with structural allograft to provide stabilization as an adjunct to cervical fusion. Indications for use of the Optio-C Anterior Plate with structural allograff/ autograft include degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion. The Optio-C Anterior Cervical Plate is intended to be used with a structural allograft and with three Optio-C bone screws.

When Optio-C Anterior Cervical Plate is used with an Optio-C PEEK IBF Spacer it becomes an Optio-C Anterior Cervical Intervertebral Body Fusion Device (IBFD), indicated for stand-alone anterior cervical interbody fusion procedures in skeletally mature patients with cervical degenerative disc disease at one level from C2 to T1. Degenerative disc disease (DDD) is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Optio-C IBFD is comprised of one Optio-C PEEK IBF Spacer, one Optio-C Anterior Cervical Plate and three Optio-C bone screws.

The Optio-C IBFD is to be used with autograft and implanted via an open, anterior approach in patients who have had six weeks of non-operative treatment.

The Optio-C Anterior Cervical System consists of two different configurations, an Optio-C Anterior Cervical PEEK Intervertebral Body Fusion Device (IBFD) (K132894, SE on January 16, 2014) and the subject of this submission, the Optio-C Anterior Cervical Plate System. Both configurations share the same cervical plate, bone screws and instrumentation and are used only in anterior surgical procedures and at the same spinal level of C2 to T1.

The subject cervical plate and bone screws of this submission are designed for use with structural allograft or autograft and is supplied sterile to the end user. The bone screws and instrumentation are supplied non-sterile and are intended to be sterilized by the end user.

The cervical plate with an Optio-C PEEK IBF Spacer or an allograft/autograft is placed in the cervical disc space, flush with the adjacent vertebral bodies. Bone screws pass through the screw holes of the plate and affix to bone to help prevent implant migration. The implant construct can be implanted in two orientations: Standard orientation, two screws cephalic and one screw caudal or Inverted orientation, one screw cephalic and two screws caudal.

The Optio-C Anterior Cervical Plate System is a stand-alone system designed to provide structural stability in skeletally mature individuals following discectomy. The implants are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Screws are inserted through the anterior titanium portion of the implant into adjacent vertebral bodies for bony fixation. The Optio-C Anterior Cervical Plate System is used with structural bone graft material and is manufactured from Titanium with Titanium bone screws that allow intradiscal fixation to the vertebral body. The superior and inferior surfaces of the implant have a pattern of ridges that provide increased stability and help prevent migration of the device.

The Optio-C Anterior Cervical System is provided for single use only.

The provided document is a 510(k) premarket notification for the Optio-C Anterior Cervical System, which is a medical device. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a clinical study with detailed performance metrics. Therefore, many of the requested elements for describing acceptance criteria and a study proving device performance are not applicable or cannot be extracted from this type of document.

However, I can extract information related to the device description, indications for use, and a summary of performance testing that aims to establish substantial equivalence.

Here's a breakdown of the information that can be extracted, and where the requested details are not applicable:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria in terms of specific performance targets (e.g., accuracy, sensitivity, specificity, or clinical outcomes) for the Optio-C Anterior Cervical System as would be found for a diagnostic or AI-based device. Instead, it describes performance testing conducted to demonstrate substantial equivalence to predicate devices. The reported device performance is qualitative, indicating acceptability for intended use and substantial equivalence to predicates.

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

This information is not provided. The document describes bench testing (mechanical tests) and cadaveric testing (biomechanical tests), but not a patient-based "test set" in the context of clinical data for an AI/diagnostic device.

3. 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. The ground truth for this type of device (spinal implant) is related to mechanical and biocompatibility standards, and biomechanical performance, not expert assessment of clinical images or data.

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

Not applicable. This concept is relevant for studies involving human interpretation or clinical endpoints, not for the engineering and biological tests described for this spinal implant.

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 spinal implant, not an AI-assisted diagnostic device or a system for human readers to interpret.

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

Not applicable. This is a physical medical device (spinal implant), not an algorithm.

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

The "ground truth" for the performance testing of this device is based on:

• Engineering standards: ASTM 1717 for mechanical properties.
• Biomechanical principles: Used in cadaveric testing.
• Biological safety standards: ISO 11137, ISO 11737, ISO 11607, ISO 17665, AAMI TIR12 for sterilization and packaging; ISO 10993-1 for biocompatibility.
• Comparison to predicate devices: The ultimate "standard" for substantial equivalence.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" as it is not an AI/machine learning model.

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

Not applicable, as there is no "training set."

Summary of the Study that Proves the Device Meets Acceptance Criteria (as interpreted for this device type):

The "study" described in the document is a series of non-clinical performance tests designed to demonstrate that the Optio-C Anterior Cervical System is substantially equivalent to legally marketed predicate devices and is safe and effective for its intended use.

Components of the Study:

• Bench Testing: Performed according to ASTM 1717 for Static Torsion, Static and Dynamic Compression Bending. This tested the mechanical properties of the cervical plate. The results concluded that its performance is "acceptable for its intended use" and comparable to the predicate devices (Synthes CSLP and Trinica devices).
• Design Validation / Cadaver Testing: This type of testing assesses the biomechanical performance and confirms the device's acceptability for its intended use, ensuring substantial equivalence to the predicate(s).
• Biomechanical Cadaveric Testing: Conducted to evaluate the device's performance in a more realistic anatomical setting.
• Sterilization Validation:
  • Gamma Sterilization: Performed for sterile implant components under international standards ISO 11137 and ISO 11737.
  • Packaging Sterility Testing: Conducted per ISO 11607 to ensure the packaging maintains a sterile barrier.
  • End-user Sterilization: Validated for non-sterile components (instrumentation and bone screws) under ISO 17665 and AAMI TIR12 to ensure equivalence to predicate devices, including dry time and cleaning instructions.
• Biocompatibility Assessment: Conducted per ISO 10993-1 to ensure the materials used in the Optio-C System are biocompatible and similar to those of the predicate devices.

Conclusion of the Study:

The document explicitly states: "The test results conclude the Optio-C™ Anterior Cervical Plate System to be substantially equivalent to the predicate devices listed above." It further notes that "The Optio-C Anterior Cervical Plate System performance, intended use and fundamental scientific technology remain unchanged from the predicate devices. The implant construct design does not change the stabilization fixation of the cervical vertebra found in the predicate devices. The Optio-C Anterior Cervical Plate is substantially equivalent to the predicate devices, a traditional anterior cervical plate."

In essence, the "acceptance criteria" for this 510(k) submission are met by demonstrating that the device performs mechanically, biologically, and functionally in a manner that is substantially equivalent to already approved predicate devices for the same indications for use.

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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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The Trinica® Anterior Lumbar Plate System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels. This system is indicated in the treatment of lumbar or lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthrosis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous fusion.

The Trinica® Anterior Lumbar Plate (ALP) System is a temporary supplemental fixation device consisting of a variety of shapes and sizes of plates and screws. The Trinica Anterior Lumbar Plate System is used as an implant for the correction and stabilization of the spine. This system provides temporary stabilization and augments the development of a solid spinal fusion. Additionally, this system provides the surgeon with the ability to supplement an interbody device with anterior plate fixation. The Trinica Anterior Lumbar Plate System components can be locked into a variety of configurations and each construct may be customized to individual cases. The plates are low profile and anatomically designed to provide optimal fit from either anterior or anterior-lateral approach. This system also features anti-migration locking caps to help secure the fixation screws. All Trinica Anterior Lumbar Plate System implant components are made from titanium alloy (Ti-6AI-4V ELI).

The Trinica Anterior Lumbar Plate System is supplied with the instrumentation necessary for implantation of the system. The Trinica" Anterior Lumbar Plate System is for single use only.

The provided documentation focuses on a 510(k) summary for the Zimmer Spine Trinica® Anterior Lumbar Plate System, which is a medical device for spinal fixation. This type of submission typically demonstrates substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the way a diagnostic AI/ML device would.

Therefore, the requested information regarding acceptance criteria, study details (sample size, data provenance, expert adjudication, MRMC study, standalone performance), and ground truth establishment is not applicable to this document. The document describes a sterilization validation as the primary "performance testing" conducted.

Here's a breakdown of the applicable information:

1. A table of acceptance criteria and the reported device performance:

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

• Not Applicable. The submission does not detail a "test set" for a performance study in the context of diagnostic accuracy. The performance testing was related to sterilization validation.

3. 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. Ground truth, in the context of expert review, is not relevant to sterilization validation.

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

• Not Applicable.

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

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

• Not Applicable. This device is a spinal implant.

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

• Not Applicable. For sterilization validation, the "ground truth" would be the successful killing of microorganisms, which is assessed through specific microbiological testing methods and standards (ISO 17665, AAMI TIR12).

8. The sample size for the training set:

• Not Applicable. There is no "training set" for this type of medical device submission.

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

• Not Applicable.

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