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The Virage Navigation System instruments are to be used during the preparation and placement of Virage® OCT polyaxial screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in open procedures. When used with the Medtronic NavLock arrays, the Virage Navigation instruments can be used with the Medtronic StealthStation ® S7. When used with the ZimVie reference arrays, the Virage Navigation instruments can be used with the Brainlab Navigation System.

The Virage® Navigation System is comprised of nonsterile, reusable instruments including drills, taps, and drivers that can be operated manually and/or under a power surgical technique to prepare for and insert Virage OCT polyaxial screws. The Virage Navigation System instruments are designed for use with either the Medtronic StealthStation S7 or the Brainlab Spine & Trauma Navigation software (version 2.0 and higher). The ZimVie reference arrays can only be used with the Brainlab Spine & Trauma Navigation System. The Virage Navigation System is also compatible with the Zimmer Biomet Universal Power System.

The provided document is a 510(k) Premarket Notification from the FDA regarding the Virage® Navigation System. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about a comprehensive clinical study in the format requested.

Here's a breakdown of the information that can be extracted or inferred from the provided text, along with what is not available:

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)

This information is not provided in the document. The document mentions "verification and validation activities" but does not detail the sample sizes for these tests, nor the data provenance. These are typically included in the full 510(k) submission, but not in this summary letter.

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 information is not provided in the document. The document mentions "usability" but doesn't specify if experts were involved in establishing ground truth for any performance metrics.

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

This information is not provided in the document.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the document. The device in question is a navigation system for surgical procedures, not an AI diagnostic tool that human readers would interpret. The goal is to assist surgeons, not necessarily "improve human readers." The study described is a performance assessment of the navigation system itself.

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

The studies mentioned ("positional accuracy, usability, and tolerance analysis") appear to be evaluating the device performance, which is inherently a "standalone" evaluation of its mechanical and computational capabilities. However, these are not directly comparable to "algorithm only" performance for AI diagnostic tools. The device's function is to assist in surgical navigation, which implies it is always with a human in the loop during actual use.

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

The document mentions "positional accuracy." For this, the ground truth would likely be established through precise measurements using calibrated instruments or imaging techniques to determine the true position relative to the navigated object. However, the specific method of establishing this ground truth is not detailed. For "usability," the ground truth would be user feedback and observation against predefined tasks.

8. The sample size for the training set

This information is not provided in the document. The Virage® Navigation System, as described, is a mechanical and software-based navigation tool, not an AI/ML-driven diagnostic device that typically undergoes a separate "training set" for model development. The "training" for such systems would involve software development and testing rather than data-driven machine learning model training.

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

As there is no mention of a "training set" in the context of an AI/ML model, this information is not applicable as per the provided document. If there are underlying algorithms that use data to improve, those details are not present here.

In summary:

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance. It confirms that the device met specified acceptance criteria for various performance aspects (positional accuracy, usability, tolerance analysis, packaging, sterilization, cleaning, and material biocompatibility). However, it does not provide the detailed study design, sample sizes, expert qualifications, or ground truth establishment methods typically found in a clinical study report for an AI/ML diagnostic device. The device itself is a surgical navigation system, not a diagnostic AI.

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The Vital® Spinal Fixation System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-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. scoliosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis and/or failed previous fusion. When used as an adjunct to fusion, the Vital Spinal Fixation System is intended to be used with autograft and/or allograft.

In addition, the Vital Spinal Fixation System is intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the L5S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and or ilium with removal of the implant after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3sacrum/ilium.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Vital System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Vital System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The use of the Vital® Spinal Fixation System in skeletally mature patients may include the fixation of the Instinct® Java™ Spinal Fixation System hooks, APEX Spinal System™ hooks, or fixation of the Universal Clamp® Spinal Fixation System to the Vital® Spinal Fixation System. The Vital® Spinal Fixation System may also be used in skeletally immature patients when connected with the Universal Clamp Spinal Fixation System.

To achieve additional levels of fixation in skeletally mature patients, the Vital® Spinal Fixation System may be connected to the Virage® OCT Spinal Fixation System and the Instinct Java Spinal Fixation System offered by Zimmer Biomet Spine, using rod connectors.

The Vital® 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, hooks 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 allov. Implants made from 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 implant construct.

Vital® MIS System is a percutaneous screw delivery system that is an extension of the Vital® System. The predicate Vital implants consist of a variety of spinals rods and pedicle screws that are modified under the MIS line extension to feature cannulated screws (extended and nonextended tab) and modified spinal rods (bullet nose, connection, curvature). The system includes a variety of instrumentation which are also compatible with Vital and Vital MIS implant offerings in the Vital® System and allow for a minimalized, percutaneous, or mini-open surgical approach, extending MIS capabilities to the cannulated implants of the wider Vital System.

This is a 510(k) summary for the Vital Spinal Fixation System, which is a spinal implant system, not an AI/ML medical device. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth, experts, and comparative effectiveness studies that are typically associated with AI/ML device evaluations is not present in this document.

The document discusses the substantial equivalence of the new Vital® Spinal Fixation System to a predicate device (Vital® System K230116). The assessment focuses on mechanical and material aspects, not algorithmic performance.

Here's a breakdown of the specific information that can and cannot be provided from the given text:

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

• This document does not specify quantitative acceptance criteria or detailed performance metrics in the way an AI/ML device submission would. Instead, it states that the "Vital® System's indications for use, intended use, design, materials, and performance assessments are substantially equivalent to the currently marketed Vital® System and do not impact the safety and effectiveness of the system." This suggests that the acceptance criteria are met by demonstrating equivalence to the predicate device, likely through bench testing (mechanical and material properties) which are not detailed here.

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 as this is not an AI/ML device. There is no mention of a "test set" in the context of data for an algorithm.

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 as this is not an AI/ML device. "Ground truth" in this context would relate to the physical properties and performance of the device, established through engineering and biomechanical testing, rather than expert interpretation of data.

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

• Not applicable as this is not an AI/ML device.

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

• Not applicable as this is not an AI/ML device. No human-in-the-loop AI assistance is described.

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

• Not applicable as this is not an AI/ML device.

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

• For a spinal fixation system, "ground truth" for demonstrating safety and effectiveness would typically be established through biomechanical testing, material characterization, and potentially animal or cadaveric studies to ensure the device meets specified engineering standards for strength, fatigue, corrosion, and biocompatibility. The document infers these types of assessments were done to show "substantial equivalence" to the predicate, but does not detail them.

8. The sample size for the training set

• Not applicable as this is not an AI/ML device.

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

• Not applicable as this is not an AI/ML device.

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The Vital Navigation System instruments are used during the preparation and placement of the Vital vy System screws during spinal surgery to precisely locate anatomical structures in either open or minimally invasive procedures. The Vital Navigation System instruments are designed for use with either the Medtronic StealthStation S7 or the Brainlab Spine & Trauma Navigation software. The ZimVie reference arrays can only be used with the Brainlab Spine & Trauma Navigation System.

The Vital™ Navigation System is comprised of nonsterile, reusable instruments including awls, probes, taps, and drivers that can be operated manually. The Vital Navigation System instruments are designed for use with either the Medtronic StealthStation S7 or the Brainlab Spine & Trauma Navigation software. The ZimVie reference arrays can only be used with the Brainlab Spine & Trauma Navigation System. Both combinations are used to assist surgeons in precisely locating anatomical structures in either open or minimally invasive procedures for preparation and placement of Vital and Vitality Screws. This surgical imaging technology provides surgeons visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. The use of these navigation systems provides the surgeon access to real-time multi-plane 3D images) providing confirmation of hardware placement.

The provided text states that the Vital™ Navigation System underwent performance testing, including positional accuracy, usability, and tolerance analysis, and that all met the acceptance criteria when the Vital Navigation instruments were attached to the ZimVie reference arrays.

However, the document does not provide a specific table of acceptance criteria or the reported device performance values for these tests. It also does not detail the study design elements like sample sizes, data provenance, expert qualifications, or the use of MRMC studies.

Therefore, for aspects not explicitly stated in the document, I will indicate "Not specified in the document."

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and the Reported Device Performance:

Note: The document states that these tests were performed and met the criteria, but the specific metrics or values for the acceptance criteria and the performance are not provided.

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

• Sample size: Not specified in the document.
• Data provenance (country of origin, retrospective/prospective): Not specified in the document.

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

• Not specified in the document. The testing described (positional accuracy, usability, tolerance analysis) seems to be related to the device's technical specifications rather than the generation of clinical ground truth by experts for classification tasks.

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

• Not specified in the document.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No, an MRMC comparative effectiveness study is not mentioned as having been performed. The device is a "Stereotaxic Instrument" and "Navigation System," which aids surgeons in locating anatomical structures and placing screws. It is not an AI-assisted diagnostic imaging device that would typically involve human readers interpreting images.

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

• The device is a "Navigation System" used with human surgeons. It's an instrument assisting a human operator, not a standalone algorithm making autonomous decisions or interpretations that would have an "algorithm only" performance metric in the traditional sense of AI diagnostics. The "positional accuracy" testing would be the closest analogue to a standalone performance metric for a navigation system, indicating its inherent precision.

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

• The nature of the "ground truth" for a navigation system's performance would primarily be related to its engineering precision and accuracy (e.g., actual vs. measured positions, successful and precise placement in simulated or cadaveric models during testing). The document refers to "positional accuracy," "usability," and "tolerance analysis," which imply engineering and usability testing rather than a clinical ground truth established by medical outcomes or expert consensus on a diagnosis.

8. The sample size for the training set:

• Not applicable/Not specified. This device is not described as an AI/ML-based system that undergoes a "training" phase with a dataset. Its performance is validated through engineering and usability testing.

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

• Not applicable. As noted above, this device does not appear to be an AI/ML-based system with a training phase.

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The Vital/Vitality Spinal Fixation System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-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. scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis and/or failed previous fusion. When used as an adjunct to fusion, the Vital/Vitality Spinal Fixation System is intended to be used with autograft and/or allograft.

In addition the VitallVitality Spinal Fixation System is intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and or ilium with removal of the implant affer attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Vital/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 Vital/Vitality Spinal Fixation System in skeletally mature patients may include the fixation of the Instinct® Java™ Spinal Fixation System* hooks, APEX Spinal System™* hooks, or fixation of the Universal Clamp® Spinal Fixation System* to the Vital/Vitality Spinal Fixation System. The Vital/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 Vital/Vitality Spinal Fixation System may be connected to the Virage® OCT Spinal Fixation System* and the Instinct Java Spinal Fixation System offered by Zimmer Biomet Spine, using rod connectors.

The Vital™ 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, hooks 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 are made from medical grade titanium alloy; select rods are also available in 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 alloy, and/or cobalt chromium with stainless steel in the same implant construct. The Vital™ Spinal Fixation System is compatible with components from other cleared spinal fixation systems.

This looks like a 510(k) premarket notification for a spinal fixation system, not a device that uses AI or machine learning. Therefore, the questions about acceptance criteria for AI/ML performance, training sets, test sets, expert adjudication, and comparative effectiveness studies are not applicable.

The document discusses the substantial equivalence of the Vital™ Spinal Fixation System to a previously cleared predicate device (K203507). The key focus of this submission is to seek clearance for MRI conditional information in the Instructions for Use and to disclose minor changes introduced via Letters-to-File.

However, I can extract the performance testing that was done to support the MRI conditional labeling:

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)

This document does not specify the sample size for the MRI evaluation or the provenance of any data. The testing described is physical performance testing, 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)

Not applicable. This is not a study requiring expert clinical assessment for ground truth. The evaluation is against established ASTM standards for MRI safety.

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

Not applicable. This is not a study requiring adjudication. The evaluation is against established ASTM standards for MRI safety.

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 not an AI/ML diagnostic tool.

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

Not applicable. This device is not an AI/ML algorithm.

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

The "ground truth" or standard for compliance in this context refers to the established ASTM International standards for evaluating MRI safety for medical devices:

• ASTM F2052: Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment.
• ASTM F2182: Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants in a Magnetic Resonance Environment.
• ASTM F2213: Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment.
  (Note: The document lists ASTM 2213, but F2213 is the standard for torque. Image artifact generation is typically assessed using other methods, but the document specifically lists these three. It's possible "image artifact generation" is an overall outcome considered when performing these tests.)

8. The sample size for the training set

Not applicable. This device does not involve a training set as it is not an AI/ML device.

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

Not applicable. This device does not involve a training set.

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