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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. The Virage® Navigation System Instruments are specifically designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

The Virage® Navigation Instruments are also compatible with the Zimmer Biomet Universal Power System and the WalterLorenz® Surgical Assist Arm.

The Virage Navigation System is comprised of non-sterile, 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. These instruments are intended to be used with the Medtronic StealthStation® System to assist surgeons in precisely locating anatomical structures. This surgical imaging technology provides surgeons visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. Use of these navigation systems allows the surgeon access to real-time, multi-plane 3D images) thereby providing confirmation of hardware placement.

The provided text does not describe a study involving an AI/ML device or its performance against acceptance criteria. Instead, it describes a 510(k) premarket notification for the Virage Navigation System, which is a stereotaxic instrument used in spinal surgery, not an AI/ML device.

The document focuses on demonstrating substantial equivalence to existing predicate devices (Navigated INFINITY™ Instruments and StealthStation® System) through comparisons of technological characteristics, intended use, and performance data. The "performance data" section primarily discusses accuracy testing of the stereotactic instruments according to ASTM F2554-18 and a clinical validation lab to demonstrate compatibility and safety with existing navigation and power systems.

Therefore, I cannot extract the requested information about acceptance criteria, study details for an AI/ML device (e.g., sample size for test/training sets, expert ground truth establishment, MRMC studies, standalone performance) because this information is not present in the provided document. The device is a traditional medical instrument, not an AI/ML system.

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The Polaris Spinal System is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterior or anterolateral fixation system for use with autograft and/or allograft. The Polaris Spinal System is indicated for the following conditions: 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), deformity or curvature (i.e., scoliosis, kyphosis, Scheuermann's disease, and/or lordosis,), tumor, stenosis, pseudoarthrosis, or failed previous fusion.

The Ballista and Cypher MIS instruments are intended to be used with Ballista/ Cypher MIS /Polaris 5.5mm implants. Cannulated screws and percutaneous rods may be used with the Ballista/ Cypher MIS instruments to provide the surgeon with a percutaneous approach for posterior spinal surgery for the above indications.

For pediatric patients, the Polaris Spinal System may be used for posterior, non-cervical pedicle screw fixation as an adjunct to fusion to treat adolescent idiopathic scoliosis and is also indicated for treatment of the following conditions: spondylolysis and fractures caused by tumor and/or trauma. Pedicle screw fixation is limited to a posterior approach.

The Polaris Spinal System may be used with the instruments in the AccuVision Minimally Invasive Spinal Exposure System to provide the surgeon with a minimally invasive approach for posterior spinal surgery.

The dominos in the Polaris Spinal System can be used to connect the Polaris Spinal System to the Altius Spinal System, Lineum OCT Spine System, the Array Spinal System, the Biomet Omega21 Spinal System, or the Synergy Spinal System to achieve additional levels of fixation. Please refer to the individual system's Package Insert for a list of the indications for use for each system.

The Polaris Spinal System is a non-cervical spinal fixation device made from titanium alloy (Ti-6Al-4V) per ASTM F136, unalloyed titanium per ASTM F67, stainless steel per ASTM F138 or ASTM F1314 and Cobalt Chrome Alloy (Co-28Cr-6Mo) per ASTM F1537. The system includes screws, various types and sizes of rods, locking nuts, hooks, lateral connectors, plugs, fixation washers, rod connectors/dominos, various cross connectors and accessories. This submission is to update a contraindication related to the translation screws.

This document (K210275) is a 510(k) premarket notification for the Polaris Spinal System. It seeks clearance for a minor modification to the labeling related to a contraindication for translation screws, rather than a new device or significant design change requiring extensive performance studies.

Therefore, the typical battery of performance studies with large sample sizes, expert ground truth establishment, MRMC studies, and standalone algorithm performance evaluations are not applicable in this context.

The document explicitly states:

• "This submission is to update a contraindication related to the translation screws." (Page 3)
• "The purpose of this submission is to seek clearance for minor modifications to the labeling related to the translation screw." (Page 4)
• "No changes were made to any physical component of the Polaris Spinal System." (Page 5)
• "A risk assessment was conducted due to new information from a complaint. That risk assessment led to the inclusion of a contraindication to the labeling." (Page 5)
• "Per the FDA Guidance, The Special 510(k) Program, a Special 510(k) is appropriate when it is a change to the manufacturer's own device and performance data is not needed to evaluate the change." (Page 5)
• "Based on this information, the subject modifications do not raise any new issues regarding the safety or efficacy when compared to its predicates." (Page 5)

Given this, the requested information about acceptance criteria and detailed study designs (as they would apply to a new or significantly modified device) is not present in this 510(k) submission.

The "study" in this case was a risk assessment driven by a complaint, leading to a labeling change. It was not a performance study of the typical kind for a medical device.

Here's how to interpret the request in the context of this document:

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

• Acceptance Criteria (Implied): The acceptance criteria for this specific submission revolved around ensuring that the updated labeling (including the new contraindication) adequately addressed the identified risk and maintained the device's substantial equivalence to its predicates without introducing new safety or efficacy concerns. Since no physical changes were made, mechanical performance or clinical outcomes were not re-evaluated.
• Reported Device Performance: Not applicable in the traditional sense of performance metrics (e.g., accuracy, sensitivity, specificity, computational speed). The "performance" here is that the risk assessment was completed, and the resulting contraindication was deemed appropriate to mitigate the identified risk.

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

• Not applicable. There was no "test set" of clinical data for performance evaluation. The basis for the change was "new information from a complaint" (Page 5). This suggests a single or very limited number of reported adverse events or observations that triggered the re-evaluation of risk and subsequent labeling update.

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

• Not applicable. Ground truth for a performance study was not established. The "ground truth" for the labeling change was likely the outcome of an internal risk assessment by Zimmer Biomet's regulatory, engineering, and possibly clinical teams, based on the complaint information. The qualifications of these individuals are not detailed in the FDA letter.

4. Adjudication method for the test set:

• Not applicable. No test set requiring adjudication was used.

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 mechanical spinal fixation system, not an AI software.

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

• Not applicable. This device is a mechanical spinal fixation system, not an algorithm.

7. The type of ground truth used:

• Not applicable for a performance study. The "ground truth" for the labeling change was the company's internal assessment of the risk associated with the translation screws, likely derived from post-market surveillance (a "complaint").

8. The sample size for the training set:

• Not applicable. No training set was used as this is not a learning algorithm.

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

• Not applicable. No training set was used.

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The 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 sites), 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 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 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 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 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 and/or allograft. 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® Java™ System hooks, APEX® System hooks, or fixation of the Universal Clamp® Spinal Fixation System to 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 connected to the Virage® OCT Spinal Fixation System* and the Instinct Java Spinal Fixation System offered by Zimmer Biomet 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, 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 during surgery. 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 and securing of the implants. All 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, titanium alloy, and/or cobalt chromium with stainless steel in the same implant construct.

The Vitality Spinal Fixation System is compatible with the Virage® OCT Spinal Fixation System Rods, Instinct® Java" Spinal Fixation System Rods and Universal Clamp® Spinal Fixation System.

The provided text describes a 510(k) premarket notification for the "Vitality® Spinal Fixation System" and its substantial equivalence to predicate devices. It focuses on mechanical testing to demonstrate substantial equivalence for a medical device (spinal fixation system), not an AI/ML powered device. Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment, which are typical for AI/ML device evaluations, are not present.

However, based on the provided text, I can extract the following information regarding the performance study:

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

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

• Sample Size: Not specified. The document refers to "mechanical testing of the modified screw implants" but does not quantify the number of screws or tests performed.
• Data Provenance: Not applicable in the traditional sense for AI/ML. The "data" here refers to the outcomes of physical mechanical tests.

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

• Not applicable. This is a mechanical device, not an AI/ML device requiring human expert ground truth. The "ground truth" is established by the predefined ASTM standards and the physical properties of the materials and design.

4. Adjudication method for the test set:

• Not applicable. As a mechanical device study, there is no expert adjudication process. The results are based on objective measurements against engineering standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

• No, an MRMC study was not done. This type of study is relevant for AI/ML devices that assist human readers in tasks like image interpretation, which is not the function of a spinal fixation system.

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

• Not applicable in the context of AI/ML algorithms. The device itself (the spinal fixation system) is standalone in its mechanical function, but "standalone performance" usually refers to an AI algorithm operating without human intervention.

7. The type of ground truth used:

• Engineering Standards: The ground truth for performance is based on established engineering standards (ASTM F1717 and ASTM F1798) for spinal implant mechanical testing. These standards define the acceptable performance parameters.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device, so there is no training set in the machine learning sense. The device design and manufacturing processes are informed by engineering principles and previous designs, not by a data-driven training set.

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

• Not applicable. As there's no training set for an AI/ML algorithm, this question is irrelevant to this device.

In summary, the provided document describes a 510(k) submission for a spinal fixation system, focusing on demonstrating substantial equivalence through mechanical testing against established ASTM standards. It does not pertain to an AI/ML device, and thus, many of the questions related to AI/ML specific evaluation criteria are not applicable.

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The Epic Anterior Thoracolumbar Plate System is intended to provide fixation of the thoracic. Jumbar, and/or sacral spine (T1-S1) as an adjunct to fusion using autograft or allograft in skeletally mature patients in the following instabilities or deformities:

• Degenerative Disc Disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);

• • Spinal Stenosis (indicated for L1-S1 only);
• • Spondylolisthesis;
• • Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
• • Trauma (i.e., fracture, dislocation, or subluxation);
• • Spondylolysis;
• • Tumor;
• • Pseudoarthrosis: and/or
• • Failed previous fusion

The Epic Anterior Thoracolumbar Plate System is indicated for use via the lateral or anterolateral surgical approach for fixation of the thoracic and thoracolumbar spine, or via the anterior surgical approach for fixation of the lumbosacral spine below the bifurcation of the great vessels.

The Gallery Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laninoplasty has been performed. The Gallery Laminoplasty Fixation System holds or buttresses the allograft in place in order to prevent the allograft from expulsion or impinging on the spinal cord.

The Concero Facet Screw System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from C2 to S1 for 3.5mm and 4.0mm screws and from L1 to S1 for 4.5mm screws. For transfacet fixation, the screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the superior side of the facet, across the facet joint, and into the pedicle. The Concero Facet Screw System is indicated for treatment of any or all of the following:

• • Pseudoarthrosis and failed previous fusions;
• • Spondylolisthesis;
• • Spondylolysis;

• Degenerative Disc Disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies;

• • Degeneration of the facets with instability and;
• • Trauma including spinal fractures and/or dislocations.

The Zimmer Biomet Spinal Fixation System is intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The system is intended for use with autograft or allograft.

The Zimmer Biomet Spine Spinal Fixation System is intended for posterior, non-cervical (T1-S2/illum) pedicle and nonpedicle spinal fixation, to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following instabilities or deformities: degenerative disc disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; deformities or curvatures (i.e., scolosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Alpine XC Adjustable MIS Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); trauma (i.e., fracture or dislocation); and/or tumor. The Alpine XC Adjustable MIS Fusion System is intended for use with bone graft material, not intended for stand-alone use.

The Aspen device is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the noncervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); and/or tumor. The Aspendevice is intended for use with bone graft material, not intended for stand-alone use.

The LPlate device is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the noncervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. The LPlate device is intended for use with bone graft material, not intended for stand-alone use.

The Zimmer Biomet Spine Miscellaneous Spinal Fixation Systems referred to in this submission include the following systems: Epic, Gallery, Concero, Alpine XC, Aspen and L-Plate. These subject Miscellaneous Spinal Fixation Systems are identical to the predicate Miscellaneous Spinal Fixation Systems, Epic, Gallery, Concero, Alpine XC, Aspen and L-Plate, currently marketed. As defined within the product-specific Indications for Use, the subject Miscellaneous Spinal Fixation Systems are intended for the stabilization and immobilization of spinal segments as an adjunct to fusion in the cervical, thoracic, lumbar and/or sacral spine.

The provided text is a 510(k) summary for several Zimmer Biomet Spine fixation systems. It explicitly states that "Performance testing is not necessary" for this particular submission because the systems themselves are identical to already marketed predicate devices. The purpose of this submission is solely to obtain clearance for modified product labeling establishing the safety and compatibility of these existing passive implants in the magnetic resonance (MR) environment.

Therefore, the document does not contain information about acceptance criteria or a study demonstrating device performance in the traditional sense of evaluating efficacy or accuracy against a pre-defined standard. It's a regulatory filing based on demonstrating substantial equivalence to already cleared devices.

Based on the provided text, I can extract the following information:

1. Table of acceptance criteria and the reported device performance: This information is not present in the document. The document states "Performance testing is not necessary to evaluate the effects within magnetic fields during Magnetic Resonance Imaging (MRI) on the subject Miscellaneous Spinal Fixation Systems." The submission is for modified labeling regarding MRI safety of existing devices, which are substantially equivalent to their predicates.

2. Sample size used for the test set and the data provenance: Not applicable. No performance testing was conducted for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth was established for performance testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set or adjudication was involved.

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 about spinal fixation systems, not AI-powered medical imaging devices.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document is about spinal fixation systems, not standalone algorithms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth was established for performance testing.

8. The sample size for the training set: Not applicable. This document is about physical medical devices, not machine learning models with training sets.

9. How the ground truth for the training set was established: Not applicable. No training set or ground truth was established.

In summary, the provided FDA 510(k) summary (K202309) primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices for the purpose of clarifying MRI safety labeling. It explicitly states that performance testing is not necessary because the devices themselves are identical to their predicates, and the changes are limited to labeling regarding MRI compatibility. Therefore, the details requested about acceptance criteria, study design, and performance metrics are not present in this specific document.

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Vital Navigation instruments are to be used during the preparation and placement of Vital and Vitality screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Vital Navigation instruments are specifically designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

The Vital Navigation System is comprised of nonsterile, reusable instruments including awls, probes, taps, and drivers that can be operated manually. These instruments are intended to be used with the Medtronic Synergy™ Experience StealthStation® System 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. Use of these navigation systems provides the surgeon access to real-time, multi-plane 3D images (and 2D images) providing confirmation of hardware placement.

The provided document is a 510(k) clearance letter for the Zimmer Biomet Vital Navigation System. It primarily outlines the regulatory approval for a medical device and its intended use, rather than detailing a study focused on the performance of an AI/algorithm against acceptance criteria.

The document discusses "accuracy testing of the stereotactic instruments" and cites ASTM F2554-18, which is a standard practice for measuring positional accuracy of computer-assisted surgical systems. This testing is for the hardware (instruments used in conjunction with the Medtronic StealthStation System), not an AI or algorithmic component that would require a study with human readers or AI-specific performance metrics like sensitivity, specificity, or AUC.

Therefore, many of the requested details, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone AI performance, and ground truth for training sets, are not applicable or not present in this regulatory clearance letter because the device is a set of physical surgical instruments, not an AI or software algorithm.

Here's a breakdown of the relevant information that can be extracted, and where the document is silent on AI/algorithmic performance:

Device: Vital Navigation System (non-sterile, reusable instruments: awls, probes, taps, drivers)
Function: To be used with the Medtronic StealthStation System to assist surgeons in precisely locating anatomical structures for placement of Vital and Vitality screws during spinal surgery.

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

Based on the document, the device's performance is tied to "accuracy testing" of its stereotactic instruments. The acceptance criteria are implicitly that the device "functioned as intended" and "demonstrated substantial equivalence" to predicate devices, particularly regarding positional accuracy. Specific numerical acceptance criteria for accuracy are not provided in this summary document, nor are specific numerical results.

Note: This is an approval for physical instruments, not an AI system. The "performance" refers to the mechanical and operational accuracy of the instruments, not an algorithm's diagnostic or predictive capabilities.

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

• Not Applicable/Not Provided for AI study. The document only mentions "accuracy testing" of the instruments per ASTM standards. It does not disclose the sample size (e.g., number of tests, number of cases/patients) or data provenance (e.g., country of origin, retrospective/prospective nature) for the engineering verification testing. This information would typically be detailed in the test reports, which are not part of the 510(k) summary provided.

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

• Not Applicable. This information is relevant for studies involving human interpretation or AI performance where expert ground truth is established. The device discussed here is a set of surgical instruments evaluated for mechanical/positional accuracy, not for diagnostic performance requiring expert interpretation.

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

• Not Applicable. See point 3.

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. This is a hardware device (surgical instruments), not an AI assistance system for human readers. Therefore, an MRMC comparative effectiveness study is not relevant or mentioned.

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

• No. The device is a set of surgical instruments; there is no standalone algorithm. Its function is to assist in real-time surgical navigation when used with the Medtronic StealthStation System.

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

• Engineering/Physical Measurement: For the "accuracy testing" of the stereotactic instruments, the ground truth would have been established through precise engineering measurements of positional accuracy, likely using calibrated tools and fixtures as prescribed by ASTM F2554-18. It would not involve expert consensus on medical images or pathology.

8. The sample size for the training set

• Not Applicable. This device did not involve machine learning or a "training set" in the context of an AI algorithm. Its performance is based on its mechanical design and precise manufacturing.

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

• Not Applicable. See point 8.

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The Zimmer Biomet Universal Navigation System is indicated for use during the preparation and insertion of Zimmer Biomet screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The universal adaptors are specifically designed for use with the Zimmer Biomet ROSA One System, which is indicated for providing spatial positioning and orientation of instrument holders or tool guides based upon an intraoperative plan developed with three dimensional imaging software provided that the required fiducial markers and rigid patient anatomy can be identified on 3D CT scans. The ROSA One Spine System is intended for the placement of pedicle screws in vertebrae with a posterior approach in the thoracolumbar region.

The Zimmer Biomet Universal Navigation System includes Universal Adaptors that are intended to be used with instrumentation from Vitality Spinal Fixation System (including Vitality MIS), Pathfinder NXT Minimally Invasive Pedicle Screw System, and Polaris Spinal Fixation System (including Cypher MIS Screw System) to facilitate preparation and insertion of Zimmer Biomet screws using navigation.

The provided text describes the Zimmer Biomet Universal Navigation System and its 510(k) clearance. However, it does not contain specific details about acceptance criteria, a detailed study proving performance against those criteria, or the methodology (sample size, expert qualifications, ground truth, MRMC study, standalone performance) typically associated with a robust clinical or technical validation study for an AI/ML medical device.

The closest information provided is:

• "Accuracy testing of the Zimmer Biomet Universal Navigation System Instruments was performed in accordance ASTM F2554-18 Standard Practice For Measurement of Positional Accuracy of Computer Assisted Surgical Systems."
• "Clinical data was not needed for the Zimmer Biomet Universal Navigation System."

This indicates that the validation was focused on the system's positional accuracy and relied on a standardized test method (ASTM F2554-18), rather than a clinical study evaluating diagnostic or treatment outcomes with human readers.

Therefore, many of the requested details cannot be extracted from this document.

Here's a breakdown of what can and cannot be answered from the provided text:

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 for test set: Not specified. The document mentions "accuracy testing" but does not detail the number of trials, cases, or specific measurements performed.
• Data provenance: Not applicable in the context of clinical data, as it states "Clinical data was not needed." For the accuracy testing, the "data" would be the measurements taken during the experimental procedure according to ASTM F2554-18. The origin of this experimental setup is not stated.

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 validation was a technical accuracy test, not a clinical study requiring expert interpretation of medical images or outcomes.

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

• Not applicable. There was no clinical test set 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

• No. The document explicitly states, "Clinical data was not needed for the Zimmer Biomet Universal Navigation System." Therefore, an MRMC study and AI assistance comparison were not conducted.

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

• Yes, implicitly. The "Accuracy testing of the Zimmer Biomet Universal Navigation System Instruments" performed per ASTM F2554-18 is a standalone technical performance test of the device's ability to measure spatial positioning accurately, independent of human interpretation of clinical outcomes. However, the specific metrics of this standalone performance are not reported.

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

• For the accuracy testing, the ground truth would be based on precisely established physical reference points and measurements in a controlled environment, as defined by the ASTM F2554-18 standard for measuring the positional accuracy of computer-assisted surgical systems. It's a "physical ground truth" related to spatial measurement, not a biological or clinical ground truth.

8. The sample size for the training set

• Not applicable. This device is a navigation system, not an AI/ML algorithm that requires a training set in the conventional sense (e.g., for image classification or risk prediction). Its "training" would be its engineering design and calibration.

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

• Not applicable, as there isn't a "training set" for an AI/ML algorithm in this context.

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The Zimmer Biomet Universal Navigation System is indicated for use during the preparation and insertion of Zimmer Biomet screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These adaptors are specifically designed for use with the Medtronic StealthStation System which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone or vertebra can be identified relative to an acquired image: CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Zimmer Biomet Universal Navigation System includes Universal Adaptors that are intended to be used with instrumentation from Vitality Spinal Fixation System (including Vital Power Instrument System), Pathfinder NXT Minimally Invasive Pedicle Screw System, and Polaris Spinal Fixation System (including Cypher MIS Screw System) to facilitate preparation and insertion of Zimmer Biomet screws using navigation.

Due to the nature of the provided document, which is a 510(k) summary for a medical device and not a study detailing specific acceptance criteria and performance data in the typical sense of AI/ML device testing, many of the requested fields cannot be directly extracted or are not applicable.

The document describes the Zimmer Biomet Universal Navigation System, a stereotaxic instrument for spinal surgery. The performance data provided focuses on accuracy testing of the instruments in accordance with a particular ASTM standard, rather than clinical performance metrics often associated with AI/ML systems (e.g., sensitivity, specificity, AUC).

Here's a breakdown based on the available information:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for performance in the format of a table with numerical targets and reported values. Instead, it refers to validation activities and accuracy testing. The primary performance claim is related to accuracy as measured by a standard practice.

Implied Acceptance Criterion: The device should meet the performance requirements for accuracy as defined by ASTM F24554-18.

Here's a table based on the summary of performance data presented in the document:

Missing Information: Crucially, the specific numerical results of the accuracy testing are not included in this 510(k) summary. The document states that "validation activities ... confirm the instruments meet performance requirements," implying that the acceptance criteria were met, but the criteria themselves (e.g., "accuracy must be within X mm") and the measured performance (e.g., "accuracy achieved Y mm") are not detailed here.

Additional Requested Information (Based on Document Content)

• Sample sized used for the test set and the data provenance: Not explicitly stated. The testing mentioned in the document is "Accuracy testing of the Zimmer Biomet Universal Navigation System Instruments" in accordance with an ASTM standard. This likely refers to in-vitro/bench testing, not a clinical test set with patient data. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" are not applicable here.

• 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 device is not an AI/ML diagnostic or predictive tool that relies on expert interpretation to establish ground truth in a test set. The validation is for the accuracy of navigation instruments, which is typically measured against physical standards or known positions.

• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for the reasons mentioned above.

• 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 not an AI-assisted diagnostic or interpretation device that would involve human readers or an MRMC study. It's a navigation system designed to aid surgeons in precisely locating anatomical structures.

• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The "accuracy testing" mentioned is likely a standalone performance assessment of the navigation system's instruments, independent of a human surgeon's interaction during a live procedure, but it's not an "AI algorithm" in the typical sense. It is testing the instrument's ability to accurately track or guide.

• The type of ground truth used (expert consensus, pathology, outcomes data, etc): For positional accuracy testing of a navigation system, the ground truth would typically be established by highly precise measurement devices or known physical reference points in a controlled laboratory setting, not expert consensus or pathology.

• The sample size for the training set: Not applicable. This device is not described as an AI/ML device that undergoes a "training" phase.

• How the ground truth for the training set was established: Not applicable for the reasons mentioned above.

Conclusion based on provided text:

The provided document is a 510(k) summary for a navigation system, not an AI/ML diagnostic or predictive device. As such, many of the questions related to AI/ML device testing methodologies (like training sets, expert adjudication of ground truth, MRMC studies) are not applicable to the information presented. The key performance aspect is the accuracy of the navigation instruments, which was validated according to a recognized ASTM standard, though specific numerical results of this validation are not included in the summary. The FDA deemed this sufficient for substantial equivalence.

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The 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 sites), 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 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 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 after 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 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 and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Assembly of a spinal fixation construct using the Vitality® Spinal Fixation System may include additionally any Instinct® Java™ System hook, any APEX® System hook, or the Universal Clamp® (titanium). These direct-connect single point of fixation implants act in concert with the Vitality® System rods and implants to support its surgical indications for use.

In order to achieve additional levels of fixation, the Vitality® Spinal Fixation System rods may be connected to the Instinct® Java™ System (Ø5.5mm rod) or the Virage® OCT Spinal Fixation System (Ø3.5mm rod) with the corresponding Vitality® rod connectors. Refer to the Instinct® Java™ System and Virage® OCT Spinal Fixation System package inserts for instructions for use.

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, 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 hot 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 and removal and securing of the implants. All 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, titanium alloy, and/or cobalt chromium with stainless steel in the same implant construct.

The Vitality Spinal Fixation System is compatible with the Virage® OCT Spinal Fixation System Rods, Instinct® Java" Spinal Fixation System Rods and Hooks, and Universal Clamp® Spinal Fixation System.

The provided document pertains to a 510(k) premarket notification for a medical device, specifically the Vitality® Spinal Fixation System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study as would be seen for a novel AI/software medical device.

Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable to this submission. The document explicitly states:

• "To support substantial equivalence, mechanical testing of the modified screw implants of the subject Vitality® Spinal Fixation System were assessed and tested appropriately in accordance with ASTM standards. Performance testing included tests per ASTM F1717 (dynamic compression bending) and demonstrated the subject devices are safe and effective for use with pedicle screw fixation. In all instances, the modified device functioned as intended and demonstrated substantial equivalence to the predicate device(s)."
• "The subject Vitality® Spinal Fixation System is substantially equivalent to the Vitality® Spinal Fixation System (K171907)."
• "Based on this information, the subject device does not raise any new issues regarding the safety or efficacy when compared to its predicates."

This means the "acceptance criteria" and "study" are primarily focused on mechanical performance testing against established ASTM standards and demonstrating substantial equivalence to a previously cleared device (Vitality® Spinal Fixation System, K171907). There is no mention of an AI algorithm, human readers, or clinical performance studies with ground truth in the context of this submission.

Here's how to address the request based on the provided text:

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 mentions "mechanical testing of the modified screw implants."

• Sample size: Not explicitly stated (e.g., number of screws, number of tests performed). It refers to "the modified screw implants" generally.
• Data provenance: Lab-generated data from mechanical testing according to ASTM standards for medical devices (product testing). Not applicable to country of origin, retrospective/prospective in the clinical sense.

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

Not applicable. Ground truth for mechanical testing is based on engineered specifications and standardized test results rather than expert consensus on clinical data.

4. Adjudication method for the test set

Not applicable. Mechanical testing results are objective measurements against a standard.

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 mechanical implant; no AI component or human reader studies are mentioned.

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

Not applicable. This device is a mechanical implant; no AI algorithm is involved.

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

For mechanical testing, the "ground truth" would be the pass/fail criteria defined by the ASTM F1717 standard (e.g., maximum force before failure, displacement at yield, fatigue life cycles) for the specific type of spinal fixation device.

8. The sample size for the training set

Not applicable. This is a mechanical device, not a machine learning algorithm that requires a training set.

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

Not applicable. This is a mechanical device, not a machine learning algorithm.

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Avenue P is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels.

The device is implanted via a transforaminal or posterior approach and intended for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Avenue P is designed for use with or without integrated fixation and must be used in conjunction with posterior supplemental fixation cleared for use as an adjunct to fusion in the lumbar spine.

The Avenue® P Cage System consists of various sized, titanium coated, PEEK intervertebral body fusion cages, titanium anchoring plates for integrated fixation, and associated instrumentation. The system is intended to be used to stabilize lumbosacral spinal segments, promote spinal fusion in combination with bone graft and to restrict motion at the implanted vertebral level.

The Avenue® P cages have been designed for use with optional VerteBRIDGE® integrated fixation anchoring plates. Upon insertion, the VerteBRIDGE® anchoring plate provides and maintains additional stability and expulsion resistance by direct purchase into the bony vertebral endplates.

The base material of the Avenue® P Cage System implant is polyetheretherketone (PEEK-OPTIMA LT1) which conforms to ASTM F2026-12. This PEEK base is coated on the superior and inferior surfaces with a plasma sprayed, commercially pure titanium (SPONDYCOAT-T 371A) conforming to ASTM F1580-12.

The provided text describes the Zimmer Biomet Spine, Inc. Avenue® P Cage System (K181096), an intervertebral body fusion device. The submission is a 510(k) premarket notification, which aims to demonstrate that the device is substantially equivalent to legally marketed predicate devices, rather than proving its effectiveness through a de novo study with specific clinical performance criteria. Therefore, the information typically requested in your prompt regarding acceptance criteria, study details, and ground truth establishment for AI/algorithm-based devices is not directly applicable in this context.

Here's a breakdown of what is available in the document, and what is not:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is typically found in submissions for novel devices or those undergoing a de novo classification, where a specific performance threshold needs to be met to demonstrate safety and effectiveness. For a 510(k) submission like K181096, the "acceptance criteria" revolve around demonstrating substantial equivalence to predicate devices through various tests.

2. Sample size used for the test set and the data provenance: Not applicable. This submission is for a medical device (intervertebral cage) and primarily relies on mechanical and safety testing against established standards and comparisons to predicate devices, not on a test set of data like an AI algorithm would use.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment by experts is relevant for clinical studies or AI algorithm validation, not for the mechanical and material testing described here.

4. Adjudication method for the test set: Not applicable for the reasons stated above.

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 not an AI-assisted diagnostic or treatment planning device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical implantable medical device.

7. The type of ground truth used: For this type of device, the "ground truth" aligns with established engineering principles, material science, and biocompatibility standards. The various ASTM standards (F2077 for mechanical testing, F2052, F2213, F2119, F2182 for MR safety) represent the accepted criteria and methodologies for evaluating the performance and safety of such implants.

8. The sample size for the training set: Not applicable. This is not an AI algorithm.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) summary for an intervertebral body fusion device. Its focus is on demonstrating "substantial equivalence" to existing, legally marketed predicate devices through engineering and material testing, rather than presenting clinical study data with acceptance criteria for a novel therapeutic or diagnostic outcome. Therefore, many of your specific questions related to AI/algorithm validation or clinical efficacy studies are not addressed in this type of regulatory submission.

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The Polaris Spinal Growth System is indicated in patients with potential growth under 10 years of age who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities, including early-onset scoliosis, which are associated with or at risk of thoracic insufficiency syndrome.

The Polaris Spinal Growth System may be used with any cleared traditional Polaris Spinal System construct, including any cleared Polaris Spinal System compatibilities.

The Polaris Spinal Growth System is a non-cervical spinal fixation device made from titanium alloy (Ti-6Al-4V) per ASTM F136 and Cobalt Chrome Alloy (Co-28Cr-6Mo) per ASTM F1537. The system is comprised of Growth Connectors which are intended to be used with the Polaris Spinal System implants and instruments. The design and size offerings of the Polaris Spinal Growth System connectors are identical to those currently available in the Polaris Spinal System but are indicated for growth rod constructs. These growth rod constructs typically require repeated plannedlengthening procedures until a determination is made that the patient is ready for a final fusion procedure. After the spine is fused, these devices serve no functional purpose and may be removed.

The provided text describes a 510(k) submission for a medical device called the "Polaris Spinal Growth System." This submission is a declaration of substantial equivalence to a predicate device, as opposed to a new device requiring extensive clinical trials and complex acceptance criteria for AI/Software-as-a-Medical-Device (SaMD) performance.

The document primarily focuses on mechanical testing to demonstrate that the Polaris Spinal Growth System performs as intended and is substantially equivalent to existing, legally marketed devices. It does not contain information relevant to AI/SaMD performance, such as:

• Acceptance criteria for an algorithm's diagnostic or therapeutic performance. The device is a physical implant, not a software algorithm.
• Study design for evaluating algorithm performance (test sets, ground truth, expert review, MRMC studies).
• Sample sizes for training sets for machine learning models.
• Effect size for human reader improvement with AI assistance.

Therefore, I cannot extract the information required to answer your prompt in detail. The available information relates to the acceptance criteria for the mechanical performance of a physical implant, not the performance of an AI/SaMD.

Here's what I can provide based on the document, focusing on the mechanical performance. Please note that this is not related to AI/SaMD and will not fill all requested fields:

Acceptance Criteria and Device Performance (for Mechanical Properties):

Study Details (for Mechanical Testing):

• Sample size used for the test set and data provenance: The document states "mechanical testing of the Polaris Spinal Growth System constructs were assessed and tested." It does not specify the exact number of constructs tested (sample size) or where these tests were physically performed (data provenance in terms of country of origin). It is not a clinical study with retrospective/prospective human data.
• Number of experts used to establish ground truth: Not applicable. Ground truth for mechanical testing is based on engineered specifications and standardized test methods (ASTM F1717, ASTM F1798).
• Adjudication method: Not applicable. Mechanical tests have objective, measurable outcomes.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable. This is not a study assessing human readers or AI assistance.
• Standalone (algorithm only) performance: Not applicable. This device is a physical implant.
• Type of ground truth used: Engineering standards (ASTM F1717, ASTM F1798) for mechanical properties.
• Sample size for the training set: Not applicable. This is not an AI/ML device.
• How the ground truth for the training set was established: Not applicable.

In summary, the provided document details the regulatory clearance for a traditional medical device (spinal implant) based on mechanical testing and substantial equivalence, not an AI/SaMD. As such, it does not contain the information requested in your prompt regarding AI/SaMD performance evaluation.

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