Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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) providing confirmation of hardware placement.

Through the introduction of new styluses in this submission, the previously cleared Vital Navigation Taps and Reduction Driver (K191722) can be used with the existing Vital MIS PAT Handle (K203507) to allow the user to navigate while using the PAT or PASIT assembly. It is important to note that these styluses will not be navigated. As such, the toolcard for the NavLock taps or NavLock driver will not change with this new use scenario.

The provided text describes the regulatory clearance of the Vital Navigation System (K213720) and highlights its substantial equivalence to predicate devices. However, it does not contain a detailed study proving that the device meets specific acceptance criteria in the manner requested (e.g., a comparative effectiveness study with human readers, standalone algorithm performance, or a specific test set with ground truth established by experts).

The document states: "Furthermore, accuracy testing and other supporting information sufficiently demonstrate the substantial equivalence of the subject components to the Navigated Instrument System which has been cleared for stereotactic guidance during orthopedic surgery procedures." This suggests that some form of accuracy testing was performed, but the specifics of this testing, including acceptance criteria, sample size, ground truth establishment, and expert involvement, are not detailed in the provided text.

Therefore, I cannot fulfill all parts of your request based on the provided input. I can, however, extract information about the device, its intended use, and the regulatory context.

Information that can be extracted from the provided text:

• Device Name: Vital Navigation System
• Intended Use/Indications for Use: 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. 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.
• Device Type: Stereotaxic Instrument (Class II)
• Regulatory Clearance: 510(k) clearance (K213720) based on substantial equivalence to predicate devices (Primary Predicate: Vital Navigation System K191722; Additional Predicates: Vital Spinal Fixation System K203507, Medtronic StealthStation System K133444).
• Nature of the Submission: A Special 510(k) due to the introduction of new styluses and techniques (navigated PAT/PASIT) for an existing cleared device.

Information NOT present in the provided text, rendering the requested table and study details incomplete:

• Acceptance Criteria Table: No specific acceptance criteria (e.g., accuracy metrics, precision targets) for the device's performance are provided.
• Reported Device Performance: No quantitative performance data (e.g., mean accuracy, standard deviation, error rates) from actual testing is presented.
• Sample Size for Test Set: Not specified.
• Data Provenance (country, retrospective/prospective): Not specified.
• Number of Experts for Ground Truth: Not specified.
• Qualifications of Experts: Not specified.
• Adjudication Method: Not specified.
• MRMC Comparative Effectiveness Study: The document indicates a device for surgical assistance, not an AI for image reading; therefore, an MRMC study with human readers assisting AI or vice versa is not directly applicable in the context of this device description. The text does not mention any study of this nature or effect sizes.
• Standalone Performance (algorithm only): Not applicable as this is a navigation system with physical instruments used in conjunction with a separate imaging system (Medtronic StealthStation), not a standalone AI algorithm.
• Type of Ground Truth Used: Not specified, beyond general "accuracy testing."
• Sample Size for Training Set: Not applicable/specified for this type of device (not an AI/ML algorithm that requires a training set in the conventional sense).
• How Ground Truth for Training Set was Established: Not applicable.

Given these limitations, I cannot construct the table or fully describe the study as requested. The provided document is a regulatory clearance letter and summary, not a technical report detailing the performance validation study.

Ask a specific question about this device

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.

Ask a specific question about this device

CaP Spheres Pellet Pack™ is intended for use as a bone void filler for bony voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects resulting from traumatic injury to the bone. CaP Spheres Pellet Pack™ is intended to be used in conjunction with autograft bone as a bone graft extender and gently packed into bony voids or gaps in the posterolateral spine. CaP Spheres Pellet Pack™ provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process.

CaP Spheres Pellet Pack™ is a synthetic, osteoconductive, and resorbable bone void filler device consisting of hollow and microporous biphasic calcium phosphate spheres contained within a resorbable mesh pouch to aid in intraoperative handling. The device may be implanted directly, or hydrated with saline or autologous blood, and is intended to be combined with autograft.

The provided text describes a medical device, CaP Spheres Pellet Pack™, and its FDA 510(k) submission. However, it does not contain information about acceptance criteria, a study proving the device meets those criteria, or details regarding AI/ML device performance.

The document is a 510(k) clearance letter and summary for a physical medical device (bone void filler), not an AI/ML powered device. Therefore, the requested information regarding acceptance criteria, test set details, expert involvement, MRMC studies, or standalone algorithm performance, as commonly applied to AI/ML devices, is not present in this text.

The text focuses on:

• Device Description: What the CaP Spheres Pellet Pack™ is.
• Indications for Use: When and how the device should be used.
• Substantial Equivalence: Comparison to existing, legally marketed predicate devices to show it's as safe and effective.
• Performance Testing: Bench testing (physical, chemical, degradation), biological safety, sterilization, shelf-life, and an in vivo animal study.

The closest information related to "acceptance criteria" is the overall demonstration of "substantial equivalence" to predicate devices, and that all performance tests "yielded acceptable results." However, specific numerical acceptance criteria for performance metrics (like sensitivity, specificity, AUC) are not defined, as they are not typically applicable to this type of device in the same way they are for diagnostic AI/ML products.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, or answer the subsequent questions, as the input document does not contain this information for an AI/ML device.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device