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

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

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

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

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

Here's the breakdown based on the provided text:

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

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

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

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

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

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

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

• Not specified in the document.

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

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

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

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

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

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

8. The sample size for the training set:

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

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

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

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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.

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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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