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Precision Spine Navigation Instrumentation are intended to be used during the preparation and placement of Precision Spine screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Precision Spine Navigation Instrumentation are specifically designed for use with the Medtronic Stealth Station 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 a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

Precision Spine Navigated Instruments are non-sterile, reusable instruments that can be operated manually. These instruments are intended to be used with the Medtronic StealthStation® System to aid in implantation of associated Precision Spine screw implants. The instruments are manufactured from stainless steel per ASTM F899

The provided text describes a 510(k) premarket notification for "Precision Spine Navigation Instrumentation." It outlines the device's intended use and claims substantial equivalence to predicate devices, but it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving those criteria.

Specifically, the document is a regulatory submission rather than a research study report. It discusses the types of performance data collected (accuracy and precision testing per ASTM F2554-10, mating interface assessments, CMM inspection, instrument verification, and simulated use) but does not provide:

• Specific acceptance criteria values.
• Reported device performance values against those criteria.
• Sample sizes for test sets (other than implying "simulated use" was done).
• Provenance of data (country of origin, retrospective/prospective).
• Number or qualifications of experts.
• Adjudication methods.
• Effect sizes for human readers with/without AI assistance (as this is not an AI device).
• Standalone algorithm performance (as this is not an AI device).
• Ground truth types with specifics.
• Sample size for the training set (not applicable as it's not a machine learning device).
• How ground truth for the training set was established (not applicable).

Therefore, I can only provide information based on what is present in the document, which is limited regarding a detailed study demonstrating acceptance criteria.

Based on the provided text, here is what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions "Accuracy and Precision Testing of Navigation System per ASTM F2554-10 Standard Practice for Measurement of Positional Accuracy of computer Assisted Surgical Systems," and that "The accuracy and precision testing...was performed, per ASTM F2554-10." This ASTM standard defines methods for assessing accuracy, but the specific acceptance criteria (e.g., "accuracy must be within X mm") and the reported values achieved by the device are not detailed in this document. Therefore, a table with specific values cannot be created from this text.

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

• Sample Size: Not explicitly stated. The text mentions "The accuracy and precision testing...was performed" and "Simulated Use," implying a test set was used for these activities, but the number of tests or samples is not provided.
• Data Provenance: Not specified.

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

• Not applicable/Not specified. This device is an instrument for navigation, not an AI or diagnostic imaging device that typically requires expert-established ground truth in the same way. The testing mentioned appears to be engineering and performance verification.

4. Adjudication method for the test set:

• Not applicable/Not specified.

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 "Navigation Instrumentation" and not an AI or diagnostic tool. It assists surgeons, but the documentation does not describe an MRMC study or AI assistance.

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

• Not applicable. This is not an algorithm-only device. It is a physical instrument used with an existing navigation system (Medtronic StealthStation System).

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

• For the performance tests mentioned (accuracy, precision, CMM inspection), the "ground truth" would likely be based on established engineering standards, calibration references, and design specifications. For example, CMM inspection measures against CAD models or specified tolerances. "Simulated Use" would likely have predefined successful outcomes. No "expert consensus," "pathology," or "outcomes data" in the diagnostic sense is described.

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not a machine learning or AI algorithm that requires a training set.

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

• Not applicable.

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