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The SPINEART® Navigation Instrument System reusable instruments are intended to be used during the preparation and placement of Spineart screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SPINEART® Navigation Instrument System reusable 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 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.

The SPINEART® Navigation Instrument System reusable instruments are surgical instruments for use with the Medtronic® StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of pedicle screw system implants.

The SPINEART® Navigation Instrument System includes the following: Screwdrivers, Taps, Drills, and Drill Guides.

The SPINEART® Navigation Instrument System are to be used with the following Spineart Systems:

• ■Romeo® 2
  ▪Romeo® 2 MIS

▪Perla® Cervico-thoracic Fixation System

All instruments are made of stainless steel per ASTM F899. Taps range in size from Ø4mm to Ø7.5mm for the Romeo® 2 systems and from Ø3mm to Ø4mm for the Perla system.

The SPINEART® Navigation Instruments are not compatible with implants from other manufacturers.

The SPINEART® Navigation Instrument System are designed for use only with Medtronic StealthStation Navigation System hardware and software.

The provided text describes the regulatory clearance for the "SPINEART® Navigation Instrument System" and includes information about its intended use, technological characteristics, and performance data. However, it does not describe a study to prove the device meets acceptance criteria in the format requested, particularly for an AI/algorithm-driven device with detailed metrics like sensitivity, specificity, or AUC based on expert reads.

The device described is a surgical navigation instrument system, which is a physical device used during surgery to assist in precisely locating anatomical structures. The performance data section refers to non-clinical testing such as connection, registration, simulated use, and accuracy testing, which are relevant to the physical instrument's functionality and compatibility, rather than the performance of an AI/algorithm in interpreting medical data.

Therefore, I cannot fulfill the request as framed, as the provided document details the clearance of a physical medical instrument, not an AI/algorithm, and the information required for AI acceptance criteria and study design (e.g., sample size for test/training sets, expert consensus for ground truth, MRMC studies) is not present.

The document primarily focuses on establishing substantial equivalence to predicate devices based on:

• Identical Technological Characteristics: Indications for use, materials, principle of operation, device technology, sizes, mechanical performance, packaging.
• Performance Data: Connection, registration, simulated use, and accuracy testing (per ASTM F2554-10) to ensure functionality and compatibility with the Medtronic StealthStation®.

To illustrate why I cannot answer the specific questions:

• 1. Table of acceptance criteria and reported performance: The document only mentions "accuracy testing per ASTM F2554-10" and states results "show that the performance...is sufficient for its intended use and is substantially equivalent." It doesn't provide specific numerical acceptance criteria (e.g., "accuracy > 95%") or reported performance values.
• 2. Sample sized for the test set and data provenance: Not applicable in the context of physical instrument testing. "Test set" here refers to the instruments themselves and their interaction, not a dataset for an AI.
• 3. Number of experts and qualifications: Not applicable. Ground truth for a physical instrument's accuracy is typically measured engineeringly, not through human expert interpretation of images.
• 4. Adjudication method: Not applicable.
• 5. MRMC comparative effectiveness study: Not applicable, as this is a physical instrument, not an AI assisting human readers.
• 6. Standalone (algorithm only) performance: Not applicable, as there is no standalone algorithm being evaluated in the document.
• 7. Type of ground truth: For a physical instrument, ground truth for accuracy testing would be engineering measurements against known standards, not expert consensus, pathology, or outcomes data in the sense of an diagnostic AI.
• 8. Sample size for the training set: Not applicable, as this is not an AI model.
• 9. How ground truth for training set was established: Not applicable.

In conclusion, the provided text describes the regulatory submission for a physical surgical instrument system, not an AI or algorithm. Therefore, the specific criteria and study design elements typically associated with AI/algorithm acceptance (e.g., sensitivity, specificity, expert consensus, MRMC studies) are not applicable and are not found in the document.

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