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The BRIDALVEIL NAVIGATED INSTRUMENTS are intended to be used in the preparation and placement of BRIDALVEIL screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are 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 of the anatomy.

The BRIDALVEIL Navigated Instruments are comprised of nonsterile, reusable instruments including taps and drivers that can be operated manually. These instruments are intended to be used with the Medtronic StealthStation® System (v 2.1.0) and are manufactured from stainless steel, as specified in ASTM F899.

The provided text describes the BRIDALVEIL Navigated Instruments, but it does not contain detailed information about acceptance criteria or a study proving that the device meets specific performance metrics.

The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a performance study against predefined acceptance criteria for a novel device.

However, based on the NON-CLINICAL TEST SUMMARY, we can infer the types of evaluations conducted. Here's what we can extract and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states: "The results of these evaluations indicate that the BRIDALVEIL NAVIGATED INSTRUMENTS are equivalent to the predicate devices." However, it does not provide specific numerical acceptance criteria (e.g., "navigation accuracy must be within X mm") or quantitative performance results.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified. The document mentions "dimensional analysis" and "anatomical simulated use," but without detailing the number of instruments tested or the number of simulated uses/scenarios.
• Data Provenance: Not specified. The tests are non-clinical, so human data provenance (country, retrospective/prospective) is not applicable. The evaluations were likely conducted in-house by Astura Medical or a contracted test lab.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable: This was a non-clinical, device-centric evaluation (dimensional analysis, mechanical testing, simulated use) and not a study requiring expert interpretation of results to establish ground truth in a clinical context.

4. Adjudication Method for the Test Set

• Not Applicable: As this was a non-clinical engineering and functional evaluation, adjudication methods like 2+1 or 3+1 (often used for expert consensus in clinical image interpretation) are not relevant here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No: The document states, "No clinical studies were performed." Therefore, no MRMC study or AI assistance evaluation was conducted.

6. Standalone Performance Study

• Partially Addressed (Non-Clinical): While no "standalone" clinical performance in the sense of an algorithm operating without human intervention for diagnostic or therapeutic outcomes was performed, the non-clinical tests (dimensional analysis, anatomical simulated use, navigation accuracy) represent an evaluation of the device's inherent functional performance characteristics. However, these are mechanical and functional tests, not clinical outcome studies.

7. Type of Ground Truth Used

• Engineering Specifications and Predicate Performance: For dimensional analysis, the ground truth would be the design specifications and the dimensions of the predicate devices. For navigation accuracy, the ground truth would typically be established by a highly accurate measurement system (e.g., CMM, optical tracking system) comparing the navigated instrument's reported position to its actual position in a controlled setup.

8. Sample Size for the Training Set

• Not Applicable: This device is a set of physical surgical instruments, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of data used for model development.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable: No training set for an AI/ML algorithm was used.

In summary, the provided document is a 510(k) summary demonstrating substantial equivalence primarily through non-clinical mechanical and functional evaluations. It does not provide detailed specific performance metrics or acceptance criteria as would be found in a clinical performance study with predefined endpoints.

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