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The system accessories are indicated for all cranial and spinal surgical procedures covered by the OTS where anatomical Spinal Surgicur procedures is is where a desired target is close to critical structures.

The above modular product groups consist of a registration device, LED array hardware, and operational software. When coupled with the OTS workstation, the devices allow for preoperative and operative planning of surgical procedures through workstation images.

Here's an analysis of the provided 510(k) summary regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided 510(k) summary, there is no explicit mention of specific acceptance criteria or quantitative device performance metrics (e.g., accuracy, precision) reported in a study. The summary primarily focuses on establishing substantial equivalence to a predicate device.

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

This information is not provided in the 510(k) summary. The document does not describe a performance study with a distinct test set.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not provided in the 510(k) summary. As no explicit performance study with a test set is described, there's no mention of ground truth establishment by experts.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary. No adjudication method is mentioned as there's no described test set or evaluation process involving multiple readers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

This information is not provided in the 510(k) summary. There is no mention of an MRMC study or any comparison of human readers with and without AI assistance. The device in question is an "Intraoperative Guidance Device" that acts as a "visualization aid to surgery" using LED tracking, not an AI-powered diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This information is not provided in the 510(k) summary. The device's function is described as providing "tracking information as an aid to surgery" and correlating instrument/microscope location to patient scan data, which inherently involves human interaction. There isn't a standalone algorithm performance without human involvement described.

7. The Type of Ground Truth Used

This information is not provided in the 510(k) summary. Since no specific performance study is detailed, the type of ground truth used is not mentioned.

8. The Sample Size for the Training Set

This information is not provided in the 510(k) summary. The document does not describe a machine learning model or an algorithm that would require a 'training set.' The device relies on "LED systems" for tracking.

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

This information is not provided in the 510(k) summary. As there is no mention of a training set, the establishment of its ground truth is also not discussed.

Summary of Device and Regulatory Context:

The provided document is a 510(k) summary for the Radionics Universal Instrument Registration and Microscope Module I accessories. The core of this submission is to demonstrate substantial equivalence to existing predicate devices (Zeiss Surgical Microscope Navigator and Surgical Tool Navigator).

The device is an "Intraoperative Guidance Device" that uses LED array hardware and operational software to:

• Allow surgeons to correlate instrument location to patient scan data.
• Allow surgeons to correlate the focused viewing area of a microscope to patient scan data.
• Guide the microscope to a desired target using workstation images.

The safety and effectiveness are primarily based on the demonstrated technological similarity to predicate devices, which also use LED systems for tracking information as an aid to surgery. No specific performance study with acceptance criteria, test sets, or ground truth is detailed in this 510(k) summary. The FDA's approval letter confirms their determination of substantial equivalence based on the provided information, allowing the device to be marketed under general controls.

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