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The Midas Rex™ attachments and dissecting tools for Mazor are indicated for the incision/cutting, drilling, burring, and removal of hard tissue and bone in open and minimally invasive spine procedures.

Computer-assisted surgery and its associated applications are intended as an aid for locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition for which the use of stereotactic surgery may be appropriate and where reference to a rigid anatomical structure, such as a long bone or vertebra, can be identified relative to a CT- or MR-based model, fluoroscopic images, or digitized landmarks of the anatomy.

Midas Rex™ attachments and surgical dissecting tools for Mazor are intended for the incision/cutting, drilling, burring, and removal of hard tissue and bone. The subject instruments are designed to be utilized through a cannula, for use with the Mazor X Stealth Edition™ system in open and minimally invasive spine procedures.

The subject devices perform the intended function as part of the existing Medtronic Midas Rex TM surgical drill systems which consist of the subject attachments and dissecting tools, electric and pneumatic drill handpieces and system accessories.

The provided text describes the acceptance criteria and a study for the "Midas Rex Attachments and Dissecting Tools" which are intended for surgical navigation.

Here's the detailed information based on your request:

1. Table of Acceptance Criteria and the Reported Device Performance

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

The document indicates that "Navigational Accuracy Analysis" was performed, which "Provides confirmation that the subject devices satisfy the necessary navigational accuracy requirements." However, the specific sample size used for this test set is not explicitly mentioned in the provided text.

Regarding data provenance, the study appears to be an internal performance verification study conducted by Medtronic Powered Surgical Solutions (MPSS) to demonstrate the device's adherence to specified accuracy metrics. The data would therefore be prospective in the context of this regulatory submission, generated specifically for the purpose of demonstrating substantial equivalence. The document doesn't specify the country of origin of the data beyond the manufacturer's location in Fort Worth, Texas.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth for the navigational accuracy analysis. The "Navigational Accuracy Analysis" is likely a technical measurement against a known reference, rather than an expert-adjudicated ground truth like in image interpretation studies.

4. Adjudication method for the test set

No adjudication method (e.g., 2+1, 3+1, none) is mentioned or implied for the navigational accuracy analysis. This type of test typically involves direct measurement against a known physical standard or simulated environment, rather than expert consensus on subjective interpretations.

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 multi-reader multi-case (MRMC) comparative effectiveness study was done, as this device is a surgical tool with navigation capabilities, not an AI-assisted diagnostic or interpretive system involving human readers. The device itself provides assistance to the surgeon in locating anatomical structures.

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

A standalone performance evaluation was conducted for the device's navigational accuracy. The "Navigational Accuracy Analysis" measured the device's performance (Mean Positional Error and Mean Trajectory Error) against predefined acceptance criteria, independent of a human operator actively engaged in a clinical task. This assessment is purely about the device's technical specifications.

7. The type of ground truth used

For the "Navigational Accuracy Analysis," the ground truth is based on technical specifications and precision measurements. The comparison is against a known, presumably highly accurate, reference or measurement standard that determines what constitutes "0 mm error" and "0 degrees error." It is not based on expert consensus, pathology, or outcomes data in the typical sense of a diagnostic device.

8. The sample size for the training set

The provided document describes a medical device (surgical tools with navigation) and its substantial equivalence submission, not a machine learning or AI model that requires a training set. Therefore, there is no mention of a "training set sample size."

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

As mentioned above, this device is not an AI/ML model and therefore does not have a "training set" or a corresponding "ground truth for the training set" in the context of typical AI/ML development.

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