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The Medtronic Midas Rex MR7 System is a pneumatically operated surgical instrument system. The pneumatic motors provide power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery; as well as Ear Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial and sternotomy surgeries.

The Midas Rex MR7 Pneumatic High Speed System includes a pneumatic motor; either the MR7 option which is foot controlled or the MR7t option which is finger controlled. A coaxial hose system, designed with an inner high-pressure supply hose located within an exhaust hose, connects the motor to the foot controller. One end of the coaxial hose system is permanently attached to the motor. The inner high-pressure hose supplies the compressed gas to the internal components of the motor. The outer hose captures the exhausted gas from the internal components of the motor and transports this exhaust gas to the diffuser section of the lubricant diffuser cartridge located on the foot control end of the hose at floor level. This self-contained lubricant/diffuser system consists of two components; a permanently attached receptor base on the foot control connector section of the hose and a disposable lubricant/diffuser cartridge. The cartridge provides two functions; the lubrication for the internal components of the motor and the capture of the exhausted gas from the motor. the foot or finger controller is used to activate the flow of compressed air or nitrogen (gas) into the pneumatic motor and is connected to the pressure regulator of the gas supply system through the regulator hose. The Midas Rex MR7 Pneumatic High Speed System is intended to be used with all existing Midas Rex Legend attachments and dissecting tools previously cleared through K020069.

The provided text describes the Medtronic Midas Rex MR7 Pneumatic High Speed System, a pneumatically operated surgical instrument system. The submission (K090112) is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics in the way one might see for a diagnostic AI device.

Therefore, the requested information elements related to specific performance criteria, ground truth, sample sizes for training/testing, expert adjudication, and MRMC studies, which are typical for AI/diagnostic device evaluations, are not applicable in this context.

This document focuses on regulatory approval through substantial equivalence based on bench testing.

Here's the relevant information based on the provided text:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The testing mentioned is "laboratory bench testing," which typically involves engineering-focused stress, durability, and functional tests rather than data-driven performance metrics on a "test set" of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the evaluation is based on bench testing for substantial equivalence of a surgical instrument, not on expert-adjudicated performance for a diagnostic device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable for the reasons stated above.

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

An MRMC study is not applicable as this is a surgical instrument, not an AI-powered diagnostic device.

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

This is not applicable as this is a surgical instrument, not an algorithm.

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

The "ground truth" in this context would be the functional specifications and performance characteristics of the predicate device. The MR7 system was tested to demonstrate that its performance characteristics were "substantially equivalent" to these established characteristics.

8. The sample size for the training set

This is not applicable as this is a physical medical device, not an AI/algorithm that requires a training set.

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

This is not applicable for the reasons stated above.

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