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The Medtronic MR8 Drill System is incision/cutting, removal, drilling, and sawing of soft and hard tissue, bone, and biomaterials in Neurosurgical (Craniofacial including craniotomy); Ear, Nose and Throat (ENT), Maxillofacial, Orthopedic, Arthroscopic, Spinal, Sternotomy, and General Surgical Procedures.

Additionally, the MR8 Drill System is indicated for the incision/cutting, and sawing of soft and hard tissue, bone, and biomaterials during open and minimally invasive spine procedures, which may incorporate application of various surgical techniques during the following lumbar spinal procedures:

• Lumbar Microdiscectomy
• Lumbar Stenosis Decompression
• Posterior Lumbar Interbody Fusion (PLIF)
• Transforaminal Lumbar Interbody Fusion (TLIF)
• Anterior Lumbar Interbody Fusion (ALIF)
• Direct Lateral Interbody Fusion (DLIF)

The Midas Rex MR8 ClearView Tools are used only in conjunction with the MR8 Drill System to perform as intended. Please refer to the Midas Rex MR8 Drill System and associated User's Guides for the Indications of Use.

The Medtronic MR8TM Drill System is comprised of both Electric and Pneumatic powered, rotary cutting handpieces, attachments, surgical dissecting tools, and accessories designed to remove soft and hard tissue, bone, and biomaterials during various surgical procedures. The surgical dissecting tools are provided sterile and are single use, while the rest of the system components are provided non-sterile and are reusable.

The Midas Rex™ MR8TM ClearView™ Tools are designed to interface with Midas Rex™ MR8 Drill System motor to support bone and tissue removal during surgical procedures. The Midas Rex™ MR8™ ClearView™ Tools are part of a larger portfolio of tools and accessories designed to be used with the Midas Rex™ MR8 System/Platform.

This document describes the Medtronic MR8 Drill System and Midas Rex MR8 ClearView Tools. The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than independent performance claims against specific acceptance criteria. Therefore, the information provided primarily compares the device to existing predicate devices.

1. Table of Acceptance Criteria & Reported Device Performance:

The document does not explicitly present a table of "acceptance criteria" for the overall device in the typical sense of a clinical trial or performance study with defined thresholds. Instead, it details performance testing conducted for the Midas Rex MR8 ClearView Tools to ensure functionality with the MR8 Drill system and comparability to predicate devices. The "acceptance criteria" for this testing appear to be qualitative (e.g., "similar and/or better," "same or more," "below the burn threshold").

No additional testing was performed on the MR8 Drill System itself as there were no design changes to it for this submission. The Midas Rex MR8 ClearView Tools are the new elements being evaluated for their compatibility and performance within the existing MR8 Drill System.

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

The document does not specify the sample size for the individual performance tests (Tool Chatter and Hand Vibration, Irrigation Rate vs IPC Setting, Thermal Performance)conducted on the Midas Rex MR8 ClearView Tools.

The provenance of the data is not explicitly stated (e.g., country of origin, retrospective/prospective). However, given that this is a 510(k) submission for a medical device by Medtronic, a US-based company, it is highly likely that the testing was conducted under standard quality systems and engineering practices, likely within a controlled laboratory environment. The tests appear to be engineering/bench testing rather than clinical studies with human subjects.

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

This information is not applicable to the type of testing described. The tests are engineering performance tests, not clinical evaluations requiring expert interpretation of ground truth (e.g., diagnosis from medical images).

4. Adjudication Method for the Test Set:

This information is not applicable. The tests are objective, quantitative measurements or qualitative observations during engineering performance testing, not subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

This information is not applicable. The device described is a surgical drill system and associated tools, not an AI-assisted diagnostic or interpretative system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:

This information is not applicable. This is not an AI-driven device or algorithm. The performance evaluation focuses on the mechanical and operational characteristics of the surgical tools.

7. The Type of Ground Truth Used:

The "ground truth" for the performance tests effectively refers to the physical and functional parameters of the device as designed and expected, as well as established safety thresholds (e.g., burn threshold for thermal performance). It's based on engineering specifications and safety standards relevant to surgical instruments.

8. The Sample Size for the Training Set:

This information is not applicable. No "training set" is mentioned as this is not a machine learning or AI-driven device.

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

This information is not applicable. As there is no training set mentioned, there is no ground truth established for one.

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The Medtronic MR8 Drill System is indicated for the incision/cutting, removal, drilling, and sawing of soft and hard tissue, bone, and biomaterials in Neurosurgical (Craniofacial including craniotomy); Ear, Nose and Throat (ENT), Maxillofacial, Orthopedic, Arthroscopic, Spinal, Sternotomy, and General Surgical Procedures.

The MR8 Drill System consists of electric and pneumatic drill handpieces, attachments, surgical dissecting tools, and system accessories. The handpieces, attachments, and system accessories are provided non-sterile and are reusable. The surgical dissecting tools are provided sterile and are single use.

The document provided is a 510(k) summary for the Medtronic MR8 Drill System. It describes the device, its intended use, and comparison to predicate devices, along with a summary of performance testing. However, it does not provide the detailed acceptance criteria and study information typically found in a clinical study report for an AI/ML medical device. The MR8 Drill System is a surgical drill, not an AI/ML device.

Therefore, many of the requested sections below, such as details on AI performance, sample sizes for training/test sets, expert ground truth establishment, adjudication methods, and MRMC studies, are not applicable to this submission. The information provided primarily focuses on the substantial equivalence of a physical surgical device.

1. Table of Acceptance Criteria and the Reported Device Performance

The document does not explicitly state numerical acceptance criteria for the performance tests in the same way typical for AI/ML performance, but rather states the criteria implicitly by comparing to predicate devices or conformity to standards.

Regarding AI/ML Specific Information (Many are Not Applicable to this Device):

This device is a surgical drill system, a physical medical device, and not an AI/ML-driven diagnostic or therapeutic device. Therefore, the following sections are largely not applicable based on the provided FDA submission summary.

2. Sample size used for the test set and the data provenance: Not applicable. The "test set" for this device involved physical product testing and cadaveric use. Specific sample sizes for the cadaveric study are not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable in the context of AI/ML ground truth. For the cadaveric study, professional users (surgeons/medics) would have evaluated the device, but specific numbers and qualifications are not detailed in this summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for this type of device and study.
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: Not applicable, as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the cadaveric use, the "ground truth" would be the subjective and objective assessment of the device's performance and acceptability by the users during surgical simulation. For other tests, it's conformance to technical specifications and safety standards.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

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