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The Midas Rex III pneumatic motor is designed for used in Ear, Nose and Throat, Otolaryngology and Maxillofacial specifications.

Ergonomically designed motor, 62 gram in weight, 15 mm in diameter with an overall length of approximately 10.25 centimeters. The Midas Rex III motor operates at variable speeds from 25 to 70 thousand rpm's. Operating pressures range from 20-150 psi (2-10 bar), with a suggested operating pressure of 100-psi (6.9 bar) and approximately 60 thousand rpm. The Midas Rex III has a standard quick disconnect GS dissecting tool and tube attachment system, which includes a fixed or rotating footed attachment, the telescoping micro systems, and the micro mini drill guide attachment.

The provided document is a 510(k) summary for a medical device submitted in 1996. This type of document is for premarket notification to the FDA for medical devices and primarily focuses on demonstrating substantial equivalence to a predicate device already on the market.

It is highly unlikely that a 510(k) summary from 1996 for a pneumatic cranial drill motor will contain acceptance criteria or a detailed study proving performance in the manner you've requested. The information you're asking for (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance of AI, specific ground truth types) is standard for performance evaluations of AI/ML-driven medical devices, which became prevalent much later than 1996.

Therefore, based on the provided text, I cannot extract the information you've requested. The document describes a physical medical device (a surgical drill motor) and its characteristics, not an AI/ML algorithm.

However, I can explain why the information isn't present based on the nature of the document:

• Acceptance Criteria & Reported Performance Table: For mechanical devices like this, acceptance criteria would typically involve engineering specifications (e.g., RPM range, torque, pressure tolerance, material strength, sterility) and performance would be reported against these in internal testing or design validation, but not usually detailed in a public 510(k) summary in this format. The 510(k) focuses on showing it's "as safe and effective as" a predicate, not necessarily detailed performance metrics.
• Sample Size for Test Set & Data Provenance: These concepts are relevant for statistical studies involving data, particularly in AI/ML, not for verifying the mechanical operation of a drill motor in the way described here.
• Number of Experts, Qualifications, Adjudication Method: These are crucial for establishing ground truth in diagnostic or image analysis studies. While experts might be involved in evaluating the usability or safety of a surgical tool, it's not the "ground truth" establishment in the AI sense.
• MRMC Comparative Effectiveness Study: This is specific to evaluating diagnostic AI algorithms against human readers. It's entirely inapplicable to a surgical drill motor.
• Standalone Performance: This term is for AI algorithms operating without human intervention. Again, not relevant to a physical surgical tool.
• Type of Ground Truth Used: For AI, this refers to the definitive labels (e.g., pathology report, clinical outcome). For a drill, "ground truth" would be its engineering specifications and successful (safe, effective) operation in a surgical context, evaluated through validation studies.
• Sample Size for Training Set & Ground Truth for Training Set: These are concepts exclusively for machine learning model development.

In summary, the provided 510(k) document describes a traditional medical device (a surgical drill motor) and does not contain the information requested about acceptance criteria and study details relevant to AI/ML device performance evaluation.

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