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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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The Midas Rex Motor is designed for skull base and other microsurgical applications, including otolaryngology, ear, nose and throat, craniofacial and maxillofacial specifications in which a small, lightweight, high speed bone dissection system is desired.

Ergonomically, designed lightweight motor featuring small, overall diameter for comfort and ease of handling. The Midas Rex III motor operates at variable speeds. Operating pressures range from 20-150 psi (2-10 bar), with a suggested operating pressure of 100 psi (6.9 bar). 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 microsystems, and the micro mini drill guide.

This document is a 510(K) summary for a medical device (Midas Rex Motor (Midas III) - a pneumatic cranial drill motor). The provided text does not contain any information about acceptance criteria, device performance metrics, or study designs that would typically be found in a clinical study report or a more detailed regulatory submission.

The content focuses on:

• Administrative details: Date prepared, submitter information, contact person, trade name, common/classification name, device classification, and predicate devices.
• Description of the device: Ergonomic design, lightweight, small diameter, variable speeds (20-150 psi, suggested 100 psi), quick disconnect system.
• Statement of Intended Use: Skull base and other microsurgical applications (otolaryngology, ENT, craniofacial, maxillofacial) where a small, lightweight, high-speed bone dissection system is desired.
• Technological Characteristics: States the modified device has the "same technological characteristics (i.e., design, material, energy source) as the predicate device" and that "The specifications are as follows:", but then the specifications themselves are not provided in the excerpt.

Therefore, I cannot provide the requested information because it is not present in the given text. A 510(K) summary typically focuses on demonstrating substantial equivalence to a predicate device, and while it may reference performance data, the detailed study information is usually in a separate, more comprehensive submission.

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