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The Midas Rex MRIV pneumatic motor provides power to operate an assortment of rotating surgical cutting tools. The motor is intended for skull based bone dissection and other microsurgical applications, including specialties in which a lightweight, high-speed bone dissecting system can be used in or near a magnetic field.

The Midas Rex MRIV motor is an Ergonomically, designed lightweight variable speed motor, with a small overall diameter. The motor provides pneumatic power to operate removable attachments and rotating surgical dissecting tools. The motor operates at variable speeds on operating pressures range from 20-150 psi.

This document (K972289) is a 510(k) premarket notification for a medical device submitted to the US FDA. The 510(k) pathway is used to demonstrate that a device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and technological characteristics, or if there are differences, those differences do not raise new questions of safety and effectiveness.

The document does not describe a study that proves the device meets specific acceptance criteria in the manner one would typically expect for a software or AI/ML device. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Here's an analysis based on the provided text, addressing your questions where applicable given the nature of a 510(k) for a pneumatic motor:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not contain a table of acceptance criteria and reported device performance in the context of a clinical or performance study. The "performance" described is largely comparison of technological characteristics to a predicate device. The acceptance criteria for substantial equivalence are met by showing that the new device is as safe and effective as the predicate.

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

Not applicable. This is a mechanical device (pneumatic motor), not a diagnostic device relying on a "test set" of data for performance evaluation in the way a software or AI/ML device would. The "test" here involves comparing the device's technical specifications and intended use to a predicate device. There is no mention of a "test set" of patient data or clinical images.

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

Not applicable. This is a mechanical device. "Ground truth" in the context of expert consensus on medical conditions is not relevant for this type of submission. The "ground truth" for a 510(k) for a pneumatic motor would relate to its manufacturing specifications, mechanical properties, and performance parameters, verified through engineering tests rather than expert interpretation of clinical data.

4. Adjudication Method for the Test Set

Not applicable. See point 3.

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. This is a pneumatic surgical motor, not an AI or imaging diagnostic device. MRMC studies are used for evaluating the performance of diagnostic tools (often imaging-based) where human reader interpretation is involved.

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

Not applicable. This is a mechanical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission primarily relies on engineering specifications and comparative analysis to the predicate device. For example, the material specifications (e.g., Titanium Alloy, Stainless Steel) are a form of ground truth for the device's composition. Performance characteristics (like operating pressure range 20-150 psi) would be verified through engineering testing, which serves as the "ground truth" for its functional parameters. There is no pathology, outcomes data, or expert consensus on clinical cases mentioned.

8. The Sample Size for the Training Set

Not applicable. This is a mechanical device. There is no concept of a "training set" in the context of an AI/ML algorithm for this type of submission.

9. How the Ground Truth for the Training Set was Established

Not applicable. See point 8.

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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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To provide power to operate removable rotating surgical cutting tools or drill bits on a patient's skull.

The Midas Rex Motors (Midas I, Midas II and Convertible models) are air-powered, rotating motors designed to operate at 20-120 psi or at up to 200 psi. The motor is connected to an air-supply source by means of a stainless steel joint and a plastic air hose with inner rubber pressure hose. The motors are constructed of stainless steel, aluminum and brass and are designed to operate at 20-120 psi or at up to 200 psi with the same performance characteristics. Depending on user preference, the 200 psi motor is available in either a round or hexagonal casing, approximately 0.75 inch in diameter. Similarly, the 120 psi motor can be supplied in either a round or hexagonal casing in diameters of approximately 0.375, 0.5 or 0.75 inch. Again depending on user preference, the joint connecting the motor to the air hose can be equipped with a rotating cuff at one or both ends, allowing the motor and/or air hose to swivel independently with respect to the joint, thus providing greater freedom of movement during surgical procedures and avoiding possible "kinking" of the air hose. Thus, a variety of device configurations are possible based on the surgeon's personal preference, as shown below:

This looks like a 510(k) submission for a medical device. Based on the provided text, the device is a pneumatic surgical motor (Midas Rex Motors). The submission is a comparison to a predicate device (Midas Rex Whirlwind™ Motor) to demonstrate substantial equivalence, not a study proving the device meets acceptance criteria in the context of an AI/ML medical device.

Therefore, many of the requested elements of the prompt (such as acceptance criteria, sample sizes, expert ground truth, MRMC studies, standalone performance, training sets, etc.) are not applicable to this type of device and submission. This is a mechanical device, not an AI/ML-driven diagnostic or prognostic tool.

However, I can extract the relevant information from the provided text as it pertains to the comparison to the predicate device, which serves as the "proof" of its safety and effectiveness for a 510(k) submission.

Here's an interpretation based on the given document:

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

The "acceptance criteria" for a 510(k) submission like this are demonstrating substantial equivalence to a legally marketed predicate device. The performance of the new Midas Rex Motors is presented in comparison to the predicate (Whirlwind™ Motor).

Explanation of "Acceptance Criteria": For a 510(k), the "acceptance criteria" are generally met by demonstrating that the new device is as safe and effective as the predicate device. This often involves showing similar technological characteristics and performance specifications for the intended use. In this case, the table shows that the new Midas Rex Motors have similar or expanded capabilities/configurations while maintaining core performance characteristics (RPM, Stall Torque) within acceptable ranges of the predicate. The "Intended Use" is also shown as substantially equivalent.

The following points are NOT APPLICABLE to this 510(k) submission as it is for a mechanical surgical instrument, not an AI/ML device.

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

• Not applicable. This device is evaluated based on its mechanical specifications and comparison to a predicate, not clinical data sets in the way AI/ML devices are.

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)

• Not applicable. Ground truth in the context of data interpretation by experts is not relevant here. The "ground truth" for a mechanical device is its engineering specifications and physical performance.

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

• Not applicable. Adjudication methods are used in studies involving human interpretation of data, which is not the case here.

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. This is a mechanical device, not related to human readers or AI assistance.

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

• Not applicable. This device does not involve algorithms or AI.

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

• Not applicable. The "ground truth" for this device would be its validated engineering specifications and functional testing, not expert consensus or pathology on patient data.

8. The sample size for the training set

• Not applicable. This device does not involve a "training set" in the context of machine learning.

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

• Not applicable. See point 8.

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