(85 days)
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.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Intended Use: Same as predicate device | The Midas Rex MRIV pneumatic motor is designed for skull based and other microsurgical applications. (Same as predicate) |
| Technological Characteristics: Same or equivalent to predicate, raising no new safety/effectiveness questions | Material changes (e.g., Titanium alloy for some components) are described, but the document asserts "same technological characteristics in design properties and features, quality and energy source as the predicate devices." No new safety/effectiveness issues are raised by these changes. |
| Safety: Device is as safe as predicate | Implicitly accepted by the FDA's clearance letter based on the submission. Specific safety testing results are not detailed in this summary. |
| Effectiveness: Device is as effective as predicate | Implicitly accepted by the FDA's clearance letter based on the submission. Specific effectiveness testing results are not detailed in this summary. |
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.
§ 882.4370 Pneumatic cranial drill motor.
(a)
Identification. A pneumatic cranial drill motor is a pneumatically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.(b)
Classification. Class II (performance standards).