(300 days)
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).
| Feature | Acceptance Criteria (Predicate: Whirlwind™ Motor) | Reported Device Performance (Midas I, Midas II, Convertible) |
|---|---|---|
| Construction | Stainless steel, brass and aluminum | Stainless steel, brass and aluminum |
| Case Shape/Diameter | Round/0.75 inch | Round or hexagonal; 0.375, 0.5 or 0.75 inch |
| Motor/Air hose Joint | Straight | Straight, Angled, and Swivel Joint |
| Motor Alignment | Fixed | Fixed or Swivel |
| Hose Alignment | Fixed | Fixed or Swivel |
| Air Operating Pressure | 200 psi | 20-120 psi or 200 psi |
| RPM (000's) | 30-75 | 40-75 (20-120 psi); 30-75 (200 psi) |
| Stall Torque | 1.3-5.3 | 1-5.3 (20-120 psi); 1.3-5.3 (200 psi) |
| Intended Use | To provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. | To provide power to operate removable rotating surgical cutting tools or drill bits on a patient's skull. |
| Sterilization Method | Not explicitly detailed for predicate, but new device specifies compatibility with Ethylene Oxide and Steam Sterilization (Flash/Standard) | Compatibility with Ethylene Oxide and Steam Sterilization (Flash/Standard). Specific cycles and aeration times recommended. |
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.
§ 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).