(120 days)
The LEGEND® Power Adapter is intended to be used with the MIDAS REX® LEGEND® System. When the LEGEND® Power Adapter is attached to the MIDAS REX® LEGEND® System, the MIDAS REX® LEGEND® System motors provide power to operate removable rotating surgical cutting tools and their accessories intended for neurosurgery, including craniotomy and spinal surgery; as well as Ear Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, and sternotomy surgeries.
The LEGEND® Power Adapter is a stainless steel adapter that can be used with the MIDAS REX® LEGEND® System to provide power to MEDTRONIC rotating surgical cutting tools. The LEGEND® Power Adapter provides a 20:1 gear ratio reduction when used with the MIDAS REX® LEGEND® System.
The provided text describes the LEGEND® Power Adapter and mentions a study conducted to demonstrate its performance. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Function appropriately when attached to the MIDAS REX® LEGEND® Power Systems (as tested by dynamometer). | The subject adapter successfully met the acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size used for the dynamometer testing. It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The study described is a performance test (dynamometer testing) of a mechanical adapter, not a study requiring expert interpretation or ground truth establishment in the traditional sense of clinical or image-based studies.
4. Adjudication Method for the Test Set:
Not applicable. As noted above, this was a performance test, not a study requiring adjudication of expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The study focuses on the mechanical performance of the adapter.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Not applicable. The "device" in question is a mechanical power adapter, not an algorithm, so the concept of standalone or human-in-the-loop performance for an algorithm does not apply. The dynamometer testing assesses the standalone mechanical performance of the adapter.
7. The Type of Ground Truth Used:
The "ground truth" for this device would be its ability to function appropriately and consistently deliver the specified gear ratio reduction (20:1) and power, as measured by dynamometer testing. It's essentially a direct measurement of mechanical performance against engineering specifications.
8. The Sample Size for the Training Set:
Not applicable. There is no mention of a training set as this is not a machine learning or AI-based device.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. There is no training set mentioned.
§ 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).