(203 days)
High Speed Drall Syst પ્રાહ-95 for use during neurological to provide power to ope proc or attachments acı assurili
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The provided text is a clearance letter from the FDA for a medical device called the "XK-95 High Speed Motor Drill System." It confirms that the device is substantially equivalent to a previously marketed device. However, this document does not contain any information regarding:
- Acceptance criteria for the device's performance.
- Study details proving the device meets acceptance criteria.
- Sample sizes for test or training sets.
- Data provenance.
- Number or qualifications of experts for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used.
- How ground truth was established.
This document is solely a regulatory approval letter based on "substantial equivalence" to a predicate device, not a performance study report. Therefore, I cannot fulfill your request for the specific information listed.
§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
(a)
Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.(b)
Classification. Class II (performance standards).