Search Results
Found 1 results
510(k) Data Aggregation
K Number
K984035Device Name
XK-95 HIGH SPEED MOTOR DRILL SYSTEMManufacturer
Date Cleared
1999-06-03
(203 days)
Product Code
Regulation Number
882.4310Type
TraditionalPanel
NeurologyReference & Predicate Devices
N/A
Why did this record match?
Device Name :
XK-95 HIGH SPEED MOTOR DRILL SYSTEM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
High Speed Drall Syst પ્રાહ-95 for use during neurological to provide power to ope proc or attachments acı assurili
Device Description
Not Found
AI/ML Overview
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.
Ask a Question
Ask a specific question about this device
Page 1 of 1