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Found 2 results
510(k) Data Aggregation
K Number
K010606Device Name
SAFARIManufacturer
Date Cleared
2001-03-16
(15 days)
Product Code
Regulation Number
890.3800Type
SpecialPanel
Physical MedicineReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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K Number
K970646Device Name
SAFARIManufacturer
Date Cleared
1997-08-25
(195 days)
Product Code
Regulation Number
890.3800Type
TraditionalPanel
Physical MedicineReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Provides mobility for the disabled.
Device Description
Not Found
AI/ML Overview
The provided documents are a 510(k) clearance letter from the FDA for a device named "Safari," described as a scooter providing mobility for the disabled. This letter indicates that the device has been found substantially equivalent to a legally marketed predicate device.
However, the documents do not contain any information regarding:
- Acceptance criteria
- Reported device performance
- Specific studies conducted
- Sample sizes for test or training sets
- Data provenance
- Number or qualifications of experts
- Adjudication methods
- Multi-reader multi-case (MRMC) comparative effectiveness studies
- Standalone algorithm performance
- Type of ground truth used
- How ground truth was established
The letter is a regulatory approval document and not a clinical study report or a technical performance specification. Therefore, I cannot fulfill your request with the input provided.
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