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510(k) Data Aggregation
(28 days)
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(15 days)
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(195 days)
Provides mobility for the disabled.
Not Found
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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(112 days)
"Provides mobility for the disabled".
Not Found
This document is a 510(k) clearance letter from the FDA for a device called "Solo" (and "Safari scooters"). It states that the device is substantially equivalent to legally marketed predicate devices and can be marketed.
However, the provided text does not contain any information regarding acceptance criteria, device performance, study details, sample sizes, expert qualifications, adjudication methods, or ground truth establishment.
The letter is a regulatory approval, not a scientific study report. It simply states the device's intended use: "Provides mobility for the disabled."
Therefore, based only on the provided input, I cannot answer the questions about acceptance criteria, study details, or performance.
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