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510(k) Data Aggregation
K Number
K022993Manufacturer
Date Cleared
2002-12-02
(84 days)
Product Code
Regulation Number
890.3860Type
TraditionalPanel
Physical MedicineReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The Hoveround Rehab Seating System is intended for people using a powered wheelchair and requiring positional change.
Device Description
Not Found
AI/ML Overview
I am sorry, but based on the provided text, there is no information regarding acceptance criteria or a study that proves a device meets such criteria.
The document is a US FDA 510(k) clearance letter for the "Hoveround Rehab Seating System." This letter:
- Confirms that the device is substantially equivalent to a legally marketed predicate device.
- States the regulatory class and product code.
- Outlines general control provisions the manufacturer must adhere to (registration, listing, GMP, labeling, etc.).
- Provides contact information for regulatory compliance.
- Includes the Indications For Use.
It does not contain details about:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or data provenance.
- Number/qualifications of experts for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for training sets.
- How ground truth for training sets was established.
Therefore, I cannot fulfill your request as the necessary information is not present in the provided input.
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