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510(k) Data Aggregation
(17 days)
SUPERIOR BATH, MODEL 6300
The Superior Bath is intended for bathing patients and/or residents of nursing homes, hospitals, and assisted living facilities. These baths are to be given by trained personnel only.
Superior Bath Model 6300
I apologize, but the provided text from the FDA 510(k) clearance letter for the "Superior Bath Model 6300" does not contain any information regarding:
- Acceptance criteria for performance.
- Results of a study to prove the device meets acceptance criteria.
- Details about sample sizes (training or test sets).
- Data provenance.
- Number or qualifications of experts.
- Ground truth establishment or type.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance studies.
The document is a standard FDA clearance letter confirming that the device, a bath for patients, is substantially equivalent to a legally marketed predicate device. It defines the "indications for use" as "The Superior Bath is intended for bathing patients and/or residents of nursing homes, hospitals, and assisted living facilities. These baths are to be given by trained personnel only."
Therefore, I cannot fulfill your request for the tables and study details based on the information provided in the input.
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