(17 days)
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.
§ 890.5100 Immersion hydrobath.
(a)
Identification. An immersion hydrobath is a device intended for medical purposes that consists of water agitators and that may include a tub to be filled with water. The water temperature may be measured by a gauge. It is used in hydrotherapy to relieve pain and itching and as an aid in the healing process of inflamed and traumatized tissue, and it serves as a setting for removal of contaminated tissue.(b)
Classification. Class II (special controls). The device, when it is a hydromassage bath or a powered sitz bath, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.