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The Pacific 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. The Pacific Bath will not be marketed for therapeutic or other medical uses.

Pacific Recumbent Height Adjustable Bath

This document is a 510(k) clearance letter from the FDA for a medical device called the "Pacific Recumbent Height Adjustable Bath." It confirms that the device is substantially equivalent to legally marketed predicate devices.

The document does not contain information about acceptance criteria, device performance, ground truth, study design, or sample sizes related to the technical performance or clinical effectiveness of the device.

This type of FDA letter is primarily for regulatory clearance based on substantial equivalence to existing devices, meaning it likely relies on the established safety and performance of those predicate devices rather than requiring new, extensive performance studies with acceptance criteria as one might see for novel technologies or for specific performance claims.

Therefore, I cannot provide the requested information from this document.

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The Cascade Bath is intended for bathing patients and/or residents in nursing homes, hospitals, and assisted living facilities. These baths are to be given by trained personnel only.

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This document is a 510(k) premarket notification from the FDA to Penner Manufacturing Inc. regarding their Cascade Bath Model 6900. It's a clearance letter, not a study report. Therefore, it does not contain any information about acceptance criteria, device performance metrics, study designs, sample sizes, expert qualifications, adjudication methods, or ground truth establishment.

The document's purpose is to state that the FDA has reviewed Penner Manufacturing's notification and determined that the Cascade Bath Model 6900 is "substantially equivalent" to legally marketed predicate devices, allowing them to market the device.

To answer your request, information from a separate study report or regulatory submission (that would have been part of Penner Manufacturing's 510(k) submission but is not included here) would be needed.

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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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