(67 days)
The RP Lite 760R is indicated for the temporary relief of minor muscle aches and for temporary increase in blood circulation to the treated areas in people who are in good health.
The RP Lite 760R simulates kneading and stroking of tissues by using an inflatable garment.
Not Found
The provided text is a U.S. FDA 510(k) clearance letter for a medical device called "RP Lite 760R". It states that the device is substantially equivalent to legally marketed predicate devices for the indications for use. However, this document does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.
The FDA 510(k) clearance process primarily establishes substantial equivalence based on indications for use, technological characteristics, and safety/effectiveness data compared to a predicate device. It does not typically detail the specific performance metrics, acceptance criteria, or the results of the rigorous clinical or technical studies that would be necessary to populate a table like the one requested.
Therefore, I cannot fulfill your request using only the provided text, as the information you're asking for (acceptance criteria, specific study details, sample sizes, ground truth establishment, etc.) is not present in this regulatory clearance letter.
To answer your question, information from a separate submission document (e.g., the 510(k) submission itself, a clinical study report, or a technical performance evaluation document) would be required.
§ 890.5650 Powered inflatable tube massager.
(a)
Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.(b)
Classification. Class II (performance standards).