(46 days)
The Pain Therapy Device (Model: DH-P.T.S-I, DH-P.T.S-II, DH-P.T.S-IIA, DH-P.T.S-IIB, DH-CP-I): TENS: - For relief of pain and management of pain associated with sore and aching muscles in the upper and lower back, back of the neck, upper extremities (shoulder and arm), lower extremities (leg and feet) due to strain from exercise, work or normal household work activities by applying transcutaneous electrical current to stimulate the nerves. - For relief of pain associated with arthritis. - For symptomatic relief and management of chronic intractable pain EMS: - To stimulate healthy muscles in order to improve and facilitate muscle performance. - To temporarily increase local blood circulation in healthy muscles. NMES: - For relaxation of muscle spasm. - Increase of blood flow circulation. - Prevention or retardation of disuse muscle atrophy. - Muscle re-education. - Maintaining or increasing range of motion. - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. - For Users with conditions or diseases that are associated with impaired (poor) blood flow in the legs/ankle/feet. NMES through the foot electrodes is intended to use as an adjunctive treatment (as an additional treatment to your existing treatment) to temporarily reduce lower extremity pain, swelling and cramping.
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This document is a marketing clearance letter from the FDA for a Pain Therapy Device (models DH-P.T.S-I, DH-P.T.S-II, DH-P.T.S-IIA, DH-P.T.S-IIB, DH-CP-I).
It is NOT a report or study that details acceptance criteria and device performance. The letter states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices, which means it clears the device for marketing. However, it does not provide details of specific performance testing, clinical study results, or the methodology (sample size, expert qualifications, etc.) used to establish performance.
Therefore, I cannot provide the requested information because the provided text does not contain:
- A table of acceptance criteria and reported device performance: This document does not describe specific performance metrics or their acceptable thresholds.
- Sample size used for the test set and data provenance: There is no mention of a test set, its size, or the origin of any data.
- Number of experts used to establish ground truth and their qualifications: No information about expert involvement in establishing ground truth is present.
- Adjudication method for the test set: No test set means no adjudication method is discussed.
- Multi-reader multi-case (MRMC) comparative effectiveness study: This is not a study report, so no MRMC study details are provided.
- Standalone (algorithm only) performance: This device is a physical electromedical device, not an AI algorithm.
- Type of ground truth used: Not applicable as this is not a study of an AI or diagnostic device.
- Sample size for the training set: Not applicable; this is a hardware device.
- How ground truth for the training set was established: Not applicable.
The document is solely an FDA clearance letter based on substantial equivalence to existing devices, not a detailed technical or clinical performance report.
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).