(55 days)
Diathermy Component. Indications for Use: To generate deep heating within body tissues for the treatment of conditions such as relief of pain, muscle spasms, and joint contractures.
Muscle Stimulator Component To increase local blood flow, muscle re-education, relaxation of muscle spasms, prevention or retardation of disuse atrophy, and immediate post surgical stimulation of calves to prevent deep vein thrombosis.
SeliTherm Model C100
The provided text is a 510(k) premarket notification letter from the FDA for the SeliTherm Model C100 device. This document does not contain the kind of detailed information requested about acceptance criteria and study designs that would typically be found in a clinical study report or a more comprehensive premarket submission.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or their data provenance.
- Information about experts used for ground truth.
- Adjudication methods.
- Details on multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
- Standalone algorithm performance.
- Types of ground truth used (pathology, outcomes data, etc.).
- Sample size for training sets.
- How ground truth for training data was established.
The letter merely states that the device is "substantially equivalent" to legally marketed predicate devices for the indications for use listed. This phrase implies that the FDA has determined the new device performs as intended and is as safe and effective as a similar device already on the market, but it does not provide the specifics of the data used to reach that conclusion.
Therefore,Based on the provided text, I cannot answer the questions about the acceptance criteria and the study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter, which confirms substantial equivalence to a predicate device but does not detail the specific performance studies, acceptance criteria, or methodology of such studies.
§ 890.5290 Shortwave diathermy.
(a)
Shortwave diathermy for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. A shortwave diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body electromagnetic energy in the radiofrequency (RF) bands of 13.56 megahertz (MHz) or 27.12 MHz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.(2)
Classification. Class II (performance standards).(b)
Nonthermal shortwave therapy —(1)Identification. A nonthermal shortwave therapy is a prescription device that applies to the body pulsed electromagnetic energy in the RF bands of 13.56 MHz or 27.12 MHz and that is intended for adjunctive use in the palliative treatment of postoperative pain and edema of soft tissue by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section.(2)
Classification: Class II (special controls). The device is classified as class II. The special controls for this device are:(i) Components of the device that come into human contact must be demonstrated to be biocompatible.
(ii) Appropriate analysis/testing must demonstrate that the device is electrically safe and electromagnetically compatible in its intended use environment.
(iii) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Non-clinical performance testing must characterize the output waveform of the device and demonstrate that the device meets appropriate output performance specifications. The output characteristics and the methods used to determine these characteristics, including the following, must be determined:
(A) Peak output power;
(B) Pulse width;
(C) Pulse frequency;
(D) Duty cycle;
(E) Characteristics of other types of modulation that may be used;
(F) Average measured output powered into the RF antenna/applicator;
(G) Specific absorption rates in saline gel test load or other appropriate model;
(H) Characterization of the electrical and magnetic fields in saline gel test load or other appropriate model for each RF antenna and prescribed RF antenna orientation/position; and
(I) Characterization of the deposited energy density in saline gel test load or other appropriate model.
(iv) A detailed summary of the clinical testing pertinent to use of the device to demonstrate the effectiveness of the device in its intended use.
(v) Labeling must include the following:
(A) Output characteristics of the device;
(B) Recommended treatment regimes, including duration of use; and
(C) A detailed summary of the clinical testing pertinent to the use of the device and a summary of the adverse events and complications.
(vi) Nonthermal shortwave therapy devices marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with these special controls.