(145 days)
The 2-in-1 Abdominal Muscle Training & Back Pain Relief System has two modes of stimulation; a transcutaneous electrical nerve stimulation (TENS) BP-313 mode and a powered muscle stimulation (PMS) TS-212 mode.
The TENS (BP-313 Mode) is indicated for temporary relief of pain associated with sore and aching muscles in the waist. back, arm, leg due to strain from exercise or normal household and work activities.
The PMS (TS-212 Mode) is indicated for the improvement of abdominal muscle tone, for strengthening of abdominal muscles and for the development of a firmer abdomen. This system is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.
2-in-1 Abdominal Muscle Training & Back Pain Relief System is a portable multifunctional device, offering both Transcutaneous Electronic Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) qualities.
2-in-1 Abdominal Muscle Training & Back Pain Relief System has 12 operation modes, which can give certain electrical pulse through 4 of electrode pads placed on the skin to help users to enjoy body stimulation.
The support belt which fastens around your waist provides appropriate stimulation position for a quick and easy exercise for users of all different waist sizes. The adhesive pads adhere to the belt to conduct the signal from the unit to your abdominal muscles. Snap cables are for connecting the stimulator and the support belt. Each unit comes with one battery (6F22/1604) so you can start exercising right away.
The provided document is a 510(k) Summary for a medical device called "2-in-1 Abdominal Muscle Training & Back Pain Relief System." This type of document is submitted to the FDA to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. As such, it focuses on comparing the new device to existing ones rather than detailing a specific clinical study for the new device's performance against defined acceptance criteria in the format requested.
Therefore, the specific information about detailed acceptance criteria, a dedicated study proving performance, sample sizes for test/training sets, experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for this specific device's clinical performance is not present in the provided text.
The document primarily outlines design validation tests performed to ensure electrical safety, electromagnetic compatibility, biocompatibility, and software functionality, as well as a waveform test to verify output specifications. These are essential for establishing substantial equivalence but are not clinical performance studies with acceptance criteria in the sense of demonstrating diagnostic accuracy or treatment efficacy in human subjects.
However, I can extract information related to the tests performed and the standards they comply with:
1. A table of acceptance criteria and the reported device performance
The document does not provide specific quantitative acceptance criteria or reported device performance in the format of a clinical trial. Instead, it states that the device was evaluated against various standards. The "performance" in this context refers to compliance with these standards and the device's technical specifications.
| Test Category | Acceptance Criteria (Stated as Compliance Standard) | Reported Device Performance |
|---|---|---|
| Electrical Safety | IEC 60601-1 and IEC 60601-2-10 standards | Complies with IEC 60601-1 and IEC 60601-2-10 requirements. |
| Electromagnetic Compatibility | IEC 60601-1-2 standard | Complies with IEC 60601-1-2 requirements. |
| Biocompatibility | ISO 10993-5 and ISO 10993-10 standards | Complies with ISO 10993-5 and ISO 10993-10 requirements for user-contacting materials. |
| Software Verification/Validation | FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices" | Complies with FDA guidance requirements. |
| Waveform Test (Output Specifications) | FDA "Guidance for Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use" and "Guidance for Powered Muscle Stimulator for Muscle Conditioning" | Verified output specifications according to FDA guidance. (Specific parameters like Voltage, Current, Pulse Duration, etc., are compared to predicate devices and deemed compliant with standards/guidance). |
| Patient Leakage Current | Comply with IEC 60601-1 and IEC 60601-2-10 | AC: 54.5µA, DC: 0.5µA (Subject Device) vs. Comply with IEC 60601-1 and IEC 60601-2-10 (Predicate) |
| Average DC current through electrodes (no pulses) | Comply with IEC 60601-1 and IEC 60601-2-10 | 0A (Subject Device) vs. |
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).