(107 days)
The Electronic Pulse Stimulator MDTS100 is to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (leg) due to strain from exercise or normal household and work activities.
The Electronic Pulse Stimulator is powered by internal battery. It is intended for at home use in delivering electric pulses to tired and sore muscles. These pulses are generated by the device & delivered through electrode pads placed on the skin. The device has 7 stimulation modes: Model-Mode 7. These stimulation modes can be selected by pressing the MODE button on the front of the unit. The device generates small pulses of electrical current. It transmits these pulses to the user's skin through adhesive electrode pads, which activates the nerves below and temporarily relieves pain related to soreness. Its accessories include connecting wires, electrode pads, 2 AAA batteries. The device is for over the counter use. The device does not contain drug or biological products. The device includes Bluetooth functionality, however, in this model of the device, the Bluetooth functionality is not used.
This document is a 510(k) premarket notification for an Electronic Pulse Stimulator (Model MDTS100), seeking clearance for market. The core purpose of this submission is to demonstrate substantial equivalence to a predicate device, not to prove clinical effectiveness through a standalone study with defined acceptance criteria for a novel AI/device performance.
Therefore, the requested information regarding acceptance criteria, performance tables, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable in the context of this 510(k) submission.
Explanation:
- Device Type: The device is an Electronic Pulse Stimulator, a transcutaneous electrical nerve stimulator (TENS) for pain relief. TENS devices are well-established medical devices.
- Regulatory Pathway (510(k)): The 510(k) pathway "demonstrates that the device is at least as safe and effective as a legally marketed predicate device that is not subject to premarket approval (PMA)." It primarily relies on demonstrating substantial equivalence in technological characteristics, intended use, and safety/performance without requiring new clinical efficacy trials for established device types unless there are significant differences that raise new questions of safety or effectiveness.
- Stated Testing: The document mentions various engineering and safety tests, such as biocompatibility, electrical safety, EMC, performance bench tests (e.g., output amplitudes, pulse durations), and software verification/validation. These tests ensure the device meets established engineering and safety standards, and its performance parameters are within acceptable ranges for a TENS device.
- Absence of Clinical Testing: The document explicitly states: "The clinical testing was not needed in this submission." This confirms that efficacy was not assessed through a clinical trial with human subjects.
- Focus on Equivalence: The "Comparison list of the technological characteristics" table (pages 5-7) directly compares the proposed device to the predicate device, emphasizing identical or very similar specifications across all key parameters (e.g., waveform, output voltage/current, pulse duration, frequency, number of output modes). The conclusion (page 8) explicitly states, "The proposed device and the predicate device have same performance specification."
Summary of inapplicable information based on the provided text:
- 1. A table of acceptance criteria and the reported device performance: Not applicable. Performance is established through comparison to a predicate device and engineering benchmarks, not a separate clinical study with predefined acceptance criteria.
- 2. Sample sized used for the test set and the data provenance: Not applicable. No test set involving patient data for clinical performance evaluation is described. System performance (e.g., electrical parameters) is tested on the device itself.
- 3. Number of experts used to establish the ground truth... and qualifications: Not applicable. No "ground truth" for clinical outcomes or diagnoses is established as there is no clinical study.
- 4. Adjudication method: Not applicable. No clinical data requiring adjudication.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is not an AI-assisted diagnostic device, and no MRMC study was conducted.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not feature an AI algorithm.
- 7. The type of ground truth used: Not applicable.
- 8. The sample size for the training set: Not applicable. No AI model or training set is mentioned for the device's function.
- 9. How the ground truth for the training set was established: Not applicable.
The "study that proves the device meets the acceptance criteria" in this 510(k) context is primarily the bench testing, electrical safety testing, software verification, and the demonstration of substantial equivalence to the predicate device through side-by-side comparison of technical specifications, as detailed in the document. The acceptance criteria for these tests are typically engineering standards and limits rather than clinical performance metrics.
§ 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).