(113 days)
Transcutaneous Electrical Nerve Stimulator (TENS) can be used for the following applications (Available for WR-2603/2603A, and TENS function of WR-2605/ 2605A):
· For symptomatic relief of chronic intractable pain
Electrical Muscle Stimulation (EMS) on can be used for the following applications (Available for WR-2604/2604A, and EMS function of WR-2605/ 2605A):
- · Relax muscle spasms
- Prevent or retard disuse atrophy
- Increase local blood circulation
- · Re-educate muscles
- · Maintain or increase the range of motion
Not Found
The provided text is a Food and Drug Administration (FDA) 510(k) clearance letter for the WELL LIFE Rx Wireless TENS/EMS Stimulator. This document indicates that the device has been deemed substantially equivalent to a legally marketed predicate device.
Crucially, this document does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the manner you've outlined for diagnostic or AI-driven medical devices.
Instead, the 510(k) process focuses on demonstrating equivalence to another legally marketed device, often through a comparison of technological characteristics, safety, and performance. While performance data may be submitted, it's typically to show that the new device performs as intended and is as safe and effective as the predicate, rather than meeting predefined numerical acceptance criteria against a clinical ground truth as would be seen in studies for novel diagnostic algorithms.
Therefore, I cannot populate the table or answer most of your specific questions based on the provided text. The requested information (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is typically found in detailed clinical validation reports that are not part of this summary FDA clearance letter.
Here's what I can and cannot infer from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | Not specified in document |
Explanation: The document states the device is "substantially equivalent" to predicate devices. This implies it meets the performance and safety standards of those predicates, but it doesn't provide specific numerical acceptance criteria or performance metrics (like sensitivity, specificity, accuracy) for a new device's performance against a gold standard.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified. The 510(k) process primarily reviews comparisons to predicate devices and engineering/bench testing, not necessarily large-scale clinical trials with defined test sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The document does not describe a study involving human experts establishing ground truth for a test set.
4. Adjudication method for the test set:
- Not applicable. The document does not describe a study with a test set requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a Transcutaneous Electrical Nerve Stimulator (TENS) and Electrical Muscle Stimulator (EMS), not an AI-driven diagnostic tool that would typically involve an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a stimulator, not an algorithm. Its performance is inherent in its electrical output and design.
7. The type of ground truth used:
- Not applicable. No "ground truth" (in the context of a diagnostic or AI study) is mentioned. Compliance with safety and performance standards for TENS/EMS devices would be verified through engineering tests and comparison to predicates.
8. The sample size for the training set:
- Not applicable. No "training set" is relevant for this type of device and submission.
9. How the ground truth for the training set was established:
- Not applicable.
In summary: The provided document is an FDA clearance letter for a medical device (TENS/EMS stimulator) based on substantial equivalence. It does not contain the detailed methodology and results of a clinical study designed to establish acceptance criteria or evaluate performance against a ground truth, as would be expected for a diagnostic or AI-enabled device.
§ 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).