(29 days)
The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain.
The WL-2206D are the device which generates the small true-sine pulses of electrical current. The qenerated current may be delivered to the patient skin and/or underlying nerves through the cable and electrode placed on skin.
The provided text is a 510(k) summary for the IF series True sine interferential stimulator, Model: WL-2206D. It primarily focuses on demonstrating substantial equivalence to a predicate device (WL-2206B) and does not contain detailed information about a specific study comparing performance against acceptance criteria in the way envisioned by the request. The submission emphasizes non-clinical tests and compliance with standards rather than human-data performance studies.
Therefore, many of the requested details about acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment are not available in the provided document.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics in the format of a table as typically seen for AI/diagnostic devices. Instead, the "acceptance criteria" are implied by adherence to voluntary standards and the claim of substantial equivalence to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with ANSI/AAMI, NS4-1985 | Performed |
| Compliance with EN 60601-1 | Performed |
| Compliance with EN 60601-1-2 | Performed |
| Software verification according to FDA software guidance | Carried out |
| Maintain same safety and effectiveness as predicate device (WL-2206B) despite engineering differences | Demonstrated by verification and validation tests |
| Not affect intended use compared to predicate device | Demonstrated by verification and validation tests |
| Not alter fundamental scientific technology of the device compared to predicate device | Demonstrated by verification and validation tests |
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not applicable and not provided. The submission focuses on non-clinical engineering and software verification/validation, not a clinical "test set" in the context of device performance on human data.
- Data provenance: Not applicable. The tests are engineering and software validations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not applicable and not provided.
- Qualifications of experts: Not applicable and not provided.
4. Adjudication method for the test set:
- Adjudication method: Not applicable and not provided.
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:
- MRMC study: No, an MRMC study was not done. This device is an interferential stimulator, not an AI-powered diagnostic or interpretive tool that would involve human "readers" or AI assistance in that sense.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone performance: Not applicable. The device itself is a stimulator; there isn't a standalone "algorithm" for performance evaluation in isolation from the device's function. The "software verification" mentioned confirms the software functions as designed within the device.
7. The type of ground truth used:
- Type of ground truth: The "ground truth" for this submission is adherence to engineering standards, functional specifications, and documented software requirements. There isn't a "ground truth" derived from patient outcomes, pathology, or expert consensus in the context of a clinical performance study.
8. The sample size for the training set:
- Sample size for training set: Not applicable and not provided. This device does not involve machine learning or AI models developed using training sets of data.
9. How the ground truth for the training set was established:
- Ground truth for training set: Not applicable as there is no training set mentioned or implied.
§ 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).