(30 days)
The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain.
The WL-2206A1 and WL-2206A2 are the device which generates the small true-sine pulses of electrical current. The generated current may be delivered to the patient skin and/or underlying nerves through the cable and electrode placed on skin. Through the current stimulation the chronic and/or acute pain is to be relieved.
The provided text is a 510(k) summary for an interferential stimulator device, not an AI/ML medical device. Therefore, the requested information regarding acceptance criteria, study details, ground truth, and AI/ML specific metrics (like MRMC studies or standalone performance) is not applicable or available in this document.
The document focuses on demonstrating substantial equivalence to a predicate device (WL-2206A, K050847) by proving that engineering differences do not affect intended use or alter fundamental scientific technology.
Here's a breakdown of what is available based on the provided text, and why the requested information isn't present:
1. A table of acceptance criteria and the reported device performance
- Not Applicable in this context. This device is an interferential stimulator, not an AI/ML diagnostic tool. The "performance" assessment focuses on showing that the new models (WL-2206A1 and WL-2206A2) maintain the same safety and effectiveness as the predicate device (WL-2206A).
- Reported "performance" (as described): "verification and validation tests contained in this submission demonstrate that the difference in the submitted demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device."
- Acceptance Criteria Mentioned (for substantial equivalence):
- Compliance to applicable voluntary standards: ANSI/AAMI, NS4-1985, EN 60601-1, and EN 60601-1-2.
- Software verification according to FDA software guidance.
- Engineering differences do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device compared to the predicate.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. Clinical test sets with patient data are not described for this type of device submission. The verification and validation tests are likely engineering and electrical performance tests, not clinical studies in the AI/ML sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. "Ground truth" in the AI/ML sense (e.g., expert consensus on clinical findings) is not relevant for this physical stimulator device. The "ground truth" for its safety and effectiveness is tied to engineering standards and a comparison to a legally marketed predicate.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No clinical test set requiring adjudication of findings is described.
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 is not an AI/ML device, so no MRMC study would be conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. As mentioned, "ground truth" in the AI/ML context is not relevant here. The "truth" for this device revolves around meeting established electrical, safety, and performance standards as set against a predicate device.
8. The sample size for the training set
- Not Applicable. This device does not use a "training set" in the machine learning sense.
9. How the ground truth for the training set was established
- Not Applicable. No training set exists for this device.
In summary: The provided 510(k) summary is for an electro-medical stimulator device (IF series True sine interferential stimulator / Model: WL-2206A1 & WL-2206A2), not an AI/ML-driven device. As such, the study design and criteria requested are based on AI/ML device approval processes and are fundamentally different from what is described in this document. The submission focuses on demonstrating substantial equivalence to a predicate device through engineering verification and validation, and compliance with general safety standards.
§ 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).