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Indications For Use (Available for WL-2203B & 'TENS function' of WL-2205B): This device is a prescription device and only for symptomatic relief of chronic intractable pain. Indications For Use (Available for WL-2204B, 2204B-P1, 2204B-P2 & 'EMS function' of WL-2205B): - Relaxation of muscle spasms. - Prevention or retardation of disuse atrophy. - Increasing local blood circulation. - Muscle re-education. - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. - Maintaining or increasing range of motion.

The Digi-Pro TENS series, including WL-2203B, WL-2204B-P1, WL-2204B-P1, WL-2204B-P2, and WL-2205B are transcutaneous electrical nerve stimulator used for pain relief and/or powered muscle stimulator by applying an electrical current to electrodes, which are attached on the patient's skin. The output and waveform is adjustable according to the situation of patient. Digi-Pro TENS series, models WL-2203B, WL-2204B, WL-2204B-P1, WL-2204B-P2, and WL-2205B, consist mainly of two parts: the stimulus generator, electrode. The stimulus qenerator generates the output current specified as the input of controller. The output port transmits the output current to the electrode, which is attached to the patient's skin so as to transmit this stimulus current to the patient for pain relief. The stimulation mode for Digi-Pro TENS includes several different operation modes as mentioned on the comparison table. These operation modes are generated from the software control by using the microprocessor as its main control unit.

The provided text describes a 510(k) summary for the Well-Life TENS device. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting a de novo effectiveness study with specific acceptance criteria and performance metrics against a ground truth.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, as there wasn't an independent effectiveness study performed in the way an AI/ML device would typically undergo.

Here's why the requested information isn't present:

1. Acceptance Criteria and Reported Device Performance: This device is a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS). Its clearance is based on substantial equivalence to existing TENS/PMS devices (K021359 & K020314, SD603/Model III, SD-605/program and Q-MS). The "acceptance criteria" here are that the new device's technical specifications and safety features are comparable to the predicate devices and meet relevant electrical safety standards (e.g., ANSI/AAMI, EN 60601 series). There are no specific quantitative "performance" metrics (like accuracy, sensitivity, or specificity common in AI/ML studies) reported in this summary.

2. Sample Size and Data Provenance for Test Set: Not applicable. There was no clinical "test set" in the context of an effectiveness study for this 510(k). The evaluation focused on engineering performance and substantial equivalence to predicates.

3. Number of Experts and Qualifications for Ground Truth: Not applicable. Ground truth, in the sense of expert consensus on diagnostic or efficacy outcomes, was not established for a clinical effectiveness study.

4. Adjudication Method: Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This is not an AI-assisted diagnostic device, so no such study was performed or is relevant.

6. Standalone Performance: Not applicable as there is no "algorithm" in the modern AI sense. The device's "standalone" performance is its electrical output and safety characteristics, which were assessed against standards and predicate device specifications.

7. Type of Ground Truth: Not applicable. The ground truth for this type of device regulatory submission is compliance with established electrical safety and performance standards for therapeutic devices, and demonstration that its technical characteristics are consistent with predicate devices that have prior clearance for their intended uses.

8. Sample Size for Training Set: Not applicable. This is not an AI/ML device, so there is no training set in that context.

9. How Ground Truth for Training Set was Established: Not applicable.

What the document does describe in terms of performance and testing:

• Non-Clinical Tests: Compliance to applicable voluntary standards: ANSI/AAMI, NS4-1985, EN 60601-1, EN 60601-1-1, and EN 60601-1-2.
• Software Verification: Carried out according to FDA software guidance.
• Conclusion: Verification and validation tests demonstrate that differences in the submitted models maintain the same safety and effectiveness as the cleared predicate devices, and do not affect the intended use or alter the fundamental scientific technology.

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