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Indications For Use (Available for WL-2202A, WL-2203A & 'TENS function' of WL-2205A):

This device is a prescription device and only for symptomatic relief of chronic intractable pain.

Indications For Use (Available for WL-2204A, WL-2204A-P1, WL-2204A-P2 & 'EMS function' of WL-2205A):

• · 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 T-tech Digital TENS series, including WL-2202A. WL-2204A. WL-2204A. WL-2204A-P1. WL-2204A-P2, and WL-2205A 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.

T-tech Digital TENS series, models WL-2202A, WL-2203A, WL-2204A, WL-2204A-P1, WL-2204A-P2, and WL-2205A, consist mainly of two parts: the stimulus generator, electrode. The stimulus generator 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 T-tech Digital 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 document is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulation (TENS) device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the new device meets specific, quantitative acceptance criteria through a standalone clinical study.

Therefore, many of the requested elements for an acceptance criteria study, such as sample sizes, ground truth establishment, expert qualifications, and MRMC studies, are not applicable to this 510(k) submission. Instead, the study demonstrating the device meets the "acceptance criteria" here refers to the testing performed to show equivalence to the predicate device and compliance with relevant standards.

Here's the breakdown of the information that can be extracted and a clear indication of what is not present:

Acceptance Criteria and Device Performance

Study Details

1. Sample sizes used for the test set and the data provenance:

   • N/A. This submission is for a TENS device and relies on engineering and performance testing to demonstrate substantial equivalence to a predicate device, not a test set based on patient data in the way an AI/CADe device would. The testing would involve specific units of the device.
   • Data Provenance: The document does not specify the origin of any test data beyond the general submission from Well-Life Healthcare Inc. in Taipei, Taiwan. The studies cited are non-clinical (compliance to standards, software verification).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • N/A. Ground truth in the context of expert consensus on medical images or diagnoses is not relevant for this type of device submission. The "ground truth" here is the established safety and effectiveness of the predicate device and compliance with engineering standards.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • N/A. Adjudication methods are typically associated with expert review of data/images in clinical studies, which is not described here.

4. 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:

   • No. An MRMC study is not mentioned. This device is a direct patient-use electrical stimulator, not an AI/CADe device designed to assist human readers.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • N/A. This device is hardware with embedded software for control, not a standalone AI algorithm. Its performance is inherent to the device's function.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for this 510(k) submission is established by:
     • Predicate Device Performance: The known performance, safety, and effectiveness of the previously cleared predicate device (K030537: WL-2203B, WL-2204B, WL-2204B-P1, WL-2204B-P2, and WL-2205B).
     • Voluntary Standards: Established engineering and safety standards (ANSI/AAMI, NS4-1985, EN 60601-1, EN 60601-1-1, EN 60601-1-2).
     • FDA Software Guidance: Best practices for software verification.

7. The sample size for the training set:

   • N/A. There is no mention of a "training set" in the context of machine learning or AI models. This device does not use an AI learning algorithm that requires a training set.

8. How the ground truth for the training set was established:

   • N/A. As no training set is mentioned, this question is not applicable.

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