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The Mini Patch, model: WL-2301A & WL-2301B Transcutaneous Electrical Nerve Stimulators are intended for temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.

The Mini Patch, models WL-2301B are transcutaneous electrical nerve stimulator used for pain relief by applying an electrical current to electrodes, which are attached on the skin. The output and waveform characteristic is fixed for every model, only the intensity is adjustable.

The Mini Patch, models WL-2301A & WL-2301AB, 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 Mini Patch is burst mode with fixed pulse rate, frequency, and fixed timer, only amplitude is adjustable. This operation way is considered the simplification from the burst mode of comparison clear model, WL-2302(K020020). Every model of Mini-TENS has its individual stimulation operation cycle.

This 510(k) summary describes a Transcutaneous Electrical Nerve Stimulator (TENS) device, the "Mini Patch" (models WL-2301A & WL-2301B), intended for temporary pain relief. The submission focuses on demonstrating substantial equivalence to a predicate device, not on proving clinical efficacy through a new clinical effectiveness study. Therefore, many of the requested criteria (like ground truth, expert adjudication, MRMC studies, standalone performance, and training set information) are not applicable as this type of submission typically relies on engineering and performance testing to show the new device operates similarly and safely to an already cleared device.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device and submission (510(k) for substantial equivalence), the "acceptance criteria" are primarily established through compliance with recognized standards and comparison to a predicate device's specifications. The study demonstrating this is a non-clinical comparison and verification/validation testing.

The "study" that proves the device meets the acceptance criteria is the non-clinical testing, verification, and validation activities performed by the manufacturer, as summarized in sections 6, 8, and 9 of the 510(k) submission. These tests compare the new device's technical specifications and safety features against those of the predicate device and relevant voluntary standards to demonstrate that the small differences do not raise new questions of safety or effectiveness.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not applicable in the context of a clinical test set. The submission refers to engineering and performance verification and validation tests for the device itself, not patient data. These tests would involve multiple units of the new device to confirm consistency and adherence to specifications.
• Data Provenance: Not applicable for clinical data. The data provenance is from the manufacturer's internal engineering and testing labs in Taiwan, ROC, where the device was developed and tested. This is a retrospective comparison to an existing predicate device's specifications and prospective engineering testing of the new device's physical and electrical properties.

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

• Not applicable. This submission is for substantial equivalence of a TENS device based on engineering and performance testing, not a diagnostic or clinical study requiring expert-established ground truth from patient data. The "ground truth" here is the adherence to electrical engineering specifications and safety standards as outlined by regulatory bodies and voluntary standards.

4. Adjudication method for the test set

• Not applicable. No expert adjudication of clinical cases was performed, as this was not a clinical study involving interpretation of patient data.

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 TENS unit, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was 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 (TENS unit), not an algorithm. Its "standalone" performance refers to its operational characteristics (output voltage, current, etc.) which were assessed through engineering tests as described in the comparison tables.

7. The type of ground truth used

• Engineering Specifications and Safety Standards (e.g., ANSI/AAMI, IEC 60601-1, IEC 60601-1-2): The "ground truth" for this submission is adherence to established electrical and mechanical safety standards and conformity to the operational parameters of a legally marketed predicate device (Well-Life OTC TENS, K091757), which itself was cleared based on similar principles.

8. The sample size for the training set

• Not applicable. This device does not use machine learning or AI, so there is no training set in the conventional sense.

9. How the ground truth for the training set was established

• Not applicable. As there is no training set, this is irrelevant.

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The i. Pro TENS; model WL-2407Rx is a portable, battery-powered, transcutaneous electrical nerve stimulator (TENS device) that is intended for symptomatic relief of chronic intractable pain.

The Well Life TENS devices, WL-2407Rx is the model of prescription TENS intended for symptomatic relief of chronic intractable pain.

WL-2407Rx is a selectable dual channel, 4.5V (3xAA/Alkaline battery) operated TENS device with the following features:

• The operation of device is via the connection of wire and electrode through the dual operation channels.
• The stimulation electrode includes adhesive electrode and garment electrode. It may be chosen depending upon the prescription of physician.
• The output waveform is selectable pre-programming change among P1-P6.
• The output strength is adjustable at 080 mA, with setting time 560 minutes counting from switching ON.
• The LCD display is provided for the indication of operation status including operation mode, output wave form, output strength, time to cut-off, and battery low warning.

The provided 510(k) summary describes a TENS device (Transcutaneous Electrical Nerve Stimulator) and focuses on demonstrating its substantial equivalence to a previously cleared predicate device, rather than providing an independent study proving the device meets specific acceptance criteria through a clinical trial or detailed performance study.

Therefore, many of the requested sections (acceptance criteria table, sample sizes for test/training sets, number of experts, adjudication methods, MRMC study, standalone performance, type of ground truth, ground truth establishment for training) cannot be fully populated from the provided document.

Instead, the submission relies on the successful clearance of the predicate device (WL-2402, K020020) and non-clinical tests to assert equivalence.

Here's a breakdown based on the information available:

1. Table of acceptance criteria and the reported device performance

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 / Not Provided. This submission is for substantial equivalence based on non-clinical testing and comparison to a predicate device, not a clinical study involving a test set of data or patients.

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. No clinical test set requiring expert ground truth establishment is described.

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

• Not Applicable. No clinical test set requiring adjudication 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

• No. This is a TENS device, not an AI-assisted diagnostic or therapeutic device that would involve human readers or image interpretation.

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

• Not applicable. This TENS device is a physical medical device for pain relief, not an algorithm or software requiring standalone performance testing in that context. The "software verification" mentioned is likely for the embedded firmware controlling the device functions.

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

• Not Applicable. The "ground truth" for this submission is adherence to engineering specifications, safety standards, and functional equivalence to the predicate device.

8. The sample size for the training set

• Not Applicable. No training set for a machine learning algorithm is discussed.

9. How the ground truth for the training set was established

• Not Applicable. No training set for a machine learning algorithm is discussed.

Summary of the Study performed (as described in the 510(k)):

The "study" undertaken for the WL-2407Rx device to meet acceptance criteria was a demonstration of substantial equivalence to a predicate device (WL-2402, K020020). This involved:

• Non-clinical tests: These included compliance with voluntary standards (ANSI/AAMI, NS4-1985, EN 60601-1, EN 60601-1-2) and software verification according to FDA guidance.
• Comparison of intended use and technological characteristics: The submission explicitly states the new device has "the same intended use and the similar technological characteristics" as the predicate.
• Assertion of safety and effectiveness: The submission concludes that "verification and validation tests... demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device."

No human subjects studies, clinical trials, or expert-reviewed test sets were used or required for this 510(k) submission, as it falls under a Class II device and leverages the substantial equivalence pathway.

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