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The devices of this submission are designed to temporarily relieve muscle soreness and pain in the shoulder, wast, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom caused by exercise or normal household activities. Also used to stimulate healthy muscles to improve muscle performance.

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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for an "OTC TENS & EMS Unit." This document primarily focuses on regulatory approval, substantial equivalence to predicate devices, and general controls and regulations. It does not contain any information about acceptance criteria for device performance, scientific studies, or data related to the device's efficacy or safety.

Therefore, I cannot provide the requested information regarding acceptance criteria and the study that proves the device meets them from this document. The document explicitly states:

• "We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices."
• "Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading."
• "FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies."

The 510(k) process primarily confirms substantial equivalence to a legally marketed predicate device, not necessarily a de novo clinical study proving performance against specific criteria in the way you've outlined.

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This TENS device is to be used for temporary relief of pain associated with sore or aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.

The Counter Pain Therapy Device, Model P.T.S.-IV (K161537) is identical to the previous cleared version of the device with the same name (K132993). The purpose of this 510(k) submission is to seek different (expanded) Indications for Use. The only changes are in the 'Indication for Use Statement'.

The Counter Pain Therapy Device, Model P.T.S.-IV features two channels and seven (7) preset programs. The output of both channels can be adjusted individually for intensity in sixteen (16) steps and the treatment time is selectable from 20, 30 or 40 minutes. All features are well indicated by large icons on a backlit LCD screen for easy reading.

The device is powered by three (3) rechargeable Lithium Batteries which are permanently built into the main unit and can be recharged with the charging unit supplied for the device.

The Pain Therapy Device consists of the handheld main unit (controller), two pairs of self-adhesive electrodes, a plug-in charging unit (adaptor 120VAC to 5VDC) and two pairs of electrode cables.

This document describes the regulatory clearance (K161537) for the OTC TENS Device, Model PTS-IV. However, it explicitly states that no clinical tests were performed or relied upon to determine substantial equivalence for this specific submission because the device itself is identical to a previously cleared version (K132993), and the only change made was an expansion of the Indications for Use. Therefore, the information requested regarding acceptance criteria and a study proving the device meets those criteria, particularly in the context of clinical performance, cannot be fully provided from this document.

The document primarily focuses on non-clinical testing and substantial equivalence to predicate devices based on design, technological characteristics, and safety standards.

Here's a breakdown of the information that can be extracted or inferred from the provided text, and where the requested details are not available:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: The document refers to meeting the requirements of recognized consensus standards for safety and performance. These standards are the acceptance criteria for non-clinical aspects.
• Reported Device Performance: The performance is stated in terms of compliance with these standards.

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 for clinical performance. The document explicitly states: "Counter did not conduct, nor rely upon, clinical tests to determine substantial equivalence of the Pain Therapy Device Model P.T.S.-IV. vs. the predicates."
• For non-clinical testing, the "sample size" would refer to the number of devices tested to the standards. This specific number is not provided, only that "testing" was performed. The data provenance would be from internal company testing and third-party lab testing for standards compliance (e.g., electrical safety).

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 with human data and expert-established ground truth was used for this specific 510(k) submission. The regulatory decision was based on substantial equivalence to predicate devices and non-clinical engineering and safety testing.

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

• Not applicable. No clinical test set requiring adjudication was used.

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 Transcutaneous Electrical Nerve Stimulator (TENS device), 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. The device is a TENS unit, not an algorithm. Its performance is inherent in its electrical output and mechanical operation, as demonstrated by compliance with engineering standards.

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

• For the non-clinical tests, the "ground truth" was established by the requirements of the international consensus standards (e.g., IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2) which define the acceptable limits and performance criteria for safety and electrical characteristics.
• For biocompatibility, the ground truth would be chemical/biological analyses demonstrating safety as per relevant biocompatibility standards for medical devices, which were part of the electrode's separate FDA clearance.
• For software, the ground truth was the expected functional specifications and safety requirements as defined internally and verified through testing.

8. The sample size for the training set

• Not applicable. This device does not use machine learning or AI that requires a "training set."

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

• Not applicable. As above, there is no training set for this type of device.

In summary:

This 510(k) cleared the OTC TENS Device, Model PTS-IV, by demonstrating substantial equivalence to a previously cleared version of the same device (K132993) and to another predicate device (K121757) for its expanded indications for use. The clearance was based entirely on non-clinical testing which confirmed the device's compliance with established safety and performance standards (IEC 60601 series). No clinical studies or human performance data were used for this submission, as the physical device itself had already been vetted in a prior submission, and the current submission only sought to expand its marketing claims (Indications for Use) based on existing equivalence.

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The OTC TENS for Arm & Leg Pain Relief / model WL-2407 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 Well Life TENS devices, WL-2407 is the model of OTC TENS 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. Basically the stimulation model WL-2407 is completely identical to that of model as mentioned in the Well-Life K063660- 510(K) cleared device. To change the indication for use for the treatment location as the chosen predicate devices. Well-Life change the design of electrode.

For the device included in this submission, we use the following third party 510(K) legally marketed predicate components: <1>K022494, the Home Care Jelly.

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

• <1> The operation function is dual channels completely identical to the model being modified, WL-2407 for low back pain relief(K063660).
• <2> For the stimulation electrode. Well-Life uses upper arm belt as well as snap type adhesive electrode as standard accessories.
• <3> The output waveform is selectable pre-programming change among P1~P8.
• <4> The output strength is adjustable at 0~80 mA, with setting time 21 minutes counting from switchina ON.
• <5> The LCD display is provided for the indication of operation status including operation mode, output program mode, output intensity, time to cut-off, and battery low warning.

The provided text describes a 510(k) summary for the "OTC TENS for Arm & Leg Pain Relief / Model: WL-2407". This device is a Transcutaneous Electrical Nerve Stimulator (TENS) intended for temporary relief of pain in the upper and lower extremities.

The relevant section for acceptance criteria and the study proving the device meets them is Section 6, "Power level testing comparison and acknowledge of comparison result with Prizm 5000Z system", and Section 7, "Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence".

Here's an analysis of the provided information:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria here are implicitly based on demonstrating "lower output power and power density" compared to the predicate device, the Prizm 5000-Z system, under standardized 1K ohm loading resistance. This is presented as proving safety rather than effectiveness in this specific comparison.

Note: The reported current for "Sleeve & Knee" for WL-2407 (0.00386) is slightly higher than for Prizm 5000-Z (0.00385). The document acknowledges that "the model WL-2407 has a lower output power and power density than that of Prizm 5000-Z system while using the same electrode". This suggests that the slight increase in current for "Sleeve & Knee" was deemed acceptable given the overall trend of lower power and power density, or perhaps due to rounding in the provided data. The focus seems to be on overall safety margins.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The described testing is a non-clinical, benchtop comparison of electrical output parameters. Therefore, there is no human "test set" or data provenance in the sense of patient data. The "test set" would refer to the electrical measurements taken from the device and the predicate device.

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)

This type of information is not applicable to this submission. The "ground truth" for the electrical output comparison is the objective measurement of current and power density using specified loading resistance. This does not involve expert interpretation or clinical ground truth.

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

Not applicable. Adjudication methods are used to establish ground truth in studies involving human interpretation (e.g., medical imaging reads). This submission describes objective electrical measurements.

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 MRMC study was done. This device is a TENS unit, not an AI-powered diagnostic tool. The submission focuses on substantial equivalence based on technical characteristics and safety, not on human reader performance with or without AI assistance.

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 or software. The performance is assessed through direct electrical measurements, not algorithmic output.

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

The "ground truth" for this particular demonstration is the physical measurement of electrical output parameters (current and power density) under specific, controlled conditions (1K ohm loading resistance). This is an objective, quantitative measurement rather than a subjective or clinical "ground truth."

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning model, so there is no concept of a "training set."

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

Not applicable. As there is no training set, there is no ground truth for it to be established.

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The model WL-2407 are intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.

The Well Life TENS devices, WL-2407 is the model of OTC TENS intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.

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

<1> The stimulation electrode is dual channels electrode.

• <2> The output waveform is selectable pre-programming change among P1~P8.
• <3> The output strength is adjustable at 0~80 mA, with setting time 21 minutes counting from switching ON.
• <4> 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 for the Well Life Healthcare Limited OTC TENS for Low Back Pain Relief / Model: WL-2407 (K063660) does not contain detailed information about specific acceptance criteria, a clinical study proving device performance against those criteria, or the methodology typically used for such studies (e.g., sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance).

Instead, this submission focuses on demonstrating substantial equivalence to previously cleared predicate devices (WL-2402 K040512, and WL-2406 K052785). The "study" referenced in the document is a comparison to these predicate devices and non-clinical testing.

Here's an analysis based on the provided text, addressing the requested points where possible, and noting where information is absent:

Acceptance Criteria and Device Performance Study

The document does not explicitly state acceptance criteria in terms of quantitative performance metrics for the device itself (e.g., pain reduction scores, specific levels of electrical output accuracy, or patient satisfaction thresholds). Instead, the "acceptance criteria" are implied by demonstrating:

1. Compliance to applicable voluntary standards: ANSI/AAMI, NS4-1985, EN 60601-1, and EN 60601-1-2.
2. Software verification: Carried out according to FDA software guidance.
3. Substantial Equivalence: The primary "acceptance criterion" for this 510(k) pathway is that the device has the same intended use and similar technological characteristics, and that any differences do not affect intended use or alter fundamental scientific technology compared to the predicate devices.

Table of Acceptance Criteria and Reported Device Performance:

Detailed Information Regarding the "Study" (Comparison to Predicate Devices and Non-Clinical Testing)

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

• Sample Size: Not applicable in the context of a clinical test set in this submission. The "test set" in this case refers to the technical specifications and performance data of the WL-2407 device itself, which were compared against the specifications and established performance of the predicate devices.
• Data Provenance: The document does not specify the origin of any clinical data (e.g., country) because a clinical study with human subjects validating the device's efficacy was not conducted or presented. The data provenance primarily relates to the technical specifications and verification/validation testing performed on the device itself. This would be considered "prospective" in the sense that the testing was performed on the WL-2407.

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

• Not applicable. This submission relies on substantial equivalence to predicate devices and non-clinical testing. There was no "ground truth" derived from expert consensus on human data for a device performance test set. The efficacy of the predicate devices in relieving pain (the "ground truth" of performance) was previously established through their own clearance process.

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

• Not applicable. No clinical test set requiring adjudication of findings was described in this submission.

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 Transcutaneous Electrical Nerve Stimulator (TENS), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is irrelevant to this submission.

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

• Not applicable. This device is a physical medical device (TENS unit) and not an algorithm with standalone performance metrics. Its performance is inherent to its electrical stimulation capabilities.

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

• For the equivalence claim: The "ground truth" for the WL-2407's efficacy is the established safety and effectiveness of its predicate devices (WL-2402 K040512 and WL-2406 K052785) for the same intended use.
• For non-clinical testing: The "ground truth" would be objective measurements against established engineering standards (e.g., electrical output parameters, safety features) as per ANSI/AAMI, NS4-1985, EN 60601-1, and EN 60601-1-2.

8. The sample size for the training set:

• Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

• Not applicable. This device is not an AI/ML algorithm that requires a training set with established ground truth.

In summary: K063660 is a 510(k) submission for a TENS device seeking clearance based on substantial equivalence to existing predicate devices. The "study" described is primarily a comparison of the new device's technical characteristics and intended use to the cleared predicates, supported by non-clinical verification and validation testing against recognized standards. It does not involve a clinical study with human subjects, nor does it pertain to AI or diagnostic software.

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The model WL-2406 TENS is intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.

The Well Life TENS devices, WL-2406 is the model of OTC TENS intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.

WL-2406 is a dual channel, 3V battery operated TENS device with the following features:

• <1> The operation mode is "Wire" with dual channels.
• <2> The stimulation electrode is connected via electrode belt for "Wire" operation mode.
• <3> The output waveform is selectable pre-programming changed amonq P1~P8.
• <4> The output strength is adjustable at 0~50 mA, with setting time 21 minutes counting from switching ON.
• <5> 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.

This a TENS device, and the information provided does not describe a study that uses a test set, ground truth, experts, or AI. Therefore, I will respond to the specific points based on the information available regarding non-clinical tests for medical devices.

Here's a breakdown of the acceptance criteria and how the device (WL-2406 TENS) met them, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The study that proves the device meets the acceptance criteria is described as "verification and validation tests" and a demonstration of "substantial equivalence" to a legally marketed predicate device (WL-2402, K040512).

Here's a breakdown of the requested information based on the provided text:

1. Sample size used for the test set and the data provenance: Not applicable. This submission relies on substantial equivalence to a predicate device and compliance with voluntary standards for non-clinical testing. There is no mention of a clinical test set with patient data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth typically refers to clinical outcomes or expert diagnoses in a clinical study. This submission focuses on non-clinical engineering and safety standards. The "experts" involved would be the engineers and regulatory specialists performing the verification and validation tests and assessing compliance with standards like ANSI/AAMI NS4-1985, EN 60601-1, and EN 60601-1-2. Their qualifications are implicitly in their ability to conduct these standard tests.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. There is no mention of a human-adjudicated test set in this 510(k) summary.

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: Not applicable. This device is a Transcutaneous Electrical Nerve Stimulator (TENS), not an AI-powered diagnostic or assistive technology. It does not involve human readers interpreting cases or AI assistance.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device for pain relief, not an algorithm. The "standalone" performance refers to the device's electrical and functional parameters as measured against engineering standards.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's safety and effectiveness is established through:

   • Compliance with recognized voluntary standards: ANSI/AAMI NS4-1985 (electrical safety), EN 60601-1 (general medical electrical equipment), and EN 60601-1-2 (electromagnetic compatibility).
   • Software verification: Though not explicitly detailed, compliance with FDA software guidance would involve verifying the software's functional requirements, design specifications, and safety measures.
   • Substantial equivalence demonstration: The primary "ground truth" for marketing clearance is that the device is "as safe and effective" as a legally marketed predicate device. This is achieved by showing that any differences in technological characteristics do not raise new questions of safety or effectiveness and that the intended use is the same.

7. The sample size for the training set: Not applicable. This device does not use machine learning or AI, so there is no "training set."

8. How the ground truth for the training set was established: Not applicable, as there is no training set.

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