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POCKET TENS (EP-300) which is home used device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.

This device powered by CR2032 Lithium 3V battery is a self-adhesive TENS with 15 adjustable intensity levels falling into the electro-stimulation device category. It includes pocket storage rack for electrodes and TENS device. It designed for shoulder, back, upper extremities (arm) and lower extremities (leg) pain relief. Users only need to place the electrode gel pads on the sides of pain point and then power on the device, and adjust the pulse intensity to a proper level to start a 20 minute treatment session. For optimum result, rest 30 minutes between sessions.

TENS refers to the electrical stimulation of nerves through the skin which is a non-pharmacological method of pain relief. Any symptoms that could be relieved using TENS must be checked by patient's general practitioner who will also give patient instruction on how to carry out a TENS self-treatment regime.

This device is only compatible with the 75 mm x 48 mm gel pads which are the OTC medical device cleared by FDA under K083302 or K180865, and come with the device.

The provided text describes the acceptance criteria and the study conducted for the POCKET TENS (EP-300) device.

Here's the information extracted from the document:

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

The document states that the POCKET TENS (EP-300) device underwent a series of safety and performance tests. It doesn't explicitly list specific quantitative acceptance criteria values next to the device performance for most parameters, but generally states that "All the test results demonstrate the subject device, POCKET TENS (EP-300), meets the requirements of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate devices."

However, a comparison table (Section 12) between the subject device and two predicate devices provides various specifications. This comparison indirectly implies the acceptance criteria are met if the subject device's specifications are comparable or within acceptable ranges of the predicate devices and comply with relevant standards.

Here's a summary of the stated performance and comparison points, implying acceptance criteria are met by equivalence or compliance:

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

The document does not explicitly mention a "test set" in the context of clinical data. It states, "No clinical test data was used to support the decision of substantial equivalence."

Instead, the evaluation appears to be based on non-clinical testing, compliance with recognized standards, and comparison with predicate devices. For these non-clinical tests (e.g., biocompatibility, software validation, EMC, electrical safety, performance verification, usability), the sample sizes are not specified, nor is the country of origin or whether they were retrospective or prospective.

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, as no clinical test data was used and therefore no need for experts to establish ground truth for a clinical test set. The substantial equivalence relies on technical comparison and compliance with standards.

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

Not applicable, as no clinical test data was used and therefore no adjudication was necessary.

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. The device is a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief, not an AI-assisted diagnostic or interpretative tool that would involve human readers.

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

Not applicable. The device is a physical TENS unit, not an algorithm.

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

Not applicable, as no clinical test data was used. The "ground truth" for the non-clinical tests would be the established scientific and engineering principles outlined in the referenced national and international standards (e.g., ISO, IEC, ANSI/AAMI standards, FDA guidance documents).

8. The sample size for the training set

Not applicable, as the 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, as the device is not an AI/ML algorithm.

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TENS:

[RS-18, RS-28, RS-38 models]: For temporary relief of pain associated with sore and 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.

[RS-18, RS-38 models]: For temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medications.

[RS-18, RS-28 models]: It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

EMS:

[RS-18. RS-28]: To stimulate healthy muscles in order to improve and facilitate muscle performance.

Environments of Use: Clinics, hospital and home environments (over-the-counter) Patient Population: Adult

"Wireless Electrical Stimulator" is a battery-powered wireless electrical stimulator designed and intended to provide Transcutaneous Electrical Nerve Stimulation (TENS) and Electrical Muscular Stimulation (EMS) for the use of non-pharmacological pain relief and improve muscle performance and recovery.

The "Wireless Electrical Stimulator" includes a remote control, stimulator pod(s) and several accessories. Both the remote control and the stimulator pod are powered by a 3.7V lithium-ion polymer battery. The remote control has a 1.77" TFT LCD screen and 4 buttons to control multiple stimulator pod(s) at the same time. Each stimulator pod has two output channels, and will perform electrical stimulation according to the parameter settings sent by the remote control. The stimulator pods can also be used independently via its own 3 buttons based on preset parameter.

The accessories include self-adhesive electrodes, kneelelbow brace, and the USB Type-C charging cable. The adhesive electrodes for "Wireless Electrical Stimulator" are connected with the Stimulator Pod(s) via magnetic snap and lead wire. There are replaceable hydrogel pads on the self-adhesive electrode pads. Users can replace the hydrogel when it exceeds its useful life, but does not need to discard the entire electrode. To apply electrical stimulation to body joints (e.g. knees and elbows), users can easily place electrodes on specific body parts using the Knee/elbow brace. The remote control and stimulator pods are the same for all models. The 3 models have different accessories to match their specific usage instructions.

The provided text is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS) / Electrical Muscle Stimulator (EMS) device. It details the device's characteristics, comparison to predicates, and performance testing for FDA clearance.

However, the provided text DOES NOT contain the type of AI/ML-specific acceptance criteria and study information requested in the prompt. The device is a medical stimulator, not an AI/ML-driven diagnostic or prognostic tool. Therefore, information like "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone (i.e. algorithm only without human-in-the-loop performance)," "ground truth established by experts/pathology," or sample sizes for training/test sets for AI models are not applicable to this document.

The document focuses on demonstrating substantial equivalence to legally marketed predicate devices through comparisons of indications for use, technological characteristics, and various non-clinical performance data (biocompatibility, electrical safety, EMC, software verification, human factors, bench testing).

Therefore, I cannot populate the requested table or answer the specific questions related to AI/ML acceptance criteria and studies based on the provided text.

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StimOn™ Pain Relief System (GM2439) is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical or post-traumatic pain.

StimOn™ Pain Relief System (GM2439) is a hand-held stimulator designed to pass electrical signals via surface electrodes through the skin to the underlying nerves. It may be used as a TENS device to aid the blocking of pain signals traveling to the brain.

The document describes the StimOn™ Pain Relief System (GM2439) and its substantial equivalence to predicate devices, but it does not contain specific acceptance criteria for performance metrics (like sensitivity, specificity, accuracy) for an AI/algorithm-based device, nor does it detail a study proving the device meets such criteria in terms of AI performance.

Instead, the document focuses on the regulatory clearance of a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief, primarily through comparison with existing predicate devices and compliance with relevant electrical safety and performance standards. The "performance testing" mentioned refers to these safety and electrical performance standards, not to clinical efficacy measured by AI performance metrics.

Therefore, many of the requested items regarding acceptance criteria and study details for an AI-based device's performance cannot be extracted from this document.

Here's the information that can be extracted, and where the document does not provide the requested information:

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

The document does not specify quantified acceptance criteria for AI performance (e.g., sensitivity > X%, specificity > Y%). Instead, it discusses the device's technical characteristics and how they compare to predicate devices. The "performance testing" section refers to compliance with electrical safety and performance standards, not AI accuracy.

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. The document states "No Human Clinical Performance Testing have been required" for this application. The performance testing refers to electrical and safety standards, not clinical performance data from a test set of patients/cases.

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 / Not provided. No clinical test set requiring expert ground truth was used for assessing the device's efficacy, as per the submission.

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

• Not applicable / Not provided. 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 / Not provided. This device is a Transcutaneous Electrical Nerve Stimulator, not an AI-assisted diagnostic or interpretative device that augments human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.

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

• Not applicable / Not provided. This device is hardware for pain relief, not an algorithm/AI system in the sense of a diagnostic or predictive tool.

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

• Not applicable / Not provided. No clinical ground truth was established for "performance" as it relates to AI or clinical efficacy. The "performance testing" was for electrical safety, electromagnetic compatibility, and biocompatibility, which rely on technical standards and laboratory measurements.

8. The sample size for the training set

• Not applicable / Not provided. Not an AI/algorithm-based device requiring a training set.

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

• Not applicable / Not provided. Not an AI/algorithm-based device requiring a training set.

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