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

Avazzia OTC TENS electronic pulse massage devices are electrically powered device intended for overthe-counter use and used to apply a microcurrent electrical pulses to electrodes on a user's skin to relieve pain. They are easy-to-use, handheld, AA battery-operated portable devices for use in the home or clinic. The candidate devices have pre-set modes. The devices are portable, battery operated microcurrent electrical stimulation device that applies charge and power to the tissue through electrodes where maximum power delivered to the load is controlled and limited, and an automatic shut off is implemented. The user can apply the built-in onboard electrodes or place self-adhesive conductive electrodes where indicated and apply stimulation for a period of time. The user controls the output by selecting the mode and power setting.

This document is a 510(k) premarket notification for the Avazzia OTC TENS Model Best-AV1™ family of devices. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical trial with acceptance criteria for device performance. Therefore, directly answering all your questions about acceptance criteria and a study proving the device meets them, in the typical sense of a diagnostic or therapeutic study, is not applicable to this document.

However, I can extract the information related to safety and performance from the perspective of substantial equivalence.

Here's an analysis based on the provided document:

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

Since this is a 510(k) submission for a TENS device, the "acceptance criteria" are primarily established by demonstrating that the new device (candidate) has similar technological characteristics and performance specifications to a predicate device that has already been cleared by the FDA, and that it does not raise new questions of safety or effectiveness. The reported device performance is presented as a comparison to the predicate.

Study Proving Acceptance Criteria:

The document states: "Verification and validation tests as well as certificates and test reports contained in this submission demonstrate that the submitted models are substantially equivalent to the safety and effectiveness as that of the cleared devices."

Specifically, it mentions:

• "The software verification is conducted according to the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices – Guidance for Industry and FDA Staff – May 11, 2005."
• "The candidates devices and accessories meet general safety requirements IEC 60601-1 and requirements EMC: IEC 60601-1-2."

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

This document does not describe a clinical trial or performance study with a "test set" of human subjects or patient data in the typical sense of evaluating a diagnostic or therapeutic performance. The "test set" here refers to the device itself undergoing engineering and safety testing. The provenance of this engineering test data is not explicitly stated beyond being part of the submission by Avazzia, Inc. in Dallas, Texas, USA. These tests are typically conducted in a laboratory setting.

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

Not applicable. This is not a study that involved human experts establishing ground truth for a diagnostic or clinical outcome. The "ground truth" for the engineering performance and safety tests would be the established international standards (IEC 60601-1, IEC 60601-1-2) and the technical specifications of the predicate device.

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

Not applicable. This is not a study involving expert adjudication of clinical findings.

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) for pain relief, not an AI-assisted diagnostic or imaging device used by human "readers."

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

Not applicable. This is a medical device, not a standalone algorithm in the AI sense. The device's performance is inherently "standalone" in that its electrical output is measured without human intervention in the primary performance tests, but it is used by a human.

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

The "ground truth" for this 510(k) submission is based on:

• Engineering Standards: Compliance with international safety and electromagnetic compatibility standards (IEC 60601-1, IEC 60601-1-2).
• Predicate Device Specifications: The technical and performance characteristics of the previously cleared predicate device (Prospera OTC TENS Electronic Pulse Massager, Models PL009, PL009A, and PL029, K122744). The new device is deemed substantially equivalent if its performance is similar or better, and it doesn't introduce new safety concerns.
• Software Verification: Adherence to FDA guidance for software in medical devices.

8. The sample size for the training set

Not applicable. This device does not employ a machine learning algorithm that requires a "training set" of data.

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

Not applicable. As there is no training set for a machine learning algorithm, there is no ground truth established for it.

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The Gemore OTC TENS, Model GM310PP/GM321PP/GM330PP, is intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities

The Gemore OTC TENS. model GM310PP/GM321PP/GM321PP/GM330PP is a dual channel transcutaneous electrical nerve stimulator used for pain relief by applying an electrical current to electrodes, which are attached on the user's skin. The output and waveform characteristic is fixed for every operation mode, only the intensity is adjustable within specified limit.

The Gemore OTC TENS, model GM310PP/GM320PP/GM321PP/GM330PP, consist mainly of two parts: the stimulus generator, electrode. The stimulus generates the output current specified as the innut of controller. The output port transmits the output current to the electrode, which is attached to the user's skin so as to transmit this stimulus current for pain relief.

The stimulation modes for Gemore OTC TENS is pre-program modes width, pulse rate, frequency. The timer and amplitude for each program are adjustable. This operation way is considered the simplification from the pre-program modes of comparison clear model, OTC TENS For Low Back Pain Relief/ Model GM310PP/GM320PP /GM321PP/ GM330PP (K060222). Every operation mode of Gemore OTC TENS, model GM310PP/GM320PP/ GM321PP/GM330PP has its individual stimulation operation cycle.

My apologies, but the provided text from the FDA 510(k) K150681 document does not contain information about acceptance criteria for a study proving device performance, nor details of such a study for the Gemore OTC TENS.

The document is a 510(k) summary, which is essentially a submission to the FDA demonstrating that a new medical device is "substantially equivalent" to a legally marketed predicate device. This process primarily relies on comparing the new device's intended use and technological characteristics to those of predicate devices, rather than requiring extensive clinical trials or performance studies with specific acceptance criteria in the same way a PMA (Premarket Approval) might.

Here's a breakdown of what is and is not in the document, relative to your request:

What the document does include relevant to device performance, but not in the format of "acceptance criteria study":

• Non-Clinical Tests Performed (Section 6): It mentions compliance with voluntary standards like IEC 60601-1, IEC 60601-1-2, ISO 10993-5, and ISO 10993-10, as well as software verification according to FDA guidance. These are safety and performance standards that the device is stated to meet, but they are not presented as "acceptance criteria" against which a specific study's results are presented.
• Comparison of Significant Device Features (Section 7) and Output Characteristics (Section 8): These sections compare the new device's specifications (e.g., max phase charge, max current density, waveform, voltage, current) to those of the predicate devices. The implicit "acceptance criteria" here is that the new device's characteristics are "very close and within the acceptable range as specified in FDA guidance" (Section 10) and do not "affect the intended use or alter the fundamental scientific technology" (Section 11) compared to the predicate.
• Conclusions (Section 11): States that "verification and validation tests contained in this submission demonstrate that the submitted models could maintain the same safety and effectiveness as that of cleared device." However, the details of these "verification and validation tests" are not provided in this summary document.

What the document does not include from your request:

• A table of explicit acceptance criteria and corresponding reported device performance from a specific study.
• Sample sizes used for a test set.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts used to establish ground truth, nor their qualifications.
• Adjudication method for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study, or effect sizes for human readers with/without AI assistance.
• Standalone (algorithm only) performance study.
• Type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

In summary:

This 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on similar design, intended use, and conformance to recognized safety and performance standards for TENS devices. It does not document a specific study with acceptance criteria to prove the device's performance in the way your request outlines, which is typically seen for higher-risk devices or novel technologies requiring clinical efficacy studies. The "performance" assessment here is primarily a comparison to established devices and compliance with general device standards.

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