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The Everyway EV-820 OTC Pain Relief TENS 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 Everyway EV-820 OTC Pain Relief TENS 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 Everyway EV-820 OTC Pain Relief TENS consists 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 user's skin so as to transmit this stimulus current for pain relief.

The stimulation modes for Everyway EV-820 OTC Pain Relief TENS is pre-program modes with fixed pulse width, pulse rate, frequency. The timer and amplitude for each program are adjustable. This operation way is considered the simple design change from the pre-program modes of comparison clear model, existing 510(k) cleared devices, Low Back Pain Relief System/ Model EV-820(K110716). Every operation mode of Everyway EV-820 OTC Pain Relief TENS Syste has its individual stimulation operation cycle.

I am unable to provide a description of acceptance criteria and a study that proves the device meets the acceptance criteria from the provided document. The document is a 510(k) premarket notification letter from the FDA to Everyway Medical Instruments Co., Ltd. regarding their Everyway EV-820 OTC Pain Relief TENS device.

Here's why I cannot fulfill your request based on the provided text:

• No specific acceptance criteria are stated: The document primarily focuses on establishing substantial equivalence to predicate devices based on regulatory classification, intended use, and technological characteristics. It does not define specific performance metrics or acceptance criteria for the device itself (e.g., pain reduction percentage, battery life benchmarks).
• No detailed study is presented to prove acceptance criteria: The document explicitly states: "No particular Clinical Test was conducted for Everyway EV-820 OTC Pain Relief TENS." It mentions compliance with voluntary standards (IEC 60601-2-10, IEC 60601-1, and IEC 60601-1-2) and software verification, which are non-clinical tests for safety and performance, but these are not presented as studies designed to prove specific acceptance criteria for the device's therapeutic effectiveness. The comparison tables provided highlight characteristics, not performance against acceptance criteria.
• The document is a regulatory submission, not a research paper: A 510(k) summary aims to demonstrate substantial equivalence to legally marketed predicate devices, not to present a detailed clinical study proving device effectiveness against pre-defined acceptance criteria.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving their fulfillment from this document.

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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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The GEMORE TENS System, model GM310TP/GM320TP/GM330TP/GM340TP Transcutaneous Electrical Nerve Stimulators are indicated for:

• symptomatic relief of chronic, intractable pain .
• adjunctive treatment for post-surgical and post-traumatic acute pain
• relief of pain associated with osteoarthritis of the knee and rheumatoid arthritis of the hand

The Gemore TENS System / Model GM310TP, GM320TP, GM330TP, and GM340TP transcutaneous electrical nerve stimulators for pain relief, are the electrically power devices used to apply an electrical current to electrode on a patient's skin to relieve pain. This series of TENS devices are indicated for:

• symptomatic relief of chronic, intractable pain
• . adjunctive treatment for post-surgical and post-traumatic acute pain
  . relief of pain associated with osteoarthritis of the knee and rheumatoid arthritis of the hand
  For this definition of intended use, the Gemore TENS system is classified with the "NYN" & "GZJ" product code under 21CFR/Part 882.5890 FDA regulation classification number.
  The Gemore TENS system consists mainly of two parts: the stimulus generator and electrode. The stimulus generator generates the output current specified as the input of controller. The output of controller is able to be adjusted for B/C/M/P1/P2/P3/P4/P5 eight operation modes which bear different combination for the output parameters of pulse width, pulse rate, and pulse cycle. For every operation mode, the operator could adjust output intensity, pulse rate and operation time. The output parts transmit the output current to the electrodes which is attached to the patient's skin so as to .transmit the generated stimulus to patient for pain relief treatment.
  GM310TP/GM320TP/GM330TP/GM340TP is completely identical to that of model as mentioned in our previous submission of GEM STIM TENS, model GM310TE/ GM320TE/GM330TE/GM340TE (K032720). To change the indication for use as that of the chosen predicate devices, Gemore changed the software for these four models.
  For the device included in this submission, we use the following of our 510(K) legally marketed predicate garment electrodes:
• K062675, "Gemore Reuseable Self Adhesive Electrode" ; Wire Series/ Model FA5050 ( 5x5 CM or bigger size) self adhesive electrode.
  GM310TP/GM320TP/GM330TP/GM340TP is a selectable dual channel, 9V battery operated TENS device with the following features:
• The operation function is dual channels completely identical to the model being modified, GM310TE/GM320TE/GM330TE/GM340TE (K032720).
• The output of controller is able to be adjusted for B/C/M/P 1/P2/P3/P4/P5 eight operation modes which bear different combination for the output parameters of pulse width, pulse rate, and pulse cvcle.
• The output strength is adjustable at 0~80 mA, with maximum setting time 60 minutes counting from switching ON.
• The LCD display is provided for the indication of operation status including CH1/CH2, output program mode, pulse width, pulse rate, timer, and battery low warning

Here's an analysis of the provided text regarding the acceptance criteria and study for the GEMORE TENS System:

Summary of Device Performance and Acceptance Criteria

The submission for the GEMORE TENS System (models GM310TP/GM320TP/GM330TP/GM340TP) is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a legally marketed predicate device (Empi - SELECT TENS System, K061650). This type of submission generally does not involve a clinical study to directly prove efficacy against acceptance criteria in the same way a de novo or PMA submission might. Instead, it focuses on demonstrating that the new device is as safe and effective as the predicate device by meeting similar technological characteristics and performance specifications.

The "acceptance criteria" here are implicitly defined by the performance characteristics of the predicate device and relevant voluntary standards. The "study" proving the device meets these criteria is a series of non-clinical tests and comparisons.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence claim based on non-clinical testing and comparison to a predicate, the "acceptance criteria" are the performance specifications and safety standards met by the predicate device and relevant industry standards. The "reported device performance" is how the new device compares to these.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not applicable in the context of this 510(k) submission. This is a technical comparison and non-clinical performance verification, not a clinical trial with a "test set" of patients. The "test set" for performance characteristics would refer to the TENS devices themselves being tested in a lab environment.
• Data Provenance: The data comes from the manufacturer's (Gemore Technology Co., Ltd., Taiwan) internal testing and comparison against the specifications of the predicate device (Empi - SELECT TENS System). It is entirely non-clinical.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Number of Experts: Not applicable. Ground truth for a device's technical specifications and compliance with standards is established through engineering and electrical testing, not typically by clinical experts in the sense of reviewing patient data.
• Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no ambiguous patient data requiring expert adjudication in a 510(k) submission focused on technical equivalence.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is specifically for evaluating the diagnostic performance of a device (often imaging AI) by multiple human readers across multiple cases, and comparing performance with and without AI assistance. The GEMORE TENS System is a pain relief device, and this specific submission is for technical equivalence, not clinical efficacy through such a study design.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: While the TENS device itself operates "standalone" in delivering electrical stimulation, the concept of "standalone performance" and "human-in-the-loop" typically applies to AI diagnostic algorithms. For a TENS device, the "performance" is its ability to deliver specified electrical outputs accurately. This was verified through engineering tests. There's no AI algorithm here that performs a diagnostic task independently or with human input.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" here is the technical specifications and performance characteristics of the predicate device, as well as the relevant voluntary standards (ANSI/AAMI NS4-1985, IEC 60601-1, and IEC 60601-1-2) for electrical safety and electromagnetic compatibility. The new device's performance was measured against these established engineering benchmarks.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device does not use machine learning or AI that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not applicable. As there is no training set, there is no ground truth establishment for it.

Conclusion of the Submission:

The study presented here is a pre-market submission (510(k)) demonstrating substantial equivalence between the new GEMORE TENS System and a previously cleared predicate device. This is achieved through:

• Detailed technical comparison of features, intended use, operating modes, and physical characteristics.
• Performance comparison of electrical output parameters (voltage, current, pulse duration, frequency, phase charge, current density, average current, power density).
• Declaration of compliance with recognized voluntary standards (ANSI/AAMI NS4-1985, IEC 60601-1, and IEC 60601-1-2).
• Software verification according to FDA guidance.

The manufacturer asserts that despite some minor differences (e.g., power source, maximum output parameters, timer range), these differences do not affect the intended use or alter the fundamental scientific technology of the device, thus maintaining the same safety and effectiveness as the cleared predicate. The FDA agreed with this assessment, granting 510(k) clearance.

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