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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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TENS stands for Transcutaneous Electrical Nerve Stimulation. The itouch TENS system is indicated for:

• Symptomatic relief and management of chronic, intractable pain. .
• Adjunctive treatment for post-surgical and post-trauma acute pain. .

A portable TENS device for pain relief.
Features:

• Innovative design
• Large LCD display
• Dual output isolated channels
• 2 AA Alkaline Batteries
• Adjustable frequency, pulse width, and timing parameters
• 9 different modes
• Timer option
• Doctor lock/unlock facility
• Open circuit detectors
• Non-volatile

The provided 510(k) summary for the Tenscare TENS Model itouch (K082377) does not contain a study that proves the device meets specific acceptance criteria in the way typically found for novel diagnostic algorithms or devices.

Instead, this submission primarily focuses on demonstrating substantial equivalence to predicate devices (EasyMed TENS Unit TN-28C and Gemore GM300T) via technological comparison, labeling comparison, and compliance with recognized safety standards. For TENS devices, the primary "acceptance criteria" are related to safety, electrical output specifications, and efficacy established by existing, legally marketed devices.

Here's an breakdown based on the provided text, addressing your points where information exists:

1. Table of Acceptance Criteria and Reported Device Performance

As per the document, specific, quantifiable acceptance criteria (e.g., target accuracy, sensitivity, specificity) for a clinical study proving device efficacy are not presented for the Tenscare itouch. Instead, the "performance" is implicitly tied to compliance with standards and equivalence to predicate devices which are already accepted as safe and effective.

The closest to "acceptance criteria" are:

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

• No specific clinical test set is described. The submission relies on technological comparison and compliance with standards rather than a new clinical performance study with a dedicated test set of patient data.
• The reference to "itouch has been marketed in Europe" and "review of Customer Complaints, Returned Product and the results of Post Market Feedback" suggests retrospective data analysis from real-world usage in Europe. However, no sample sizes for this feedback are provided.

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

• This is not applicable as there is no described clinical study with a "test set" and associated "ground truth" derived by experts for performance evaluation.

4. Adjudication method for the test set

• This is not applicable as there is no described clinical study with a "test set" requiring adjudication.

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

• This is not applicable. The device is a Transcutaneous Electrical Nerve Stimulator (TENS), not an AI-powered diagnostic tool, and therefore, an MRMC study involving human readers and AI assistance is outside its scope.

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

• This is not applicable. The Tenscare itouch is a medical device for pain relief, not an algorithm.

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

• For the European post-market review, the "ground truth" was implicitly the real-world performance as intended by the device's design and specified requirements, based on customer complaints, returned products, and feedback. This can be considered a form of "outcomes data" related to device function and patient satisfaction, rather than a diagnostic ground truth.
• For the submission to the FDA, the "ground truth" for demonstrating equivalence is the established safety and efficacy profile of the predicate devices and compliance with recognized electrical safety and performance standards.

8. The sample size for the training set

• This is not applicable. The device is not an AI algorithm that requires a "training set." Its design and development are based on established engineering principles for TENS devices and comparison to predicate devices.

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

• This is not applicable as there is no "training set" for an AI algorithm.

In summary:

The K082377 submission for the Tenscare TENS Model itouch demonstrates substantial equivalence to predicate devices through technical comparisons, adherence to safety standards, and general claims of satisfactory performance in the European market. It does not present a clinical study with specific acceptance criteria, test sets, or ground truth establishment in the manner typically seen for novel diagnostic or AI-driven medical devices. The primary "proof" relies on the device being technologically similar to and meeting the same safety standards as already cleared TENS devices.

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The model GM310PP, GM320PP, GM321PP, and GM321PP 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 Gemore Low Back Pain Relief System, models GM310PP, GM320PP, GM321PP, and GM330PP are non-invasive devices which are intended for over the counter use in temporary relief of pain associated with sore and aching muscles in the lower back due to stain from exercise or normal household and work activities.

The devices contain the following main parts: TENS stimulation unit, Support Belt, Self-adhesive pads, and Snap Cable.

The device can be worn on the low back part of user so as to place the stimulation pads on the treatment location of low back.

The main stimulation function is achieved through the stimulation unit of GM310PP, GM320PP, GM321PP, and GM330PP. Those stimulation units have been cleared for 510(k) before being submitted on this new submission for OTC application. The K-number for these four models are K032720.

The provided 510(k) summary for the "Low Back Pain Relief System, model GM310PP, GM320PP, GM321PP, and GM330PP" indicates that its acceptance criteria and clinical performance were established through a substantial equivalence pathway, rather than a de novo study with specific performance targets. This means the device's safety and effectiveness are demonstrated by showing it is as safe and effective as a legally marketed predicate device.

Here's an analysis based on the provided text, addressing your specific points:

1. Table of Acceptance Criteria and Reported Device Performance

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

This submission does not refer to a "test set" in the context of clinical performance data generated specifically for this device (GM310PP, GM320PP, GM321PP, GM330PP).

Instead, the submission relies on:

• Previous 510(k) submissions (K032720) for the core TENS stimulation units (GM310PP, GM320PP, GM321PP, GM330PP) for their performance and safety testing. The specific details of any clinical "test set" from K032720 are not provided in this document.
• Bench testing and materials characterization for the new components (e.g., neoprene belt). These are not clinical studies with human subjects for efficacy.

Therefore, information regarding country of origin of data or retrospective/prospective nature is not applicable for a direct clinical test set for this specific 510(k) submission. It's an affirmation of equivalence based on existing data and bench testing.

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

Not applicable. This substantial equivalence submission does not describe a clinical study that required expert consensus for ground truth on human subjects. The "ground truth" here is compliance with established engineering and biocompatibility standards, and the predicate's known safety and performance.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication of results from multiple readers/observers is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC comparative effectiveness study was not done for this device. The submission relies on demonstrating equivalence to an already marketed device, not on showing human reader improvement with or without AI assistance. This device is a Transcutaneous Electrical Nerve Stimulator, not an AI-powered diagnostic system.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical medical device (TENS unit) for pain relief, not an algorithm, and thus standalone algorithm performance is not relevant.

7. Type of Ground Truth Used

The "ground truth" for this submission is based on:

• Compliance with recognized voluntary consensus standards: ANSI/AAMI NS4 (performance for TENS), EN 60601-1 series (electrical safety), and ISO 10993-1 (biocompatibility).
• Demonstrated safety and effectiveness of the predicate device (K040512). The predicate device serves as the benchmark against which substantial equivalence is claimed.

8. Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device, so there is no "training set."

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

Not applicable. As there is no training set for an AI/ML algorithm, no ground truth needed to be established in that context.

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