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GM511TE & GM511T- for temporary relief of pain associated with sore and aching muscles in the lower back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 to P9 or P17 to P19 and C/B/M/H1/H2 adjustable mode)

GM511TE & GM511T- for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis). It is also used as an adjunctive treatment for post-surgical and post-traumatic acute pain. (Choose TENS Mode P10)

GM511TE & GM511E - for use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance. (Choose EMS Modes P11 to P16 and C/S/A adjustable mode)

GM510TE & GM510T- for temporary relief of pain associated with sore and aching muscles in the lower back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 to P9 or P17 to P19)

GM510TE & GM510T- for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis). It is also used as an adjunctive treatment for post-surgical and post-traumatic acute pain. (Choose TENS Mode P10)

GM510TE & GM510E - for use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance. (Choose EMS Modes P11 to P16)

GM520TE & GM520T- for temporary relief of pain associated with sore and aching muscles in the lower back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 to P9 or P17 to P19)

GM520TE & GM520T- for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis). It is also used as an adjunctive treatment for post-surgical and post-traumatic acute pain. (Choose TENS Mode P10 )

GM520TE & GM520E - for use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance. (Choose EMS Modes P11 to P16)

GM530TE & GM530T- for temporary relief of pain associated with sore and aching muscles in the lower back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 to P9 or P17 to P19)

GM530TE & GM530T- for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis). It is also used as an adjunctive treatment for post-surgical and post-traumatic acute pain. (Choose TENS Mode P10)

GM530TE & GM530E - for use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance. (Choose EMS Modes P11 to P16)

GM540TE & GM540T- for temporary relief of pain associated with sore and aching muscles in the lower back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 to P9 or P17 to P19)

GM540TE & GM540T- for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis). It is also used as an adjunctive treatment for post-surgical and post-traumatic acute pain. (Choose TENS Mode P10)

GM540TE & GM540E - for use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance. (ChooseEMS Modes P11 to P16)

Not Found

This document is a 510(k) premarket notification clearance letter from the FDA for the GEM-STIM OTC TENS/EMS System. It does not contain information about acceptance criteria or studies proving device performance. The letter primarily states that the FDA has reviewed the submission and determined that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies from the provided text. This type of detailed performance data is typically found in the actual 510(k) submission, not in the clearance letter itself.

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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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For Transcutaneous electrical nerve stimulator.

This device is a prescription device and only for symptomatic relief of chronic intractable pain.

For Power Muscle Stimulator.

• Relaxation of muscle spasms.
• Prevention or retardation of disuse atrophy.
• Increasing local blood circulation.
• Muscle re-education.
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
• Maintaining or increasing range of motion.

For Interferential Stimulator.

The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain.

The GEM-STIM Combo Stimulator; Model: GM304/GM384/GM394 is the combination of transcutaneous electrical nerve stimulator(TENS) and Interferential stimulation (IF) used for pain relief and/or powered muscle stimulator(EMS) by applying an electrical current to electrodes, which are attached on the patient's skin. The output and waveform is adjustable according to the situation of patient.

The GEM-STIM Combo Stimulator: Model: GM304/GM384/GM394 consist mainly of two parts: the stimulus generator, electrode. The stimulus 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 patient's skin so as to transmit this stimulus current to the patient for pain relief or muscle stimulation of intended use purpose.

The GEM-STIM Combo Stimulator; Model: GM304/GM504 is basically the dual output channels unit which includes several different operation modes as mentioned on the comparison table. These operation modes are generated from the software control by using the microprocessor as its main control unit. And the model GM384/GM394 is the 4 channels model with the housing to install two independent units of GM504 and to provide the similar operation buttons which allow each unit of device being operated independently as that of the model GM504.

Basically the new models GM304/GM504/GM384/GM394 was developed from the predicate model GM38Y/Z (K042559). For the new models GM304/GM504/GM384/GM394, the stimulation waveform, significant specification, and the indication for use(IFU) were remained the same as that of Gemore 510(K) cleared predicate model GM38Y/Z (K042559).

Here's an analysis of the provided text, focusing on the acceptance criteria and the study performed:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly define quantitative acceptance criteria or report specific device performance metrics in a comparative table. Instead, it relies on demonstrating "substantial equivalence" to a predicate device.

The core of the "acceptance criteria" can be inferred as:

• Maintain the same intended use as the predicate device.
• Maintain the same technological characteristics (e.g., stimulation waveform, significant specifications) as the predicate device.
• Comply with applicable voluntary standards.
• Demonstrate that engineering differences do not affect intended use or alter fundamental scientific technology.

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

The document describes non-clinical tests (compliance to standards, software verification) rather than a clinical study with a "test set" of patient data. Therefore, concepts like sample size and data provenance (country of origin, retrospective/prospective) are not applicable in the context of this 510(k) submission. The evaluation is based on device specifications and engineering comparisons.

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

Since no clinical "test set" with patient data was used, the concept of establishing ground truth by experts is not applicable. The "ground truth" for this submission refers to adherence to engineering standards and the equivalence of device specifications to the predicate.

4. Adjudication Method for the Test Set:

As there is no clinical "test set" involving patient data and human readers, an adjudication method is not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size:

No MRMC comparative effectiveness study was done. This 510(k) submission is for a device that relies on physical stimulation (TENS, EMS, IF), not image-based diagnosis requiring human interpretation. The study is focused on engineering specifications and safety/effectiveness equivalence.

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

This device is a physical stimulator. The concept of "standalone performance" typically applies to AI algorithms that process data or images. In this context, the device's "standalone performance" would be its ability to generate the specified electrical outputs. The non-clinical tests (compliance to standards, software verification) assess the device's inherent functionality and safety without a human-in-the-loop performance measurement.

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

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

• Engineering Specifications and Performance: Comparison to the established specifications of the predicate device.
• Voluntary Standards: Adherence to recognized national and international standards (e.g., ANSI/AAMI, IEC 60601-1, IEC 60601-1-2).
• Software Verification Guidelines: Compliance with FDA's software guidance.

8. The sample size for the training set:

As this is not an AI/machine learning device being trained on data, the concept of a "training set" and its sample size is not applicable.

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

Since there is no training set, this question is not applicable. The "ground truth" for the overall submission is established via engineering design conformity and compliance with regulatory standards.

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The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain.

The Gemore IF series True sine interferential stimulator / Model: GM3A00IF/GM3A10IF/ GM3A20IF/GM3A50IF are the device which generates the small true-sine pulses of electrical current. The generated current may be delivered to the patient skin and/or underlying nerves through the cable and electrode placed on skin.

This 510(k) summary describes a submission for the Gemore IF True Sine Interferential Stimulator (Models GM3A001F/GM3A10IF/GM3A20IF/GM3A50IF). The submission aims to demonstrate substantial equivalence to a predicate device (Gemore IF TENS, Model GM322IF, K032719).

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly define specific "acceptance criteria" in terms of measurable performance metrics and then report the device's achievement against these in a table format. Instead, it relies on demonstrating compliance with recognized standards and similarity to the predicate device to establish substantial equivalence.

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

The summary does not provide details on a specific "test set" in the context of clinical or performance data for the device. The testing mentioned largely refers to engineering verification and validation against standards and comparisons to the predicate device's specifications. Thus, there is no disclosed sample size or data provenance (e.g., country of origin, retrospective/prospective) for a clinical or performance "test set" in the sense of patient data.

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

This information is not provided in the submission. The submission focuses on substantial equivalence through engineering changes and compliance with standards, not on clinical performance evaluated against expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not provided. As there is no clinical or performance "test set" with ground truth established by experts discussed, an adjudication method is not applicable here.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a stimulator, not an AI-assisted diagnostic or interpretive tool that would involve "human readers" or AI assistance in that context.

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

This refers to an "algorithm only" performance study, typically for AI or software-based diagnostic devices. The Gemore IF stimulator is a physical electrical stimulation device. While it has firmware/software, the primary "performance" is the electrical output. The summary indicates "software verification has been carried out according to the FDA software guidance," but this is about the software itself functioning correctly, not about a standalone clinical performance evaluation of an algorithm in the sense of AI.

7. The Type of Ground Truth Used

The concept of "ground truth" (expert consensus, pathology, outcomes data) as typically applied to diagnostic or prognostic devices is not directly applicable or detailed in this submission. The "truth" for this submission revolves around:

• Compliance with engineering standards: The device's electrical output and safety features meet established international and voluntary standards (e.g., ANSI/AAMI. NS4-1985, IEC 60601-1, IEC 60601-1-2).
• Verification of software functionality: The software operates according to design and FDA guidance.
• Substantial equivalence to the predicate: The device's intended use and fundamental technological characteristics are equivalent to the previously cleared predicate device, despite stated modifications.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The device is an electrical stimulator, not a machine learning or AI-based device that would typically involve a "training set" for model development.

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

This information is not applicable and not provided. As there is no AI/ML component with a training set, the establishment of ground truth for such a set is not relevant to this submission.

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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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The Gemore Muscle Conditioner, model GM310PE/GM320PE/GM330PE/GM340PE/ GM350PE are intended to stimulate healthy muscles in order to improve or facilitate muscle performance.

The Gemore Muscle Conditioner, model GM310PE/GM320PE/GM330PE/GM340PE/ GM350PE are not intended to be used in conjuction with therapy or treatment of medical diseases or medical conditions of any kind. None of the Gemore Muscle Conditioned training programs are designed for injured or ailing muscle and it's use on such muscle in contraindicated.

The Gemore Muscle Conditioner, model GM310PE/GM320PE/GM330PE/GM340PE/ GM350PE electrically impulse triggering actions potentials on motoneurones of motor nerves(excitations). The excitations of motoneurones are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber response that correspond to muscle work. Depending on the parameters of the electrical impulses(pulse frequency, duration of contraction, duration of rest, total session duration), different type of muscle work can be imposed on the stimulated muscles.

The various types of muscle work that Gemore Muscle Conditioner can impose on the stimulated muscles are able to improve or facilitate muscle performance. The Gemore Muscle Conditioner, model GM310PE/GM320PE/GM330PE/GM340PE/ GM350PE may therefore be considered a technique of muscle training.

The Gemore Muscle Conditioner, model GM310PE/GM330PE/GM340PE/GM340PE/GM350PE are the battery-operated programmable muscle stimulator intended to improve or facilitate muscle performance by applying an electrical current to electrodes, which is attached on the healthy muscle.

Gemore Muscle Conditioner, model GM310PE/GM330PE/GM330PE/GM40PE/GM350PE, consists mainly of three parts: the stimulator , special butterfly type self-adhesive electrode (GelPads), and leader wire fitting for the stimulation of any healthy muscle of body. The stimulator 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 specified region, so as to transmit this stimulus current to the healthy muscle the following intended purposes:

• to stimulate healthy muscles in order to improve or facilitate muscle performance.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

Device: Gemore Muscle Conditioner (models GM310PE/ GM320PE/GM330PE/GM340PE/GM350PE)
Intended Use: To stimulate healthy muscles in order to improve or facilitate muscle performance. Not intended for therapy or treatment of medical diseases or conditions, or for use on injured or ailing muscles.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the Gemore Muscle Conditioner is a Powered Muscle Stimulator, and its clearance is based on substantial equivalence to predicate devices. This means its "acceptance criteria" are primarily met by demonstrating that it performs comparably and safely to already legally marketed devices with a similar intended use and technological characteristics. The document does not explicitly list specific quantitative acceptance criteria (e.g., "device must achieve X% accuracy" or "output current must be within Y range") as might be seen for diagnostic AI/ML devices.

Instead, the "performance" proof is qualitative, asserting equivalence to predicate devices.

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

The provided text does not contain information about a specific "test set" in the way one would describe data used for evaluating an AI/ML or diagnostic device. The evaluation appears to be based on engineering and design verification/validation against standards and predicate devices, rather than a clinical study with a defined patient population or dataset. Therefore, there is no mention of sample size or data provenance (e.g., country of origin, retrospective/prospective).

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

This information is not applicable or not provided in the document. The device is a powered muscle stimulator, not a diagnostic device requiring expert interpretation of results for ground truth. Its evaluation is against engineering standards and the performance of predicate devices.

4. Adjudication Method for the Test Set

This information is not applicable or not provided. There is no "test set" and thus no adjudication method described.

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

An MRMC study was not done. This device is a muscle stimulator, not an AI/ML diagnostic tool that would assist human readers in interpreting cases.

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

This information is not applicable or not provided. The device is a physical muscle stimulator, not an algorithm, so the concept of "standalone algorithm performance" does not apply.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically applied to diagnostic studies (e.g., pathology, outcomes data) is not directly relevant to the described evaluation. Instead, the "ground truth" for this device's performance demonstration lies in:

• Compliance with recognized voluntary electrical and medical device safety/performance standards (e.g., ANSI/AAMI, EN 60601 series).
• Demonstrating that its technological characteristics and intended use align with legally marketed predicate devices that have prior FDA clearance.
• Internal verification and validation tests (details not provided beyond their mention in the conclusion).

8. The Sample Size for the Training Set

This information is not applicable or not provided. This device is not an AI/ML system that requires a "training set."

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

This information is not applicable or not provided, as there is no "training set" for this type of device.

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The GEMORE GEM-TONE Abdominal Training System/model GEM-TONE 310PE/320PE/340PE/340PE/350PE are the electrical muscle stimulator intended for the following indication for use:

• Strengthening, toning and firming of the abdomen region.
  The GEMORE GEM-TONE Abdominal Training System and its stimulation programs are not designed for injured or ailing muscles, and use on such muscles is contraindication.

The GEM-TONE Abdominal Training System model GEM-TONE 310PE/ 320PE /330PE /340PE / 350PE is battery-operated programmable muscle stimulator intended to improve or facilitate muscle performance by applying an electrical current to electrodes, which is attached on abdomen region.
GEM-TONE Abdominal Training System model GEM-TONE 310PE / 320PE /330PE /340PE /350PE, consists mainly of three parts: the stimulator , electrodes, and support belts fitting for special parts of body. The stimulator 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 specified region, so as to transmit this stimulus current to the region of abdomen for the following intended purposes:

• Strengthening, toning and firming of the abdomen region.
  The GEMORE GEM-TONE Abdominal Training System and its stimulation programs are not designed for injured or ailing muscles, and use on such muscles is contraindication.
  To adequately locate the stimulation on the intended treatment area, the following support belt is provided together with the stimulator:
• · The abdomen belt, which is capable of connecting to the both two output channels of stimulator.
  The stimulation mode for GEM-TONE Abdominal Training System includes several different operation modes as mentioned on the comparison table. These operation modes are generated from the software control by using the microprocessor as its main control unit.

This submission describes a premarket notification (510(k)) for the GEM-TONE Abdominal Training System, a powered muscle stimulator. The purpose of the 510(k) is to demonstrate substantial equivalence to a predicate device, the Slendertone Flex (K010335).

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in terms of performance metrics like sensitivity, specificity, or accuracy, as would be typical for diagnostic or AI-driven devices. Instead, the "acceptance criteria" for this muscle stimulator appear to be centered around compliance with recognized electrical safety and regulatory standards, and demonstrating equivalent functionality to the predicate device.

2. Sample Size for the Test Set and Data Provenance

The provided document does not specify any clinical studies or test sets with human participants that would typically involve a "sample size" for performance evaluation in the way an AI/diagnostic device would. The "verification tests" mentioned are likely technical and engineering tests to ensure compliance with electrical and software standards, rather than a clinical trial.

Therefore, information on:

• Sample size used for the test set: Not applicable/not provided for clinical performance testing.
• Data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable, as no clinical data studies are described.

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

This information is not applicable as the submission focuses on demonstrating electrical safety, software compliance, and functional equivalence to a predicate device through non-clinical testing. There is no mention of a ground truth established by experts for a test set in the context of this 510(k) summary.

4. Adjudication Method for the Test Set

This information is not applicable as there is no described test set of clinical data with expert ground truth to be adjudicated.

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

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being performed, nor any effect size for human readers improving with or without AI assistance. This type of study is typically relevant for interpretative diagnostic devices, not for a muscle stimulator.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

This concept is not applicable to the GEM-TONE Abdominal Training System described. This device is a powered muscle stimulator, and its functionality does not involve an "algorithm only" performance or human-in-the-loop interpretation in the way a diagnostic AI would. Its performance is directly tied to its electrical output and user interaction (attaching electrodes).

7. Type of Ground Truth Used

There is no mention of a specific "ground truth" (e.g., expert consensus, pathology, outcomes data) being established for clinical performance as no such clinical study is described. The "ground truth" for this submission refers to the established safety and effectiveness standards of the predicate device and the relevant electrical safety standards. The device's performance is measured against these technical and regulatory benchmarks.

8. Sample Size for the Training Set

This information is not applicable. The device is a muscle stimulator, not an AI/machine learning model that requires a "training set" of data. The software verification mentioned refers to adherence to good software engineering practices and FDA guidance, not to training an AI model.

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

This information is not applicable as there is no training set for an AI model.

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The Gemore Reuseable Self Adhesive Electrode / Wire series, Snap series, and Double side series are intended for use as a disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Gemore Reuseahle Self Adhesive Electrode / Wire series, snap series, and double side series are designed and intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation), MENS (Microcurrent Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) and PGS (Pulsed Galvanic Stimulation).

Gemore Reuseable Self Adhesive Electrode / Wire series and Double side series and Double side series are non-sterile, disposable laminated, flexible structures composed of materials commonly used in this application:

First Layer – White spun faced nonwoven tape or White 1/32" thick Polyethylene foam or a polypropylenc substrate, coated with biocompatible adhesive. Second Layer - Conductive plastic film.

Third Layer – Biocompatible conductive hydrogel coupling media

The electrodes are designed for single-patient/multiple application use. Because of the adhesive nature of the biocompatible hydrogel, no securing materials are required to secure the device to the patient's skin. The electrode has one type of connection point that can be used to connect the stimulation device to the electrodes. This connection point is compatible with all standard, marketed Neurostimulation devices.

For the electrical connection, Gemore provides three different types:

Snap Series – Snap connection – 1.65" standard size of mail. Snap is provided to connect to the wire female snap.

Wire Series – Lead wire assembly – 4.5" ~ 6" wire with .080 in. diameter female socket connected to one side of the wire.

Double side series – adhesive gel was also provided at the reverse side of skin contact. With this adhesive side, the electrode can be mounted on the electricity conductive sufface of device without additional lead wire or snap.

The provided text describes a 510(k) submission for the "Gemore Reuseable Self Adhesive Electrode / Wire series, Snap series, and Double side series." However, it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria beyond general safety and effectiveness.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices (K052875 and K050788) for the purpose of a 510(k) clearance. This involves showing that the new device is as safe and effective as existing legally marketed devices, rather than meeting specific quantifiable performance targets derived from a clinical study with detailed acceptance criteria.

The information provided relates to:

• Biocompatibility: The gel used meets skin sensitivity testing criteria specified in the Tripartite Biocompatibility Guidance for Medical Devices and ISO 10993-1.
• Electrical Safety: Electrical safety testing was conducted according to ANSI/AAMI EC12.

Since there is no detailed performance study with explicit acceptance criteria provided in the document, I cannot fill out the requested table or answer most of the questions.

Here's what can be extracted from the document:

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

• Acceptance Criteria: Not explicitly stated in terms of performance metrics. The criteria are implicitly tied to demonstrating equivalence to predicate devices and meeting established safety standards (biocompatibility, electrical safety).
• Reported Device Performance:
  • Biocompatibility: The gel used for skin contact "passed the required skin sensitivity testing criteria as specified in the Tripartite Biocompatibility Guidance for Medical Devices and ISO 10993-1 requirements for skin contact."
  • Electrical Safety: "We have conducted and completed the electrical safety testing according to the chosen performance standard, ANSI/AAMI EC12. The testing report was included in this submission."

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

• Not applicable. No specific "test set" for performance evaluation is described. The biocompatibility and electrical safety tests would have involved specific samples, but the details of these are not provided in this summary.

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 expert review for a "test set" to establish ground truth is described.

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

• Not applicable.

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 an electrode for neurostimulation, not an AI-assisted diagnostic tool involving human readers.

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

• Not applicable. This is not an algorithmic device.

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

• Not applicable for a performance study. For safety, the ground truth for biocompatibility is defined by established international standards (ISO 10993-1) and for electrical safety by ANSI/AAMI EC12.

8. The sample size for the training set

• Not applicable. No "training set" is described as this is not a machine learning device.

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

• Not applicable.

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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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