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The SMART TENS is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

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This document is an FDA 510(k) clearance letter for a medical device called "Smart TENS, Model: D-BC05T." It states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the other specific details requested in the prompt. This document is solely a regulatory clearance letter and does not include the technical study report.

Therefore, I cannot fulfill your request for the tables and detailed information as the source text does not contain it.

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The Body Clock Stimplus Pro and Body Clock Stimplus are used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the symptomatic relief and management of post-surgical and post-traumatic acute pain.

The TENS devices are used to transmit electrical pulses through the skin to the underlying peripheral nerves to aid in the blocking of the pain signal travelling to the brain.

The devices, "Body Clock Stimplus Pro" and "Body Clock Stimplus," are Transcutaneous Electrical Nerve Stimulators (TENS units) intended for pain relief.

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

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided document, there are no specific, quantitative acceptance criteria defined for device performance (e.g., a certain level of pain reduction in percentage, or a specific range of electrical output). Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device.

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

• Sample Size for Test Set: Not applicable. The submission explicitly states "Clinical Testing: Not Applicable." The basis for clearance is substantial equivalence to a predicate device, not a new clinical performance study.
• Data Provenance: Not applicable, as no new clinical testing was performed. The data provenance would refer to the existing predicate device's historical performance and regulatory clearance.

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

• Not applicable. No new clinical trials were conducted to establish a ground truth for the device's performance.

4. Adjudication Method for the Test Set:

• Not applicable. No new clinical trials with a test set requiring adjudication were conducted.

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

• No, an MRMC comparative effectiveness study was not done. The submission explicitly states "Clinical Testing: Not Applicable." TENS units are typically evaluated for efficacy in pain relief through clinical trials; however, for this 510(k), equivalence to an already approved device negated the need for new clinical trials.

6. If a Standalone (Algorithm only without human-in-the-loop performance) was done:

• Not applicable. This device is a TENS unit, not an AI/algorithm-based diagnostic or assistive system. Its function is direct electrical stimulation, not processing data or providing outputs for human interpretation.

7. The Type of Ground Truth Used:

• The implicit "ground truth" for this 510(k) submission is the established safety and efficacy of the predicate device (Solitens Modified - Stimplus Pro, K913522), as determined by its prior regulatory clearance. The current submission argues that the new devices are so similar (identical or substantially equivalent) that their performance, and thus their "ground truth," would be the same.

8. The Sample Size for the Training Set:

• Not applicable. This device is a TENS unit, not typically involving a "training set" in the context of machine learning or complex diagnostic algorithms. The design and manufacturing are based on established engineering principles and safety standards, rather than data-driven model training.

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

• Not applicable, as there is no "training set" in this context.

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As a TENS unit, the Body Clock Duo is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

As a Powered Muscle Stimulator unit the Body Clock Duo is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area. It is indicated for the following:

• 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; and .
• Maintaining or increasing range of motion. ●

The Body Clock Duo has two facilities, enabling it to function as both a TENS unit and as a Powered Muscle Stimulator. As a TENS unit, the Body Clock Duo transmits electrical pulses through the skin to the underlying peripheral nerves to aid in the blocking of pain signals travelling to the brain. As a Powered Muscle Stimulator, the Body Clock Duo can be used to relax muscle spasms, prevent or retard disuse atrophy, maintain or increase range of motion, increase local blood circulation, re-educate muscle and provide immediate post-surgical stimulation of calf muscle to prevent venous thrombosis.

The Body Clock Duo is a Transcutaneous Electric Nerve Stimulator (TENS) and Powered Muscle Stimulator. The submission states that no clinical testing was performed to establish acceptance criteria or demonstrate device performance because "there are no new or innovative aspects that have been introduced." Instead, the device's substantial equivalence to predicate devices (FUJI TENS 804SIII (K893874) and Altoona EMS 400 (K913272)) and compliance with relevant non-clinical standards are relied upon.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance.
• Sample size used for the test set and the data provenance.
• Number of experts used to establish the ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size.
• Whether a standalone performance study was done.
• The type of ground truth used.
• The sample size for the training set.
• How the ground truth for the training set was established.

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The 804SIII, 804W, Libra TENS, 410 and S-TENSII are used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

The TENS devices are used to transmit electrical pulses through the skin to the underlying peripheral nerves to aid in the blocking of pain signals travelling to the brain.

This document describes a 510(k) premarket notification for several Transcutaneous Electrical Nerve Stimulator (TENS) devices (804SIII, 804W, Libra TENS, 410, S-TENSII) by Body Clock Health Care Ltd. The notification primarily relies on substantial equivalence to predicate devices rather than new clinical studies for acceptance criteria.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

No clinical test set was used. The submission relies on non-clinical testing and substantial equivalence to legally marketed predicate devices.

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

Not applicable. No clinical test set or expert ground truth establishment was conducted for the purpose of this 510(k) submission.

4. Adjudication Method for the Test Set:

Not applicable. No clinical test set was used.

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

No MRMC study was done, as no clinical testing was performed. The submission explicitly states "Clinical Testing: Not Applicable as there are no new or innovative aspects that have been introduced."

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

Not applicable. These are physical TENS devices, not an algorithm, and no standalone performance study in a clinical context was conducted. The performance evaluation was based on compliance with electrical and safety standards.

7. Type of Ground Truth Used:

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

• Predicate Device Characteristics: The established design and performance of the legally marketed FUJI TENS devices.
• Industry Standards: Compliance with AAMI/ANSI NS-4, IEC 60601-1, and IEC 601-1 for electrical medical equipment.

8. Sample Size for the Training Set:

Not applicable. There is no mention of a "training set" in the context of machine learning or an algorithm development in this 510(k) submission for TENS devices.

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

Not applicable, as there was no training set.

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The V TENS Plus is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

The TENS devices are used to transmit electrical pulses through the skin to the underlying peripheral nerves to aid in the blocking of the pain signal travelling to the brain.

This 510(k) summary describes a Transcutaneous Electrical Nerve Stimulator (TENS) device called the V-TENS Plus. The submission focuses on demonstrating substantial equivalence to a predicate device, the FUJI TENS 804SIII (K893874), rather than conducting an independent study to establish device performance against specific acceptance criteria.

Therefore, many of the requested sections regarding a standalone study proving device performance against acceptance criteria are "Not Applicable" or cannot be extracted directly from the provided text, as the application relies on equivalence.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria for Substantial Equivalence:

The primary "acceptance criteria" for this 510(k) submission are that the V-TENS Plus is substantially equivalent to the predicate device (FUJI TENS 804SIII) in terms of:

• Intended Use
• Technological Characteristics
• Safety and Effectiveness (not raising new questions)

Reported Device Performance (against the predicate):

Conclusion from 510(k) Summary (10.9): The V-TENS Plus has the same intended use and similar technical characteristics as the FUJI TENS 804SIII (K893874). The information supplied illustrates that the device does not pose any new questions of safety and effectiveness, thus it is substantially equivalent to the predicate device.

Study Information (Based on Substantial Equivalence Submission)

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

• Sample Size for Test Set: Not applicable. This submission did not involve a clinical trial or "test set" in the sense of a new study to prove device performance. The assessment was a comparison to an existing legally marketed device.
• Data Provenance: Not applicable for a new clinical test set. The data provenance is effectively the existing regulatory approval and performance history of the predicate device (FUJI TENS 804SIII).

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

• Not applicable. No ground truth for a new clinical test set was established. The review relies on regulatory and technical experts within the FDA and the manufacturer's engineering/regulatory personnel for the comparison.

4. Adjudication method for the test set:

• Not applicable. There was no clinical 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:

• Not applicable. This device is a TENS unit, not an AI-powered diagnostic or assistive technology for human readers.

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

• Not applicable. The V-TENS Plus is a medical device for direct patient use, not an algorithm. Its "standalone performance" is implicitly established by its equivalence to the predicate device and compliance with electrical safety standards.

7. The type of ground truth used:

• The "ground truth" for this submission is the established safety and effectiveness of the predicate device (FUJI TENS 804SIII), as determined by its prior market clearance (K893874). The submission aims to show that the new device is sufficiently similar to share this ground truth.
• For the non-clinical testing, the "ground truth" is compliance with recognized engineering and safety standards (AAMI/ANSI NS-4, IEC 60601-1, IEC 601-1).

8. The sample size for the training set:

• Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

• Not applicable.

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The Body Clock EMS 400 is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area. It is indicated for the following:

• 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; and
• Maintaining or increasing range of motion.

The EMS 400 a dual channel EMS (Powered Muscle Stimulator) unit. It is identical to the Altoona EMS 400 (K913272). It has two intensity (amplitude) dials for each channel, placed on the front of the unit. Directly below the left-hand-side intensity dial is a pulse rate dial, which sets the pulse rate for both channels. Below the right-hand dial is a timer dial, which controls the time of each cycle when cycle or reciprocal mode is used. If the dial is set to 0, the unit provides a constant mode.

The provided text describes a 510(k) summary for the Body Clock EMS 400, a powered muscle stimulator. It states that clinical testing was "Not Applicable as there are no new or innovative aspects that have been introduced." The device's substantial equivalence is based on its similarity to a predicate device (EMS 400, K913272) and adherence to non-clinical standards (CE marking, ISO, EN standards).

Therefore, the specific information requested regarding acceptance criteria, device performance, study details (sample size, data provenance, ground truth, expert involvement, adjudication, MRMC, standalone performance, training set) is not available in the provided document. The submission relies on the concept of substantial equivalence rather than a new clinical study demonstrating performance against specific acceptance criteria.

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The First Choice and First Choice Plus are used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

The TENS devices are used to transmit electrical pulses through the skin to the underlying peripheral nerves to aid in the blocking of pain signals travelling to the brain.

The provided text is a 510(k) summary for the First Choice and First Choice Plus TENS units. It does not describe a clinical study focused on meeting acceptance criteria for device performance in a typical sense (e.g., diagnostic accuracy metrics). Instead, it's a submission for demonstrating substantial equivalence to a predicate device.

Here's an analysis of the provided text in relation to your request, highlighting what is present and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present a table of specific acceptance criteria for performance metrics (e.g., sensitivity, specificity, or improvement in pain scores from a clinical trial) and reported device performance.

Instead, the "acceptance criteria" are implied by meeting regulatory standards and demonstrating substantial equivalence to a predicate device. The "device performance" is primarily considered in terms of its technological characteristics and safety compared to the predicate.

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

• Test Set Sample Size: Not applicable. The submission does not describe a test set in the context of evaluating diagnostic or clinical performance with a specific sample size. The evaluation is based on non-clinical testing against standards and comparison to a predicate device.
• Data Provenance: Not applicable. No clinical data or patient data is mentioned.

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

• Number of Experts: Not applicable. No "ground truth" for a test set was established by experts in this context. The assessment is regulatory and technical.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. No test set requiring expert adjudication was described.

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

• MRMC Study: No. The document explicitly states: "Clinical Testing: Not Applicable as there are no new or innovative aspects that have been introduced." Therefore, no MRMC study, or any clinical study comparing human readers with or without AI assistance, was performed or presented.
• Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable, as no such study was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Standalone Performance Study: No. This submission is for a TENS unit, which is a physical medical device, not an algorithm or AI software. Therefore, the concept of "standalone performance" for an algorithm is not relevant here. The evaluation focused on the device's adherence to safety and performance standards and its comparison to the technical specifications of a predicate physical device.

7. The Type of Ground Truth Used:

• Type of Ground Truth: Not applicable in the context of diagnostic accuracy or clinical outcomes. The "ground truth" for this submission revolves around:
  • Regulatory Compliance: Meeting established AAMI/ANSI and IEC standards (e.g., electrical safety, mechanical integrity).
  • Technical Specifications: Demonstrating that the device's electrical characteristics and functionality are comparable to the stated specifications of the predicate device.
  • Intended Use: Confirming the device's intended use aligns with that of the predicate.

8. The Sample Size for the Training Set:

• Training Set Sample Size: Not applicable. This document describes a physical medical device, not a machine learning model or algorithm that would require a training set.

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

• Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this type of device.

Summary of the Study Proving Acceptance Criteria:

The "study" in this context is the non-clinical testing and comparison outlined in section 10.7 ("Non-clinical Testing") and 10.6 ("Technological Comparison to Predicate Devices").

• Non-Clinical Testing: The manufacturer conducted tests to ensure the TENS units met all required sections of the AAMI/ANSI NS-4 Standard and passed the IEC 60601-1 and IEC 601-1 standards. They also ensured the use of "shrouded patient cable connector's" to comply with FDA's Final Rule. This testing demonstrates the device's adherence to established safety and performance standards for TENS units.
• Technological Comparison: The manufacturer compared the functionality and technical characteristics of the First Choice and First Choice Plus devices to the predicate device, FUJI TENS 804SIII (K893874). They identified slight differences (e.g., single dial for pulse rate control) but concluded that these differences did not introduce new questions of safety or effectiveness. The First Choice Plus also added pulse width adjustment, which was also found to be within acceptable parameters relative to the predicate's overall functionality.

The conclusion (Section 10.9) states that "The First Choice and First Choice Plus have the same intended use and similar technical characteristics as the FUJI TENS 804SIII (K893874)... The information supplied in this 510(k) illustrate that the devices do not pose any new questions of safety and effectiveness. The First Choice and First Choice Plus are substantially equivalent to the predicate device(s)." This statement, supported by the non-clinical testing and technological comparison, serves as the "proof" that the device meets the implied acceptance criteria for substantial equivalence necessary for 510(k) clearance.

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