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

The Counter Pain Therapy Device, Model P.T.S.-IV (K161537) is identical to the previous cleared version of the device with the same name (K132993). The purpose of this 510(k) submission is to seek different (expanded) Indications for Use. The only changes are in the 'Indication for Use Statement'.

The Counter Pain Therapy Device, Model P.T.S.-IV features two channels and seven (7) preset programs. The output of both channels can be adjusted individually for intensity in sixteen (16) steps and the treatment time is selectable from 20, 30 or 40 minutes. All features are well indicated by large icons on a backlit LCD screen for easy reading.

The device is powered by three (3) rechargeable Lithium Batteries which are permanently built into the main unit and can be recharged with the charging unit supplied for the device.

The Pain Therapy Device consists of the handheld main unit (controller), two pairs of self-adhesive electrodes, a plug-in charging unit (adaptor 120VAC to 5VDC) and two pairs of electrode cables.

This document describes the regulatory clearance (K161537) for the OTC TENS Device, Model PTS-IV. However, it explicitly states that no clinical tests were performed or relied upon to determine substantial equivalence for this specific submission because the device itself is identical to a previously cleared version (K132993), and the only change made was an expansion of the Indications for Use. Therefore, the information requested regarding acceptance criteria and a study proving the device meets those criteria, particularly in the context of clinical performance, cannot be fully provided from this document.

The document primarily focuses on non-clinical testing and substantial equivalence to predicate devices based on design, technological characteristics, and safety standards.

Here's a breakdown of the information that can be extracted or inferred from the provided text, and where the requested details are not available:

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

• Acceptance Criteria: The document refers to meeting the requirements of recognized consensus standards for safety and performance. These standards are the acceptance criteria for non-clinical aspects.
• Reported Device Performance: The performance is stated in terms of compliance with these standards.

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

• Not applicable / Not provided for clinical performance. The document explicitly states: "Counter did not conduct, nor rely upon, clinical tests to determine substantial equivalence of the Pain Therapy Device Model P.T.S.-IV. vs. the predicates."
• For non-clinical testing, the "sample size" would refer to the number of devices tested to the standards. This specific number is not provided, only that "testing" was performed. The data provenance would be from internal company testing and third-party lab testing for standards compliance (e.g., electrical safety).

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 clinical test set with human data and expert-established ground truth was used for this specific 510(k) submission. The regulatory decision was based on substantial equivalence to predicate devices and non-clinical engineering and safety testing.

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

• Not applicable. No clinical test set requiring adjudication was used.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is a Transcutaneous Electrical Nerve Stimulator (TENS device), not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

• Not applicable. The device is a TENS unit, not an algorithm. Its performance is inherent in its electrical output and mechanical operation, as demonstrated by compliance with engineering standards.

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

• For the non-clinical tests, the "ground truth" was established by the requirements of the international consensus standards (e.g., IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2) which define the acceptable limits and performance criteria for safety and electrical characteristics.
• For biocompatibility, the ground truth would be chemical/biological analyses demonstrating safety as per relevant biocompatibility standards for medical devices, which were part of the electrode's separate FDA clearance.
• For software, the ground truth was the expected functional specifications and safety requirements as defined internally and verified through testing.

8. The sample size for the training set

• Not applicable. This device does not use machine learning or AI that requires a "training set."

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

• Not applicable. As above, there is no training set for this type of device.

In summary:

This 510(k) cleared the OTC TENS Device, Model PTS-IV, by demonstrating substantial equivalence to a previously cleared version of the same device (K132993) and to another predicate device (K121757) for its expanded indications for use. The clearance was based entirely on non-clinical testing which confirmed the device's compliance with established safety and performance standards (IEC 60601 series). No clinical studies or human performance data were used for this submission, as the physical device itself had already been vetted in a prior submission, and the current submission only sought to expand its marketing claims (Indications for Use) based on existing equivalence.

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To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower back due to strain from exercise or normal household work activities (Choose Mode A, B, or C)

To be used for temporary relief of pain associated with sore and aching muscles in the upper extremities (Arms) due to strain from exercise or normal household work activities (Choose Mode A, B or C)

To be used for temporary relief of pain associated with sore and aching muscles in the lower extremities (Legs) due to strain from exercise or normal household work activities (Choose Mode A, B or C)

To be used for symptomatic relief and management of chronic, intractable pain associated with Arthritis (Choose Mode A)

To stimulate healthy muscles in order to improve and facilitate muscle performance (Choose Mode B)

The Pain Therapy System, Model PTS-II is a selectable dual channel TENS and EMS device operated by DC 3.0V (AAA*2 batteries). It is made up of one main unit, two electrode cables, and two pairs of electrode pads.

There are 3 selectable, pre-programmed output waveforms (modes) to choose from. The two channels share one knob to adjust, the intensity are adjustable from 0 to 5. Running time can be selected among 10, 20 or 40min and recycled. There is a dial with on/off on the side that enables the device to be turned on or off, and it can be used to adjust the output intensity level, turn clockwise to increase intensity and turn anticlockwise to decrease the intensity. In the front of the device, there are 2 buttons and 6 indicator lights, in which one button is the mode selection button, and the other is for time selection. There are three modes A. B. C. respectively indicated by three indicator lights, which are on the right of the mode selection button. The device has 3 timing levels, namely 10, 20, 40 min, and indicated by three indicator lights, which are on the right of the timing selection button.

The provided document is a 510(k) premarket notification from the FDA for a device called "Pain Therapy System, Model PTS-II". It describes the device, its intended use, and a comparison to a predicate device to establish substantial equivalence.

Crucially, this document is for a Transcutaneous Electrical Nerve Stimulator (TENS) device, not an AI/ML medical device. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/ML device (e.g., performance metrics like accuracy, sensitivity, specificity, or reader studies) are not applicable here. The substantial equivalence for this TENS device is established through non-clinical testing against recognized consensus standards and a comparison of technological characteristics with a legally marketed predicate device.

The questions you've asked (about sample sizes, ground truth experts, MRMC studies, standalone performance, training sets, etc.) are highly relevant to the evaluation of AI/ML medical devices. However, they do not apply to the traditional medical device evaluation process exemplified by this 510(k) submission for a TENS device.

Here's a breakdown of what is relevant from the document regarding its "acceptance criteria" (which are more accurately "conformance criteria" in this context) and "proof":

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

Instead of acceptance criteria for AI performance, the document lists technological characteristics of the proposed device and compares them to the predicate device. The "acceptance criteria" here are essentially that the proposed device's characteristics are sufficiently similar to the predicate device, or any differences do not raise new questions of safety or effectiveness.

The "reported device performance" is essentially the demonstrated compliance with the listed consensus standards and the presentation of these technological parameters. The conclusion (Page 8) states: "bench testing and safety report documentation demonstrate that the submitted device could maintain the same safety and effectiveness as that of predicate device."

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

• Not applicable. This isn't a study involving human subjects or data sets in the AI/ML sense. The "testing" refers to bench testing and compliance with electrical safety and performance standards.
• The device is manufactured by "Counter Scientific Development (GZ) Ltd" in Guangzhou, China.

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. Ground truth in the AI/ML context is not relevant for this type of device submission. The "ground truth" here is the adherence to established engineering and safety standards.

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

• Not applicable. No adjudication in the AI/ML context.

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. No MRMC study. This is a physical device, not an AI assistance tool for human readers.

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

• Not applicable. Not an algorithm. The "standalone performance" is the device's ability to meet its operational specifications and safety standards on its own.

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

• Not applicable. The "ground truth" for this device's evaluation is compliance with recognized consensus standards (ANSI/AAMI ES60601-1, IEC 60601-2-10, IEC 60601-1-2) which define safety and essential performance parameters, and the comparison of its technical specifications to a predicate device.

8. The sample size for the training set

• Not applicable. No training set for an AI/ML model.

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

• Not applicable. No training set.

In summary, the provided document details a 510(k) submission for a non-AI medical device (TENS). The evaluation methodology relies on comparison to a predicate device and compliance with established electrical and safety standards, rather than the AI/ML-specific testing and evaluation criteria you've outlined.

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To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower back due to strain from exercise or normal household work activities choose Manual modes A, B, C, D, F, E or Auto 4.

To be used for temporary relief of pain associated with sore and aching muscles in the upper extremities (arm) due to strain from exercise or normal household work activities choose Manual modes A, B, C, D, F, E or Auto 1 or Auto 3..

To be used for temporary relief of pain associated with sore and aching muscles in the lower extremities (leg) due to strain from exercise or normal household work activities choose Manual modes A, B, E or Auto 1 or Auto 4.

To be used for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis, choose Manual modes A and C or Auto 1, Auto 2, Auto 3, or Auto 4.

To be used to stimulate healthy muscles in order to improve and facilitate muscle performance choose Manual Mode A or Mode B.

Not Found

The provided text is a letter from the FDA regarding a 510(k) premarket notification for a Transcutaneous Electrical Nerve Stimulator (TENS) device. It confirms the substantial equivalence of the device to legally marketed predicate devices and includes the "Indications for Use" for the device.

However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies. These types of details are typically found in the accompanying technical documentation or clinical study reports submitted as part of the 510(k) application, which are not present here.

Therefore, I cannot provide the requested information from this document. The prompt asks to "describe the acceptance criteria and the study that proves the device meets the acceptance criteria" based on the input, but this input does not contain that specific information.

Ask a specific question about this device

This TENS Device is to be used for temporary relief of pain associated with sore or aching muscles of lower back, arms, or legs due to strain from exercise or normal household and work activities.

The Counter Pain Therapy Device, Model P.T.S.-IV features two channels and seven (7) preset programs. The output of both channels can be adjusted individually for intensity in sixteen (16) steps and the treatment time is selectable from 20, 30 or 40 minutes. All features are well indicated by large icons on a backlit LCD screen for easy reading. The device is powered by three (3) rechargeable Lithium Batteries which are permanently built into the main unit and can be recharged with the charging unit supplied for the device. The Pain Therapy Device consists of the handheld main unit (controller), two pairs of self-adhesive electrodes, a plug-in charging unit (adaptor 120VAC to 5VDC) and two pairs of electrode cables.

The Counter Pain Therapy Device, Model P.T.S.-IV is a Transcutaneous Electrical Nerve Stimulator (TENS) device intended for the temporary relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities.

The device's acceptance criteria and performance were established through non-clinical testing for substantial equivalence to a predicate device, the OMRON Electro Therapy Pain Relief, Model PM3030 (K110068).

1. Table of Acceptance Criteria and Reported Device Performance

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

No specific "test set" in the context of clinical data (e.g., patient data) was used. The substantial equivalence determination was based on non-clinical testing, primarily engineering and performance verification against recognized consensus standards.

• Sample size: Not applicable in terms of patient data. Testing involved engineering samples of the device.
• Data Provenance: The testing was conducted by or for Counter Scientific Development (GZ) Ltd. in China, to demonstrate compliance with international standards for medical electrical equipment.

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

Not applicable. Ground truth, in this context, pertains to clinical outcomes or expert consensus on medical conditions, which were not part of this non-clinical submission. The "truth" in this submission was adherence to engineering and safety standards, evaluated through standard test methodologies, not expert medical assessment of patient data.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication was used.

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

No MRMC comparative effectiveness study was conducted. The submission explicitly states: "Counter did not conduct, nor rely upon, clinical tests to determine substantial equivalence of the Pain Therapy Device Model P.T.S.-IV. vs. the predicate."

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

Not applicable, as this is a physical medical device (TENS unit), not an algorithm or AI system for diagnostic or treatment decisions. The "software" mentioned refers to embedded firmware controlling the device's functions, not a standalone diagnostic algorithm.

7. Type of Ground Truth Used

The "ground truth" for this submission was compliance with recognized consensus standards for electrical safety, electromagnetic compatibility, and specific requirements for nerve and muscle stimulators (IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2). Additionally, design requirements and specifications from the manufacturer formed the basis for verifying software performance and cleaning efficacy.

8. Sample Size for the Training Set

Not applicable, as there was no artificial intelligence or machine learning component requiring a training set. This was a non-clinical device submission based on engineering and safety testing.

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

Not applicable, as there was no training set in the context of machine learning.

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