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The Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain. In particular, the TENS WMPS6-1 is indicated for use for symptomatic relief of chronic intractable pain and adjunctive treatment in the management of post-surgical and post traumatic pain.

Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain. The device has 18 programs (13 standard programs and 5 editable programs), powered by 6 pieces of 1.5V batteries or AC 100-240V, comprising electronic stimulatory module and accessories of lead wires, electrodes. Six outlet sockets are used to connect skin electrodes by lead wires. The accessories of electrodes is 510(k) cleared device (K192568), Size: 50*50mm.

The provided text is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS) device. It details the device's technical specifications and a comparison to a predicate device to establish substantial equivalence for regulatory clearance. This document does not describe an AI-powered medical device or an associated study for complex acceptance criteria like those involving AI performance metrics (e.g., sensitivity, specificity, MRMC studies, ground truth establishment by experts).

Therefore, I cannot extract the requested information regarding AI device acceptance criteria and study details from the provided text. The device is a physical medical device (TENS) and the "study" referred to in the document is a series of non-clinical bench tests to compare it to a predicate device, and to verify safety and performance standards.

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

• No AI Component: The device is a Transcutaneous Electrical Nerve Stimulator, a physical product that applies electrical current. There is no mention of any AI or machine learning component.
• No Diagnostic/Interpretive Task: The device is for pain relief, not for image analysis, diagnosis, risk prediction, or any other task that would typically involve acceptance criteria like sensitivity, specificity, or the need for ground truth established by experts.
• No Human-in-the-Loop Study: Since there's no AI component, there's no MRMC (Multi-Reader Multi-Case) study described for human readers improving with AI assistance.
• No Standalone Algorithm Performance: There is no algorithm to assess in a standalone capacity.
• No Training Set/Test Set (in the AI context): The concepts of training and test sets as they apply to machine learning models are not relevant to the clearance of this physical device. The "test set" here refers to the device itself undergoing bench tests.
• No Ground Truth Establishment by Experts: Ground truth for AI models is often established by expert consensus (e.g., radiologists reviewing images). For this TENS device, "ground truth" would refer to its physical and electrical properties meeting specified standards, validated through engineering tests, not human interpretation.

Summary of what the document DOES describe in terms of performance and comparison:

The document describes acceptance criteria in the context of substantial equivalence to an existing predicate device and compliance with voluntary standards for electrical medical equipment.

• Acceptance Criteria (Implicit via Comparison to Predicate and Standards Compliance): The acceptance criteria are primarily demonstrated by showing that the new device's specifications (e.g., power source, output channels, waveform, voltage, current, safety features) are either identical, similar with acceptable differences (justified by safety and effectiveness analyses), or meet the requirements of relevant electrical safety and performance standards (ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-10). The reported device performance is presented as compliance with these standards and the specific electrical output values listed in the comparison table.

• Study That "Proves" Compliance: The "study" here is a series of non-clinical bench tests.

  • Sample Size: This is not a study with a "sample size" in the statistical sense of patient data. It refers to testing the physical device itself.
  • Data Provenance: Not applicable as it's not a data-driven AI study. The tests are bench tests performed on the device.
  • Experts and Ground Truth: Not applicable in the way you've defined them for an AI study. Electrical engineers and regulatory compliance experts would be involved in setting and verifying the test standards.
  • Adjudication Method: Not applicable.
  • MRMC Comparative Effectiveness Study: No.
  • Standalone Performance: The "standalone" performance here refers to the device successfully passing all required electrical and safety tests independently (i.e., not reliant on human interpretation for its function).
  • Type of Ground Truth: The "ground truth" is compliance with established engineering and medical device safety standards for TENS devices (e.g., maximum current density limits, electrical isolation, waveform characteristics).
  • Training Set/Ground Truth for Training: Not applicable.

If you have a document describing an AI medical device, please provide that, and I will be able to answer your questions with the level of detail you are seeking.

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The Transcutaneous Electrical Nerve Stimulator is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain. In particular, this device is indicated for use for symptomatic relief of chronic intractable pain and adjunctive treatment of post surgical and post traumatic pain.

Transcutaneous Electrical Nerve Stimulator is Transcutaneous Electrical Nerve Stimulator for pain relief. The stimulator sends gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin. The device has standard programs and edit programs. It is a battery-powered portable device, comprising electronic stimulatory module and accessories of lead wires, electrodes and battery. Two outlet sockets are used to connect skin electrodes by lead wires. The accessories of electrodes is 510(k) cleared device (K192568), Size: 50*50mm.

This document is a 510(k) Premarket Notification for a Transcutaneous Electrical Nerve Stimulator (TENS) device. The purpose of this submission is to demonstrate that the new device, "TENStem eco basic," is substantially equivalent to a legally marketed predicate device (K112288), also a TENS device manufactured by the same company, Wuxi Jiajian Medical Instrument Co., Ltd.

Here's an analysis of the provided information regarding acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the parameters of the predicate device (K112288) and the relevant IEC standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10). The reported device performance is presented as a comparison between the proposed device ("Modified Device") and the predicate device in the "Substantially Equivalent Comparison Conclusion" table.

Justification for Similarities (Notes from the original document):

• Note 1: Differences in battery type, number of programs, weight, and dimensions are deemed insignificant in terms of safety or effectiveness, as the device passed relevant IEC tests and the battery is commonly used.
• Note 2: Differences in "Regulated Current or Regulated Voltage" and "Timer Range" are considered minor and do not raise new safety/effectiveness issues as both devices passed IEC 60601-1, and the timer is user-adjustable.
• Note 3: Differences in maximum output voltage/current, pulse width, pulse period, and max pulse frequency are analyzed. The proposed device's parameters are within safety limits based on calculation and passed IEC 60601-2-10 tests.
• Note 4: "Net Charge," "Maximum Phase Charge," and "Maximum Average Current" are similar and comply with IEC 60601-2-10 requirements. The proposed device's maximum average current is smaller, indicating better safety. Differences in maximum current density and maximum average power density are due to electrode area calculation but comply with IEC 60601-2-10 and the 0.25W/cm² limit respectively.

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

The document does not describe a "test set" in the context of clinical data or patient samples. The testing described is non-clinical bench testing to verify hardware specifications and compliance with safety standards (IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2). The sample size for this type of testing typically refers to the number of devices tested to ensure consistent performance, which is not specified but is assumed to be an adequate number for regulatory compliance.

The data provenance is from bench tests conducted on the Transcutaneous Electrical Nerve Stimulator, presumably at a testing facility compliant with quality system regulations. The manufacturer is Wuxi Jiajian Medical Instrument Co., Ltd. from Wuxi, Jiangsu, China. This is a retrospective comparison against an existing predicate device, as opposed to a prospective clinical trial.

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

This information is not applicable to this submission. The "ground truth" for comparative effectiveness in a clinical context (e.g., diagnostic accuracy of an AI algorithm) is established by expert readers or pathology. Here, the "ground truth" for showing substantial equivalence relies on:

• Compliance with recognized international standards (IEC 60601 series).
• Direct comparison of technical specifications against a previously cleared device.
• Risk analysis of any noted differences.

There is no mention of human experts interpreting test results from the device in a clinical setting to establish "ground truth" for performance.

4. Adjudication Method for the Test Set

This information is not applicable. No clinical test set involving human interpretation requiring adjudication is described. The assessment here is based on objective, quantifiable engineering and electrical performance measurements against established standards.

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 data was not including in this submission." MRMC studies are typically performed for diagnostic or prognostic devices to assess the impact of an AI algorithm on human reader performance. This device is a medical device for pain relief, whose performance is primarily evaluated through electrical parameters and safety standards, not diagnostic accuracy requiring human reader studies.

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

This concept is not applicable in the context of this TENS device. "Standalone performance" or "algorithm-only performance" usually refers to the accuracy or performance of an AI algorithm independent of human intervention. This device is an electrical stimulator, not an AI-driven diagnostic or treatment planning system that would have a "standalone algorithm." Its performance is defined by its electrical output characteristics and safety.

7. The Type of Ground Truth Used

The "ground truth" used for demonstrating substantial equivalence is based on:

• Compliance with recognized international safety and performance standards: Specifically, ANSI AAMI ES60601-1, IEC 60601-2-10, and IEC 60601-1-2. These standards define the acceptable range of electrical parameters, safety features, and electromagnetic compatibility for medical electrical equipment, including TENS devices.
• Direct comparison to the technical specifications of a legally marketed predicate device (K112288): The predicate device itself serves as a "ground truth" for acceptable performance parameters for this type of device. Any deviations from the predicate are justified by showing they either fall within acceptable variations, are safer, or still comply with relevant standards.

8. The Sample Size for the Training Set

This information is not applicable. The device is a Transcutaneous Electrical Nerve Stimulator, which is a hardware medical device, not a machine learning model or algorithm that requires a "training set" of data.

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

This information is not applicable for the reasons stated in point 8.

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