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

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

A portable TENS device for pain relief.
Features:

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The closest to "acceptance criteria" are:

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

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

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

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

4. Adjudication method for the test set

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

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

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

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

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

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

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

8. The sample size for the training set

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

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

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

In summary:

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

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