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The StimPad OTC is indicated for the relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household work activities.

The StimPad® OTC is a non-invasive nerve stimulation therapy device that can be placed directly at the site of pain for direct electrical stimulation. Stimulation is achieved through self-contained electrodes that are snap fit connected to the electronic components. There are no separate wires or electrode pads. The StimPad® OTC is powered by a replaceable, 3 volt Lithium battery (CR2032). The StimPad™ device has pre-programmed settings for frequency (ie, 7.1 Hz), pulse width (ie, 47 milliseconds for the low, medium and high intensity settings at 500 ohms, 2000 ohms, and 10,000 ohms) and the timed setting for treatment duration (4 seconds or less). The treatment duration is limited to four seconds or less of stimulation per application/treatment, and the user is prevented from modifying this setting. The intensity levels can be adjusted between low (stimulation is usually imperceptible), medium (usually the most comfortable), and high (maximum level for comfort).

I am sorry, but the provided text does not contain the specific information required to answer your request regarding the acceptance criteria and the study that proves the device meets them. The document is a 510(k) summary for the StimPad OTC device, which primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory purposes.

Here's a breakdown of what's missing:

• Acceptance Criteria Table: There is no explicit table of acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy, etc.) for the device itself. The document focuses on comparing electrical and physical parameters to predicate devices.
• Reported Device Performance: While there are output specifications and compliance with safety standards, there are no reported performance metrics against specific clinical or technical acceptance criteria.
• Study Details for Performance: The document mentions a "formal usability evaluation study" to confirm appropriateness for OTC use. However, it does not provide details like:
  • Sample size used for the test set.
  • Data provenance (country of origin, retrospective/prospective).
  • Number and qualifications of experts.
  • Adjudication method.
  • Whether it was a MRMC study or a standalone study.
  • Type of ground truth used.
  • Sample size for the training set (if applicable for a usability study).
  • How ground truth for the training set was established.

The document mainly discusses the technical characteristics and safety compliance of the StimPad OTC in comparison to its predicate devices to establish substantial equivalence. It highlights that the "StimPad® OTC and StimPad® have different indications for use and intended user populations since the former is an over the counter use device and the latter is a prescription use device. Empirical proof of substantial equivalence was not necessary in this instance since the difference between the devices is simply that StimPad® OTC is available for OTC use rather than prescription by medical practitioner. Adequacy of the StimPad® OTC for OTC use was determined by formal usability evaluation study. The study confirms that StimPad® OTC is appropriate for over the counter use."

Therefore, while a usability study was conducted, the detailed information about its methodology and results, as requested in your prompt, is not present in this document.

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The StimPad™ System is a transcutaneous electrical nerve stimulator (TENS) device intended for the delivery of electrical stimulation applied through the surface of patient's skin for the treatment of chronic intractable pain, and post-traumatic acute pain. The StimPad™ can be used for self treatment as well as for the treatment of others. It is a prescription use device.

The StimPad™ System is indicated for the symptomatic relief of chronic intractable pain, and post-traumatic acute pain.

The StimPad™ is a non-invasive nerve stimulation therapy device that can be placed directly at the site of pain for direct electrical stimulation. Stimulation is achieved through self-contained electrodes that are snap fit connected to the electronic components. There are no separate wires or electrode pads. The StimPad™ is powered by a self-contained three-volt lithium battery.

The StimPad™ device has pre-programmed settings for frequency (i.e. 7.1 Hz), pulse width [i.e. 47 milliseconds for the low, medium, and high intensity settings at 500 ohms, 2000 ohms, and 10,000 ohms] and the timed setting for treatment duration (4 seconds or less). The treatment duration is limited to four seconds or less of stimulation per application/treatment, and the user is not allowed to modify this setting. The intensity levels can be adjusted between low (stimulation is usually imperceptible), medium (usually the most comfortable), and high (maximum level for comfort).

A three-volt lithium battery powers the StimPad™. The life of the battery varies with the frequency of activation, repetition and ambient temperature conditions. The battery is not replaceable. Once the battery is depleted, the device ceases to function and should be disposed or returned to the manufacturer.

The provided text describes a 510(k) submission for the AEMED StimPad™ TENS System. This is a medical device, and the submission focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving the device's efficacy through a clinical study with detailed acceptance criteria and performance metrics.

Therefore, many of the requested details about acceptance criteria, sample sizes, expert ground truth, MRMC studies, and standalone performance are not applicable to this type of regulatory submission as they are typically associated with performance studies for novel devices or those seeking approval based on clinical effectiveness.

Here's an analysis based on the provided text:

1. Table of acceptance criteria and the reported device performance

There are no explicit "acceptance criteria" presented in the document in the format of a clinical trial outcome. Instead, the "acceptance" for this 510(k) relies on demonstrating substantial equivalence to predicate devices. The performance is assessed by comparing technical characteristics.

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

Not Applicable. No clinical test set or patient data is described for performance evaluation. The "test set" here refers to the device itself undergoing engineering, electrical safety, and EMC testing.

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 in the sense of expert clinical assessment is mentioned in the context of this 510(k) submission.

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

Not Applicable. No adjudication method for a clinical test set is mentioned.

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-assisted diagnostic tool. An MRMC study is irrelevant to this submission.

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

Not Applicable. This device is a physical TENS unit, not an algorithm.

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

For the engineering and safety tests, the "ground truth" would be the standards themselves (e.g., IEC 60601-1, IEC 60601-1-2) which define acceptable electrical safety and EMC parameters. For the claim of substantial equivalence, the "ground truth" is established by the characteristics and performance of the legally marketed predicate devices. No clinical outcomes data or expert consensus on patient conditions were used as ground truth for this submission.

8. The sample size for the training set

Not Applicable. This is a hardware medical device, not a machine learning model. There is no concept of a "training set" in this context.

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

Not Applicable. As there is no training set, there's no ground truth for it.

In summary, the provided document is a 510(k) premarket notification focused on demonstrating "substantial equivalence" of a TENS device to existing legally marketed devices. This regulatory pathway primarily relies on comparing technical specifications, indications for use, and compliance with recognized safety standards, rather than presenting clinical study results with explicit performance acceptance criteria and associated metrics like sensitivity, specificity, or reader improvement.

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