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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 1, 2, 3, 4, 5, 6 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 1, 2, 3, 4, 5, 6 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 1, 2, 6 or Auto1 or Auto1 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 1 and 3 or Auto 1, Auto 2, Auto 3, or Auto 4.

Used to stimulate healthy muscles in order to improve and facilitate muscle performance choose Manual Mode 1 or Auto Mode 2.

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The provided document is a 510(k) premarket notification letter from the FDA for the T1040 aka Aurawave device, which is a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief.

The letter does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies. It is a regulatory approval document confirming that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information from the given text. The document is strictly a regulatory approval and does not detail the technical performance studies or the clinical trial data that would contain the requested information.

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To be used for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household work activities choose Manual modes 1, 2, 3, 4, 5, 6 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 1, 2, 3, 4, 5, 6 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 1, 2, 6 or Auto1 or Auto 4

Used to stimulate healthy muscles in order to improve and facilitate muscle performance choose Manual Mode 1 or Auto Mode 2

The T1040 is a portable; battery powered (4.5 VDC) multi function device offering both Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) qualities in one device.

Independent channel (two pads) that effectively transfers your desired choice of preprogrammed electrical pulses directly through electrode adhesive pads to the suggested area of the body where the electrodes are placed, causing minimal muscle contractions. A garment belt is used to hold the electrode pads to treat the lower back muscles. There are 10 modes of operation, 6 manual and 4 automatic.

Here's a breakdown of the acceptance criteria and the study information for the T1040 device, extracted from the provided 510(k) submission:

Acceptance Criteria and Device Performance

The submission relies on demonstrating substantial equivalence to existing predicate devices rather than setting specific numerical acceptance criteria for clinical performance. The acceptance criteria essentially revolve around the T1040's technical specifications falling within the range of, or being comparable to, the predicate devices, and its safety being established.

Table 14 - Comparison Table (from the original text, showing reported device performance and predicate performance for comparison)

Study Details for T1040

The submission for T1040 primarily relies on demonstrating substantial equivalence to predicate devices through technical comparisons and a post-market safety record, rather than a specific clinical study with a defined test set, ground truth, or expert review for the T1040 itself.

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

   • Test Set Sample Size: Not applicable in the traditional sense of a clinical trial's "test set" for performance evaluation. The submission refers to a post-market safety record as evidence of safety and effectiveness.
   • Data Provenance: The device has been sold in 20 countries since 2002. This is retrospective, real-world usage data.

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

   • Not applicable. No "ground truth" was established by experts for a specific test set. The safety claim is based on the absence of reported adverse events from general public use over an extended period.

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

   • Not applicable. No formal adjudication of a test set occurred. The safety claim is based on passive surveillance (absence of adverse event reports).

4. 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:

   • No. This type of study (MRMC, AI-assisted) is not relevant to this device submission, which is for a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) that does not involve "readers" or "AI assistance" in its operation or interpretation.

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

   • Not applicable. This device is not an algorithm, but a physical electrical stimulation device. Its performance is inherent in its electrical output and user interaction.

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

   • The primary "ground truth" for safety and effectiveness is implicit:
     • Safety: The absence of reported adverse events from over 300,000 units sold over 5 years. This acts as a real-world outcome indicator for safety.
     • Effectiveness: Reference to "a number of articles in peer-reviewed publications" demonstrating the general effectiveness of electrical stimulation for muscle performance and pain reduction. This is a scientific literature-based "ground truth" for the underlying technology, not the specific device.

7. The sample size for the training set:

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

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

   • Not applicable. As no training set was used, no ground truth for it was established.

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