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Symptomatic relief of chronic intractable pain
Adjunctive treatment for the management of post-traumatic or post-surgical pain

The TENS/IF 14 is a combination TENS and Interferential device which delivers nerve stimulation by applying an electrical current to electrodes, which are attached on the patient's skin. The output and waveform is adjustable according to the intended treatment of patient. The stimulator has 2 output channels, accessed through jacks at the top of the housing, so that it may stimulate either 2 or 4 patient electrodes. The device may be powered by either 4 AA batteries or by an AC adapter, that when plugged into a wall outlet provides 6 VDC to the unit. A patient compliance timer can memorize 60 sets of operation records; the total record time is 999 hours.

Here's an analysis of the provided 510(k) summary for the TENS/IF 14, focusing on acceptance criteria and the supporting study information:

Summary of Acceptance Criteria and Device Performance:

Study Information Pertaining to Acceptance Criteria:

1. Sample size used for the test set and the data provenance:

   • The document does not specify a sample size for a test set in the context of clinical or performance data. The testing primarily involved engineering performance and safety testing in accordance with IEC 60601-1-2.
   • Data Provenance: The standard testing (IEC 60601-1-2) would typically be conducted by the manufacturer or a certified testing laboratory. The document doesn't specify a country of origin for any "data" beyond the manufacturing and submission location. This is not a study involving patient data.

2. 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. This device's clearance is based on engineering and safety performance testing against a recognized standard (IEC 60601-1-2) and demonstration of substantial equivalence to predicate devices, not on a clinical test set requiring expert ground truth for diagnostic accuracy or treatment efficacy.

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

   • Not applicable. As stated above, this was not a clinical or comparative performance study that would involve expert adjudication of results. The "adjudication" was effectively by the testing laboratory confirming compliance with the technical standard.

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:

   • Not applicable. This device is a transcutaneous nerve stimulator, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study or evaluation of AI assistance is not relevant.

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

   • Not applicable. This is a physical medical device (nerve stimulator), not an algorithm or software-as-a-medical-device (SaMD). Its performance is inherent in its electrical output and safety, not in an algorithmic assessment.

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

   • For the safety and performance testing, the "ground truth" was compliance with the technical specifications and safety limits defined by the IEC 60601-1-2 standard. There was no clinical ground truth (like pathology or outcomes data) being established for this type of submission.

7. The sample size for the training set:

   • Not applicable. This device does not use machine learning or AI, so there is no "training set."

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

   • Not applicable. There is no training set for this device.

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