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The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain.

The GM3X2IF is the device which generates the small real-sine pulses of electrical current. The generated current may be delivered to the patient skin and/or underlying nerves through the cable and electrode placed on skin. Through the current stimulation the chronic and/or acute pain is to be relieved.

Here's an analysis of the provided text regarding the acceptance criteria and study for the GEM IF TENS device, Model GM3X2IF:

The provided text, a 510(k) summary and FDA clearance letter, does not contain detailed information about specific acceptance criteria related to device performance metrics for a clinical study, nor does it describe a study explicitly proving the device meets performance acceptance criteria in the way a modern clinical trial report would.

Instead, the submission focuses on demonstrating substantial equivalence to existing predicate devices (IF-400 (K930535) and IF-4000 (K952683)) by showing:

• Same intended use: "The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain."
• Similar technological characteristics: The device "generates the small real-sine pulses of electrical current" for pain relief, similar to the predicate devices.
• Compliance with applicable voluntary standards: This is the primary "acceptance criteria" presented, focusing on safety and electrical performance, rather than clinical efficacy metrics.
• Software verification according to FDA guidance.

Because the document aims to establish substantial equivalence for a device type (TENS unit) where clinical outcomes are often well-established for the predicate, it typically relies more heavily on engineering verification and compliance with standards rather than de novo clinical performance studies with specific numerical acceptance thresholds.

Therefore, many of the requested sections (like sample size for test set, expert qualifications, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of submission.

Here's a breakdown of the available information based on your request:

Acceptance Criteria and Reported Device Performance

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

• Not explicitly stated for a clinical performance test set. The "test set" here refers to engineering verification and validation tests, not a clinical trial. The provenance of these engineering tests is likely the manufacturer (Gemore Technology Co., Ltd. in Taiwan).

3. 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 submission focuses on engineering and regulatory compliance, not clinical ground truth established by medical experts for algorithm performance.

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

• Not applicable. This relates to clinical or imaging studies, which are not described here.

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

• No. This is not an AI-assisted device and no MRMC study is mentioned.

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

• Not applicable. This is not an algorithmic device in the sense of image analysis or diagnostic AI. The device itself is the "standalone" entity whose safety and basic function are tested.

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

• The "ground truth" for this submission is regulatory compliance with recognized standards (electrical, medical device safety) and demonstration of functional equivalence to predicate devices through engineering verification and validation. Clinical outcomes data or expert consensus for performance as a medical AI/imaging device is not the basis for this type of 510(k) clearance for a TENS unit.

8. The sample size for the training set

• Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

• Not applicable. (See point 8).

Summary Takeaway:

This 510(k) submission for the GEM IF TENS device, Model GM3X2IF, demonstrates substantial equivalence to existing predicate devices (IF-400 and IF-4000). The "acceptance criteria" are primarily established by adherence to recognized voluntary standards (ANSI/AAMI, EN 60601 series) for safety and basic functionality, along with FDA guidance for software verification. The study described is not a clinical efficacy trial in the modern sense of a performance study with specific numerical metrics for an AI or diagnostic device, but rather a set of engineering verification and validation tests designed to show that the new device's differences from the predicate do not affect intended use or alter fundamental scientific technology, thereby maintaining equivalent safety and effectiveness.

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