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The Model 7500 Microcurrent TENS Device is intended to be used for the relief of chronic intractable pain.

A number of TENS and microcurrent devices have been cleared for marketing by FDA that have just a few discrete output settings, rather than having a continuously adjustable output. Such devices have been shrinking in size in recent years as advances in integrated circuits and other components allow for smaller circuits. Now NewCare Products is introducing a microcurrent TENS device that has the generator unit builtin to the back of the electrodes. By eliminating the bulky controls, the generator may be made very small and can be mounted on the electrode pad.

By providing three versions of the device, three different output levels The three versions of the Model 7500 are equivalent to are obtained. one traditional generator with three discrete output levels.

The provided text is a 510(k) summary for the Model 7500 Microcurrent TENS Device, which seeks to establish substantial equivalence to predicate devices. It does not describe a study involving specific acceptance criteria, device performance metrics, or the typical elements of a clinical trial used to prove a device meets acceptance criteria in the way a diagnostic or AI-driven device might.

Instead, the submission focuses on demonstrating that the Model 7500 Microcurrent TENS Device is substantially equivalent to already legally marketed predicate devices, meaning it has the same intended use and similar technological characteristics. The "testing" section refers to conformance with recognized electrical safety and performance standards for TENS devices, rather than clinical efficacy studies with specific performance metrics.

Therefore, many of the requested categories for a clinical study on acceptance criteria cannot be extracted from this document, as such a study was not performed or described in this 510(k) summary. I will answer based on the information available and indicate where information is not present.

Acceptance Criteria and Study for Model 7500 Microcurrent TENS Device

This 510(k) submission, K013167, for the Model 7500 Microcurrent TENS Device, aims to demonstrate substantial equivalence to existing legally marketed predicate devices, rather than proving a specific performance metric against a set of acceptance criteria through a clinical trial. The "acceptance criteria" in this context refer to conformance with established electrical safety and performance standards for TENS devices, not diagnostic accuracy or efficacy metrics.

The "study" conducted for this device was primarily focused on bench testing to ensure compliance with these recognized standards.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. The "test set" in this context refers to the device itself being subjected to bench testing against engineering standards, not a clinical data set.
• Data Provenance: Not applicable. The testing described is bench testing of the device hardware, not data derived from patients.

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

• Number of Experts: Not applicable. The "ground truth" for compliance with electrical and safety standards is determined by the standards themselves and objective measurements during bench testing, not by expert human interpretation in a clinical sense.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. Compliance with standards is typically determined by measurement against predefined limits, not by an adjudication panel.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a microcurrent TENS device for pain relief, not a diagnostic imaging device utilizing AI that would involve human readers.
• Effect Size of AI: Not applicable.

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

• Standalone Performance Study: No, a standalone performance study in the context of an algorithm or AI was not done. The device does not incorporate AI; it is an electronic medical device with discrete electronic components. Two of the predicate devices employed software, but the Model 7500 and the Healthonics unit do not.

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

• Type of Ground Truth: The "ground truth" for this 510(k) submission relates to the device meeting established electrical safety and performance standards. This is determined by objective measurements and verifications against the specifications outlined in documents like ANSI/AAMI NS4, UL2601-1, and IEC 60601-2-10. It is not based on expert consensus, pathology, or outcomes data related to patient treatment efficacy in a clinical trial.

8. The sample size for the training set

• Sample Size: Not applicable. This device is not an AI/ML algorithm requiring a training set.

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

• Ground Truth Establishment for Training Set: Not applicable.

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