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TENS: To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
PMS: It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

Pro-8AB is portable; battery powered (3.7V DC) multi-function device offering both Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) qualities in one device. Double or single channel that effectively transfer your desired choice of programmed electrical pulses directly through electrode adhesive pads to the suggested area of the body where the electrodes are placed, causing minimal muscle contractions. There are 6 modes of operations.

The provided document is a 510(k) summary for the HealthmateForever TENS and Powered Muscle Stimulator device. It describes the device, its intended use, and its substantial equivalence to a predicate device (JQ-5C).

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state "acceptance criteria" in terms of specific performance metrics that need to be met for the device to be considered safe and effective in a clinical trial. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device. The performance is reported in terms of various electrical output parameters.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not describe a traditional clinical study with a "test set" of patients or data to evaluate effectiveness. The primary basis for equivalence is non-clinical testing and comparison of technical specifications to a predicate device.

• Sample Size for Test Set: Not applicable for a traditional clinical study as presented.
• Data Provenance: The document mentions "over 100,000 units sold without a prescription in Europe and Asia" since 2007 with no adverse events reported. This suggests retrospective market surveillance data for safety. The "customer reviews" for effectiveness are not quantifiable in terms of sample size or provenance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. No clinical test set requiring expert ground truth establishment for effectiveness or diagnosis is described.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication is described.

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 and PMS device, not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies are not relevant.

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

Not applicable. This device is a physical electrotherapy device; it does not involve algorithms for interpretation or without-human-in-the-loop performance measurement in the context of AI. The "software verification" mentioned is for the device's internal control software, not a standalone diagnostic algorithm.

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

For safety, the "ground truth" relies on the absence of reported adverse events from extensive market use in Europe and Asia (outcomes/real-world data).
For effectiveness, the claim is supported by "customer reviews," which are anecdotal and not considered a rigorous form of ground truth in clinical studies. The primary justification for effectiveness is via substantial equivalence to a predicate device, meaning the predicate's established effectiveness serves as the basis.

8. The Sample Size for the Training Set

Not applicable. No training set for an AI/machine learning model is mentioned or described.

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

Not applicable. No training set for an AI/machine learning model is mentioned or described.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" presented here is a 510(k) Premarket Notification which aims to demonstrate substantial equivalence to a previously cleared predicate device (JQ-5C). This is a regulatory pathway that largely relies on comparing the new device's technological characteristics, intended use, and safety profile to a legally marketed device, rather than conducting new, extensive clinical trials for effectiveness in many cases.

The evidence for meeting acceptance criteria (which are primarily implied by the substantial equivalence framework) includes:

• Comparison of Technical Specifications: A detailed table (Section 7) is provided comparing various electrical output parameters (voltage, current, pulse width, frequency, charge per phase, current density, power density) of the new HealthmateForever models to the predicate device (JQ-5C). The submission states that the differences are "insignificant in the terms of safety or effectiveness."
• Compliance with Voluntary Standards: The device underwent non-clinical tests to comply with several IEC and ISO standards related to medical electrical equipment safety, electromagnetic compatibility, and biocompatibility (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 10993-5, ISO 10993-10).
• Software Verification: Software verification was performed adhering to FDA guidance.
• Real-world Safety Data (Retrospective Market Surveillance): For safety, the submission highlights the sale of "over 100,000 units" in Europe and Asia since 2007 with "no adverse effects reported." This serves as a retrospective, large-scale safety assessment.
• Customer Reviews (Effectiveness Support): For effectiveness, the submission briefly mentions "customer reviews" demonstrating improved muscle performance and temporary pain reduction. This is a weak form of evidence and is secondary to the substantial equivalence claim, which assumes effectiveness based on the predicate.
• Intended Use Alignment: The intended uses for both TENS and PMS functions are identical to those of the predicate device.

In essence, the "study" is a systematic comparison to a predicate device combined with non-clinical bench testing for safety standards and retrospective real-world safety data, rather than a prospective clinical trial with a defined test set and ground truth established by experts.

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