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The accufit is indicated for use for Relaxation of muscle spasms, Prevention or retardation of disuse atrophy, Increase local blood circulation, Muscle re-education, Maintaining or increasing range of motion, Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen, and Improvement of muscle tone and firmness, for strengthening muscles in arms, thighs and buttocks areas.

The principle of operation of the accufit device is to provide direct electrical stimulation of muscles which produces muscle contractions in and around the area of the treatment electrodes. The accufit generates electrical stimulation to contract the muscles to achieve the desired intended use using unique IntelliPhase waveforms and IntelliSTIM electrodes. It offers two unique IntelliPhase waveforms, Biphasic and Interferential (4P), that are designed to optimize muscle re-education and activation for patients. The four IntelliPhase waveform protocols are twist, hold, grip, and tap. Each protocol may be used for 15, 30, or 45 minutes. Not only are there four IntelliPhase protocols, but there is also a fully automated protocol (IntelliCycle) that integrates all the above listed waveforms in a comprehensive, interlaced series. This engages all the targeted muscles in a continuous program to maximize muscle effects with the touch of a button. accufit is both the proprietary-trade name and generic name. accufit is a supplement to existing treatments and does not replace any traditional treatment or therapy. The system console is the heart of the accufit and contains the Touch LCD/GUI, electrodes, and power supply module. The main console also includes a key switch used to turn the power on and off, and an emergency stop push button that quickly de-energizes the system in emergency situations. There are 4 casters in the console base that can be used when moving the system.

The accufit device is a Powered Muscle Stimulator (Product Codes IPF, NGX) indicated for various muscle-related therapies, including:

• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Increase local blood circulation
• Muscle re-education
• Maintaining or increasing range of motion
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
• Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen.
• Improvement of muscle tone and firmness, for strengthening muscles in arms, thighs and buttocks areas.

The device operates by providing direct electrical stimulation to muscles, causing contractions using unique IntelliPhase waveforms (Biphasic and Interferential (4P)) and IntelliSTIM electrodes. It offers four IntelliPhase waveform protocols (twist, hold, grip, and tap), each usable for 15, 30, or 45 minutes, as well as a fully automated IntelliCycle protocol.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document details a clinical study primarily focused on the improvement of muscle tone and firmness, specifically for strengthening muscles in the arms. While acceptance criteria in a quantitative sense (e.g., a specific percentage increase in strength) are not explicitly stated, the study's overall finding that "most patients saw improvement in muscle strength" serves as the reported device performance against an implied criterion of demonstrating clinical effectiveness for its new indication.

Given the available information, here is a summary related to the clinical study and its findings:

2. Sample Size and Data Provenance for Test Set

• Sample Size: 45 subjects were enrolled in the study.
• Data Provenance: Not explicitly stated regarding the country of origin. The study appears to be prospective as subjects were "enrolled" and "treated" with the device, and follow-up assessments were conducted.

3. Number and Qualifications of Experts for Ground Truth

Not applicable. This was a clinical study assessing the physiological effect of the device on muscle strength, not an AI/image-based diagnostic device requiring expert interpretation for ground truth. Muscle strength was measured objectively using a dynamometer.

4. Adjudication Method for Test Set

Not applicable. Muscle strength was measured using a dynamometer, which provides objective, quantitative data, thus negating the need for an adjudication method typically used for subjective assessments or interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described is a clinical trial assessing the direct effect of the device on muscle strength in human subjects.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a powered muscle stimulator for direct application to the human body, not an algorithm-only or AI-driven diagnostic tool. Its performance is intrinsically linked to human-device interaction.

7. Type of Ground Truth Used

The ground truth used in the clinical study was objective physiological measurement: muscle strength measured by a dynamometer at specified time points (baseline, final treatment, 30-day post-treatment, and 90-day post-treatment).

8. Sample Size for Training Set

Not applicable. This device is a physical therapeutic device, not an AI/machine learning model that requires a "training set" in the conventional sense of data-driven algorithm development. The "training" for the device would be its engineering and design based on established principles of electrical muscle stimulation.

9. How Ground Truth for Training Set Was Established

Not applicable, as there is no specific "training set" for the type of device described. The device's design and operational parameters would be based on scientific and engineering principles for powered muscle stimulators. Its effectiveness for specific indications is then demonstrated through clinical studies, as detailed above.

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