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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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• 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

accufit (subject device) when using the Biphasic/Interferential (4P) waveforms is a noninvasive powered muscle stimulator used to provide an electrical stimulation of muscles for muscle re-education. The accufit is used on an outpatient basis under the supervision of a clinician.

The accufit is the result of a close collaboration between Lutronic Corporation and Mettler Electronics, Corporation. Mettler is the manufacturer of both the subject and predicate device. Using the Mettler Sys*Stim ME240 (K113017) as a starting point, the accufit utilizes two of the original and unchanged waveforms for muscle reeducation.

There are four preprogrammed treatment regimens that enable users to mimic common physical exercises. Each treatment regimen has recommended treatment electrode placement depicted in both the accufit operator's manual and on the accufit graphic user interface (GU). The IntelliSTIM treatment electrodes have been designed to support the accufit and are controlled by an intelligent real-time impedance feedback Mettler System. The IntelliSTIM are held in place with hydrogel adhesive strips and Velcro body wraps. The user may select the treatment duration of either 15, 30 or 45 minutes. The size, type of electrode and technical/performance characteristics.

This document is a marketing submission for a medical device (510(k)). It describes the "accufit" powered muscle stimulator and its associated electrodes ("IntelliSTIM" and "IntelliGEL"). The submission aims to demonstrate substantial equivalence to previously cleared predicate devices, rather than presenting a study to prove acceptance criteria for a novel device with new performance claims.

Therefore, the typical acceptance criteria and study design for performance claims (e.g., sensitivity, specificity, accuracy against a gold standard, or comparative effectiveness studies) are not applicable in the context of this 510(k) summary. The "acceptance criteria" here are essentially the demonstration that the new device is as safe and effective as the predicate device based on its design, technical specifications, and compliance with recognized standards.

However, I can extract the information on the technical specifications and performance testing that were conducted to support the claim of substantial equivalence.

Here's a breakdown of the requested information based on the provided text, adapted to the context of a 510(k) submission for substantial equivalence:

1. Table of Acceptance Criteria and the Reported Device Performance

As this is a 510(k) showing substantial equivalence, the "acceptance criteria" are not framed as specific performance metrics against a disease state or outcome. Instead, the criteria are the demonstration of comparable technical characteristics and compliance with relevant safety and performance standards to the predicate device. The "reported device performance" is the accufit's (and its electrodes') specifications and test results, which are shown to be identical or substantially equivalent to the predicate devices and compliant with standards.

Here's a summary of the key comparisons and performance aspects for the accufit powered muscle stimulator:

Here's a summary of the key comparisons and performance aspects for the IntelliSTIM and IntelliGEL electrodes:

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

This information is not provided in the document as it's not a clinical study with a "test set" in the traditional sense of evaluating a new performance claim against a ground truth dataset. The testing performed consists of:

• Bench Testing: To ensure compliance with electrical safety, EMC, and powered muscle stimulator standards. These are engineering verification tests, not clinical evaluations on patient data.
• Biocompatibility Testing: Conducted on the IntelliGel hydrogel adhesive strips according to ISO 10993 standards. These tests are typically performed in a lab on material samples and don't involve a "patient test set" or clinical data provenance.
• Software Verification and Validation Testing: Performed on the accufit's software. This is also an engineering/software quality assurance process, not a data-driven clinical performance study.

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. As described above, there was no clinical "test set" requiring ground truth established by experts for performance evaluation against a diagnostic or therapeutic outcome. The "ground truth" for the performed tests is adherence to recognized performance standards (e.g., the output voltage/current should be within a certain range as per engineering specifications, or a material should not cause cytotoxicity based on ISO 10993).

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

Not applicable. No clinical test set or adjudication process for clinical outcomes was 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. The device is a powered muscle stimulator, not an AI-assisted diagnostic or interpretive tool that would involve "human readers" or "AI assistance" in the sense of image interpretation or similar cognitive tasks.

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

Not applicable. This device is a powered muscle stimulator, not an algorithm. Its operation inherently involves human interaction (clinician supervision, patient interrupt switch).

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

Not applicable. For the purposes of this 510(k), the "ground truth" for the device's substantial equivalence is its compliance with internationally recognized safety and performance standards (e.g., IEC 60601 series, ISO 10993 for biocompatibility) and the demonstration that its technical specifications (e.g., output characteristics like voltage, current, pulse width) either match or are equivalent to those of the predicate device for the claimed indications.

8. The sample size for the training set

Not applicable. This device is not an AI/ML product developed using a "training set" of data.

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

Not applicable. There was no training set for an algorithm.

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