Search Results
Found 2 results
510(k) Data Aggregation
(99 days)
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:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device effectively strengthens arm muscles. | "most patients saw improvement in muscle strength from the initial to final treatment, as measured by the dynamometer." |
| Device is well-tolerated with no significant adverse events. | "There were no significant adverse events noted in the duration of the study." |
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.
Ask a specific question about this device
(123 days)
The Gymform® TOTAL ABS (Model: WB-245) is intended to stimulate healthy muscles in order to improve or facilitate muscle performance.
The large belt is intended for use on the muscles in abdomen. The small belt for working the leg and arm muscles, intended for use on the muscles in arms, legs (lower extremities) and thighs areas separately.
The Gymform® TOTAL ABS( Model: WB-245) consists of a control unit, large belt, small belt and electrode pads. The control unit enclosed in ABS plastic case. The device is design based on Microcurrent technology (Electro Muscle Stimulation-EMS) which uses a gentle current to condition, tone and strengthen muscles.
The Gymform® TOTAL ABS( Model: WB-245) is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The TOTAL ABS may be considered a technique or method for muscle training. It is a battery operated muscle stimulation system specifically designed to training muscles.
The large belt is intended for use on the muscles in abdomen. The small belt for working the leg and arm muscles, intended for use on the muscles in arms, legs (lower extremities) and thighs areas separately.
The stimulator sends gentle electrical current to targeted muscle group through the electrodes placed on the skin. The parameters of the unit are controlled by the buttons. Its intensity level can be adjustable by user.
There are 6 modes for output stimulation, and for each mode, there are 10 levels of output intensity can be choose. Default time is 10minutes for output stimulation.
Power is derived from 3 pieces of AAA batteries located in a compartment protected by a removable battery cover for the Fitness Belt.
The provided document, a 510(k) Summary for the Gymform® TOTAL ABS, Model: WB-245, describes the device's technical specifications and claims substantial equivalence to predicate devices. However, it does not detail specific acceptance criteria for a study proving the device meets those criteria in clinical performance metrics. Instead, the document focuses on demonstrating safety and performance through compliance with recognized standards and a usability study, and by comparing its technical specifications to legally marketed predicate devices.
Here's an analysis of the provided information, structured around your request, with an emphasis on what is available and what is not explicitly stated:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for clinical performance. Instead, it relies on demonstrating compliance with recognized electrical safety, EMC, and biocompatibility standards, and demonstrating substantial equivalence to predicate devices, which generally implies that if the predicate device is safe and effective, and the new device is sufficiently similar and meets safety standards, it is also safe and effective.
The performance data summarized focuses on technical benchmarks and compliance:
| Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1, IEC 60601-2-10 | Comply with IEC 60601-1 and IEC 60601-2-10 |
| EMC | Compliance with IEC 60601-1-2 | Comply with IEC 60601-1-2 |
| Biocompatibility | Compliance with ISO 10993-5, ISO 10993-10 | Non cytotoxic, No skin sensitization, No skin irritation |
| Software Integrity | Compliance with FDA Guidance for Software in Medical Devices (Moderate concern) | Software verification and validation testing conducted and documented |
| Waveform Parameters | Verified to demonstrate substantial equivalence to predicate devices | Output voltage, output current, Output waveform frequency, pulse width, maximum current and power density verified |
| Usability (OTC) | Lay user can: 1) Self-select, 2) Apply safely, 3) Understand indications/contraindications/warnings | Usability testing completed in 24 subjects; tests demonstrate device meets requirements |
| Max Output Voltage | Comparable to predicate devices, within safe limits | 81.6V @ 500Ω, 96V @ 2kΩ, 99.2V @ 10kΩ. Lower than primary predicate, covered by range of predicate and reference devices. |
| Max Output Current | Comparable to predicate devices, within safe limits | 163mA @ 500Ω, 48mA @ 2kΩ, 9.92mA @ 10kΩ. Lower than primary predicate, covered by range of predicate and reference devices. |
| Frequency Range | Comparable to predicate devices, within safe limits | 50, 60, 70 Hz. Within predicate devices' ranges and IEC 60601-2-10/FDA guidance. |
| Pulse Width Range | Comparable to predicate devices, within safe limits | 200 us. Within predicate devices' ranges and IEC 60601-2-10/FDA guidance. |
| Max Current Density | Compliance with IEC 60601-2-10 and FDA guidance | 0.041 mA/cm² @ 500Ω. Compliant with standards. |
| Max Power Density | Compliance with IEC 60601-2-10 and FDA guidance, below 0.25 W/cm² | 28.81 µW/cm². Compliant with standards and below 0.25 W/cm². |
2. Sample Size for the Test Set and Data Provenance
- Usability Study Test Set: 24 subjects
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The study is described as "Usability testing (OTC Study)," which is typically prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable for a usability study. The "ground truth" for a usability study is typically the direct observation of user interaction and self-reported comprehension, not expert consensus on a medical diagnosis.
4. Adjudication Method for the Test Set
Not applicable. Usability studies do not typically involve adjudication in the same way clinical diagnostic studies do. The assessment is usually based on predefined tasks and criteria for successful completion and comprehension by the "lay user."
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 MRMC comparative effectiveness study was mentioned. This device is a muscle stimulator, not an AI-powered diagnostic tool for interpretation by human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This device is not an algorithm for diagnosis. Its performance is inherent in its electrical stimulation output and how users interact with it. The stated performance evaluations (electrical, EMC, biocompatibility, waveform, usability) are effectively "standalone" in that they assess the device itself without requiring a human medical expert to interpret its output for diagnostic purposes.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For Biocompatibility: Laboratory testing results based on established ISO standards.
- For Electrical Safety/EMC/Waveform: Measurement against recognized engineering standards (IEC, FDA guidance).
- For Usability: User performance and comprehension against specified usability objectives for "lay users." There isn't a "ground truth" in the diagnostic sense, but rather a determination of whether users can operate the device safely and effectively according to instructions.
8. The sample size for the training set
Not applicable. This document pertains to the evaluation of a physical medical device (muscle stimulator) rather than an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as no training set for an AI/ML algorithm was used.
Ask a specific question about this device
Page 1 of 1