(463 days)
The AK Body Toning Device is intended for use by healthy persons to apply transcutaneous electrical muscle stimulation (EMS) through skin-contact electrodes in order to improve or facilitate muscle performance.
The AK Body Toning Device is a battery-operated, hand-held, single-program, muscle stimulation system to tone healthy muscles of the abdomen, thighs, and buttock. The device is self- contained with three rows of axels under a rounded unit with a handle that is shaped to allow a comfortable hand-grip for the user. Each axel has three knobbed wheels. The two sets of stainless on the ends are the powered electrodes and the middle set of plastic wheels allows for easier movement across the skin.
The device produces transcutaneous electrical muscle stimulation through the powered electrodes that are approximately four inches apart. An on-off switch applies the power and an adjustable knob sets the intensity of the treatment. An electroconductive gel is applied to the skin in the area to be treated and the device is rolled across the treatment area. The knob is adjusted until the treatment is effective and may be increased after initial use.
This document is a 510(k) Premarket Notification from the FDA regarding the AK Body Toning Device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria and performance metrics for a diagnostic or AI device. Therefore, much of the requested information regarding diagnostic accuracy, sample sizes for training/test sets, expert ground truth, and MRMC studies is not applicable or available in this document.
However, I can extract the information that is present and indicate where requested information is not provided.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for the device's intended use of improving or facilitating muscle performance. Instead, it focuses on demonstrating that the device performs similarly to the predicate device and meets safety standards.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Functional Equivalence: Muscle stimulation similar to predicate device | Study: A study used ultrasound imaging to observe real-time muscle movement from stimulation of the anterior thigh muscle. |
| Result: The muscle stimulation was similar for the AK Body Toning Device (both held stationary and rolled) and the predicate device. | |
| Biocompatibility: Safe for skin contact | Testing: Biocompatibility evaluation conducted in accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1. |
| Result: Not explicitly stated as "passing" but implicitly found to be acceptable as part of the substantial equivalence determination. | |
| Electrical Safety & EMC: Performs safely and meets standards | Testing: Performance and electrical safety testing conducted. |
| Standards Met: IEC 60601-1, IEC 60601-1-2, UL 60601-1, CSA C22.2 No. 601.1, IEC 60601-2-10. | |
| Result: Test results demonstrate that the device safely performs as intended and raised no new questions of safety or performance compared to the predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document does not specify the number of subjects or the sample size used in the muscle movement observation study.
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided. The study involved direct observation of muscle movement, rather than interpretation of diagnostic images requiring expert ground truth in the traditional sense.
4. Adjudication method for the test set
This information is not applicable and not provided given the nature of the "muscle movement observation" study 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
This is not an AI device or a diagnostic imaging device, so an MRMC comparative effectiveness study involving human readers and AI assistance was not performed and is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not an AI device, so a standalone algorithm performance study was not done and is not applicable.
7. The type of ground truth used
The "ground truth" for the muscle stimulation study was the direct observation of muscle movement via ultrasound imaging, compared between the investigational device and the predicate device. It's a direct physiological observation, not an expert consensus, pathology, or outcomes data in the typical sense of a diagnostic study.
8. The sample size for the training set
This is not an AI device, so there is no mention of a training set or its sample size.
9. How the ground truth for the training set was established
This is not an AI device, so there is no mention of a training set or how its ground truth was established.
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).