(75 days)
The Tyece OTC EMS System, Model EM37 is intended for use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance.
Not Found
This FDA document (K183454) is a 510(k) clearance letter for the Tyece OTC EMS System, Model EM37, a powered muscle stimulator. It does not contain information about acceptance criteria, study details (sample size, data provenance, ground truth, expert qualifications, etc.), or specific device performance metrics that would be typically found in a clinical study report.
The letter primarily states that the device is "substantially equivalent" to legally marketed predicate devices and outlines the regulatory requirements for the manufacturer. The "Indications for Use" section simply describes the intended use of the device.
Therefore, many of the requested details cannot be extracted from this document. However, I can still indicate where the information would typically be found in a study report, and what kind of information is available here:
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
- Not Available in the Document: This document is a 510(k) clearance letter, not a clinical study report. It does not contain a table of acceptance criteria or specific quantitative device performance metrics (e.g., accuracy, sensitivity, specificity, or any measurable physiological outcome) that would typically be reported from a study.
- What this document does state: The device "is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This implies that the device was deemed to perform equivalently to existing, cleared devices under its stated intended use.
2. Sample Size Used for the Test Set and Data Provenance
- Not Available in the Document: The 510(k) clearance letter does not describe any specific test set size or data provenance (e.g., country of origin, retrospective/prospective nature) for a study. This information would typically be found in the clinical study protocol and report submitted to the FDA as part of the 510(k) submission, but it is not detailed in this public clearance letter.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Available in the Document: Given that this is a powered muscle stimulator, and not a diagnostic imaging device, the concept of "ground truth" established by human experts in the traditional sense (e.g., radiologists for image interpretation) is unlikely to be directly applicable in the same way. The evaluation for such a device would more likely involve performance testing against electrical safety standards, physiological response measurements, or comparative efficacy against a predicate device, as determined by clinical endpoints. However, no such details are provided in this document.
4. Adjudication Method for the Test Set
- Not Applicable / Not Available: As no expert review or "test set" in the context of interpretation is described, no adjudication method is provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not Applicable / Not Available: An MRMC study is typically performed for diagnostic devices where multiple readers interpret cases. This device is a powered muscle stimulator and the document does not suggest such a study was performed or required for its clearance. Therefore, no effect size of human reader improvement with AI assistance is mentioned.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not Applicable / Not Available: This device is a physical electromedical device, not an AI algorithm. A "standalone" performance study in the context of an algorithm is not relevant here. The device's performance would be evaluated as a system delivering electrical stimulation.
7. Type of Ground Truth Used
- Not Available in the Document: As explained in point 3, the type of "ground truth" for a muscle stimulator would relate to its physiological effects or direct performance metrics, rather than interpretive ground truth. The document does not describe what specific performance metrics were used as "ground truth" for evaluating the device, nor the methods used to establish them.
8. Sample Size for the Training Set
- Not Applicable / Not Available: This device is not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable / Not Available: As the device is not an AI/ML algorithm, this question is not relevant.
Summary of Available Information from the Provided Document:
- Device Name: Tyece OTC EMS System, Model EM37
- Regulation Name: Powered Muscle Stimulator
- Intended Use: For use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance.
- Regulatory Status: Cleared via 510(k) as substantially equivalent to predicate devices.
- Type of Use: Over-The-Counter Use.
To obtain the detailed information regarding acceptance criteria and performance studies, one would typically need to refer to the full 510(k) submission materials, which are usually not publicly available in their entirety, or specific clinical study reports if they were publicly published. The FDA 510(k) clearance letter serves as a summary of the regulatory decision, not a detailed technical report of the studies performed.
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February 26, 2019
Tyece Ltd. % Guenter Ginsberg President Media Trade Corporation 11820 Red Hibiscus Dr Bonita Springs, Florida 34135
Re: K183454
Trade/Device Name: Tyece OTC EMS System, Model EM37 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: December 13, 2018 Received: December 13, 2018
Dear Guenter Ginsberg:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, VivekJ. Pinto -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K183454
Device Name Tyece OTC EMS System, Model EM37
Indications for Use (Describe)
The Tyece OTC EMS System, Model EM37 is intended for use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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§ 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).