(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.
§ 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).