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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.

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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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The Tyece OTC EMS System, Model EM35 is intended for use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance.

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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a powered muscle stimulator. It does not contain information about acceptance criteria, study details, or device performance as typically found in a clinical study report or a detailed summary of safety and effectiveness. Therefore, I cannot extract the requested information to fill in the table or answer the specific questions about a study proving device performance.

The document primarily states that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls provisions of the Act. It also includes the indications for use for the device.

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The Tyece OTC TENS Device, Model SEM44 is to be used for temporary relief of pain associated with sore and aching muscles in the lower back, arms, or legs due to strain from exercise or normal household activities.

The Tyece OTC TENS Device, Model SEM44 is a dual channel TENS device operated by DC 4.5V (3 AAA batteries). It is made up of one main unit, two electrode cables, and two pairs of electrode pads. There are 12 selectable, pre-programmed output waveforms (modes) to choose from, blus 3 programmable modes. The two channels can be individually adjusted for intensity from 0 to 50. Running time can be selected from 5 to 100 minutes. All parameters (Menu, Program Number, Impulse intensity for channels, Jow battery, key-lock, frequency, pulse width and timer) are displayed on a full screen display. The only patient contacting components are the Electrode Pads. The patient contacting materials are FDA cleared under K132588.

This is a premarket notification (510(k)) for a Transcutaneous Electrical Nerve Stimulator (TENS) device. The purpose of a 510(k) submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device, meaning it is as safe and effective. In this context, the "acceptance criteria" and "device performance" usually refer to the equivalence demonstrated through engineering and non-clinical testing against recognized standards and comparison to the predicate device. Clinical studies for proving effectiveness in terms of pain relief are typically not required for 510(k) submissions of TENS devices if substantial equivalence can be shown through non-clinical means.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission of a TENS device, the acceptance criteria are generally defined by compliance with recognized consensus standards for electrical safety, electromagnetic compatibility, and performance, as well as demonstrating comparable technical characteristics to the predicate device. The "device performance" reported is its compliance with these standards and its specified output characteristics.

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

The document states: "Savia did not conduct, nor rely upon, clinical tests to determine substantial equivalence of the SEM44 vs. the predicate." Therefore, there is no test set of clinical data from human subjects in the traditional sense. The testing performed was non-clinical bench testing to validate design and ensure conformance with voluntary design standards. This means there is no data provenance related to human subjects (country of origin, retrospective/prospective).

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 noted above, no clinical test set was used for determining substantial equivalence, hence no experts were involved in establishing ground truth for such a set. The "ground truth" was established by the requirements of the recognized consensus standards and direct comparison of technical specifications to the predicate device.

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

Not applicable, as no clinical test set involving human subjects requiring adjudication was used.

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. This device is a TENS unit, not an AI-assisted diagnostic or therapeutic device that would typically involve human readers or MRMC studies.

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

Not applicable. The device is a Transcutaneous Electrical Nerve Stimulator; it's a physical device that delivers electrical impulses, not an algorithm in the context of AI or imaging. Performance was evaluated as a standalone product against technical specifications and standards.

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

The "ground truth" for this 510(k) submission is primarily established by:

• Recognized consensus standards: Electrical safety, EMC, performance standards (e.g., IEC 60601 series).
• Technical specifications of the predicate device: The Tyece device's technical characteristics are compared directly to the cleared predicate device to ensure substantial equivalence.
• Design requirements: Internal company design requirements for the device.

There is no "expert consensus," "pathology," or "outcomes data" ground truth in the clinical sense, as clinical studies were not performed for this submission.

8. The sample size for the training set

Not applicable. Since no clinical studies were performed and the device is not an AI/machine learning model, there is no concept of a "training set" of data.

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

Not applicable, as no training set was used.

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