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The Tyece OTC TENS Device EM26 is intended for use by healthy adults for temporary relief of pain associated with sore and aching muscles in the shoulder and neck due to strain from exercise or normal household and work activities.

The Tyece OTC TENS Device EM27 is intended for use by healthy adults for temporary relief of pain associated with sore and aching muscles in the lower extremities (leg) due to strain from exercise or normal household and work activities.

The Tyece OTC TENS Device EM28 is intended for use by healthy adults for temporary relief of pain associated with sore and aching muscles in the upper extremities (arm) due to strain from exercise or normal household and work activities.

The Tyece OTC TENS Device EM29 is intended for use by healthy adults for temporary relief of pain associated with sore and aching muscles in the upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household and work activities.

The Tyece OTC TENS Device EM26, EM27, EM28 and EM29 powered by 4.5V (3 x 1.5V AAA /Alkaline batteries), is similar to the predicate device, LT3060 (K130802), with the following features:
a. It is a portable single-channel, battery operated Transcutaneous Electrical Nerve Stimulator stimulation system. The predicate is a dual-channel TENS device.
b. It contains 4 programs, similar to the predicate device which has 12 programs
c. The output strength is adjustable from 0-110mA, similar to the predicate device at 0-96mA, via regulated voltage.
d. The LCD display is provided for the indication of operation status including operation mode, output program mode, output intensity, time to cut-off, and battery low indication.

The provided document is a 510(k) Premarket Notification from the FDA regarding the Tyece OTC TENS Devices (Models EM26, EM27, EM28, and EM29). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through novel studies.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria, as it relates to a typical AI/ML device submission's performance evaluation.

Specifically, it lacks data on:

1. A table of acceptance criteria and reported device performance: The document compares technical specifications of the Tyece TENS devices to a predicate device, but this is not an "acceptance criteria" table in the context of an AI/ML device's performance (e.g., sensitivity, specificity, AUC).
2. Sample size and data provenance for a test set: No specific test set for evaluating AI/ML algorithm performance is mentioned.
3. Number and qualifications of experts for ground truth: Not applicable, as there's no AI/ML algorithm requiring expert ground truth for interpretation.
4. Adjudication method: Not applicable.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not conducted. The TENS device is a physical product, not an AI.
6. Standalone (algorithm only) performance: Not applicable.
7. Type of ground truth: Not applicable.
8. Sample size for training set: Not applicable.
9. How ground truth for training set was established: Not applicable.

Instead, the document details the technical comparisons of the Tyece TENS devices to a predicate TENS device (LT3060, K130802) and a reference device (Savia OTC TENS Model EM-38, K113321). The "study" mentioned here refers to non-clinical testing performed to validate design conformance with voluntary standards (e.g., IEC 60601 series for electrical safety and electromagnetic compatibility) and software validation. These tests are intended to demonstrate that the Tyece devices maintain the same safety and effectiveness as the predicate device despite some differences in specifications (e.g., single vs. dual channel, different battery types, output parameters). The "discussion of differences" in the tables explains why these differences do not adversely impact safety and effectiveness, leading to the conclusion of substantial equivalence.

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