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As an NMES device, the Ttech NMES is indicated for the following conditions:

• Relaxation of muscle spasms .
• . Prevention or retardation of disuse atrophy
• Increasing local blood circulation .
• . Muscle re-education
• Immediate post-surgical stimulation of calf muscles to prevent . venous thrombosis; and
• t Maintaining or increasing range of motion

The Ttech NMES is a dual channel NMES device that produces a mild electrical current that is transmitted via leads to electrodes placed on the skin in areas predetermined by the clinician. The device, a set of electrodes with their lead wires, a battery (9 volt), carrying case, and instructions for use make up the Ttech NMES system.

The provided document is a 510(k) premarket notification for the Ttech NMES device. It details the device's characteristics and compares it to predicate devices to establish substantial equivalence. However, it does not contain specific acceptance criteria or an analytical study that proves the device meets such criteria in the way typically found for AI/ML-based medical devices with performance metrics like sensitivity, specificity, etc.

Instead, the document focuses on bench testing to demonstrate safety and performance equivalence to existing predicate devices. The conclusion explicitly states: "Bench testing raised no additional patient safety or performance issues so clinical testing was not indicated." This implies equivalence was established through non-clinical means.

Therefore, many of the requested details about acceptance criteria, sample sizes for test/training sets, expert ground truth, MRMC studies, or standalone algorithm performance are not applicable or present in this document.

Here's an attempt to answer the questions based on the provided text, while highlighting what is not present:

Acceptance Criteria and Study Details for Ttech NMES

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly met by demonstrating that the Ttech NMES device performs "Good" in critical functions like "Current pulse regulation" and that its output parameters are within a range comparable to the predicate devices. The study performed was primarily bench testing to ensure safety and performance equivalence, rather than a clinical trial measuring specific performance metrics against pre-defined acceptance thresholds.

2. Sample size used for the test set and the data provenance

Not applicable. The document describes non-clinical "bench testing" and does not refer to a "test set" in the context of patient data for performance evaluation. The data provenance would be laboratory testing in a controlled environment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No expert ground truth on patient data was established, as no clinical testing was performed or deemed necessary.

4. Adjudication method for the test set

Not applicable. No test set involving human interpretation and 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 powered muscle stimulator (NMES), not an AI/ML-based diagnostic or assistive technology for human readers. No MRMC study was performed.

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

Not applicable. This device is electro-mechanical, not an algorithm.

7. The type of ground truth used

For the safety and performance features, the "ground truth" was established through engineering standards and specifications (e.g., 21 CFR 898 for patient lead safety) and direct comparison of electrical output parameters against established values for predicate devices. There is no biological or clinical "ground truth" like pathology or outcomes data mentioned in this submission.

8. The sample size for the training set

Not applicable. As this is not an AI/ML device, there is no "training set."

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

Not applicable. See point 8.

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