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The E-Stim II is intended for use in the symptomatic relief of chronic intractable pain, post traumatic acute pain, and post surgical pain.

The device consists of a battery powered portable instrument with dual channel outputs connected to lead wires and electrodes. Setting the output switch and the intensity controls will deliver the desired stimulation. Adjusting the frequency control will change the stimulation as well. Treatment continues as long as the intensity control dial switch is on.

This 510(k) summary describes a premarket notification for the E-Stim II, a portable transcutaneous electrical nerve stimulator (TENS) intended for pain relief.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly define acceptance criteria as typically seen for AI/ML device performance (e.g., sensitivity, specificity, AUC thresholds). Instead, the substantial equivalence determination for the E-Stim II is based on its conformity to established safety and performance standards and its similarity to a legally marketed predicate device (Well-TENS).

The "study" used here is a comparison of the E-Stim II to a predicate device and adherence to relevant standards.

2. Sample Size for Test Set and Data Provenance

This submission is for a medical device (TENS unit), not an AI/ML product that typically involves a "test set" of data. The "testing" refers to non-clinical bench testing for electrical safety, electromagnetic compatibility, and biocompatibility against recognized standards. Therefore, concepts like "sample size for the test set" and "data provenance" (country of origin, retrospective/prospective) are not directly applicable in the context of this 510(k) submission for a TENS device. The performance is assessed against engineering and medical device standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable to this 510(k) submission. "Ground truth" in the context of electrical device testing relies on adherence to the specifications of the standards (e.g., a waveform must be a square wave; a certain current must be delivered within a defined range). No human experts are used to establish "ground truth" for the device's electrical output or material properties in the same way they would for diagnostic image interpretation.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical studies, particularly for diagnostic imaging or similar scenarios where expert consensus is needed to define a reference standard. This is not relevant for the technical performance testing of a TENS device against established engineering standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. These types of studies are typically performed for diagnostic devices (especially AI-powered ones) to assess the impact of a device on reader performance. This submission is for a therapeutic TENS device, and its evaluation relies on its technical specifications, safety, and equivalence to a predicate device, not on how it changes human reader performance.

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

Not applicable. This device is a hardware-based TENS unit, not an algorithm or AI product. Its performance is inherently "standalone" in the sense that it delivers electrical stimulation as designed, but this is not an "algorithm-only" performance as understood in AI/ML contexts.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance, in the absence of an AI/ML component, is derived from:

• Compliance with Recognized Standards: The device meets the technical specifications and safety requirements outlined in the listed ISO, EN, IEC, and AAMI standards (e.g., electrical output parameters, biocompatibility, risk management). These standards define the expected and acceptable performance characteristics.
• Equivalence to Predicate Device: The electrical characteristics and intended use are considered "substantially equivalent" to a legally marketed predicate device (Well-TENS), implying that its performance is comparable and acceptable.

8. The Sample Size for the Training Set

Not applicable. 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, as there is no "training set" for this device.

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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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