(196 days)
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.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Safety and Electrical Performance Conformity to Standards | The E-Stim II has been designed and tested to conform to the following standards: ISO 14971:2000, EN ISO 10993.1:1997/EN ISO 10993.5:1999/EN ISO 10993.10.2002, EN 60601-1:1990+A1:1993+A2:1995+A13:1996/IEC 60601-1:1988+A1:1991+A2:1995, EN 60601-1-2:2001/IEC 60601-1-2:2001, EN 980:2003. Applicable testing criteria from the AAMI standards for Transcutaneous Electrical Nerve Stimulators NS4:1985 for Well-TENS. |
| Intended Use Equivalence to Predicate Device | 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 intended use of the Well-Tens is identical." |
| Technological Characteristics (No New Safety Concerns) | Both devices (E-Stim II and Well-TENS) use one 9-volt battery. During stimulation, the electrical output for both devices is square waveform pulses. "Details of electrical output are different but new safety concerns are not raised by the differences." Controls on each device regulate stimulation intensity and frequency. Material composition of the electrodes and the lead wires is identical. |
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.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).