(328 days)
The StimPad™ System is a transcutaneous electrical nerve stimulator (TENS) device intended for the delivery of electrical stimulation applied through the surface of patient's skin for the treatment of chronic intractable pain, and post-traumatic acute pain. The StimPad™ can be used for self treatment as well as for the treatment of others. It is a prescription use device.
The StimPad™ System is indicated for the symptomatic relief of chronic intractable pain, and post-traumatic acute pain.
The StimPad™ is a non-invasive nerve stimulation therapy device that can be placed directly at the site of pain for direct electrical stimulation. Stimulation is achieved through self-contained electrodes that are snap fit connected to the electronic components. There are no separate wires or electrode pads. The StimPad™ is powered by a self-contained three-volt lithium battery.
The StimPad™ device has pre-programmed settings for frequency (i.e. 7.1 Hz), pulse width [i.e. 47 milliseconds for the low, medium, and high intensity settings at 500 ohms, 2000 ohms, and 10,000 ohms] and the timed setting for treatment duration (4 seconds or less). The treatment duration is limited to four seconds or less of stimulation per application/treatment, and the user is not allowed to modify this setting. The intensity levels can be adjusted between low (stimulation is usually imperceptible), medium (usually the most comfortable), and high (maximum level for comfort).
A three-volt lithium battery powers the StimPad™. The life of the battery varies with the frequency of activation, repetition and ambient temperature conditions. The battery is not replaceable. Once the battery is depleted, the device ceases to function and should be disposed or returned to the manufacturer.
The provided text describes a 510(k) submission for the AEMED StimPad™ TENS System. This is a medical device, and the submission focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving the device's efficacy through a clinical study with detailed acceptance criteria and performance metrics.
Therefore, many of the requested details about acceptance criteria, sample sizes, expert ground truth, MRMC studies, and standalone performance are not applicable to this type of regulatory submission as they are typically associated with performance studies for novel devices or those seeking approval based on clinical effectiveness.
Here's an analysis based on the provided text:
1. Table of acceptance criteria and the reported device performance
There are no explicit "acceptance criteria" presented in the document in the format of a clinical trial outcome. Instead, the "acceptance" for this 510(k) relies on demonstrating substantial equivalence to predicate devices. The performance is assessed by comparing technical characteristics.
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance (StimPad™) |
|---|---|
| Indications for Use: Same as predicate devices. | Intended Use: "The StimPad™ System is a transcutaneous electrical nerve stimulator (TENS) device intended for the delivery of electrical stimulation applied through the surface of patient's skin for the treatment of chronic intractable pain, and post-traumatic acute pain." |
| Indications for Use: "The StimPad™ System is indicated for the symptomatic relief of chronic intractable pain, and post-traumatic acute pain." | |
| These are stated to be "essentially the same indications for use and intended use as the predicate devices." | |
| Fundamental Technology & Operating Principles: Same as predicate devices. | "The StimPad™ also uses the same fundamental technology and operating principles as the Gemore Technology Company Limited GM3 Series HV... and the Innovative Designer Products Inc. Solitens Modified... and the Medipoint Microcurrent Therapy device." |
| All are described as "portable hand held battery operated micro current devices that delivers electrical current by means of a direct contact point for the purpose of alleviating or relief of pain." | |
| Basic Design Features: Similar to predicate devices. | "The basic design features of StimPad™ are similar to the predicate devices." |
| Electrical Output Performance Characteristics: Comparable and consistent with predicate devices, with overlap. | "The electrical output performance characteristics of the StimPad™ device consisting of current and voltage output, pulse frequency, pulse width, pulse duration, maximum current amplitude, time setting, and waveform are comparable and consistent with those of the predicate devices. The user controls and displays are operated in a comparable manner by the user, and the operating modes are analogous." |
| Specific pre-programmed settings are mentioned: 7.1 Hz frequency, 47 milliseconds pulse width, and 4 seconds or less treatment duration. Intensities are low, medium, high. | |
| Electrical Safety & Electromagnetic Compatibility (EMC): Compliance with recognized standards. | "The StimPad™ device was subjected to electrical safety and electromagnetic compatibility testing and was found to be in compliance with the requirements of the standards IEC 60601-1:1988 and IEC 60601-1-2:2001 respectively." |
| Design Verification Testing: Characterize and assure consistent electrical output and comparability to predicates. | "Design Verification testing to characterize and assure consistent electrical output performance and comparability to the predicate devices was also successfully performed in association with the software validation testing activities." |
2. Sample size used for the test set and the data provenance
Not Applicable. No clinical test set or patient data is described for performance evaluation. The "test set" here refers to the device itself undergoing engineering, electrical safety, and EMC testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable. No ground truth in the sense of expert clinical assessment is mentioned in the context of this 510(k) submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not Applicable. No adjudication method for a clinical test set is mentioned.
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 tool. An MRMC study is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This device is a physical TENS unit, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the engineering and safety tests, the "ground truth" would be the standards themselves (e.g., IEC 60601-1, IEC 60601-1-2) which define acceptable electrical safety and EMC parameters. For the claim of substantial equivalence, the "ground truth" is established by the characteristics and performance of the legally marketed predicate devices. No clinical outcomes data or expert consensus on patient conditions were used as ground truth for this submission.
8. The sample size for the training set
Not Applicable. This is a hardware medical device, not a machine learning model. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
Not Applicable. As there is no training set, there's no ground truth for it.
In summary, the provided document is a 510(k) premarket notification focused on demonstrating "substantial equivalence" of a TENS device to existing legally marketed devices. This regulatory pathway primarily relies on comparing technical specifications, indications for use, and compliance with recognized safety standards, rather than presenting clinical study results with explicit performance acceptance criteria and associated metrics like sensitivity, specificity, or reader improvement.
§ 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).