(217 days)
The AD-2129A TENS device is intended for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities. It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
The AD-2129A Transcutaneous Electrical Nerve Stimulator(TENS) is transcutaneous electrical nerve stimulator for relief of muscular pain and sold without prescription. The device consists of a microprocessor, buttons, electrical pads, and display. Keys can control the device to choose the operation modes, adjust pulse output strength, then the channel that effectively transfers your desired choice of programmed electrical pulses directly through electrode adhesive pads to the suggested area of the body where the electrodes are placed, causing minimal muscle stimulation. The LCD display can show user the mode and strength chosen and other information like date and time Self-adhesive electrodes are used in this devices, and they are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. The electrodes is for OTC use, and mainly consists of substrate and wire.
The provided document is a 510(k) Premarket Notification for a Transcutaneous Electrical Nerve Stimulator (TENS) device, AD-2129A. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo acceptance criteria and proving performance against them through a clinical study.
Therefore, the document does not report on acceptance criteria or a study designed to prove the device meets these criteria in the way one would for a novel AI/ML medical device or a device requiring clinical performance validation against specific metrics.
Instead, the document details:
- Regulatory Substantial Equivalence: The primary goal is to show that the AD-2129A TENS device is substantially equivalent to legally marketed predicate TENS devices (Smart Relief K131159 and EasyStim TN28_OTC K140168).
- Safety and Performance to Standards: The "Performance Summary" and "Non-clinical Testing Summary" sections confirm that the device conforms to relevant electrical safety, electromagnetic compatibility (EMC), and biocompatibility standards (e.g., IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2, ISO 10993). These are general safety and performance standards for the device type, not specific outcome-based acceptance criteria for a novel technology.
- Comparison Table: A detailed comparison table highlights similarities and differences between the subject device and the predicates regarding product name, regulatory information, intended use, physical characteristics, and electrical parameters.
To directly answer your request based on the provided document:
1. A table of acceptance criteria and the reported device performance:
The document does not present acceptance criteria in a quantitative, outcome-based manner for clinical efficacy or diagnostic accuracy, as would be expected for an AI/ML device. Instead, "acceptance criteria" are implied by adherence to recognized electrical, EMC, and biological safety standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with IEC 60601-1 (Electrical Safety) | "the device meet all the applicable requirements." |
| Compliance with IEC 60601-2-10 (Nerve & Muscle Stimulators Safety) | "particular safety test has been performed... and the device meet all the applicable requirements." |
| Compliance with IEC 60601-1-2 (Electromagnetic Compatibility) | "the test result show that, the device meet all the applicable requirements." |
| Compliance with ISO 10993-5 (In vitro cytotoxicity - Biocompatibility) | "the result shows it meet the applicable requirements." |
| Compliance with ISO 10993-10 (Irritation & skin sensitization - Biocompatibility) | "the result shows it meet the applicable requirements." |
| Substantial Equivalence to Predicate Devices | "The new device AD-2129A TENS has the same intended use, design, technological characteristics as the predicate device K131159 and K140168." |
2. Sample size used for the test set and the data provenance:
- The document describes non-clinical bench testing (electrical safety, EMC, biocompatibility) rather than a clinical "test set" of patient data. Therefore, concepts like sample size for a test set and data provenance (country, retrospective/prospective) are not applicable in this context. The "sample" tested would be the physical device units and their components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth as typically understood for medical imaging or diagnostic AI (e.g., expert consensus on clinical findings) is not established here. The "ground truth" for the non-clinical tests is adherence to engineering and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There is no expert adjudication process described, as clinical interpretation is not being evaluated.
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:
- No. This is a TENS device, not an AI-assisted diagnostic tool. No MRMC study was conducted or is relevant to this submission type.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance evaluation against standards is defined by the technical specifications and limits set by the referenced IEC and ISO standards for electrical safety, EMC, and biocompatibility.
8. The sample size for the training set:
- Not applicable. This device does not involve machine learning or a "training set."
9. How the ground truth for the training set was established:
- Not applicable. 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).