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510(k) Data Aggregation
(217 days)
EasyStim TN28 OTC is intended for the relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities.
EasyStim TN28 OTC is a portable, battery powered T.E.N.S. device for pain relief intended for over-the-counter use.
There are totally eight (8) modes that are intended for application to the following areas: Shoulder/ Arm, Lower Back and Leg/Foot.
The accessories include electrode cable and electrodes pads which are placed on the specific body part. Generally, the electrodes are connected to the device through electrode cable. The device produces either a fixed or modulated electrical signal through electrodes normally placed on a patient's skin over the area of pain.
Since the device is battery powered, there is no connection to AC mains supply.
The provided document is a 510(k) Summary for the EasyStim TN28 OTC device, a Transcutaneous Electrical Nerve Stimulator (T.E.N.S.). It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study proving the device meets specific acceptance criteria in the context of diagnostic or treatment performance.
Here's an analysis based on the information provided, addressing the questions as best as possible within the scope of the document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy) for diagnosis or treatment effectiveness, as would be common for AI/ML-based medical devices or novel therapies. Instead, the substantial equivalence hinges on meeting electrical safety, electromagnetic compatibility, usability, risk management standards, and having similar technical characteristics and indications for use as predicate devices.
The "device performance" reported is primarily a comparison of its technical specifications to those of legally marketed predicate devices.
| Attribute | Acceptance Criteria (Implied by Predicate Comparison) | Reported Device Performance (EasyStim TN28 OTC) |
|---|---|---|
| Indications for Use | Same as predicate devices | Relief of pain associated with sore or aching muscles of lower back, arms, or legs due to strain from exercise or normal household and work activities. |
| Product Code | NUH (or similar, like GZJ) | NUH |
| Regulation No. | 21 CFR 882.5890 | 21 CFR 882.5890 |
| Prescriptive or OTC | OTC | OTC |
| Environment of use | Clinics, hospital and home environments | Clinics, hospital and home environments |
| Maximum Phase charge (500 ohm) | < 25µC (based on predicate comparison) | 20.02μC |
| Maximum Average Power Density (500 ohm) | < 0.25W/cm² (based on predicate comparison) | 0.00752W/cm² |
| Frequency (Hz) | Within range of predicate devices (e.g., 1-150Hz) | From 1Hz to 150Hz |
| Compliance Standards | AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-1-6, IEC 62304, ISO 14971, IEC 60601-2-10 | AAMI/ANSI ES60601-1:2005/(R)2012 And A1:2012,, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, Mod). (General I (QS/RM)); IEC 60601-1-2 Medical Electrical Equipment-Part 1-2: General Requirements for Safety-Collateral Standard: Electromagnetic Compatibility- Requirements and Tests(Ed.3) (General); IEC 60601-1-11 (Edition1.0 2010-04), Medical Electrical Equipment - Part 1-11: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment [Including: Technical Corrigendum 1(2011)]. (General I (QS/RM)); IEC 60601-1-6 Medical Electrical Equipment-Part 1-6: General Requirements for Basic Safety and Essential Performance- Collateral Standard: Usability: 2010; IEC 62304 ED.1.0, Medical devices software life cycle processes (Software/ Informatics); ISO 14971: Medical devices-Application of risk management to medical devices. (General); IEC 60601-2-10 Edition 2.0 2012-06, Medical Electrical Equipment -- Part 2-10: Particular Requirements For The Basic Safety And Essential Performance Of Nerve And Muscle Stimulators. (Neurology) |
| Usability | Users able to use the device correctly and safely | Usability study conducted and showed users were able to use the device correctly and safely. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions a "usability study" but does not provide any details on the sample size for the test set, data provenance (country, retrospective/prospective), or methodology beyond stating that it "showed that users were able to use the device correctly and safety."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. For a T.E.N.S. device, "ground truth" might relate to observed pain relief or proper device operation, but the document does not elaborate on how these were established or by whom. The "experts" for the usability study are not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. The usability study details are minimal.
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 MRMC study was performed or is mentioned. This device is a Transcutaneous Electrical Nerve Stimulator, not an AI-assisted diagnostic or interpretation system that would typically involve human "readers." The focus is on the device's electrical characteristics and safety, not on improving human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable in the context of this device. The EasyStim TN28 OTC is a physical medical device (T.E.N.S. unit) that operates to deliver electrical stimulation, not a standalone algorithm. Its performance is inherent in its electrical output and user interface, with human interaction being fundamental to its application.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document does not specify a type of "ground truth" in the context of clinical effectiveness or diagnostic accuracy. The usability study would likely rely on direct observation of user interaction and safety, which is a form of observational data. The "performance tests" relate to compliance with electrical and safety standards, not clinical outcomes.
8. The sample size for the training set
This information is not applicable / not provided. This device is not an AI/ML system that undergoes a "training set" for model development.
9. How the ground truth for the training set was established
This information is not applicable / not provided for the same reason as point 8.
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