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510(k) Data Aggregation
(321 days)
The TOPTENS-01 can be used for the Symptomatic relief of chronic intractable pain, Post traumatic pain adjunctive treatment, Post-surgical pain adjunctive treatment.
The proposed device is transcutaneous electrical nerve stimulator for pain relief. this is a device used to apply an electrical current to electrodes on a patient's skin to treat pain. It only has one model: TOPTENS-01. TOPTENS-01 is mainly composed: host, built-in power supply, output lead and electrode. TOPTENS-01 power supply is DC4.5V, using built-in removable 3 AAA batteries. TOPTENS-01 comes with 2 independent output channels (A&B). Users can be adjust independently the two output channels Intensity by pressing the Left and right sides Intensity adjustment key. LCD screen display the remaining stimulation time in the top left corner. The default stimulation time is 30 minutes. TOPTENS-01 has 9 types stimulation modes: Mode1, Mode2, Mode 3, Mode 4, Mode 5, Mode6, Mode 7, Mode 8, Mode 9.
This is a 510(k) premarket notification for a medical device called the Transcutaneous Electrical Nerve Stimulator (TOPTENS-01) manufactured by Top-Rank Health Care Co., Ltd. The document aims to demonstrate that the TOPTENS-01 device is substantially equivalent to a legally marketed predicate device (K152374, also a Transcutaneous Electrical Nerve Stimulator).
This document does not contain acceptance criteria or a study proving the device meets those criteria in the context of clinical performance or diagnostic accuracy. Instead, it demonstrates substantial equivalence based on a comparison to a predicate device, focusing on technical specifications and safety standards.
Therefore, many of the requested sections (acceptance criteria related to clinical performance, sample sizes for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance, and ground truth types) are not applicable or cannot be extracted from this specific 510(k) summary, as these types of studies were not conducted or reported for this submission.
Here's an analysis based on the provided document:
1. A table of acceptance criteria and the reported device performance
This document does not establish performance acceptance criteria in terms of clinical outcomes or accuracy. Instead, it demonstrates substantial equivalence based on compliance with harmonized electrical safety and EMC standards, and a comparison of the device's technical specifications to a predicate device. The "performance" being evaluated is its adherence to these standards and the similarity of its operational parameters to the predicate.
| Acceptance Criteria Category (from 510(k) Summary) | Description of Criteria / Standard | Reported Device Performance and Compliance |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1: Medical electrical equipment Part 1: General Requirements For Basic Safety And Essential Performance; and IEC 60601-2-10: Medical electrical equipment Part 2-10: Particular requirements for the safety of nerve and muscle stimulators. | The device complies with IEC 60601-1 and IEC 60601-2-10. The 510(k) states: "The new device passed Safety testing, so these differences will not cause any safety and effectiveness issues." (Difference 4). "The pulse parameters meet the maximum current density <2mA/cm² And the maximum average power density <0.25W/cm² safety standard requirements, and passed the safety test." (Difference 6). "But they all meet the safety standard requirements of maximum current density < 2mA/cm² and maximum average power density <0.25W/cm², and the new device has passed the safety test." (Difference 7). |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2: General requirements for basic safety and essential performance-Collateral standard: Electromagnetic disturbances-Requirements and tests. | The device complies with IEC 60601-1-2. "The EMC property meets the requirements." (Section 6) |
| Home Healthcare Environment | Compliance with IEC 60601-1-11:2015: 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. | The device complies with IEC 60601-1-11:2015. (Section 6) |
| Additional Safety Standards | Compliance with ANSI/AAMI/ES 60601-1: 2005/(R)2012 and A1:2012, C1:2009/(r)2012 and a2:2010/(r)2012. | The device complies with ANSI/AAMI/ES 60601-1. (Section 6) |
| Functional Equivalence | Substantial equivalence in intended use, principle of operation, and performance specifications to the predicate device K152374. | The document provides detailed comparisons (Table 3 and Table 4) highlighting similarities in product code, regulation, indications for use, principle of operation, type of use, user interface, number of output channels, anatomical locations, regulated voltage, software control, automatic shut-off features, and display indications. Differences (e.g., power source, synchronous/alternating output, time range, dimensions, max output voltage/current, pulse parameters) were individually assessed and argued not to raise new questions of safety or effectiveness, often by referencing successful safety testing. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable for clinical data. This 510(k) submission does not include clinical studies.
- For non-clinical (engineering/safety) tests: No specific "sample size" is mentioned for these tests, as they are typically performed on a limited number of manufactured units to verify design compliance with standards. The provenance of this non-clinical testing data is implied to be from the manufacturer (Top-Rank Health Care Co., Ltd. in China) or a certified testing laboratory. The tests are prospective in the sense that they were performed on the device after its manufacture.
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)
- Not applicable. No clinical test set or ground truth established by experts is mentioned in this 510(k) submission, as no clinical studies were performed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set requiring adjudication 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 Transcutaneous Electrical Nerve Stimulator, not an AI-powered diagnostic or assistive tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is hardware and does not perform diagnostic algorithms in a standalone capacity that would require this type of evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For non-clinical tests: The "ground truth" for the non-clinical tests (electrical safety, EMC, etc.) is the adherence to the specified international and national standards (e.g., IEC 60601-x series). These standards define measurable parameters and acceptable limits.
- For clinical performance: No clinical ground truth was used as no clinical testing was performed or submitted. The statement of "Substantial Equivalence" relies on the device being technologically similar and equally safe and effective to the predicate device.
8. The sample size for the training set
- Not applicable. This device is a Transcutaneous Electrical Nerve Stimulator and does not utilize a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Not applicable. As above, there is no training set for this type of device.
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