(86 days)
The SHIAN JIA MEEI TWO Channel Digital T.E.N.S. is intended for symptomatic relief and management of chronic intractable pain.
SHIAN JIA MEEI TWO Channel Digital T.E.N.S.( Transcuntaneus Electrical Nerve Stimulator), is of independent two channels output , designed for symptomatic relief and management of chronic intractable pain. It provides a combination of adjustable frequency , adjustable Pulse Width and adjustable output current intensity. With large LCD panel. It is powered by 9V Battery. SHIAN JIA MEEI TWO Channel Digital T.E.N.S. requires the use of two (2) set of lead-wire and two (2) pairs of cutaneous stimulation electrodes. Model No. description TKL-008/ TKL-168/ TKL-268 is all the same except the Housing printing artwork , model no. & destination.
The provided 510(k) summary (K052182) describes a Transcutaneous Electrical Nerve Stimulator (TENS) device. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical efficacy studies with specific acceptance criteria in the manner of a new drug or novel medical device. Therefore, much of the requested information about device performance, sample sizes for test and training sets, expert consensus, and comparative effectiveness studies is not applicable to this specific submission type and device.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Operating Specifications | Not explicitly listed as numerical targets. Implied to be similar to the predicate device. | "provides a combination of adjustable frequency, adjustable Pulse Width and adjustable output current intensity." |
| Safety Requirements | Conformance to EN 60601-1 and EN 60601-1-2. | "device conforms to applicable standards included EN 60601-1, EN 60601-1-2 & related FDA Output waveform requirements." |
| EMC Requirements | Conformance to EN 60601-1-2. | "device conforms to applicable standards included EN 60601-1-2." |
| Output Waveform | Conformance to "related FDA Output waveform requirements." | "device conforms to...related FDA Output waveform requirements." |
| Intended Use | Symptomatic relief and management of chronic intractable pain. | "The SHIAN JIA MEEI TWO Channel Digital T.E.N.S. is intended for symptomatic relief and management of chronic intractable pain." (Matches predicate) |
| Technological Characteristics | Similar to the predicate device (TRIO 300 Multi-mode Electrical Stimulator). | "The SHIAN JIA MEEI TWO Channel Digital T.E.N.S. have the same intended use and similar technological characteristics as the TENS Mode of TRIO 300 Multi-mode Electrical Stimulator (K990787)." |
| Safety and Effectiveness (Overall) | Any differences in technological characteristics do not raise new questions of safety or effectiveness compared to predicate. | "bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness." |
2. Sample size used for the test set and the data provenance
- Not Applicable (N/A). The submission is a 510(k) for a TENS unit, which typically relies on demonstrating substantial equivalence through engineering and electrical performance testing against recognized standards and comparison to a legally marketed predicate device, rather than patient-based clinical trials with "test sets" or "data provenance" in the context of diagnostic accuracy or clinical outcomes. The "bench testing" mentioned refers to laboratory tests of the device's electrical output and adherence to safety standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. As this is a TENS device seeking 510(k) clearance, there is no mention of "ground truth" established by medical experts for a "test set" in the context of clinical performance or diagnostic accuracy. The compliance with electrical and safety standards is verified through engineering testing, not expert medical opinion on a dataset.
4. Adjudication method for the test set
- N/A. There is no "test set" in the experimental design sense that would require an adjudication method by experts.
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
- N/A. This device is an electrical nerve stimulator, not an AI-powered diagnostic or assistive tool. MRMC studies are completely irrelevant to this type of device and submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This device is a TENS unit, which is a physical medical device for therapy, not an algorithm. Therefore, "standalone performance" in the context of an algorithm or AI is not applicable.
7. The type of ground truth used
- N/A. The concept of "ground truth" as pathology, outcomes data, or expert consensus is not applicable to an electrical stimulator seeking 510(k) clearance. The "truth" in this context is the device's conformance to established electrical and safety standards and its functional equivalence to a predicate device.
8. The sample size for the training set
- N/A. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- N/A. As there is no training set, this question is not applicable.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study proving the device meets its acceptance criteria is a bench testing program demonstrating:
- Compliance with Recognized Standards: The device conforms to EN 60601-1 (Medical electrical equipment - General requirements for basic safety and essential performance) and EN 60601-1-2 (Medical electrical equipment - Electromagnetic compatibility). It also meets "related FDA Output waveform requirements." These standards establish the acceptance criteria for electrical safety, performance, and electromagnetic compatibility.
- Substantial Equivalence: The device's intended use (symptomatic relief and management of chronic intractable pain) and technological characteristics (adjustable frequency, pulse width, and output current intensity, two independent channels, 9V battery power, lead wires, cutaneous electrodes) are similar to the stated predicate device, the TRIO 300 Multi-mode Electrical Stimulator (K990787).
- No New Questions of Safety or Effectiveness: The bench testing specifically demonstrated that any differences in the technological characteristics between the new device and the predicate device do not raise any new questions of safety or effectiveness.
In essence, the "study" for this 510(k) clearance is a set of engineering tests and a detailed comparison against a known, legally marketed predicate device to confirm safety and fundamental performance characteristics, as opposed to a clinical trial demonstrating efficacy against a specific outcome with human subjects.
§ 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).