(235 days)
The SHIAN JIA MEEI DIGITAL PWM TENS is intended for symptomatic relief and management of chronic intractable pain.
The SHIAN JIA MEEI DIGITAL PWM TENS (Transcutaneous Electrical Nerve Stimulation) is designed for symptomatic relief and management of chronic intractable pain. The device has eight stimulating modes providing the different feeling of effects, with mode setting. With large LCD panel. It is powered by three(3) AAA 1.5V Battery. SHIAN JIA MEEI DIGITAL PWM TENS requires the use of a set of lead-wire and one pair of cutaneous stimulation electrodes. Model No. description · YW-6000, UC-332 , UC-330 are identical in circuitry , LCD display , housing -etc. , except they are for different customers(destination). This means the three models ST-331 is identical to model YW-6000/UC-332 /UC-330 except the customers (destination) and the layout shown on the LCD display.
The provided text describes a 510(k) premarket notification for a Transcutaneous Electrical Nerve Stimulator (TENS) device. However, it does not contain detailed information about acceptance criteria or a study proving the device meets specific performance metrics in the way a clinical trial or AI model validation would.
Instead, this document focuses on demonstrating substantial equivalence to a predicate device based on:
- Intended Use: The device shares the same intended use as the predicate (symptomatic relief and management of chronic intractable pain).
- Technological Characteristics: The manufacturer claims similar technological characteristics. Bench testing was conducted to show that any differences do not raise new questions of safety or effectiveness.
- Conformance to Standards: The device conforms to applicable safety and EMC requirements (EN 60601-1, EN 60601-1-2) and "related FDA Output waveform requirements."
Therefore, I cannot populate the table and answer the questions as requested, because the necessary information (specific acceptance criteria, detailed study design, sample sizes, expert ground truth, etc.) is not present in the provided document.
Here's what I can extract and explain based on the text:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria and reported device performance in terms of specific clinical or diagnostic metrics. The "performance summary" states:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conformance to EN 60601-1 | Conforms |
| Conformance to EN 60601-1-2 | Conforms |
| Conformance to FDA Output waveform requirements | Conforms |
| Substantial Equivalence to Predicate Device (TATUNG TMD-26AX Series TENS) | Achieved; differences do not raise new safety/effectiveness questions |
2. Sample sized used for the test set and the data provenance
Not applicable. This was not a data-driven test set for clinical performance. The evaluation was primarily bench testing against engineering standards and comparison to a predicate device.
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 device performance evaluation (e.g., diagnosis, outcome) was not established by experts for a test set in this context. The "ground truth" here is adherence to engineering standards and an assessment of equivalence by the FDA based on the provided technical documentation.
4. Adjudication method for the test set
Not applicable. There was no test set requiring expert adjudication.
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-powered diagnostic or treatment assistance tool that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device. Its performance is evaluated based on its physical and electrical characteristics conforming to standards.
7. The type of ground truth used
The "ground truth" in this context is primarily:
- Engineering Standards Conformance: Verification that the device adheres to recognized international safety and electromagnetic compatibility standards (EN 60601-1, EN 60601-1-2) and "related FDA Output waveform requirements."
- Predicate Device Characteristics: The characteristics and performance of the legally marketed predicate device (TATUNG TMD-26AX Series TENS, K021794) provided the basis for comparison to demonstrate substantial equivalence.
8. The sample size for the training set
Not applicable. This device does not use a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable.
§ 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).