(246 days)
The EmeTerm CinvStop is a wearable device for the treatment of nausea and vomiting caused by motion sickness and pregnancy.
TENS device-EmeTerm generates the electric pulses with highly specific waveforms, frequency and amplitude to stimulate the median nerve. The accurate pulse signals provide relief through electrical stimulation of the nerves in the patient's wrist.
The provided document is a 510(k) premarket notification from WAT Medical Technology (Ningbo) Co., Ltd for their TENS device-EmeTerm, CinvStop. This document is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device (ReliefBand Device, K020180) rather than presenting a performance study with acceptance criteria and detailed study results typical for an AI/ML medical device.
Therefore, much of the information requested in your prompt (e.g., sample size for test set, number of experts, adjudication methods, MRMC study details, training set size, ground truth establishment for training set) is not available in this type of regulatory submission. This device is a Transcutaneous Electrical Nerve Stimulator (TENS), which is a hardware device, not an AI/ML algorithm.
Based on the provided text, here's what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
For a TENS device, "acceptance criteria" and "device performance" are typically defined in terms of electrical output parameters, safety, and effectiveness in mitigating symptoms (nausea and vomiting). The document focuses on demonstrating substantial equivalence to a predicate device, which means proving it is as safe and effective as a device already on the market. The "performance" is implicitly deemed acceptable if it matches the predicate and meets relevant electrical safety standards.
| Acceptance Criteria (Implicit from Predicate Comparison) | Reported Device Performance (TENS device-EmeTerm) | Notes |
|---|---|---|
| Electrical Characteristics: | Listed values for EmeTerm matched or were very close to the predicate device, indicating substantial equivalence. Differences were stated as "insignificant in terms of safety and effectiveness." | |
| Waveform: AC Sharp Wave | AC Sharp Wave | Matched |
| Phase Duration: 300us(±0.5%) | 300us(±0.5%) | Matched |
| Phase Interval: 10us(±0.5%) | 10us(±0.5%) | Matched |
| Pulse Period: 505us(±0.5%) | 500us(±0.5%) | Very close; stated as insignificant difference. |
| Frequency: 33Hz(±0.5%) | 33Hz(±0.5%) | Matched |
| Net Charge per pulse: 0 µC | 0 µC | Matched |
| Maximum output voltage (@1000 ohms): 39.8V(±0.5%) | 38.2V(±0.5%) | Very close; stated as insignificant difference. |
| Maximum output current (@1000 ohms): 6mA(±0.5%) | 6mA(±0.5%) | Matched |
| Maximum phase charge (@1000Ω): 1.8 µC | 1.78 µC | Very close; stated as insignificant difference. |
| Maximum Current Density (@1000Ω): 4.32 mA/cm² | 4.30 mA/cm² | Very close; stated as insignificant difference. |
| Safety Testing: | Compliance with these standards indicates acceptance of safety for a TENS device. | |
| Electromagnetic Safety Test (IEC 60601-1-2) | Test performed (Implied Pass) | Explicitly listed as a performed non-clinical test. |
| Electrical Safety Test (IEC 60601-1, IEC 60601-1-11) | Test performed (Implied Pass) | Explicitly listed as a performed non-clinical test. |
| Biocompatibility: In Vitro Cytotoxicity (ISO 10993-5) | Test performed (Implied Pass) | Explicitly listed as a performed non-clinical test. |
| Biocompatibility: Skin Irritation (ISO 10993-10) | Test performed (Implied Pass) | Explicitly listed as a performed non-clinical test. |
| Biocompatibility: Skin Sensitization (ISO 10993-10) | Test performed (Implied Pass) | Explicitly listed as a performed non-clinical test. |
| Intended Use: | The device's stated indication for use matches that of the predicate, which is a key aspect of substantial equivalence for regulatory acceptance. | |
| Treatment of nausea and vomiting caused by motion sickness and pregnancy | Treatment of nausea and vomiting caused by motion sickness and pregnancy | Stated as identical to predicate device, allowing for "Over-The-Counter Use" for both. |
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 / Not Provided: This submission explicitly states "N/A" under "Non-Clinical Tests and Clinical Tests," indicating that a clinical study with human subjects (which would involve a "test set" in the context of an AI/ML device) was not deemed necessary for this 510(k) clearance due to the device's technological characteristics being substantially equivalent to a predicate. The focus was on non-clinical, bench testing to confirm electrical and safety specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable / Not Provided: As no clinical test set was used in the manner of an AI/ML validation, this information is not relevant to this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided: No clinical test set.
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 / Not Provided: This is a TENS device, not an AI/ML diagnostic or assistive device. No human readers or AI assistance are involved in its operation or intended use.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Provided: No algorithm component beyond basic device control.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable (for clinical performance): For the purpose of regulatory clearance, the "ground truth" for this TENS device is based on engineering specifications and established safety standards (e.g., IEC 60601 series, ISO 10993 series) and the demonstrated equivalence to a legally marketed predicate device with a known safety and effectiveness profile. The electrical characteristics and physical properties of the device are the "ground truth" verified through bench testing.
8. The sample size for the training set
- Not Applicable / Not Provided: There is no "training set" as this is not an AI/ML device that learns from data.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided: No training set.
§ 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).