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510(k) Data Aggregation
(395 days)
WAT Medical Technology (Ningbo) Co., Ltd
The TENS device-HeadaTerm is indicated for the prophylactic treatment of episodic migraine in patients 18 years of age or older.
TENS device-HeadaTerm offers a drug-free scheme, which introduces electric impulses to act on the supraorbital nerve and supratrochlear nerve, the very nerves that transmit migraine pain, to treat and prevent migraine headaches. TENS device-HeadaTerm enables an electronic feedback mechanism to adjust the electrical impulses to the specific requirements of the individual user for personalized efficacy and comfort.
The device could adhere to patients forehead with conductive paste, the current passing through the electrodes and release current stimulate the nerve underneath patients' forehead skin; the stimulation would alleviate migraine headaches, and during ramping up, patients could choose comfortable intensity level by pressing the host key to lock up the current voltage, and the patient contact material is biocompatibility safe. The conductive paste could be replaced once the paste lost its adhesiveness and patients are recommended to replace the conductive paste after 7 times of treatment uses.
The provided document is a 510(k) premarket notification for the TENS device-HeadaTerm, indicating it is substantially equivalent to a legally marketed predicate device (Cefaly). This submission focuses on demonstrating substantial equivalence through non-clinical testing and comparison of technological characteristics, rather than presenting a performance study with acceptance criteria often seen for AI/ML-driven medical devices that require a clinical effectiveness study.
Therefore, many of the requested details, such as acceptance criteria based on clinical performance metrics (e.g., sensitivity, specificity, AUC), sample sizes for test sets in clinical studies, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and details on training sets for an AI/ML model, are not applicable or not provided in this type of 510(k) submission.
This device, a Transcutaneous Electrical Nerve Stimulator (TENS), is cleared based on its equivalence to an existing TENS device for prophylactic treatment of episodic migraine, demonstrated through non-clinical testing (electrical safety, electromagnetic safety, performance of nerve and muscle stimulators, performance for home use, biocompatibility).
Here's an attempt to address the points based on the provided document, highlighting what is available and what is not:
1. A table of acceptance criteria and the reported device performance
The document does not present "acceptance criteria" in terms of clinical performance metrics like sensitivity or specificity, nor does it report device performance against such metrics. Instead, it focuses on demonstrating equivalence to a predicate device through non-clinical testing and comparison of physical and electrical specifications.
The "acceptance criteria" can be inferred as successful completion of the listed non-clinical tests and demonstrating comparable technical specifications to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance (WAT Medical - HeadaTerm) | Predicate Device (Cefaly) Performance (for comparison) |
|---|---|---|
| Non-Clinical Testing: | Results | (N/A - Predicate's test results not detailed here) |
| Electrical Safety (IEC60601-1) | Pass (per Section 1.9 & 1.10) | Yes (per Section 1.10) |
| Electromagnetic Safety (IEC60601-1-2) | Pass (per Section 1.9 & 1.10) | Yes (per Section 1.10) |
| Performance of nerve and muscle stimulators (IEC60601-2-10) | Pass (per Section 1.9 & 1.10) | Yes (per Section 1.10) |
| Performance of Device for Home Use (IEC 60601-1-11) | Pass (per Section 1.9) / Yes (per Section 1.10) | No (per Section 1.10 - This is a difference noted) |
| Biocompatibility: Cytotoxicity | Pass (per Section 1.9) | (N/A - Predicate's test results not detailed here) |
| Biocompatibility: Irritation | Pass (per Section 1.9) | (N/A - Predicate's test results not detailed here) |
| Biocompatibility: Sensitization | Pass (per Section 1.9) | (N/A - Predicate's test results not detailed here) |
| Key Technical Specifications (Comparison for Equivalence): | ||
| Intended Use | Prophylactic treatment of episodic migraine in patients ≥ 18 years | Prophylactic treatment of episodic migraine in patients ≥ 18 years |
| Power Source | One 3V lithium coin cells | One lithium battery |
| Follow Current | Yes | Yes |
| Voltage Overload Detection | Yes | Yes |
| Adjustable Intensity | ON/OFF button on front of device | ON/OFF button on front of device |
| Channel | 1 | 1 |
| Software-controlled | No | Yes |
| Time Set | No - Manually Adjust | No - Manually Adjust |
| Constant Current | No | No |
| Automatic overload trip voltage level | Yes | Yes |
| Patient override control method | On/Off button on front of device | On/Off button on front of device |
| Indicator displays | Unit functioning, Electrical connection | Unit functioning, Low battery, Electrical connection |
| Timer Setting | Yes | Yes |
| Weight | 11g | 30g |
| Dimensions | 127x35x12mm | 160 x 170 x 40 mm |
| Waveform | AC Symmetric Square Wave | AC Symmetric Square Wave |
| Phase Duration (µsec) | 250us(±20) | 250us(±0.5%) |
| Phase Interval | 10us(±0.5%) | 10us(±0.5%) |
| Pulse Period | 500us(±0.5%) | 505us(±0.5%) |
| Frequency (Hz) | 60Hz(±1) | 60Hz(±0.5%) |
| Net Charge (µC) per pulse | 0 | 0 |
| Max output voltage (V) @500 ohms | 8.00V(±0.5%) | 8.00V(±0.5%) |
| Max output voltage (V) @2000 ohms | 32V(±0.5%) | 32V(±0.5%) |
| Max output voltage (V) @10000 ohms | 60V(±3) | 60V(±0.5%) |
| Max output current (mA) @500 ohms | 16mA(±0.5%) | 16mA(±0.5%) |
| Max output current (mA) @2000 ohms | 16mA(±0.5%) | 16mA(±0.5%) |
| Max output current (mA) @10000 ohms | 6mA(±0.5%) | 6mA(±0.5%) |
| Max phase charge (μC) @500Ω | 3.95 | 4 |
| Max Current Density (mA/cm2, r.m.s.) @500Ω | 2.35 | 2.37 |
| Max Average Power Density (W/cm2) @500Ω | 0.000017 | 0.000017 |
| Max Average Current (mA) @500Ω | 0.48 | 0.48 |
2. Sample sizes used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. This submission relies on non-clinical testing (bench testing for electrical safety, biocompatibility, etc.) and a comparison of technical specifications to the predicate device, not on a clinical performance test set with patient data.
- Data Provenance: Not applicable for a clinical test set. The non-clinical testing results would originate from the testing laboratories.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There is no clinical test set requiring expert ground truth for diagnosis/classification in this 510(k) submission as it is not an AI/ML diagnostic device. The ground truth for electrical and biocompatibility testing is based on established engineering and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There is no clinical test set requiring adjudication in this submission.
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 device, not an AI-assisted diagnostic or treatment planning tool. Therefore, no MRMC study or AI assistance evaluation was conducted or required for this type of submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a TENS device, not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for this type of device is based on engineering standards (e.g., IEC standards for electrical safety, performance, and home use) and biocompatibility standards. It's about meeting specified physical, electrical, and material safety parameters, not diagnostic accuracy.
8. The sample size for the training set
- Not applicable. This submission is for a physical medical device (TENS) that does not employ machine learning or AI models, and thus does not have a "training set" in the context of AI/ML development.
9. How the ground truth for the training set was established
- Not applicable for the same reason as above (no AI/ML training set). The device is tested against established performance and safety standards, not trained on data with established ground truth.
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(246 days)
WAT Medical Technology (Ningbo) Co., Ltd
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.
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