(212 days)
The EAD is an electro acupuncture device for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
The EAD system is a battery-operated, single-use device that has a preprogrammed frequency, pulse and duration for the stimulation of auricular point nerve stimulation for pain. The device power supply connects via four (4) stainless steel wires, sheathed in a plastic over-molding, to three (3) needle arrays comprised of four (4) needles each and one (1) needle array comprised of only 1 needle.
The device is powered by one 3 Volt lithium ion battery.
The device modulates a duty cycle between 2 hours on and 2 hours at rest. The maximum performance time frame is 5 days or 120 hours (5 days X 24 hours). Weight is 4 grams including batteries. The power supply dimensions are 36 mm x 17 mm x 7 mm. The needle dimensions are 0.5 mm width x 2 mm length.
The provided document is a 510(k) Summary for a medical device called the "Electro Auricular Device" (EAD). This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a predicate device already legally marketed. As such, it focuses on comparing the new device to existing ones rather than presenting a detailed clinical study demonstrating the device's performance against specific acceptance criteria in the way a clinical trial might for a novel device.
Therefore, much of the requested information about acceptance criteria and studies that prove the device meets them, especially regarding clinical performance, is not present in this type of regulatory submission. The document primarily focuses on non-clinical aspects to establish substantial equivalence.
Here's a breakdown of what can be extracted and what is not available from the provided text, based on your request:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document in the format requested. The document emphasizes substantial equivalence to predicate devices rather than meeting specific performance acceptance criteria for a novel clinical claim. The "Performance" row in the comparison table on page 6 describes operational characteristics (e.g., "2 hours on/2 hours off; pulses with modulating frequency (1 to 10 Hz)"), but these are not presented as acceptance criteria against which a study directly measured clinical performance.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The document describes non-clinical testing (biocompatibility, electrical safety, EMC, software verification, sterilization, shelf life), but these do not typically involve patient "test sets" or data provenance in the way clinical studies do. No clinical performance testing with human subjects is mentioned.
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)
This information is not provided. As no clinical test set for performance is mentioned, there is no discussion of experts establishing ground truth for such a set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. As no clinical test set for performance is mentioned, there is no adjudication method described.
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
This information is not provided. MRMC studies are typically used for imaging or diagnostic devices where human readers interpret results, often with AI assistance. The EAD is an electro-acupuncture device, and the document describes no such study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided. The EAD does not appear to be an algorithmic diagnostic device, but rather a therapeutic device, so standalone performance in the context of an algorithm is not applicable or discussed. The software verification and validation are for the device's operational control, not for a diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided. Similarly to question 3, there is no mention of ground truth as it pertains to clinical performance outcomes.
8. The sample size for the training set
This information is not provided. The device is an electro-acupuncture stimulator, not an AI/ML-based diagnostic device that typically employs training sets for machine learning models. The software mentioned is for device control, not for learning from data.
9. How the ground truth for the training set was established
This information is not provided. As there is no mention of a training set, there's no discussion of how ground truth for it would be established.
Summary of available information related to performance and testing from the document:
While the document does not present clinical acceptance criteria or studies in the traditional sense, it outlines non-clinical performance data to support the device's safety and substantial equivalence to predicate devices:
- Biocompatibility Testing:
- Acceptance Criteria/Goal: To show the EAD adhesive is safe for tissue contact and that other patient-contacting materials are unchanged from the predicate.
- Study/Testing Done: Conducted in accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1. Included tests for Cytotoxicity, Sensitization, and Irritation.
- Reported Performance: The adhesive is considered tissue contacting for less than 30 days. The other patient-contacting materials are unchanged from the P-Stim predicate device.
- Electrical Safety and Electromagnetic Compatibility (EMC) Testing:
- Acceptance Criteria/Goal: Compliance with recognized international standards for safety and EMC.
- Study/Testing Done: Testing conducted on the EAD device.
- Reported Performance: The system complies with IEC 60601-1 and IEC 60601-2-10 (safety) and IEC 60601-1-2 (EMC).
- Software Verification and Validation Testing:
- Acceptance Criteria/Goal: To ensure the software functions as intended and does not pose a significant risk.
- Study/Testing Done: Testing conducted and documentation provided as recommended by FDA guidance.
- Reported Performance: Software considered a "minor" level of concern, as failure would not directly result in serious injury or death.
- Sterility/Shelf Life:
- Acceptance Criteria/Goal: To demonstrate the device can be sterilized and maintain its integrity and performance over time.
- Study/Testing Done: Sterilization Validation using VDMAX25 method (ISO 11137-2 and ISO 11737-2). Packaging validation (ISO 11607-1), Accelerated aging (ASTM F1980-07), and machine qualifications for sealing (ISO 11607-2).
- Reported Performance: Validation conducted according to specified standards.
Conclusion stated in the document: "The non-clinical data support the safety of the device and the hardware and software verification and validation demonstrate that the EAD device should perform as well as the predicate device in the specified use conditions." This highlights that the "performance" shown is largely about safety, functionality, and equivalence to existing devices, not a direct clinical efficacy study.
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