(378 days)
The Primaeva Medical Miratone System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles.
The Primaeva Medical Miratone System is comprised of the following components: A reusable radiofrequency (RF) generator with user interface; a reusable cooler controller; cooler handpiece/applicator; a reusable reusable a electrode insertion device/applicator; and a single patient use, disposable electrode cartridge. RF energy is delivered from the RF generator through the electrodes into the target tissue.
The provided text describes the Primaeva Medical Miratone System and its 510(k) premarket notification. However, it does not contain specific acceptance criteria for device performance or a detailed study proving the device meets those criteria.
The document states:
- "Clinical performance testing demonstrated the Primaeva Medical Miratone System to be safe and effective in the percutaneous treatment of facial wrinkles." This is a general statement of an outcome, not a presentation of acceptance criteria or performance metrics.
- "In summary, the results of non-clinical mechanical, electrical and functional bench and/or animal testing, and clinical performance testing have demonstrated that the Primaeva Medical Miratone System meets established design specifications; functions as intended; and is considered to be substantially equivalent to the above noted predicate devices." Again, this is a summary statement without specific data or criteria.
Therefore, I cannot populate the table or provide detailed answers to most of your questions based solely on the provided text. The document confirms a clinical study was done, but it doesn't offer the details you've requested.
Here's what can be inferred and what is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | "Safe and effective in the percutaneous treatment of facial wrinkles." |
| Not specified in the document | "Meets established design specifications" |
| Not specified in the document | "Functions as intended" |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The device manufacturer, Primaeva Medical, Inc., is based in Pleasanton, CA, USA, which might suggest the study was conducted in the US, but this is not explicitly stated for the clinical performance testing.
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)
- Not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
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 device is an electrosurgical unit, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC comparative effectiveness study involving human readers improving with AI assistance would not be applicable. The document does not mention any AI component.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is an electrosurgical medical device; the concept of a "standalone algorithm" is not applicable here. Studies would focus on the device's physical performance, safety, and effectiveness in treating conditions.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For "percutaneous treatment of facial wrinkles," the ground truth likely involves clinical assessment of wrinkle reduction, possibly using standardized photographic scales or other objective measures, alongside patient satisfaction and safety outcomes. However, the specific type of ground truth used is not specified in the document.
8. The sample size for the training set
- Not applicable as this is a medical device for treatment, not an AI model requiring a training set in the typical sense. The "training set" for physical devices would rather refer to engineering and clinical validation data.
9. How the ground truth for the training set was established
- Not applicable for the same reason as above.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.