(92 days)
The VYBE RF Electrosurgical System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis and the percutaneous treatment of facial wrinkles for use with Fitzpatrick Skin Type I to Skin Type V when using the 1MHz setting. The 2MHz setting has not been evaluated for use in the percutaneous treatment of facial wrinkles and is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
The VYBE RF Electrosurgical System is comprised of the following components:
- . The system main body, consisting of:
- o LCD touch screen control panel
- High-frequency generating output section (main P.C.B board or RF Generator) O
- Power supply component Switch Mode Power Supply (SMPS) O
- The accessories to the device include:
- Handpiece with Handpiece Connector O
- Disposable micro-needle cartridge (electrode) for insertion into Handpiece o
- Foot switch O
Radio frequency current (RF energy) is delivered from the RF Generator, through the handpiece and electrode tip into the target tissue. As RF energy passes through the skin, it generates an electro thermal reaction, which is capable of coagulating (causing minor dermal damage) the tissue. The bi-polar RF energy is delivered between independent adjacent electrode pairs (total 36 needle electrode, 6 x 6 array insertion). The RF generator and hand piece are not disposable. Each disposable micro-needle cartridge (electrode) is supplied sterile and is for single patient use only and cannot be re-sterilized.
The document provided describes the VYBE RF Electrosurgical System and its substantial equivalence to a predicate device, the VIVACE Electrosurgical System. It includes performance data, but does not describe an acceptance criteria and study proving the device meets the acceptance criteria in the manner requested by the prompt for a typical AI/ML medical device submission.
Specifically, the document focuses on regulatory compliance through electrical, biocompatibility, sterility, software verification and validation, and thermal testing. These are standard tests for medical devices to ensure safety and fundamental functionality, not necessarily performance benchmarks against clinical criteria in the same way an AI/ML diagnostic or prognostic tool would be evaluated.
Therefore, many of the requested categories in the prompt regarding acceptance criteria, human reader studies, and ground truth establishment are not applicable or not explicitly detailed in the provided text.
Here's a breakdown of what can and cannot be extracted from the document:
1. A table of acceptance criteria and the reported device performance
The document lists various tests and states that "All acceptance criteria were met." However, it does not provide a table with specific acceptance criteria values (e.g., a specific thermal threshold) or the quantitative reported performance for each of these tests. It only lists the standards followed.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Electrical Testing | Met IEC 60601-1, IEC 60601-1-2, IEC 60101-2-2, IEC 60601-1-6, IEC 62366 standards. |
| Biocompatibility Testing | Met ISO 10993-1, ISO 10993-5, ISO 10993-10 standards. |
| Sterility Testing (micro-needle cartridge) | Conforms to a Sterility Assurance Level (SAL) of 10^-6, meeting ISO 11135, ISO 11138-1, ISO 11138-2, ISO 11737-1, ISO 11737-2, ISO 10993-7 standards. |
| Software Verification and Validation Testing | Conducted as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", issued May 11, 2005. |
| Thermal Testing | Completed in accordance with FDA's Guidance for Industry and FDA Staff "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery", issued March 9, 2020. |
2. Sample size used for the test set and the data provenance
Not applicable for the types of tests conducted. These are primarily engineering, laboratory, and compliance tests, not clinical studies with patient data.
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 in AI/ML clinical studies (e.g., expert consensus on image interpretation) is not relevant to these engineering and compliance tests.
4. Adjudication method for the test set
Not applicable for the types of tests conducted.
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 an electrosurgical system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is an electrosurgical system.
7. The type of ground truth used
For the sterility testing, the ground truth is the established Sterility Assurance Level (SAL) of 10^-6 and adherence to the listed ISO standards.
For other tests, the "ground truth" is adherence to the specified engineering and biocompatibility standards.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires a training set in the conventional sense.
9. How the ground truth for the training set was established
Not applicable.
§ 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.