(118 days)
The VYBE RF II is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
Microneedle Array Handpiece (1MHz): The Microneedle Array Handpiece with 1 MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. At power less than 36W, the Microneedle Array Handpiece with 1 MHz functionality is intended for the percutaneous treatment of facial winkles in Skin Types I-V.
Microneedle Array Handpiece (2MHz): The Microneedle Array Handpiece with 2 MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The Microneedle Array handpiece with 2MHz functionality is not intended to treat wrinkles.
One Pin Exact Handpiece: The One Pin Exact handpiece with 1MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The One Pin Exact Handpiece is not intended to treat wrinkles.
VYBE RF II is a High Frequency Electrosurgical Unit that uses electrical currents to coagulate tissue. The device consists of the device console, Microneedle Array Handpiece, One Pin Exact Handpiece, RF plate, Foot Switch, and Power Cord. VYBE RF II is operated through an intuitive user interface (UI) on a 10.4- inch wide touch LCD screen. This product delivers high-frequency energy to the human body through the needle tip cartridge connected to the Microneedle Array Handpiece (1MHz, 2MHz) and One Pin Exact Handpiece (1MHz).
The provided text is a 510(k) Summary for the Vybe RF II electrocoagulation and hemostasis device. It details the device's intended use, comparison with predicate devices, and performance testing, but it does NOT contain an acceptance criteria table or information related to AI or clinical studies for facial wrinkles. The information provided heavily focuses on electrical safety, EMC, software lifecycle, risk management, and the device's ability to achieve consistent thermal damage profiles in ex vivo tissue, which are not directly about the performance against acceptance criteria for clinical efficacy for wrinkle treatment.
Therefore, many of the requested sections about acceptance criteria, clinical studies, sample sizes, expert ground truth, adjudication methods, and AI performance cannot be extracted from this document in the context of clinical efficacy for facial wrinkles as it states "No clinical studies were conducted as part of this submission."
However, I can extract information related to the technical performance testing conducted to support substantial equivalence.
Here's a breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly provide a table of acceptance criteria with corresponding performance for clinical use, especially for wrinkle treatment. It describes technical performance testing conducted for safety and verification of RF energy output.
| Acceptance Criteria (Implied from testing) | Reported Device Performance (Summary from testing) |
|---|---|
| Basic Safety and Essential Performance | Compliance with IEC 60601-1:2005 + A1:2012, IEC 60601-1-2:2014, IEC 60601-2-2:2017. |
| Software Life Cycle Processes | Compliance with IEC 62304:2006+A1:2015. |
| Risk Management | Compliance with EN ISO 14971:2012. |
| Usability | Compliance with IEC 60601-1-6:2010, AMD1:2013, AMD2:2020. |
| Accuracy of RF Energy Output | Bench testing performed to verify accuracy of output. (Specific metrics not provided in summary) |
| Thermal Effect (Electrocoagulation/Hemostasis) | Histopathology testing demonstrated the ability of the device to achieve consistent thermal damage profiles in line with the target treatment in ex vivo bovine kidney and Yucatan mini-pig skin. Testing was performed at minimum, medium (default), and maximum power settings (levels 1, 5, and 10) for both 1 MHz and 2 MHz frequencies with the longest pulse width. |
| Biocompatibility | Patient contacting materials determined to be biocompatible. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Histopathology (Test Set):
- Ex vivo bovine kidney (unspecified number of samples/sections).
- Ex vivo Yucatan mini-pig skin (abdomen site) (unspecified number of samples/sections).
- Data Provenance: In vitro/ex vivo lab testing. The country of origin is not specified but the applicant is from Republic of Korea. The testing itself is not clinical trial data.
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 applicable. The histopathology testing involves objective measurements of thermal damage profiles, which are typically assessed by pathologists or histologists. However, the document does not specify the number or qualifications of any experts involved in reviewing the histopathology slides.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This type of adjudication method is used in clinical studies for diagnostic accuracy, where multiple readers evaluate medical images. The testing described is bench and histopathology.
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. There is no mention of an MRMC study, human readers, or AI assistance in this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an electrosurgical unit, not an AI software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the histopathology testing, the "ground truth" was established by histological analysis of the thermal damage profiles observed in the ex vivo tissues after treatment with the device. This is a form of pathology assessment.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device. The testing described does not involve a training set for an algorithm.
9. How the ground truth for the training set was established
Not applicable. There is no training set for an algorithm.
§ 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.