(248 days)
RO handpiece and AGNES RF handpiece of RFMagik Lite are intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
RFMagik Lite is a medical device combined with RF current, to function as an electrosurgical device for use in dermatology and general surgical procedures. It is possible to select and change modes, parameters, outputs, etc. using the panel on the main body. It consists of the main device, LCD screen, two handpieces, single use electrodes, electrode pad, NE pad cable, food switch. There are two handpieces. RO handpiece and AGNES RF handpiece that delivers RF energy through the disposable electrode in the handpiece.
The provided FDA 510(k) clearance letter for RFMagik Lite does not contain information about specific acceptance criteria or a study that directly proves the device meets such criteria in terms of clinical performance or effectiveness. The document primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing (electrical, EMC, biocompatibility, sterility, shelf life, and performance bench testing) and an ex vivo study.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
No specific acceptance criteria in terms of clinical performance metrics (e.g., success rates, complication rates, or comparative outcomes) are mentioned in the document for the RFMagik Lite. The "performance testing" referenced is primarily bench testing to ensure the device operates safely within design specifications. The acceptance criteria for the non-clinical tests are implicit in the adherence to recognized standards.
| Acceptance Criteria Category | Specific Criteria (Implicit from standards) | Reported Device Performance (Implicit from successful testing) |
|---|---|---|
| Electrical Safety | Compliance with AAMI ES60601-1, IEC60601-2-2 | Passed (stated that testing shows the device is safe) |
| EMC | Compliance with IEC 60601-1-2, TR IEC 60601-4-2 | Passed (stated that testing shows the device is safe) |
| Biocompatibility | Compliance with ISO 10993 series | Passed (stated that non-clinical data shows the device should perform as intended) |
| Sterility | Compliance with ISO 11135, ISO 11138 series, ISO 10993-7 | Verified and validated (EO gas sterilization) |
| Shelf Life | Compliance with ISO 11607 series, ASTM F1929, ASTM F88M | Passed (stated that non-clinical data shows the device should perform as intended) |
| Performance Testing | Operates safely and within predefined design specifications | Passed (stated that AGNES MEDICAL conducted bench testing to assure this) |
| Ex Vivo Study | Thermal testing consistent with FDA guidance | Conducted on liver, skin, and muscle under GLP conditions (no specific performance metrics given) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical or human subject data. The testing mentioned is non-clinical (bench, ex vivo). For the ex vivo study, the number of tissue types used was three (liver, skin, and muscle), but the specific number of samples or specimens within each tissue type is not provided.
The provenance of this ex vivo data would be laboratory-based, focusing on tissue samples rather than human subjects. The country of origin for the ex vivo study is not explicitly stated, but the submission is from a South Korean company.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since there is no mention of a clinical "test set" or human subject data, there is no information about experts establishing ground truth for such a set. The ex vivo study would likely involve experts in histology or pathology for evaluating thermal effects, but their number and qualifications are not detailed.
4. Adjudication Method for the Test Set
Not applicable, as there is no described clinical "test set" requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. The RFMagik Lite is an electrosurgical device for cutting and coagulation, not an AI-assisted diagnostic or imaging device that would typically undergo an MRMC study comparing human reader performance with or without AI assistance.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. The RFMagik Lite is a physical electrosurgical device, not a standalone algorithm.
7. The Type of Ground Truth Used
For the non-clinical testing, the "ground truth" is defined by the adherence to and successful completion of recognized consensus standards (e.g., AAMI ES60601-1, IEC60601-2-2 for electrical safety, ISO 10993 for biocompatibility). For the ex vivo study, the "ground truth" would likely be the observed thermal effects on the tested tissues, assessed against predetermined safety or efficacy thresholds (though these thresholds are not explicitly stated in the document).
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML 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.