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510(k) Data Aggregation
(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.
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(464 days)
The radiofrequency energy delivery components of the DUET-V(ESK-3261DV) and Accessories are indicated for use in: - Fractional Tips (FRF Tips): Fractional Tip is intended for use in dermatological procedures requiring ablation and resurfacing of the skin. - Thermal Tips (TRF Tips): Dermatologic and general surgical procedures for electrocoagulation
DUET-V (Model: ESK-3261DV) is a High Frequency Therapy Device system using 4 MHz high frequency electrical current. Single-use, disposable Treatment Tips attach to the handpiece that comes into contact with the patient during treatment procedures. Treatment tips are classified as direct skin contact devices of limited duration (
The provided text describes the regulatory clearance for the DUET-V (Model: ESK-3261DV) electrosurgical device and its accessories. It outlines performance testing, but does not contain information about a study comparing the device's performance against human readers (MRMC study) or a standalone (algorithm only) performance study, nor does it detail the ground truth establishment for a test set in a clinical evaluation context.
Based on the provided information, here's a summary of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily focused on the device's technical specifications, safety, and functional performance.
| Item | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | No risks from biological hazards associated with materials of manufacture and final device. | Tests conducted according to ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-10:2020, ISO 10993-23:2021, and ISO 10993-11:2017 to ensure compliance. |
| Software | Verification and validation according to FDA Guidance "Content of Premarket Submission for Software Contained in Medical Devices" and IEC 62304: 2006 + A1:2015. Cybersecurity compliance to FDA guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions". | Firmware was verified and validated according to the specified FDA guidance and IEC 62304. Cybersecurity complied with FDA guidance. |
| Electrical Safety and Electromagnetic Compatibility | Control electrical and high temperature hazards; compliance with AAMI/ANSI ES 60601-1: 2005+A1: 2012 and IEC 60601-1-2:2020. | Risks controlled by design, protection method, and information according to AAMI/ANSI ES 60601-1. Electromagnetic compatibility verified according to IEC 60601-1-2. |
| Reprocessing | Cleaning and disinfection established and validated according to FDA 'Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling'. | Cleaning and disinfection for re-usable parts are established and validated in accordance with FDA guidance. |
| Bench Performance - Frequency Test | Not exceed the standard value of 4MHz. | Not explicitly stated as "met," but implied by "Performance Testing - Bench." |
| Bench Performance - Output Waveform | Confirm the waveform shape as sine wave. | Not explicitly stated as "met," but implied by "Performance Testing - Bench." |
| Bench Performance - Power Variation | 1) Input voltage fluctuates within the range of ±10% of 220V, 2) No abnormalities in each part. | Not explicitly stated as "met," but implied by "Performance Testing - Bench." |
| Bench Performance - Output Voltage and Current | Be within ±20% of standard value. | Not explicitly stated as "met," but implied by "Performance Testing - Bench." |
| Bench Performance - Output ON/OFF Time | Be within ±10% of standard value. | Not explicitly stated as "met," but implied by "Performance Testing - Bench." |
| Bench Performance - Max. Output Voltage and Current | Be within ±20% of standard value when voltage connect a 500 Ω load to the output terminal, set the maximum output. | Not explicitly stated as "met," but implied by "Performance Testing - Bench." |
| Bench Performance - Accuracy of Temperature Control | Be within ±1°C of set value. | Not explicitly stated as "met," but implied by "Performance Testing - Bench." |
| Bench Performance - Automatic Stop function when temperature rise | Automatically stop at the set temperature. | Not explicitly stated as "met," but implied by "Performance Testing - Bench." |
| Bench Performance - Switch Interlock | Be normally operated of switch interlock when control the foot or hand-piece switch select. | Not explicitly stated as "met," but implied by "Performance Testing - Bench." |
| Bench Performance - Output function upon skin contact | Output comes out when two or more of the four skin contact of FRF tip. | Not explicitly stated as "met," but implied by "Performance Testing - Bench." |
| System Testing - Thermal Effects on Tissue | Compliance with FDA guidance 'Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery' requirements. | Test performed according to FDA guidance; results not detailed but described as demonstrating "substantially equivalent performance." |
| System Testing - Temperature Monitoring | Compliance with FDA guidance 'Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery' requirements. | Test performed according to FDA guidance; results not detailed but described as demonstrating "substantially equivalent performance." |
| System Testing - Accuracy of Output control setting (monopolar) | Acceptance criteria ±20%. | Conducted according to IEC 60601-2-2 201.12.1.101; results not detailed but described as demonstrating "substantially equivalent performance." |
| System Testing - Accuracy of Output control setting (bipolar) | Acceptance criteria ±20%. | Conducted according to IEC 60601-2-2 201.12.1.101; results not detailed but described as demonstrating "substantially equivalent performance." |
| System Testing - Monotonicity of Output control setting (monopolar) | Acceptance criteria ±20%. | Conducted according to IEC 60601-2-2 201.12.1.102; results not detailed but described as demonstrating "substantially equivalent performance." |
| System Testing - Monotonicity of Output control setting (bipolar) | Acceptance criteria ±20%. | Conducted according to IEC 60601-2-2 201.12.1.102; results not detailed but described as demonstrating "substantially equivalent performance." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of a clinical performance evaluation (e.g., patient images or data). The performance testing described is focused on bench testing, electrical safety, biocompatibility, and software validation. Therefore, there is no information provided on sample size or data provenance for a clinical test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
As there is no clinical test set described, there is no information on the number or qualifications of experts for establishing ground truth. The evaluations are technical and regulatory compliance tests.
4. Adjudication Method for the Test Set
Again, given the nature of the evaluation (technical and regulatory compliance), there is no mention of an adjudication method for a clinical test set.
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
There is no mention of an MRMC comparative effectiveness study, nor is there any AI component described that would require such a study. The device is an electrosurgical unit, not an AI-powered diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
There is no mention of a standalone algorithm performance study, as the device described is an electrosurgical unit and not an AI algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the described technical and safety performance tests, the "ground truth" is established by engineering standards, regulatory guidelines (e.g., ISO, IEC, FDA guidances), and pre-defined acceptable ranges for physical and electrical parameters. For example, for "Accuracy of Output control setting," the ground truth is the ±20% acceptance criteria of the standard value. The "Thermal Effects on Tissue" and "Temperature Monitoring" tests are performed against the requirements of specific FDA guidances.
8. The Sample Size for the Training Set
The concept of a "training set" is relevant for machine learning algorithms. Since this device is an electrosurgical unit and not an AI-driven system, there is no training set described.
9. How the Ground Truth for the Training Set Was Established
As there is no training set, there is no information on how its "ground truth" was established.
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