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510(k) Data Aggregation
(507 days)
This device is intended for use in dermatologic and general surgical procedures for electro-coagulation.
This device is an instrument used for tissue coagulation by means of high-frequency current. It consists of the main unit, Four handpieces, GP Cable, foot switch, LCD touchscreen, ground pad and power cable. The SILKRO has two operating modes: monopolar mode and bipolar mode.
The provided text does not contain information about acceptance criteria and reported device performance from a clinical study for the SILKRO device. Instead, it focuses on non-clinical tests and a comparison of technological characteristics with predicate devices to demonstrate substantial equivalence for regulatory clearance.
Specifically, the document lists:
- Non-clinical tests submitted (Section 7): These are primarily related to electrical safety, electromagnetic compatibility, usability, risk management, software validation, and biocompatibility, conducted according to various IEC and ISO standards.
- Ex vivo animal testing (Section 7): This was conducted to evaluate the thermal effect of the handpieces on tissue, observing depth and zone of coagulation and thermal damage.
- Biocompatibility testing (Section 8): Confirmed that materials met biocompatibility requirements for skin contact, following ISO 10993 standards.
- Sterilization and shelf-life testing (Section 9): Demonstrated a sterility assurance level and a three-year shelf-life through accelerated aging tests.
Therefore, I cannot provide the requested information for the following points as they are not present in the given text:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs without AI assistance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- The sample size for the training set.
- How the ground truth for the training set was established.
The document's conclusion (Section 11) states that "Results of performance testing demonstrated substantial equivalence of the subject device to the predicate," but it refers to the non-clinical tests mentioned earlier, not a clinical study involving human patients or a complex diagnostic performance evaluation.
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(151 days)
The VirtueRF Electrosurgical System has separate indications for use for each of its functionalities: 1MHz and 2MHz.
1MHz Indications for use: Intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles. The VirtueRF Electrosurgical System is intended for use with Skin Types I-V.
2MHz Indications for use: Intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The 2mHz frequency is not intended to treat wrinkles.
The VirtueRF device is a radio frequency output device using 1MHz & 2Mhz to deliver radio frequency energy to the human body with an applicator attached to the connecting cable. The energy is applied to the human body using a sterile disposable needle array consisting of 36 needles. This product consists of main body, Needle Bipolar RF (Smart RF) handpiece cable, foot switch and power cord.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the VirtueRF device:
Based on the provided K202415 510(k) Summary for the VirtueRF device, the submission primarily focuses on establishing substantial equivalence to predicate devices through technical comparisons and standard performance testing. This type of submission generally does not include extensive clinical studies with specified acceptance criteria regarding diagnostic performance or human-AI comparative effectiveness, as it's not a diagnostic AI device.
Therefore, many of your requested points regarding acceptance criteria for diagnostic performance, sample sizes for test sets, expert ground truth, MRMC studies, or standalone algorithm performance are not applicable in this context. The acceptance criteria here are related to meeting safety, electrical, biological, and thermal performance standards to demonstrate equivalence to existing devices.
Nonetheless, I will extract what information is present or clearly implied.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implied/Direct) | Reported Device Performance |
|---|---|---|
| Electrical Safety & Performance | Compliance with IEC 60601-1 (General Requirements for basic safety and essential performance). | Testing was performed per IEC 60601-1. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 (General Requirements for basic safety and essential performance: electromagnetic compatibility). | Testing was performed per IEC 60601-1-2. |
| High Frequency Surgical Equipment | Compliance with IEC 60601-2-2 (Particular requirements for the basic safety and essential performance of high frequency surgical equipment). | Testing was performed per IEC 60601-2-2. |
| Biocompatibility | Compliance with ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process). | Testing was performed per ISO 10993-1. |
| Thermal Effects | Thermal effects comparable to predicate devices, demonstrating safe and effective energy delivery to tissues. | "Thermal Effect Tests on 4 types of tissues (liver, kidney, muscle and skin) per FDA guidance... Test shows that the VirtueRF is substantially equivalent to the predicate device." |
| Technical Equivalence (1MHz) | Same source of energy/modality, radiofrequency, output energy type, electrode type, max power, and RF duration as Vivace Electrosurgical System (K150409). | All characteristics (except MAX Power is 35.9W for VirtueRF vs 61W for Vivace) are "Same" or acceptable for equivalence, as stated. |
| Technical Equivalence (2MHz) | Same source of energy/modality, radiofrequency, output energy type, electrode type, max power, and similar RF duration as Secret RF (K182355). | All characteristics are "Same" except RF Duration, which is "Similar" (100ms-800ms subset of 50ms-950ms). |
2. Sample Size Used for the Test Set and Data Provenance
This information is not present for the efficacy or diagnostic performance as those types of studies were not conducted or described. The "test set" in this context refers to the samples used for the engineering and bench testing (e.g., tissue samples for thermal effect tests, electrical testing setup), not a clinical trial test set for diagnostic performance. The document does not specify the number of tissue samples or the specifics of the electrical test configurations used.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as the submission is not for a diagnostic device or an AI algorithm requiring expert-established ground truth for performance evaluation.
4. Adjudication Method for the Test Set
This information is not applicable for the reasons stated above.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices or AI-assisted diagnostic tools, which the VirtueRF electrosurgical system is not.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
No, a standalone algorithm performance study was not done. The VirtueRF is a medical device, not a standalone AI algorithm for diagnostic purposes. Its performance is evaluated through engineering, electrical, biocompatibility, and thermal tests, and comparison to predicates, not through AI-specific performance metrics.
7. The Type of Ground Truth Used
For the thermal effect tests, the "ground truth" would be established by direct physical measurements of temperature changes and tissue effects, validated against established scientific principles and comparison to the predicate device's known effects. This is a scientific and engineering ground truth rather than a clinical ground truth like pathology or expert consensus.
8. The Sample Size for the Training Set
This information is not applicable. The VirtueRF is a hardware device, not an AI model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated above.
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