(90 days)
The VIVA combo RF Ablation System is intended for use in percutaneous and intraoperative coagulation and ablation of tissue.
The VIVA combo RF System consists of RF generator, active electrode, grounding pad and peristaltic pump for electrode cooling. This device is designed to produce local tissue heating at the tip of the electrodes causing the coagulation and ablation of tissue.
The VIVA combo RF System is capable of delivering up to 200 W of RF power and the available power is limited through software control. This generator monitors the power, resistance, current and temperature.
The active electrodes are a sterile, single-use, hand-held electrosurgical instrument designed for use with VIVA combo RF System. Cooling of the electrode is provided by chilled water which is pumped through the inflow tubing, the electrode and out through the outflow tubing. This is an enclosed system within the electrode and the water is not to be in contact with the patient.
The provided document is a 510(k) summary for the STARmed VIVA Combo RF System. It details the device's characteristics, intended use, and comparison to a predicate device.
However, it explicitly states:
"No clinical studies were considered necessary and performed."
This means that the document does not contain information on acceptance criteria for device performance based on a clinical study or a study proving that the device meets such criteria. The acceptance criteria and performance data provided are based on non-clinical bench tests and compliance with electrical safety and EMC standards.
Therefore, I cannot provide a response filling in all the requested sections regarding clinical study performance, human expert involvement, ground truth, or MRMC studies, as these types of studies were not conducted for this device's 510(k) submission.
Here is what can be extracted from the document regarding the acceptance criteria and non-clinical performance:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Non-Clinical) | Reported Device Performance (Non-Clinical) |
|---|---|
| Compliance with safety requirements of standard AAMI ES60601-1 | Test results demonstrated compliance with AAMI ES60601-1 |
| Compliance with EMC requirements of standard IEC 60601-1-2 | Test results demonstrated compliance with IEC 60601-1-2 |
| Compliance with particular requirements of standard IEC 60601-2-2 | Test results demonstrated compliance with IEC 60601-2-2 |
| Software validation (MODERATE level of concern) | Software designed, developed, verified, and validated according to a software development process and FDA guidance |
| Biocompatibility (cytotoxicity, irritation/intracutaneous reactivity, sensitization, acute systemic toxicity) | Performed (tests not detailed, but implied successful for submission) |
| Sterilization and Shelf Life (ethylene oxide sterilization, 3-year shelf life for active electrode) | Confirmed (implies successful validation for submission) |
| Electrical Specifications: Output Frequency | 480 kHz ± 10% (matching predicate) |
| Electrical Specifications: Drive on Time | Up to 30 minutes (matching predicate) |
| Electrical Specifications: Maximum Power Output | Up to 200 watts @ 50 ohm (matching predicate) |
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: Not specified for non-clinical bench testing.
- Data Provenance: Non-clinical bench tests, likely performed at the manufacturer's facility in Republic of Korea.
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 as no clinical studies with expert-established ground truth were performed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as no clinical studies requiring adjudication were performed.
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
- No MRMC or human-in-the-loop studies were conducted. The device is not an AI/software as a medical device (SaMD) that typically relies on such studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No standalone algorithm performance study was done in a clinical context. The device is electrosurgical hardware, not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For non-clinical tests, "ground truth" would be the established engineering specifications, published standards (e.g., AAMI, IEC), and internal validation protocols for software, biocompatibility, and sterilization.
8. The sample size for the training set
- Not applicable, as there is no indication of machine learning or AI models with training sets being part of this device or its submission.
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.