(110 days)
The Cool-tip™ RF Ablation System (Generator and accessories) is intended for use in percutaneous, laparoscopic and intraoperative coagulation and ablation of tissue, such as partial or complete ablation of non-resectable liver tumors.
The Cool-tip ™ RF System consists of a microprocessor based RF generator, a peristaltic pump, electrodes, inflow and outflow tubing for electrode cooling, and return pads. The generator pump and electrodes are designed to produce local tissue heating at the tip of the electrodes causing the coagulation (ablation) of the tissue. The Cool-tip ™ RF System generator is capable of delivering up to 200 watts (into a 50 Ohm resistive load) while monitoring tissue impedance and electrode tip temperature during the delivery of the RF energy The generator includes manual and impedance control and displays/monitors impedance. current, power and temperature. The Cool-tip™ RF System electrodes are available in either a single electrode or a cluster electrode configuration. The electrodes are monopolar devices. The cluster electrode is three electrode shafts combined into one handle in a triangular patter with approximately 0.5 cm separation. The electrodes are provided sterile, for single use only. The shaft of the electrode is stainless steel that is insulated to various lengths from the tip of the electrode. Embedded within the tip of each electrode is a thermocouple for temperature measurement. Cooling of the electrode is provided by chilled sterile water which is pumped (using the peristaltic pump) through the inflow tubing, the electrode and out through the outflow tubing. This is an enclosed system within the electrode and the sterile water does not contact the patient. Because of the monopolar nature of the electrodes, electrical current flows through the tip of the electrode, through the target tissue and to the return pad.
The Cool-tip™ RF System is intended for percutaneous, laparoscopic, and intraoperative coagulation and ablation of tissue, specifically for partial or complete ablation of non-resectable liver tumors.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance | Comments |
|---|---|---|
| Equivalence to currently marketed devices regarding coagulation/ablation of lesions. | Comparative in vivo and ex vivo product testing has shown the Cool-tip™ RF System to be equivalent to currently marketed devices for coagulation/ablation of lesions. | This indicates that the device's functional performance in ablating tissue is comparable to established devices. |
| Clinical safety and effectiveness for ablation of primary and metastatic, unresectable liver tumors. | Independent clinical studies have shown the use of the system to be clinically safe and effective for ablation of primary and metastatic, unresectable liver tumors. | This addresses the clinical utility and patient outcomes for the intended use. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document states: "Comparative in vivo and ex vivo product testing" and "Independent clinical studies." However, it does not specify the sample size for these tests or the clinical studies.
Regarding data provenance:
- "in vivo and ex vivo product testing" likely refers to studies performed on biological tissue, potentially animal models (in vivo) and excised tissue (ex vivo), without explicit mention of human subjects for the comparative testing directly.
- "Independent clinical studies" implies human subject data, but the country of origin and whether they were retrospective or prospective studies are not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not provide information on the number of experts used or their qualifications for establishing ground truth in either the comparative testing or the independent clinical studies.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1) for establishing ground truth in the test sets.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention or describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. There is no information provided regarding human readers improving with or without AI assistance, as AI is not a component of this device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This device is a hardware system for RF ablation, not an AI algorithm. Therefore, the concept of a "standalone (algorithm only without human-in-the-loop performance)" study is not applicable to the Cool-tip™ RF System.
7. Type of Ground Truth Used
The document implies the ground truth for "coagulation/ablation of lesions" would be based on direct assessment of the ablated tissue, likely through histological examination (pathology) or macroscopic evaluation. For "clinical safety and effectiveness," the ground truth would be based on patient outcomes, imaging follow-up (e.g., to confirm tumor ablation), and adverse event monitoring. However, the specific methods for establishing ground truth are not explicitly detailed.
8. Sample Size for the Training Set
The document does not mention a training set in the context of an algorithm or machine learning. The "comparative in vivo and ex vivo product testing" and "independent clinical studies" serve as performance validation, not as training for an AI model.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set in the provided information, this question is 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.