(88 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 lesions.
The Cool-tip™ RF Ablation 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 Ablation 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™ 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 provided documentation is a 510(k) premarket notification for the Cool-tip™ RF Ablation System, indicating that the manufacturer is seeking to demonstrate substantial equivalence to previously marketed devices rather than proving safety and effectiveness through a de novo study with explicit acceptance criteria.
Therefore, the document does not contain details about acceptance criteria, a specific study proving device performance against these criteria, or the detailed information on sample sizes, ground truth establishment, or expert involvement typically found in a clinical study report for proving novel device efficacy or safety.
Instead, the submission relies on comparative in vivo and ex vivo product testing and independent clinical studies that have already shown the use of the system to be safe and effective. This implies that the device is an iteration or re-submission, building upon prior approvals.
Given this, I cannot extract the requested information in the format requested. However, I can summarize what is stated, and highlight what is missing:
Here's what can be inferred/extracted from the provided document:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated. The core acceptance for a 510(k) is "substantial equivalence" to predicate devices.
- Reported Device Performance:
Performance Aspect Reported Statement Coagulation/Ablation of Lesions "Comparative in vivo and ex vivo product testing has shown the Cool-tip™ RF Ablation System to be equivalent to currently marketed devices with regard to coagulation/ablation of lesions." Clinical Safety and Effectiveness "Independent clinical studies have shown the use of the system to be clinically safe and effective for ablation of non-resectable liver lesions."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not specified. The document mentions "comparative in vivo and ex vivo product testing" and "independent clinical studies" but does not provide details on the sample sizes, study designs (retrospective/prospective), or data provenance for these underlying studies.
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 specified. As the specific studies are not detailed, information on ground truth establishment and expert qualifications is absent.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified.
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:
- Does not apply. This device is an ablation system, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study related to interpretation improvement is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Does not apply. This is a medical device for tissue ablation, not an algorithm. The "standalone performance" would relate to its physical ablation capabilities, which are attested to by the "comparative in vivo and ex vivo product testing."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Implied: For ablation devices, ground truth would typically come from pathological examination of ablated tissue, imaging follow-up to confirm lesion necrosis, or clinical outcomes data related to disease progression. However, the document does not explicitly state which methods were used in the "independent clinical studies" or "comparative in vivo and ex vivo product testing."
8. The sample size for the training set:
- Not specified. This is not a machine learning device, so the concept of a "training set" in that context does not apply. If "training set" refers to data used to refine the device design, that information is not provided.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
In summary, the provided document is a regulatory submission demonstrating substantial equivalence for a medical device, not a detailed clinical study report. It refers to existing data and studies to support its claim without detailing the methodologies, sample sizes, or ground truth establishment of those underlying studies.
§ 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.