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510(k) Data Aggregation
(110 days)
COOL-TIP RF GENERATOR, COOL-TIP RF SYSTEM ACCESSORIES
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.
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(123 days)
COOL-TIP RF GENERATOR, COOL-TIP RF SYSTEM ACCESSORIES
The Valleylab Cool-tip RF System (generator and accessories) is intended for the use in percutaneous, laparoscopic, intraoperative coagulation and ablation of tissue, such as partial or complete ablation of non-resectable liver lesions and osteoid osteoma tumors within bone.
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 clectrodes 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.
Here's an analysis of the provided text regarding the Cool-tip™ RF Ablation System, extracting the requested information about acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document, a 510(k) summary, does not explicitly state numerical acceptance criteria in the typical sense (e.g., "sensitivity must be > X%"). Instead, the primary "acceptance criterion" for a 510(k) submission is demonstrating substantial equivalence to a predicate device. The performance aspect focuses on safety and effectiveness.
| Acceptance Criterion Type | Description from Document | Reported Device Performance |
|---|---|---|
| Safety & Effectiveness | "Independent Clinical data have shown the Cool-tip™ RF Ablation System to be safe and effective with regard to ablation of osteoid osteoma lesions." | "safe and effective with regard to ablation of osteoid osteoma lesions." |
| Technological Characteristics | "The Cool-tip™ RF Ablation System has the same basic technological characteristics as the predicate devices noted above." | Implied to be equivalent to predicate devices (K984552, K042216 ) in terms of generator, pump, electrodes, cooling, and monopolar operation. |
| Intended Use | "The Valleylab Cool-tip RF System (generator and accessories) is intended for the use in percutaneous, laparoscopic, intraoperative coagulation and ablation of tissue, such as partial or complete ablation of non-resectable liver lesions and osteoid osteoma tumors within bone." | The FDA found the device substantially equivalent for the stated indications for use. |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Independent Clinical data has shown the Cool-tip™ RF Ablation System to be safe and effective with regard to ablation of osteoid osteoma lesions."
- Sample Size: The exact sample size for the clinical data is not specified in this 510(k) summary.
- Data Provenance: The country of origin of the data is not specified. The document only mentions "Independent Clinical data." It also does not specify whether the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the 510(k) summary. The document does not detail how the ground truth for the clinical data, specifically regarding the "ablation of osteoid osteoma lesions," was established or by whom.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method for the clinical data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or described in the provided text. The submission focuses on the performance of the device itself, not on human readers' interpretive abilities with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This device is an RF ablation system, a surgical instrument, not an AI or diagnostic algorithm. Therefore, a "standalone algorithm only" study, as typically understood in the context of AI performance, is not applicable and was not performed or described. The clinical data evaluates the device's physical effect on tissue.
7. Type of Ground Truth Used
Based on the nature of the device (RF ablation system for osteoid osteoma lesions), the ground truth for effectiveness ("ablation of osteoid osteoma lesions") would most likely be established through:
- Histopathology/Pathology: Examination of tissue samples post-ablation to confirm coagulation/necrosis.
- Imaging Follow-up: Post-procedural imaging (e.g., MRI, CT) to assess the extent of ablation and lesion necrosis.
- Clinical Outcomes Data: Resolution of symptoms associated with the osteoid osteoma.
However, the specific method used to establish ground truth is not explicitly stated in the document.
8. Sample Size for the Training Set
The concept of a "training set" is typically associated with machine learning algorithms. Since the Cool-tip™ RF Ablation System is a physical medical device and not an AI algorithm, a "training set" in this context is not applicable and therefore, no sample size for such a set is provided.
9. How the Ground Truth for the Training Set Was Established
As answered in point 8, the concept of a "training set" is not applicable to this physical medical device. Therefore, the method for establishing ground truth for a training set is not relevant or described.
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(73 days)
COOL-TIP RF SYSTEM
The Radionics, Inc. Cool-Tip RF System is intended to coagulate tissue during percutaneous, laparoscopic and intraoperative surgical procedures.
Not Found
This is a 510(k) clearance letter for the Radionics, Inc. Cool-Tip RF System, dated March 5, 1999. This document only states the FDA's finding of substantial equivalence based on a premarket notification. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the other specific details requested in your prompt.
The letter focuses on the regulatory aspects of the device, indicating that it is substantially equivalent to a predicate device and can therefore be marketed.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and the study proving the device meets those criteria from the provided text.
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