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The Cool-tip RF Ablation System E Series (generator, pump, patient return electrodes, water container, active electrodes, footswitch, and accessories) is intended for use in percutaneous, laparoscopic, and intraoperative coagulation and ablation of tissue, including partial or complete ablation of non-resectable liver tumors.

The Cool-tip™ RF Ablation System E Series (subject device) is a monopolar radio-frequency (RF) generator (RFAGEN) with dedicated components and accessories. The RFAGEN generator can be operated in one of several modes that use various combinations of time, tissue temperature, tissue impedance, and manual control. An interactive touchscreen display allows user input to the generator and displays informational signals and alert messages. Active electrodes are placed in the tissue to deliver RF energy to the tissue to be ablated. One, two, or three active electrodes can be attached to the generator and can be used individually or as multiple depending on electrode type and mode. A cluster electrodes assembled into one hub in a trianqular pattern can also be used. During the ablation of tissue, RF current flows from the generator to an active electrode which delivers the current to the patient. The RF current flows from the active electrode through the patient's body tissue to the return electrode, which recovers the current and returns it to the generator. The resistance to the current, provided by the patient's tissue, produces the heat that is necessary for ablation of tissue, including partial or complete ablation of non-resectable liver tumors. A peristaltic pump circulates sterile cooling water from an I.V. bag, through active electrodes and into a wastewater container. Cooling water does not contact the patient and is not recirculated. The system does not provide fluids to or remove fluids from the patient.

The provided document is a 510(k) Summary for the Cool-tip™ RF Ablation System E Series. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove the device meets specific acceptance criteria in the context of AI/ML performance.

Therefore, many of the requested details regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, and ground truth establishment for AI/ML studies are not applicable to this type of regulatory submission. This submission does not involve an AI/ML device that requires performance metrics like sensitivity, specificity, or AUC against a defined ground truth for diagnostic or prognostic purposes.

The document primarily describes:

• Device Description: The Cool-tip™ RF Ablation System E Series is an electrosurgical cutting and coagulation device, primarily for tissue ablation, including non-resectable liver tumors. It is a monopolar radiofrequency (RF) generator system with dedicated components and accessories.
• Comparison to Predicate Device: The submission aims to show that the new E Series is substantially equivalent to previously cleared Cool-tip™ RF Ablation System predicate devices, despite some modifications (e.g., combined functionality in the generator, new return electrode, optional accessories).
• Performance Testing: Non-clinical (bench) and animal testing were conducted to demonstrate equivalence in performance and safety. Clinical studies in human subjects were not required.
• Regulatory Compliance: The device meets applicable electrical safety, electromagnetic compatibility, usability, software, and biocompatibility standards.

However, to address the prompt as best as possible given the provided text, I will interpret "acceptance criteria" as the regulatory and performance standards the device must meet to achieve substantial equivalence, and "study" as the non-clinical and animal testing conducted.

1. A table of acceptance criteria and the reported device performance

• IEC 60601-1:2005/AMD1:2012 (General Requirements for Basic Safety and Essential Performance)
• IEC 60601-1-2:2014 (4th Edition) (Electromagnetic Disturbances - Requirements and Tests)
• IEC 60601-1-6:2010, AMD1:2013 (Usability)
• IEC 60601-2-2:2017 (Particular Requirements for the Basic Safety and Essential Performance of High Frequency Surgical Equipment and High Frequency Surgical Accessories) | Bench testing and verification conducted. The system was evaluated for electrical safety and electromagnetic compatibility to establish conformity to the identified IEC 60601 standards. The Cool-tip™ E Series RF Ablation System E and optional Cart (FT900RFA) performs as specified within specified storage and use conditions and meets IEC, EMC, regulatory and safety requirements. |
  | Ablation Performance (Bench) | The Cool-tip™ E Series RF Ablation Generator must meet all design and performance requirements. Ablation zone dimensions created with the subject device and predicate device must be equivalent. Performance across the complete range of modes, electrodes, and in specified tissue types (liver, kidney, muscle) must be characterized. | Laboratory (bench) verification and simulated-use validation testing of soft tissue performance characterized the E Series system ablation performance across the complete range of modes, electrodes, and in three tissue types (liver, kidney, and muscle). It was demonstrated that the Cool-tip™ E Series RF Ablation Generator meets design requirements and that ablation zone dimensions are equivalent to the predicate. |
  | Ablation Performance (Animal) | The subject device's histological, thermal, and ablative performance, as well as procedural safety, must be equivalent to the predicate for the Cool-tip™ E Series intended use. | In-vivo testing demonstrated the histological, thermal, and ablative performance, as well as procedural safety of the subject device is equivalent to the predicate for the Cool-tip™ E Series intended use. |
  | Software | Developed in accordance with IEC 62304 (Medical device software life-cycle practices) and FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices with a Major Level of Concern. System level software testing completed successfully. | Software for the Cool-tip™ RF Ablation System E Series was developed and system level software testing (version 1.41.01) was completed successfully, adhering to specified standards and guidance. |
  | Biocompatibility | Direct patient contacting devices (patient return electrode, active electrode, remote temperature probe) must be assessed for biocompatibility (Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Materials Mediated Pyrogenicity) and determined to be acceptable. | The patient contacting materials in the RFAPAD (patient return electrode), Active Electrode, and Remote Temperature Probe (RTP20) were tested to the listed biocompatibility requirements and were determined to be acceptable. |
  | Sterilization & Shelf Life | Active electrode and optional remote temperature probe provided sterile with EtO with SAL of 10^-6^ for RTP20 and 10^-9^ for active electrodes, active electrodes/tubing having a 5-year shelf life, and patient return electrode having a 3-year shelf life. Packaging must provide protection during simulated transportation. | The active electrode/tubing are sterilized with EtO to SAL of 10^-9^ and have a 5-year shelf life. The RTP20 is sterilized with EtO to SAL of 10^-6^ and has a 3-year shelf life. The single-use patient return electrode is not sterile and has a 3-year shelf life. Packaging was validated to provide protection during simulated transportation for the RFAGEN, RFAPAD, electrode kits, and Cart. |
  | Accessory Compatibility | Previously cleared accessories (remote temperature probe and footswitch) must be compatible with the Cool-tip™ E Series Ablation Generator (RFAGEN). New accessories (RFAPAD, RFAPUMP, RFACB cable) must meet design and performance requirements. | The previously cleared accessories were found compatible. The new RFAPAD, RFAPUMP, and RFACB cable meet design and performance requirements. |

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size: The document does not specify exact "sample sizes" in terms of number of patients or specific ablation procedures for its non-clinical and animal testing.
  • For bench testing, "laboratory (bench) verification and simulated-use validation testing" was conducted across the "complete range of modes, electrodes, and in three tissue types: liver, kidney, and muscle." The extent of this testing (e.g., number of repetitions, specific test configurations) is not detailed.
  • For animal testing, "In-vivo testing" was conducted. The number of animals or specific procedures is not provided.
• Data Provenance: Not specified in terms of country of origin. The testing was conducted internally or by contracted labs as part of the manufacturer's (Covidien LLC, Boulder, CO) regulatory submission process. The testing for substantial equivalence is inherently prospective in its aim to show the new device performs as expected, but the specific collection protocols for the animal and bench testing are not detailed as retrospective or prospective data collection from broader clinical practices.

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. This submission is for an RF ablation system hardware and software, not an AI/ML diagnostic or prognostic device that relies on expert interpretation to establish a ground truth for a test set. The "ground truth" here is defined by physical measurements, electrical properties, biological effects observed in animal models, and adherence to engineering and safety standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. As there is no expert-based ground truth establishment for a diagnostic output, there is no need for an adjudication method. The assessment of equivalence was based on quantitative measurements and observations from bench and animal studies.

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

• Not applicable. This is not an AI-assisted diagnostic or prognostic device designed to improve human reader performance. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. While the device has software, it is not an AI/ML algorithm intended for standalone diagnostic or prognostic performance. The software controls the RF ablation system's generator and operational modes, and its performance is assessed as part of the overall system's safety and effectiveness, not as an isolated algorithm interpreting medical data.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• For the bench testing: The "ground truth" was established by comparing objective physical measurements, electrical performance data, and ablation zone characteristics to pre-defined engineering specifications and to the performance of the predicate device.
• For the animal testing: The "ground truth" for demonstrating equivalence relied on histological assessment (e.g., cell necrosis, tissue changes), thermal profiles, observed ablative effects, and macroscopic/microscopic evaluation of procedural safety.
• For regulatory compliance (electrical safety, EMC, biocompatibility, sterilization): Ground truth is established by adherence to recognized national and international consensus standards (e.g., IEC 60601 series, ISO standards for biocompatibility).

8. The sample size for the training set

• Not applicable. The device is not an AI/ML model that requires a training set in the conventional sense. Its software controls the hardware and operational parameters, which are developed and validated through traditional engineering processes.

9. How the ground truth for the training set was established

• Not applicable. As there is no AI/ML training set, no ground truth needed to be established for it. The development and verification of the system's software and hardware components followed established medical device design control procedures, where design inputs, specifications, and verification/validation testing define functionality and performance.

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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.

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