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The Dornier Bipolar Cable is indicated to be used with a compatible electrosurgical generator and an HF electrode for endoscopic treatment in urological applications: Cutting, ablation, resection, vaporization and coagulation with HF current.

The Dornier Bipolar Cable is a sterile, single use, disposable device that allows connection of an electrosurgical generator to an HF electrosurgical resection and vaporization electrode. The outer body of the Dornier Bipolar Cables are constructed of a medical grade thermoplastic elastomer. The cable consists of a double wire zip cord with one plug end which has four (4) banana and one (1) straight pin, style of connector that is then attached to the generator. The other end is separated and has two (2) overmolded connectors, one male pin on a wire and one female pin on a wire which are compatible with the HF Electrode.

The provided text describes the 510(k) summary for the Dornier Bipolar Cable. This is a submission for a medical device that does not involve Artificial Intelligence (AI). The submission focuses on demonstrating substantial equivalence to a predicate device through conventional engineering and safety testing.

Therefore, many of the requested categories related to AI performance, such as sample sizes for test and training sets, expert consensus, adjudication methods, and MRMC studies, are not applicable to this document.

Here's the information that can be extracted or deduced from the provided text:

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

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

This information is not applicable as the device is a physical electrosurgical cable and its evaluation did not involve a "test set" in the context of an AI algorithm or data analysis study. The testing performed was engineering and safety validation. The provenance of test data for physical components is not usually detailed in this manner for 510(k) submissions.

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)

This information is not applicable. "Ground truth" in this context typically refers to the confirmed diagnostic or clinical reality for evaluating an AI model. For a physical medical device, the "ground truth" is established through adherence to engineering standards and validated test methods by qualified engineers and technicians, not through expert consensus on medical images or diagnoses.

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

This information is not applicable as there was no test set requiring expert adjudication in the context of an AI system.

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

This information is not applicable as the device is a physical electrosurgical cable and does not involve AI assistance for human readers or direct comparative effectiveness in that manner.

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

This information is not applicable as there is no algorithm or AI component in this device.

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

The "ground truth" for this device's performance is based on meeting established engineering standards and validated test methods for its physical and electrical properties. This is typically determined by physical measurements, electrical tests, and adherence to regulatory standards (e.g., IEC 60601 series).

8. The sample size for the training set

This information is not applicable as there is no AI component or training set for this device.

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

This information is not applicable as there is no AI component or training set for this device.

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The Flexible Argon Electrode is intended to be used in open or laparoscopic and thoracoscopic surgical procedures (general, neurosurgical, gynecologic) where argon-enhanced monopolar coagulation is desired.

The Retractable Argon Electrode is intended to be used in laparoscopic and thoracoscopic surgical procedures (general, neurosurgical, gynecologic) where standard monopolar electrosurgery (cutting and coagulation) or argon-enhanced monopolar coagulation is desired.

The New Deantronics Argon Electrodes have to be attached to the argon handset and are the electrosurgical electrodes applied in electrosurgical procedures.

The New Deantronics Argon Electrode is designed to connect to a third-party argon handset. The electrosurgical energy is conducted from the argon handset, through the electrode to the electrosurgical target site, as is the argon gas flow. When the device is activated, the argon gas will be transformed into a plasma state flowing out of the electrode. By directly or indirectly contacting the energized electrode with the target tissue, the New Deantronics Argon Electrode can facilitate argon-enhanced coagulation, as well as standard electrosurgical cut and coagulation, as indicated.

The provided text describes the New Deantronics Argon Electrodes, which are electrosurgical accessories, and asserts their substantial equivalence to a predicate device based on various comparisons and non-clinical testing. However, the document does not contain the detailed information required to answer all parts of your request, particularly regarding specific acceptance criteria metrics and a human-focused study design.

Here's a breakdown of what can be extracted and what is missing:

1. Table of acceptance criteria and the reported device performance

The document mentions "pre-defined acceptance criteria" but does not provide a specific table outlining those criteria or the reported performance against them for functionality, safety, or clinical effectiveness. The only specific performance data mentioned related to criteria is:

Beyond these electrical safety parameters, the document states: "Electrical safety testing and bench testing has demonstrated that the performance of New Deantronics Argon Electrodes meet the requirements of its pre-defined acceptance criteria and intended uses." This is a general statement rather than specific data.

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

The document mentions "electrical safety testing and bench testing" but does not specify the sample size for the test sets used in these non-clinical tests. It also does not mention the data provenance or whether the tests were retrospective or prospective. Given that it's bench testing, it's typically conducted in a controlled lab environment.

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)

This information is not applicable as the document describes non-clinical "electrical safety testing and bench testing," not a study involving human interpretation or expert ground truth establishment for a test set.

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

This information is not applicable for the same reason as point 3.

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

The document describes development and testing of an "Electrosurgical accessory" (Argon Electrodes) and explicitly states it conducted "electrical safety testing and bench testing." It does not mention a MRMC comparative effectiveness study involving human readers or AI. Therefore, there is no effect size related to human readers improving with or without AI assistance.

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

The document details "electrical safety testing and bench testing" of the device itself (Argon Electrodes), which can be considered a form of standalone performance evaluation for the device's physical and electrical characteristics. However, it's not an "algorithm only" standalone performance as the device itself is a physical medical instrument, not software.

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

For the electrical safety and functional bench testing, the "ground truth" would be established by engineering specifications, industry standards (e.g., IEC 60601 series), and controlled measurements using calibrated equipment, not expert consensus, pathology, or outcomes data which are typically associated with clinical or diagnostic studies.

8. The sample size for the training set

This information is not applicable. The device is an electrosurgical accessory, not an AI/ML algorithm that requires a "training set." The testing described is for physical product performance, not algorithm training.

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

This information is not applicable for the same reason as point 8.

In summary:

This document focuses on regulatory clearance for an electrosurgical accessory based on its physical properties and electrical safety, largely through comparison to a predicate device and non-clinical bench testing. It does not involve AI, human reader studies, or complex clinical ground truth assessments as would be relevant for diagnostic imaging or similar AI-driven medical devices.

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The Model 90 Electrosurgical Probe is designed to supply energy (generated by the RITA Medical Systems' electrosurgical generator) for use in electrosurgery and is designed for the following:
Incorporation of multiple needles on each probe minimizing the number of invasive accesses necessary to achieve desired lesions.
Provide a minimally invasive laparoscopic, percutaneous, or intraoperative access to the targeted tissue.
Deliver radiofrequency energy in a controlled fashion to create coagulative necrotic lesions.
Incorporate thermocouples for temperature feedback.
Provide for local delivery of fluid.

This RITA® Model 90 device is available in 15 cm and 25 cm lengths for a variety of medical applications. The secondary electrodes deploy out from the trocar tip. The RITA Model 90 device consists of the following components: primary electrode: stainless-steel hypodermic tubing with a portion exposed as an electrode secondary electrodes: stainless-steel extendible flexible hypodermic tubing at the distal end of probe trocar insulation: fixed clear polymer shrink tubing handle: polymer materials with markings to indicate the amount of electrode array deployment from the trocar RF pathway: connection through a Lemo connector built into the handle fluid infusion: delivery through Luer port at side of the handle temperature sensors: Five temperature sensors at the periphery of the array depth indicators: Incremental 1-cm marks denote needle penetration depth.

The sponsor, RITA Medical Systems, Inc., conducted a study to verify that the Model 90 Electrosurgical Probe met its specifications.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample size used for the electrical, mechanical, and biocompatibility testing. It only mentions that the "Model 90 devices were subjected to a battery" of tests, implying multiple devices were tested. The data provenance is not specified, but it's likely to be internal testing conducted by the manufacturer, RITA Medical Systems, Inc., given the context of a 510(k) summary. It would be considered retrospective testing as it occurred prior to the 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the document. The testing appears to be objective performance testing against predefined engineering specifications rather than expert-derived ground truth.

4. Adjudication Method for the Test Set:

Not applicable. The testing described is performance-based against specifications, not a subjective assessment requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The study focuses on the device's technical specifications and safety (biocompatibility) rather than comparing its effectiveness in a clinical setting with or without human assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This device is an electrosurgical probe, which is a physical medical instrument, not an algorithm or an AI-powered system that would have standalone performance or human-in-the-loop evaluation.

7. The Type of Ground Truth Used:

The "ground truth" for the performance testing was derived from the engineering specifications for electrical and mechanical performance, and toxicological standards for biocompatibility. These are objective, pre-defined criteria that the device had to meet.

8. The Sample Size for the Training Set:

Not applicable. This document describes the testing of a physical medical device, not a machine learning model, so there is no concept of a "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for a physical electrosurgical probe.

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