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The Irreversible Electroporation Ablation Generator is indicated for the surgical ablation of soft tissue.

The Irreversible Electroporation Probe is used in conjunction with Irreversible Electroporation of CuraWay indicated for the surgical ablation of soft tissue.

The Irreversible Electroporation Ablation Generator consists of a generator, foot switch and power cord. The generator will be used together with the Irreversible Electroporation Probe and Neutral Electrode.

The Irreversible Electroporation Probe has two types: monopolar probe and bipolar probe. Monopolar probe also has two types: Standard Probe and Activation Probe.

The Irreversible Electroporation Ablation Generator has three working modes:

• A Mode 1: Monopolar steep pulse mode;
• A Mode 2: Bipolar steep pulse mode;
• A Mode 3: Needle Track Coagulation.

Mode 1 and Mode 2 are used for soft tissue ablation, the working principle is that the generator transfers non-thermal energy to electrodes which are placed at the target area, it will release high-voltage electrical pulses forming nano-scale permanent perforations on the soft tissues to disrupt the intracellular balance and induce cell apoptosis. The cells die and are removed by the human body's own lymphatic system.

The Mode 3 is used for the soft tissue coagulation during the process when the probe is pulled out. This module works at 480kHZ, the high frequency flows to the probe's tip and then is applied to the tissue. Frictional heat occurs and causes the ions to move between the negative pole and the positive pole 40,000 to 50,000 times per second. Heat generated from the tissue impedance induces tissue necrosis.

Subject device can work at ECG synchronization trigger mode. During this mode, an external R-wave detector must be connected. R-wave detector monitors the patient's cardiac rate and transfers it to R waves which will be detected by the generator and then a pulse will be triggered. Every time a R wave is detected, one pulse is triggered such that every time the heart beats, a pulse will be triggered, so that the electroporation pulses can be triggered and delivered in proper synchronization with the patient's cardiac rhythm.

This document is a 510(k) summary for a medical device and does not contain detailed acceptance criteria or a study proving the device meets specific acceptance criteria in the manner typically presented for AI/ML performance. The information provided focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.

However, based on the information provided, we can infer some "acceptance criteria" through the comparative non-clinical studies.

Here's an analysis based on your request, adapting to the provided document's content:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative performance acceptance criteria in a dedicated table for the device's efficacy. Instead, it describes non-clinical tests designed to demonstrate "substantial equivalence" to a predicate device. The performance is assessed by comparing the subject device's effects to those of the predicate and reference devices in specific animal and ex-vivo models.

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

• Test Set Sample Size:
  • Ex-vivo tissue testing: Swine muscle, liver, and kidney tissue. The specific number of tissue samples or experiments is not provided.
  • In-vivo animal testing: Swine. The specific number of animals used in the subject device group and predicate device group is not provided.
• Data Provenance: The tests were conducted internally by the manufacturer or a contracted lab. The document does not specify a country of origin for the data beyond the manufacturer being based in China. The studies are non-clinical (ex-vivo and in-vivo animal), not human clinical.

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

This information is not provided as the studies are non-clinical. The assessment of "ablation effect and ablation zones" or "blood parameters" would typically be performed by trained lab personnel, veterinarians, or pathologists, but specific details on their qualifications or number are not available in this regulatory summary.

4. Adjudication Method for the Test Set

This information is not provided. Given that these are non-clinical studies evaluating physical effects and physiological parameters, typical clinical adjudication methods (like 2+1 or 3+1 consensus) are not directly applicable. The "ground truth" is derived from direct measurements and observations in the experimental setup.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This document describes a medical device, not an AI/ML diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or applicable to this submission.

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

Not applicable. This device is an Irreversible Electroporation Ablation Generator and Probe, which is a physical medical device used for surgical ablation. It is not an AI algorithm. While it has embedded software, its performance is assessed as part of the overall device system, not as a standalone AI algorithm.

7. The Type of Ground Truth Used

For the non-clinical studies mentioned:

• Ex-vivo and in-vivo tests: The "ground truth" for evaluating ablation effect and ablation zones, blood parameters, etc., would be based on direct measurement, observation, and analysis by laboratory techniques (e.g., macroscopic and microscopic examination of tissue, blood tests). It's a form of objective measurement/pathology from the experimental models.

8. The Sample Size for the Training Set

Not Applicable. The device is not an AI/ML algorithm that requires a training set in the conventional sense. The "development" of the device would involve engineering design, prototyping, and iterative testing, not machine learning model training.

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

Not Applicable. As explained above, there is no AI/ML training set for this device.

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The Mygen M-3004 RF system is intended for use in percutaneous and intraoperative coagulation and ablation of tissue.

Mygen M-3004 RF System consists of a microprocessor based RF generator, a cooling pump and tubing, electrodes, and ground 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. Mygen M-3004 RF System generator is capable of delivering up to 200 waits (into a 50 Ohm resistive load) while monitoring tissue impedance and electrode tip temperature during the RF energy. The generator includes manual and impedance control and displays/monitors impedance, current, power and temperature.

The radiofrequency (RF) energy, which is delivered to an electrode, makes frictional heat for coagulation and ablation on diseased tissue by ionic agitation. The patient can receive safe therapy as leakage current is extremely low. Mygen M-3004 continually measures and displays RF output power, tissue impedance, and elapsed time of RF delivery. Tissue temperature is measured by the thermocouple embedded in the electrode tip and is displayed on the touch screen. This equipment automatically adjusts the output to maximize the delivery of high-frequency energy and displays the measured temperature from the treatment site during high-frequency emission.

Mygen M-3004 automatically adjusts the output to optimize radiofrequency output and displays the measured temperature from the treatment area while delivering radiofrequency energy.

This is a 510(k) summary for a medical device called the "Mygen M-3004 RF System," an electrosurgical cutting and coagulation device. The document primarily focuses on establishing substantial equivalence to a predicate device, not on clinical performance or diagnostic accuracy. Therefore, the information requested in your questions, particularly regarding acceptance criteria for diagnostic accuracy, expert review, and training/test set details, is largely not present in this type of submission.

Here's an breakdown of the available information based on your questions:

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

The document does not provide a formal table of acceptance criteria for diagnostic accuracy or performance metrics like sensitivity, specificity, or AUC. Instead, it details performance tests conducted to ensure the device functions as intended and is safe. The "acceptance criteria" here are implicit in the successful completion of these engineering and safety tests, demonstrating compliance with relevant standards.

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The ELRA Electrode is a radiofrequency (RF) catheter which provides bipolar energy to perform partial or complete ablation of tissue in the pancreatic and biliary tracts.

The ELRA Electrode is a bipolar electrode. ELRA Electrode is a sterile, single-use electrosurgical accessory intended to be used in conjunction with VIVA combo RF generator (K163450). They are not intended to function with other RF generators.

The ELRA Electrode consists of an electrode tip, insulation part, handle. Patient contacting materials of ELRA Electrode are stainless steel 304, Teflon-ETFE, UV adhesive, Nylon, PEEK and polyether block amides.

The lengths of the flexible tube available for the ELRA Electrode length are 400 mm and 1,750 mm. The tip exposures available for the ELRA Electrode length are 11 mm, 18 mm, 22mm and 33 mm. The diameter available for the ELRA Electrode diameters is 7 French.

The model with longer length(1,750 mm) are used with endoscopes. This electrode is inserted into the body through the oral rout, and are used at the application site. The shorter length(400 mm) models are performed by percutaneous resection directly at the site of application. Both methods have to be used with fluoroscopy during the procedure.

Here's an analysis of the provided text regarding acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states that the non-clinical tests all met the acceptance criteria specified in the standards, and similarly for the clinical trials. However, the specific quantitative acceptance criteria are not detailed in a table format within the provided text. Instead, it refers to compliance with established international and FDA-recognized consensus standards.

Here's an attempt to infer and structure the information:

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

The document describes two clinical studies:

• Prospective Clinical Trial:

  • Sample Size: 30 patients
  • Data Provenance: Not explicitly stated, but clinical trial implies prospective data collection. The manufacturer is based in the Republic of Korea, which might suggest the trial was conducted there, but this is not confirmed.

• Retrospective Study:

  • Sample Size: 10 patients
  • Data Provenance: Retrospective study. The patients had malignant biliary hilar duct obstruction. Country of origin not specified, but again, likely related to the manufacturer's location.

For non-clinical tests (e.g., thermal effects): The sample size isn't specified in terms of "cases," but it mentions testing on "liver, kidney, and muscle tissue."

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

The document does not provide information on the number of experts used to establish ground truth or their qualifications for either the clinical trials or the non-clinical tests.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1) for establishing ground truth in either the clinical or non-clinical studies. The clinical outcomes (stent success, complications) appear to be directly observed or reported.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not conducted. This device is an electrosurgical electrode and does not involve AI for interpretation or assistance with human readers. The comparative effectiveness assessment was against a predicate device.

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

This question is not applicable as the device is a physical electrosurgical electrode, not an AI algorithm. Its performance is intrinsic to its design and how it affects tissue, not based on an algorithm's output. The performance studies detailed are for the device's physical and functional characteristics.

7. The Type of Ground Truth used

• Clinical Trials: The ground truth appears to be based on direct clinical outcomes (successful stent placement, incidence of complications, absence of direct device-related side effects). This aligns with outcomes data.
• Non-Clinical (Thermal Effects): The ground truth was based on objective measurements of "width and depth of thermally damaged zone" in tissue samples. This is a form of objective measurement/pathology-like assessment on ex vivo tissue samples.
• Non-Clinical (Safety & Biocompatibility): Ground truth is established by adherence to and successful completion of tests outlined in international consensus standards (e.g., IEC 60601-1, ISO 10993 series).

8. The Sample Size for the Training Set

This information is not applicable as the ELRA Electrode is a hardware medical device, not an AI/machine learning model that requires a training set.

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

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

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The EUSRA RF Electrode is indicated for coagulation of soft tissue when used in conjunction with compatible radio frequency generator.

The EUSRA RF Electrode is a monopolar electrode. The EUSRA RF Electrode is a sterile, single-use electrosurgical accessory intended to be used in conjunction with VIVA combo RF generator (K163450). They are not intended to function with other RF generators. The EUSRA RF Electrode consists of the tubing set and grounding pad. The grounding pad is FDA cleared (K163450).

The EUSRA RF Electrode consists of an electrode tip, insulation part, handle. Patient contacting materials of EUSRA RF Electrode are stainless steel 304, polyimide, polyether block polyamide copolymer and PTFE. Cooling of the EUSRA RF Electrode is provided by chilled water which is pumped through the inflow tubing, the electrode and out through the outflow tubing. This is an enclosed system within the electrode and the water is not to be in contact with the patient.

This document describes the EUSRA RF Electrode, a device indicated for the coagulation of soft tissue when used with a compatible radio frequency generator. The provided text outlines the performance criteria and studies for this device, but it is important to note that this is a medical device (hardware) and not an AI/software device. Therefore, many of the typical acceptance criteria and study descriptions for AI/software (like sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details, etc.) do not apply in this context.

The document focuses on demonstrating substantial equivalence to a predicate device (Habib EUS RFA 6700) through non-clinical testing and adherence to international safety and performance standards.

Here's an adaptation of your requested information based on the provided hardware device context:

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

Since this is a hardware device submission, the "acceptance criteria" are primarily based on meeting established safety and performance standards and demonstrating equivalence to a predicate device, rather than specific performance metrics like sensitivity/specificity for an AI algorithm. The "reported device performance" refers to the successful completion of various non-clinical tests.

2. Sample size 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 to this 510(k) submission for a hardware medical device. There are no "test sets" of patient data in the context of an AI algorithm evaluation. The testing involved various non-clinical (bench, ex vivo) studies as described below.

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 is not applicable as this is a hardware medical device, not an AI/software device requiring ground truth establishment by experts for specific diagnostic or prognostic tasks.

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

Not applicable for a hardware medical device.

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. MRMC studies are relevant for evaluating AI-assisted diagnostic tools, not a hardware electrosurgical electrode.

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

Not applicable as this is a hardware device.

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

Not applicable. For the thermal effects test, the "ground truth" would be the direct measurement of thermal damage in tissue samples, determined experimentally.

8. The sample size for the training set

Not applicable. There is no concept of a "training set" for this type of hardware medical device.

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

Not applicable.

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