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The Radio Frequecy Ablation System is intended for coagulation and ablation of soft tissue. It is not intended for use in cardiac procedures.

The proposed device consists of Radio Frequency Generator, Radio Frequency Electrode Kits, Temperature Probe and Foot Switch. Wherein, the radiofrequency generator integrated with cooling pump is capable of delivering up to 200W while monitoring tissue impedance, tissue temperature and electrode tip temperature during the delivery of the RF energy. The Radio Frequency Electrode Kits consists of Radio Frequency Electrode, introducer, inflow - outflow tubing sets and Return Pad to be used for puncturing the patient's lesion position during operation and also for outputting Radio Frequency energy to ablate the tumor tissue through connection with Radio Frequency Generator. The Temperature Probe is applied to monitor the temperature of the target location and to protect important organs and tissues in the periphery of the lesion from unexpected damage by Radio Frequency energy.

The Radio Frequency generator supplies 470 kHz of radio frequency current, which enters into target tissue of patient, and builds a circuit loop with the Return Pad. The alternating current cause alternating motion of the positive ions in the tumor region. Because of the different size, mass and charge of each ion, the moving speeds of the ions are different, resulting in collision friction and thermal energy. When the temperature is above 50 °C, tumor tissue come into irreversible coagulation necrosis.

lt supports three working modes: Auto Mode, POWER Mode and TEMP Mode.

Auto Mode
The Auto Mode allows the use of 1-3 RF ablation electrodes for ablation. When multiple RF Ablation electrodes are connected, the RF generator will switch between the electrodes for energy output. In Auto Mode, the system automatically adjusts the power output according to the built-in algorithm.

Power mode
In POWER Mode, the RF generator outputs according to the maximum power set by users. In this mode, only single RF electrode is allowed to be used. The RF Electrode is kept below 40°C by means of internal cooling with cooling-water delivers from a peristaltic pump.

Temperature mode
In TEMP Mode, the RF generator detects the temperature of the RF electrode automatically, and adjusts the power output according to the detected temperature. In this mode, "SET POWER(W)" is forbade to set. Single RF electrode is permitted to use. Once the temperature of RF electrode reaches 85℃, a beep sounds. Then users can pull the RF electrode out of patient at a rate of 1centimetre every 2 seconds.

The Radio Frequency Generator is non-sterile, the return pad is non-sterile and for single use, while Radio Frequency Electrode and Temperature Probe are sterile and for single use.

The device is software-driven and the software validation is provided in Section of Software.

The provided text is a 510(k) Premarket Notification for the Surgnova Radio Frequency Ablation System. This document focuses on demonstrating substantial equivalence to a predicate device (Cool-tip™ RF Ablation System) rather than proving the device meets specific acceptance criteria through a standalone study with performance metrics like sensitivity or specificity.

Therefore, the information for some of your requested points (like table of acceptance criteria vs. device performance, sample sizes for test/training sets, expert adjudication, MRMC study, and ground truth establishment) is not present in the provided document, as these are typically part of a rigorous clinical or performance study designed to establish the device's efficacy and safety against predefined benchmarks, which was explicitly not required for this submission.

Here's what can be extracted from the provided text based on your questions:

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

This information is not provided in the document in the format of quantitative acceptance criteria and reported device performance. The submission aims to show "substantial equivalence" to a predicate device, meaning its safety and effectiveness are similar to a device already on the market. The comparison table (Section 3.5) highlights technological characteristics between the proposed device and the predicate. Performance is generally implied to be comparable based on these characteristics and non-clinical testing.

2. Sample size used for the test set and the data provenance:

• Sample size for test set: Not applicable/Not provided. No clinical studies were conducted that would involve a "test set" in the context of diagnostic or AI performance evaluation. The non-clinical tests relate to electrical safety, EMC, performance, thermal effects, etc., which are typically conducted on a limited number of devices or components under controlled laboratory conditions, not on patient data.
• Data provenance: Not applicable/Not provided. No patient data (retrospective or prospective) was used for performance evaluation in the context of this 510(k) submission, as it did not involve clinical studies to demonstrate efficacy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Not provided. There was no "test set" of medical images or patient data requiring expert ground truth establishment for this device in this submission.

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

• Not applicable/Not provided. No "test set" requiring adjudication was involved.

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:

• No. An MRMC comparative effectiveness study was not done. This device is a Radio Frequency Ablation System, a surgical instrument, not an AI-powered diagnostic or assistive tool for human readers.

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

• No. This device is hardware with integrated software. It's not a standalone algorithm in the sense of AI-driven image analysis. The "software-driven" aspect refers to control firmware, not an AI algorithm for diagnostic interpretation.

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

• Not applicable/Not provided. No ground truth in the context of diagnostic accuracy was established or used, as this submission is for a surgical ablation device and did not require clinical efficacy studies or evaluation against patient outcomes data for substantial equivalence. The "ground truth" for the non-clinical tests would be the established engineering and safety standards (e.g., IEC 60601 series, ISO 10993).

8. The sample size for the training set:

• Not applicable/Not provided. No "training set" in the context of an AI algorithm was used. The software validation mentioned (FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices) refers to testing the software's functionality, reliability, and safety, not training an AI model.

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

• Not applicable/Not provided. As there was no AI training set, there was no ground truth established for it.

Summary based on the document:

The 510(k) submission for the Surgnova Radio Frequency Ablation System primarily relies on non-clinical testing and comparison to a legally marketed predicate device to demonstrate substantial equivalence. It explicitly states: "Clinical studies were not required to demonstrate the substantial equivalence of the microwave ablation system and the predicated device." Therefore, the document does not contain the types of studies or data points that would typically be found in submissions for diagnostic AI devices, where acceptance criteria, test sets, ground truth, and reader studies are crucial.

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