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The Dophi Electroporation System is intended for surgical ablation of soft tissue by irreversible electroporation.

The Electroporation System consists of Electroporation Power Generator, Electroporation Trigger Probe, Electroporation Standard Probe, Electroporation Fixator support and Foot Switch. The single-use Electroporation Trigger Probe with EO sterilization is the same as Electroporation Standard Probe and Electroporation Fixator support. The Electroporation Power Generator and Foot Switch are non-sterile and reusable. With the Electroporation System, a voltage applied between pairs of probes in a series of pulses. The waveform of the voltage is adjustable as determined by clinician-chosen parameters. These parameters include volts, pulse width, pulse frequency and the distance between probes. Up to six probes may be placed in an array within the tissue. The probes of the array are matched as pairs by the system. When probes are activated via a foot switch, the scheduled voltage is delivered to tissue between subsequent pairs of probes. Soft tissue between the probes is ablated.

The provided text is an FDA 510(k) premarket notification for a medical device, the "Electroporation System (N3000)". It outlines the device description, indications for use, comparison to a predicate device, and various tests performed to demonstrate substantial equivalence.

However, the document does not contain information regarding acceptance criteria and a study to prove the device meets these criteria in the context of AI/ML device performance metrics (e.g., sensitivity, specificity, AUC, human reader improvement with AI assistance).

The document primarily focuses on:

• Electrical Safety and Electromagnetic Compatibility: Compliance with IEC 60601 series.
• Biocompatibility Testing: Compliance with ISO 10993-1.
• Sterilization & Shelf Life: Compliance with ISO 11135 and ISO 11607.
• Software Validation: Compliance with FDA Guidance for the Content of Premarket Submissions for Software Functions.
• Animal Testing: An in-vivo animal study on porcine models to compare ablation volume and ECG trigger mode, and potential thermal ablation effect, between the subject and predicate devices.

The "Animal testing" section states: "The results show that the safety and efficacy of the tested articles are similar to those of the control articles." This is the closest the document comes to a performance claim, but it's not quantitative or related to AI/ML acceptance criteria.

Therefore, based solely on the provided text, I cannot fill out the requested table or provide information about the specific types of studies listed (MRMC, standalone algorithm performance, AI assistance effect size, etc.) because these details are not present in the given document.

The document clearly states: "Clinical studies were not required to demonstrate the substantial equivalence of the Electroporation System and the predicated device." This further indicates that no human clinical performance study, often where metrics like sensitivity/specificity and MRMC studies would be conducted for AI/ML devices, was performed or presented in this 510(k).

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The Gas Insufflator is designed to use carbon dioxide gas to insufflate the abdominal cavity, so as to generate and maintain pneumoperitoneum, expand the surgical field and keep sufficient space during diagnostic and therapeutic laparoscopic procedures.

The subject device is composed of Gas Insufflator Unit (Model GVS100) and accessories Highpressure Gas Pipe, Insufflation Tubing Set (Model GI-S001), and power adapter). The Insufflation Tubing Set is provided sterile and disposable. The Gas Insufflator Unit is nonsterile, reusable, and AC-powered (100 - 240 VAC, 50/60 Hz, 200 W).

The Gas Insufflator is designed to use carbon dioxide gas to insufflate the abdominal cavity to generate and maintain pneumoperitoneum during laparoscopic diagnosis and/or surgical treatment. The Gas Insufflator controls gas pressure and flow rate by the solenoid valve. The touchscreen displays the gas pressure and flow output. The Gas Insufflator is insufflate CO2 to a body cavity up to 30 mmHg/40 LPM for Adult mode and 15 mmHg/15 LPM for Child mode.

The Gas Insufflator is for professional healthcare environment use.

The provided text describes the acceptance criteria and the study conducted for the Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. Gas Insufflator (K221995).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes performance testing rather than specific "acceptance criteria" in a tabular format with corresponding reported performance. However, the "Comparison of the technological characteristics" table (Table 1) acts as a de-facto acceptance criteria by demonstrating similarity or equivalence to the predicate device. The "Bench Performance testing" section lists tests conducted to demonstrate performance and safety features.

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The Ultrasonic Scalpel System is intended to transect, dissect, and coagulate tissue. The instruments are indicated for use in open and endoscopic general surgical procedures where bleeding control and minimal thermal injury to tissue are desired. The instruments allow for the coagulation of vessels (veins and arteries) up to 5 mm in diameter while using the power level 1. Device have not been shown to be effective for sterilization procedures or tubal coagulation. Do not use these instruments for these procedures.

The Ultrasonic Scalpel System is an ultrasonic dissection and coagulation system composed of four components: the single use Ultrasonic Scalpel including four shaft lengths; a multiple use transducer; a generator and a foot switch. The single-use Ultrasonic Scalpel with EO sterilization contains the waveguide, shaft, jaws, trigger and activation button. Trigger activation opens and closes the jaws against the distal tip of the waveguide where the tissue is clamped. The Ultrasonic Generator provides AC electrical energy to drive the Ultrasonic Transducer. The Ultrasonic Transducer converts the electrical energy into mechanical vibrations, making the Ultrasonic Scalpel waveguide tip keep vibrating with amplitude between 50μm-100μm at frequency about 55.5kHz. When the vibrating Ultrasonic Scalpel waveguide tip contacts with soft tissues, the hydrogen bond in proteins of the soft tissues is broken apart. The proteins become viscous and coagulate so as to stop bleeding and reduce damage to soft tissues in cutting. The single-use Ultrasonic Scalpel with EO sterilization, the Ultrasonic Generator and Ultrasonic Transducer are of non-sterile package, the transducer has to be sterilized by users before being used in surgery. This device is intended to be used in the hospital environment, such as surgical operation room and imaging intervention room.

The provided document is a 510(k) Premarket Notification for a medical device, the "Ultrasonic Scalpel System," and as such, it does not describe an AI/ML-driven device. Therefore, the questions related to AI acceptance criteria, training/test sets, ground truth establishment, expert adjudication, MRMC studies, and standalone algorithm performance are not applicable to this document.

The document discusses the regulatory review of a physical medical device (ultrasonic scalpel system) and its substantial equivalence to predicate devices, focusing on:

• Device Description: Components (generator, transducer, scalpel, foot switch), working principle.
• Indications for Use: Transect, dissect, coagulate tissue in open and endoscopic general surgical procedures, particularly for vessels up to 5mm.
• Performance Data: Bench testing, animal studies (acute and chronic), sterilization validation, biocompatibility, electrical safety/EMC, packaging, and shelf-life.

Since the request is specifically about "acceptance criteria and the study that proves the device meets the acceptance criteria" and many of the sub-questions are tailored to AI/ML devices, I will interpret "device" as the Ultrasonic Scalpel System described in the document and apply the relevant information provided.

Acceptance Criteria and Study for the Ultrasonic Scalpel System (Non-AI Device)

The document does not explicitly present a table of "acceptance criteria" in the format typically used for AI/ML performance metrics (e.g., sensitivity, specificity thresholds). Instead, the acceptance criteria for this medical device are implicitly derived from various performance tests conducted to demonstrate safety and effectiveness and substantial equivalence to predicate devices. The "reported device performance" is the successful outcome of these tests, satisfying the underlying safety and performance standards.

Here's an interpretation of the acceptance criteria and study findings based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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The Energy generator intended for use in the operating room for general procedures where ESU cutting and coagulation is required. The Energy generator is equipped with monopolar and bipolar outputs.

The Energy Generator is a microprocessor controlled, isolated output, high frequency generator designed for use in cutting and coagulation of tissue. The generator has the ability to perform both monopolar cutting and coagulation and bipolar coagulation of tissue in a wide range of surgical applications. The three models ES300, ES200 and ES100 have the same hardware. They have different software on the control board and has different electrosurgical power limit.

This is an electrosurgical generator, not an AI/ML powered device, so many of the requested fields are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance:

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

Not applicable. This is not an AI/ML powered device that uses a "test set" in the context of data analysis. The testing involved hardware and software validation against established medical device standards.

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

Not applicable. Ground truth, in the context of data for AI/ML, is not relevant for this device. Compliance was assessed against engineering and performance standards by qualified testing personnel and regulatory bodies.

4. Adjudication Method for the Test Set:

Not applicable. There was no "test set" for adjudication as it's understood in AI/ML studies. Compliance was determined by meeting predefined standards and test protocols.

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

No. This type of study is typically conducted for diagnostic AI tools involving human interpretation of data. This device is an electrosurgical generator, and such a study is not relevant to its function.

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

Not applicable. This is a hardware device with embedded software. It does not operate as a standalone algorithm in the sense of AI/ML. Its performance is evaluated through its physical and electrical outputs.

7. The Type of Ground Truth Used:

Ground truth for this device is established by:

• Engineering and Performance Standards: International Electrotechnical Commission (IEC) standards (IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2) set the objective criteria for electrical safety, electromagnetic compatibility, and specific electrosurgical device performance.
• FDA Guidance: FDA guidance documents for electrosurgical devices provide criteria for aspects like thermal effects.
• Software Validation Principles: Ground truth for software validation involves adherence to established software engineering principles and documentation requirements outlined in FDA guidance.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a training set of data.

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

Not applicable. As there is no training set of data, no ground truth needs to be established for it.

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The Video Endoscopy System & 3D Video Endoscopy System are intended to be used to provide illumination and visualization of surgical field in a wide variety of diagnostic abdominal and thoracic minimally invasive procedures, including female reproductive organs (gynecology) and urological anatomy.

The proposed Video Endoscopy Systems include the Video Endoscopy System and 3D Video Endoscopy System, Video Endoscopy System supports 2D imaqe output, 3D Video Endoscopy System supports 2D/3D image output.

Video Endoscopy System is composed of Video Endoscope (LPS21000/LPS21030) and Video Endoscopy processor (EVS100).

The Video Endoscopy Processor is a video processor, which receives the electrical signals from the Video Endoscope and process it and output the final image to the monitor. Two models 2D Video Endoscope (LPS21000/LPS21030) are available, one image sensor is located at the distal of the endoscope (LPS21000/LPS21030), they are used in conjunction with Video Endoscopy Processor (EVS100) to output 2D images.

3D Video Endoscopy System is composed of Video Endoscope (LPS31000/LPS31030) and Video Endoscopy Processor (EVS200).

The Video Endoscopy Processor is a video processor, which receives the electrical signals from the Video Endoscope and process it and output the final image to the monitor. Two models 3D Video Endoscope (LPS31000/LPS31030) are available, two image sensors are located at the distal of the endoscope (LPS31000/LPS31030), they are used in conjunction with Video Endoscopy Processor (EVS200) to output 2D/3D images.

Video Endoscopy processor is non-sterile device. The Video Endoscope is terminallysterilized device. The Video Endoscope must be sterilized by users before being used in surgery.

This submission describes the Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. Video Endoscopy System & 3D Video Endoscopy System (K210116).

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list quantitative acceptance criteria for optical performance. Instead, it states that "The device met all acceptance criteria for optical performance testing and was shown to have equivalent image quality to the predicate." This implies a comparative standard rather than absolute numerical targets.

The reported device performance is qualitative for equivalence.

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 does not provide details on sample sizes for the "test set" in terms of images or data points for the individual optical performance tests. The testing described is non-clinical bench testing rather than a study involving clinical data from patients. Therefore, terms like "country of origin of the data," "retrospective or prospective," or "test set" in the context of patient data do not apply here. The testing was performed on the device prototypes or production units.

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

Not applicable. The performance evaluation was based on bench testing against established standards and comparison to a predicate device's specifications, not on human expert review of clinical images to establish ground truth such as disease presence/absence.

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

Not applicable. There was no adjudication method used, as the testing involved objective measurements and comparisons against technical specifications and standards, not subjective expert reviews requiring consensus.

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 MRMC comparative effectiveness study was done. This submission is for a video endoscopy system as a medical device for visualization, not an AI-powered diagnostic or assistive tool.

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

Yes, the primary evaluation was standalone performance simulation/bench testing of the device's optical and functional characteristics. The device itself (the video endoscopy system) is essentially the "algorithm only" in this context, as its performance is independently measured without human operators for the technical specifications listed.

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

The "ground truth" for the non-clinical testing was based on:

• Established engineering and performance standards: e.g., IEC 60601 series, ISO 10993 series, IEC 62471.
• Predicate device specifications: The comparison table explicitly states characteristics like resolution, field angle, and depth of field that are identical or comparable to the predicate.
• Objective measurements: The various optical performance tests (Resolution, Brightness, White Balance, Color Performance, etc.) would have involved objective measurement techniques with specific targets or ranges derived from industry standards or performance requirements for such devices.

8. The sample size for the training set

Not applicable. This device is a video endoscopy system, not an AI or machine learning algorithm that requires a training set of data.

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

Not applicable, as there is no training set for this type of medical device submission.

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The Microwave Ablation System is intended for coagulation (ablation) of soft tissue. It is not intended for use in cardiac procedures.

The Microwave Ablation System M150E is microwave-based system intended to deliver energy through an antenna inserted into soft tissue for the purpose of coagulating (ablation) of a defined volume of that tissue. The Microwave Ablation System utilizes a 2450MHz generator to deliver power to single microwave ablation antenna or double microwave ablation antennas. The Microwave Ablation Generator provides for user setting of ablation time and ablation power. The proposed device consists of Microwave Ablation Generator, Microwave Ablation Electrode Kits, Temperature Probe and Foot Switch.

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the device as a Microwave Ablation System. Rather than specific performance metrics like sensitivity/specificity for a diagnostic device, the acceptance criteria for this therapeutic device are based on demonstrating equivalent technical characteristics, safety, and performance to a predicate device.

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

   • Test Set Sample Size: Not applicable. The submission states, "Clinical studies were not required to demonstrate the substantial equivalence of the microwave ablation system and the predicated device." The testing primarily involved non-clinical bench and lab testing (e.g., electrical safety, EMC, performance, thermal effects, temperature monitoring, shelf life, package verification, sterilization validation, biocompatibility).
   • Data Provenance: Not applicable, as no clinical test set was used. The non-clinical testing data provenance is implied to be from the manufacturer's internal testing.

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

   • Not applicable, as no clinical test set was used that required expert ground truth establishment in this type of 510(k) submission.

4. Adjudication method for the test set:

   • Not applicable, as no clinical test set was used for adjudication.

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 device is a therapeutic microwave ablation system, not a diagnostic imaging AI device that would involve human readers or AI assistance for interpretation.

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

   • Not applicable in the context of diagnostic AI performance. The device is a physically operated medical system. However, software validation was performed, indicating the internal algorithms and software governing the device's operation were tested in a standalone manner (without human intervention in the algorithm's execution during ablation).

7. The type of ground truth used:

   • For the non-clinical tests, the "ground truth" was established by adherence to recognized national and international standards (e.g., IEC 60601-1, IEC 60601-2-6, IEC 60601-1-2, ISO 11607-1, ISO 11135, ISO 10993), and engineering specifications for system performance, thermal effects, and temperature monitoring. These standards and specifications themselves represent a form of "ground truth" for acceptable device characteristics and safety.

8. The sample size for the training set:

   • Not applicable, as this device does not involve machine learning or AI models that require a training set in the conventional sense. The "training" here refers to the device's design, development, and adherence to established engineering principles and standards.

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

   • Not applicable, as no machine learning training set was used. The "ground truth" for the device's design and operational parameters was derived from existing medical device standards, predicate device characteristics, and established engineering and physiological principles related to microwave ablation.

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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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