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Disposable Biopsy Needle is intended for use in soft tissue biopsies such as liver, kidney, breast, thyroid, prostate, spleen, pancreas, lymph nodes, lung and various soft tissue tumors. It is not intended for use in bone.

Disposable Biopsy Needle is intended for use in obtaining an aspirate for cytology. Disposable Biopsy Needle has five models: BN-MAR-1, BN-MAR-2, BN-MAR-3, BN-MAR-4, BN-MAR-8. The Disposable Biopsy Needle consists of operating handle of Inner stylet, operating handle of cutting cannula, cutting cannula, inner stylet, depth stopper and protective sheath. The models differ as follows:

• Cutting cannula tip type: The cannula tip type of BN-MAR-1, BN-MAR-2, BN-MAR-3 is chiba. The cannula tip type of BN-MAR-4, BN-MAR-8 is greene.
• Operating handle designs:
  • BN-MAR-1, BN-MAR-3, BN-MAR-4 Models:
    a. BN-MAR-1, BN-MAR-3, and BN-MAR-4 have the same operating handle, including the operating handle of inner stylet and operating handle of cutting cannula.
    b. The Operating handle of Inner stylet connector connects to the Operating handle of cutting cannula connector via a straight snap-fit design, allowing for easy disconnection with one hand to remove the Inner stylet.
  • BN-MAR-2, BN-MAR-8 Models:
    a. The Operating handle of Inner stylet of BN-MAR-2 connects to the Operating handle of cutting cannula via a straight snap-fit design connector, allowing easy disconnection with one hand to remove the Inner stylet.
    b. The Operating handle of inner stylet of BN-MAR-8 connects to the Operating handle of cutting cannula via a female Luer taper and male Luer thread taper, which can meet the sealing performances in clinical applications.
• Bevel Angle of the Cutting cannula tip: There are three kinds of bevel angle of the Cutting cannula tip, which are α, β, δ. The bevel angle of the cutting cannula tip of BN-MAR-1 and BN-MAR-2 is α. The bevel angle of the needle tip of BN-MAR-3 is β. The bevel angle of the Cutting cannula tip of BN-MAR-4 and BN-MAR-8 is δ.

Each model has various specifications depending on different sizes such as needle lengths, needle diameters, etc. The cutting cannula has numerically ordered centimeter markings on it to provide reference for depth placement. In the distal area of the cutting cannula, an ultrasound enhancement is available to promote accurate placement under ultrasound or X-ray guidance.

An adjustable depth stopper allows the user to restrict forward movement, localizing the needle tip to the biopsy site.

The Operating handle of Inner stylet is color-coded, which indicates gauge size of the needle. It is available in several needle gauge sizes and lengths.

The Disposable Biopsy Needle is a single-use device, supplied in a sterile state sterilized by EO gas. Re-sterilization by users is forbidden. The shelf life is defined for 3 years, which is verified.

The provided document is a 510(k) clearance letter for a Disposable Biopsy Needle. It is a physical device, not an AI/software device. Therefore, the questions regarding acceptance criteria and studies related to AI performance, such as human-in-the-loop, standalone performance, ground truth establishment for training sets, multi-reader multi-case studies, and effect size of AI assistance, are not applicable.

The document discusses non-clinical tests to demonstrate the safety and effectiveness of the device as a physical product.

Here's a breakdown of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of acceptance criteria with reported performance values in a side-by-side comparison. Instead, it describes various performance tests conducted. The acceptance criteria are implied by successful completion of these tests as per relevant standards.

• Appearance
• Basic dimensions
• Sample collection space and accessibility
• Luer connection
• Connection firmness
• Stiffness
• Toughness
• Corrosion resistance
• Leakage
• Ultrasound detectability
• X-ray detectability
• Protective sheath
• Puncture force
• Chemical Characteristics
• EO and ECH Residual
• Sterility test
• Bacterial endotoxin |
  | Comparative Performance (Sampling) | No significant difference in sampling weight or cell integrity compared to predicate devices across various tissues (liver, kidney, breast, thyroid, prostate, spleen, pancreas, lymph nodes, lungs). |

2. Sample size used for the test set and the data provenance
The document details testing conducted on the device itself and does not refer to a "test set" in the context of diagnostic data. The tests performed are for physical and functional properties of the biopsy needle.

• Sample size: Not explicitly stated for each test, but standard testing practices involve a sufficient number of samples to ensure representativeness and statistical validity.
• Data provenance: Not applicable in the context of patient data; the data is generated directly from testing manufactured devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a physical device. Ground truth refers to diagnostic accuracy in AI/imaging studies.

4. Adjudication method for the test set
Not applicable. Adjudication methods are used to establish ground truth in diagnostic studies, typically involving disagreements between expert readers.

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 a physical device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "Comparative study" mentioned in section 4 (Non-Clinical Tests), the ground truth for evaluating sampling performance would inherently be pathology-based assessment of the collected tissue samples (e.g., measuring sampling weight and assessing cell integrity). While not explicitly stated as "ground truth," this is the objective measure used to compare the device's performance against predicates.

8. The sample size for the training set
Not applicable. This is a physical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established
Not applicable. This is a physical device, not an AI model.

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Automatic Core Biopsy Instrument is intended for use in obtaining biopsies from soft tissues such as breast, liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.

Semi-Automatic Core Biopsy Instrument is intended for use in obtaining biopsies from soft tissues such as lung, liver, spleen, kidney, prostate, lymph nodes, breast, thyroid, and various soft tissue tumors. It is not intended for use in bone.

Disposable Coaxial Biopsy Needle is intended for use as a guiding needle in obtaining core biopsy samples from soft tissue such as lung, liver, spleen, kidney, prostate, lymph nodes, breast, thyroid and various soft tissue tumors. It is designed for use with CuraWay Automatic Core Biopsy Instrument and CuraWay Semi-Automatic Core Biopsy Instrument. It is not intended for use in bone.

Automatic Core Biopsy Instrument has seven models. Some models are automatic firing, and others have both automatic firing and delay firing options. The structure is consisted of Inner Stylet, Cutting Cannula, Operating Handle, Actuation button, Depth stopper, Slide block, Protective sheath, Adjustable Knob (on some models), Charging handle (on some models), and Security Lock (on some models). Each model has various specifications depending on different sizes such as needle lengths, needle diameters, etc. The cutting cannula has centimeter scales and an ultrasound enhancement. The device is single-use and sterilized by EO gas.

Semi-Automatic Core Biopsy Instrument has two models. It consists of Inner stylet, Cutting cannula, Fixed handle, Windows, Safety switch, Plunger and Protective sheath. Each model has various specifications depending on different sizes such as needle lengths, needle diameters, etc. The plunger is color-coded. The Cutting cannula has centimeter scales and an ultrasound enhancement. The device is single-use and sterilized by EO gas.

Disposable Coaxial Biopsy Needle has two models. It consists of Inner Stylet, Cutting cannula, Operating handle of Cutting cannula, Operating handle of Inner stylet, Depth stopper, Protective Sheath, Adaptor (optional) and Blunt needle (optional). An adjustable depth stopper is included and is color-coded. It is available in several needle gauge sizes and lengths. It is intended for use as a guiding needle with CuraWay Automatic Core Biopsy Instrument and CuraWay Semi-Automatic Core Biopsy Instrument. The outer cannula is one gauge-size less than the compatible biopsy instrument/needle. The Cutting cannula has numerical scales and an ultrasound enhancement. The device is single-use and sterilized by EO gas.

This document describes the premarket notification (510(k)) for three medical devices: Automatic Core Biopsy Instrument, Semi-Automatic Core Biopsy Instrument, and Disposable Coaxial Biopsy Needle, manufactured by Zhejiang CuraWay Medical Technology Co., Ltd.

The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of AI/ML performance. This document primarily focuses on establishing substantial equivalence to predicate devices based on design, indications for use, and non-clinical performance testing.

Therefore, I cannot provide the requested information regarding:

• 1. A table of acceptance criteria and the reported device performance
• 2. Sample size used for the test set and the data provenance
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• 4. Adjudication method for the test set
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
• 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
• 7. The type of ground truth used
• 8. The sample size for the training set
• 9. How the ground truth for the training set was established

The document explicitly states under section 5. Clinical data: "No clinical data was provided." This reinforces that the review was based on non-clinical (bench) testing and comparison to predicate devices, not on a study demonstrating clinical performance or AI/ML algorithm performance.

Summary of available information (Non-Clinical Testing):

The manufacturer performed the following bench testing to demonstrate the intended use of the products:

• Biological Testing (Biocompatibility):
  • In Vitro Cytotoxicity Test (ISO 10993-5: 2009)
  • Intracutaneous Reactivity Test (ISO 10993-23: 2021)
  • Skin Sensitization test (ISO 10993-10: 2021)
  • Irritation or Intracutaneous Reactivity (ISO 10993-10)
  • Acute Systemic Toxicity Test (ISO 10993-11: 2017)
  • Pyrogen Test (ISO 10993-11: 2017)
• Sterilization validation: Performed according to ISO 11135: 2014, with EO and ECH validated per ISO 10993-7: 2008. Sterility test per ISO 11737-2: 2019. SAL=10^-6.
• Packaging and shelf-life testing: Performed according to ASTM F1980: 2016.
• Performance comparison with predicate devices: Included appearance, dimensions, sampling performance, connection firmness, stiffness, toughness, resistance to corrosion, puncture force, and chemical properties.

Conclusion stated in the document:
"The indications for use, design and nonclinical performance testing indicate that the technological characteristics of subject device are equivalent to that of predicate devices. In conclusion, it can be determined that subject device is substantially equivalent to predicate devices."

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The product is indicated for use in aspirating bone marrow and for use in obtaining core biopsy samples of bone and/or bone marrow.

This product is a manual, sterile and disposable biopsy needle intended to aspirate bone marrow and obtain core biopsy samples of bone and/or bone marrow. The product is available in two models, BNMAB-1 and BNMA/CB-1. The main body of product consists of stylet part and cannula part, with a depth guard that can be adjusted for puncture depth. The model BNMA/CB-1 is equipped with an extraction cannula and extraction probe, they can be inserted into the cannula assembly to assist in cutting and removing the sample. The stylet part consists of the stylet and stylet socket, and the cannula part consists of the cannula and cannula socket. The cannula socket has a universal luer connector that can be used to connect the syringe and aspiration.

The stylet and cannula are combined to penetrate into the biopsy tissue, withdrawing the stylet and pushing the cannula forward into the tissue, at the mean time the bone tissue is extracted into the cannula lumen, swing the cannula to cut the root of the specimen, a full bone tissue is obtained.

The Bone Marrow Biopsy Needle is a single-use device, supplied in a sterile state sterilized by EO gas. Re-sterilization by users is forbidden. The shelf life is defined for 3 years.

This document is a 510(k) summary for a Bone Marrow Biopsy Needle. It includes a comparison to a predicate device and non-clinical testing. However, it does not include acceptance criteria for device performance, nor does it describe a study proving the device meets specified criteria. The document explicitly states "No clinical data was provided."

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the provided text.

The information provided only demonstrates that bench tests (puncture test, torque test, stiffness test, toughness test, and corrosion resistance test) were conducted and "all test results meet the performance requirements." Furthermore, an "ex vivo sample quality comparison" was performed, and "all the result shows the subject are substantially equivalent to the predicate devices." No specific criteria or detailed results for these tests are presented.

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Radiofrequency Generator System is used in conjunction with Cura RF Electrode for coagulation of tissue during percutaneous, laparoscopic, and intraoperative surgical procedures.

The Cura RF Electrode is to be used with Radiofrequency Generator System intended for coagulation of tissue during percutaneous, laparoscopic, and intraoperative surgical procedures.

Radiofrequency Generator System consists of a genstaltic pump for electrode cooling, a foot switch and a respiratory locator. This Radiofrequency Generator System is used in conjunction with the Cura RF electrode for coagulation of tissue during percutaneous, laparoscopic, and intraoperative surgical procedures.

The Radiofrequency Generator System is capable of delivering up to 250 W of RF power is limited through software control, and the power, impedance, current are monitored by software. The temperature of the electrode's tip is monitored for charring.

The generator generates high frequency alternating current and transferred to the RF electrode and generator is interrupted, the generator will stop the power output and trigger reminder. When the temperature of RF electrode detected by the generator exceeds 99℃, or the temperature of the neutral electrode reaches the setting temperature, the device will automatically out off the power output and give a corresponding reminder. The power output can also be manually stopped.

This document is a 510(k) Premarket Notification from the FDA, a regulatory submission for a medical device. It does not describe an AI/ML-based device, but rather a Radiofrequency Generator System and Cura RF Electrode used for tissue coagulation. Therefore, many of the typical acceptance criteria and study details related to AI/ML performance (e.g., sample size for test set, number of experts, MRMC studies, ground truth establishment for training set, etc.) are not applicable or present in this type of submission.

Specifically, the document focuses on demonstrating substantial equivalence to existing predicate devices based on:

• Indications for Use: The devices have similar intended uses.
• Technological Characteristics: Comparison of physical specifications, operating principles, and safety features.
• Performance Data (Non-Clinical): Testing against recognized standards and ex-vivo tissue tests, rather than clinical efficacy studies on human subjects that would involve extensive human reader studies or large clinical trial data sets.

Therefore, the requested information cannot be fully provided as it pertains to AI/ML device evaluations, which is not the subject of this FDA submission.

However, I can extract the relevant information regarding the non-clinical performance data and the "acceptance criteria" presented in this type of regulatory context, which are primarily compliance with relevant medical device standards.

Here's a breakdown based on the provided document and the non-applicability of certain AI/ML-specific questions:

Acceptance Criteria and Device Performance for a Radiofrequency Generator System

The acceptance criteria for this device are not defined in terms of AI/ML performance metrics (like accuracy, sensitivity, specificity, AUC) but rather through compliance with established medical device safety and performance standards, and demonstration of heating effects in ex-vivo tissue that align with the intended function.

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

The "acceptance criteria" for this specific device (a radiofrequency generator and electrode) are primarily demonstrated through compliance with various national and international standards for electrical safety, electromagnetic compatibility, usability, biological compatibility, and sterilization. The "reported device performance" refers to the successful completion of these tests.

Also explicitly stated in the comparison table of Radiofrequency Generator System: "Complied with IEC 60601-1-2". |
| Usability | IEC 60601-1-6 Edition 3.1 2013-10 (Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability) | "The test results demonstrated that the proposed device complies with the following standards:" |
| Biological Evaluation | ISO 10993-5 Third edition 2009-06-01 (Tests for in vitro cytotoxicity) | "The test results demonstrated that the proposed device complies with the following standards:" |
| | ISO 10993-10 Third Edition 2010-08-01 (Tests for irritation and skin sensitization) | "The test results demonstrated that the proposed device complies with the following standards:" |
| | ISO 10993-11 Third edition 2017-09 (Tests for systemic toxicity and Pyrogen test) | "The test results demonstrated that the proposed device complies with the following standards:" |
| Sterilization & Residuals | ISO 10993-7:2008 (Ethylene oxide sterilization residuals) | "The test results demonstrated that the proposed device complies with the following standards:" |
| | ISO 11135 Second edition 2014-07-15 [Including: Amendment 1 (2018)] (Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices) | "The test results demonstrated that the proposed device complies with the following standards:" |
| | ISO 11137-2 Third edition 2013-06 [Including AMD1:2022] (Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose) | "The test results demonstrated that the proposed device complies with the following standards:" |
| Packaging & Shelf-life | ASTM F1980-16 (Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices) | "The test results demonstrated that the proposed device complies with the following standards:" |
| Software Performance | IEC 62304:2015 and FDA guidance "Content of Premarket Submissions for Device Software Functions" (Software verification and validation testing for embedded software monitoring power, time, impedance, and temperature). | "Software verification and validation testing were conducted... to support enhanced level." (Implies successful completion and meeting requirements, as the device received 510(k) clearance). |
| Thermal Effects (Ex-vivo) | FDA Guidance 'Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery' (Test on thermal effects to evaluate width and depth of thermally damaged zone in relation to active part length, gauge, working mode, and power setting on liver, kidney, and muscle tissue). | "The test on thermal effects was performed... The test results demonstrated that the proposed device complies with the following standards:" (implies the thermal effects were within expected/acceptable parameters to show equivalence for tissue coagulation, aligning with the FDA guidance). |

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

• Test Set Sample Size: For the non-clinical tests, sample sizes are not explicitly stated in the summary, but they would be typical for engineering verification and validation testing of medical devices according to the specified standards (e.g., a certain number of units for electrical tests, specific tissue samples for ex-vivo tests). These are typically small, controlled engineering samples, not large patient datasets.
• Data Provenance: The tests are likely performed by the manufacturer (Zhejiang CuraWay Medical Technology Co., Ltd. in China) or contract testing organizations on their behalf. The data is prospective in the sense that the tests were specifically conducted to support this submission.

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

This question is not applicable as this is not an AI/ML diagnostic device requiring expert consensus for "ground truth" on diagnoses. The "ground truth" for this device's performance is objective measurements (e.g., electrical parameters, temperature readings, physical dimensions of coagulation zones) and compliance with specified engineering and medical device standards.

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

This question is not applicable as it pertains to expert consensus/adjudication in diagnostic studies, which is not relevant for this type of device submission.

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 question is not applicable. An MRMC study is relevant for AI/ML diagnostic aids that assist human readers. This device is a therapeutic/surgical tool (radiofrequency generator), not a diagnostic AI.

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

This question is not applicable for the same reasons as above. The device's performance is its direct physical output (e.g., RF energy, coagulation effect), not an algorithm-only output like an AI diagnostic prediction. Its "standalone" performance is assessed through its compliance with technical standards and ex-vivo tests.

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

The "ground truth" for this device's performance is based on:

• Pre-defined technical specifications and ranges for electrical output, temperature monitoring, and safety features.
• The ability to achieve intended thermal effects (coagulation zone) in ex-vivo tissue models, compared against expectations from existing predicate devices and literature.
• Compliance with recognized national and international consensus standards (e.g., IEC, ISO, ASTM).

8. The sample size for the training set

This question is not applicable. This is not an AI/ML device that requires a "training set" in the machine learning sense. The device is a hardware system with embedded software, developed using traditional engineering principles and verified/validated against specifications and standards.

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

This question is not applicable for the reasons stated above.

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The JM-S40 Endovenous Radiofrequency Generator is intended for use with CuraWay's Endovenous RF Catheter intended for vessel and tissue coagulation.

The Endovenous Radiofrequency Catheter is intended to be used with CuraWay's JM-S40 Endovenous RF Generator indicated for endovascular coagulation of blood vessels in patients with superficial vein reflux.

The JM-S40 Endovenous Radiofrequency Generator includes a host and a power cord. The JM-S40 Endovenous Radiofrequency Generator is intended to be used with the Endovenous Radiofrequency Catheter for vessel and tissue coagulation. The JM-S40 Endovenous Radiofrequency Generator outputs RF energy and the Endovenous Radiofrequency Catheter is the applied part. The JM-S40 Endovenous Radiofrequency Generator has simple operation and simple interface, and can accurately provide real-time monitoring of temperature, power and time during RF output.

The generator generates high frequency alternating current and transfers to the catheter. When the cable of the catheter or its connection is interrupted, the host will stop the power output and trigger alarm. When the temperature of catheter detected by the generator exceeds 130 ℃, the device will automatically cut off the power output and give a corresponding reminder. The power output can also be manually stopped.

The provided FDA 510(k) summary (K232505) for the Zhejiang CuraWay Medical Technology Co., Ltd. Endovenous Radiofrequency Generator and Catheter does not contain explicit acceptance criteria tables or detailed comparative effectiveness studies with human readers (MRMC). The document primarily focuses on demonstrating substantial equivalence to a predicate device (VNUS Radiofrequency Generator K040638 and VNUS®Closure FAST™ Catheter K061373) through non-clinical performance and safety standards testing.

Here's an breakdown based on the information provided, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with specific numerical targets. Instead, it describes performance through comparison to the predicate device and compliance with established standards. The qualitative "acceptance" is based on demonstrating substantial equivalence in various aspects.

2. Sample Size for Test Set and Data Provenance

• Ex-vivo tissue thermal spread testing: "bovine liver tissue" was used. The specific number of samples or livers is not provided.
• In-vivo animal (goat) testing: "In-vivo animal (goat) testing" was conducted. The specific number of goats is not provided.
• Data Provenance: The nature of these tests (ex-vivo and in-vivo animal) suggests prospective experimental data generated for the purpose of this submission. The country of origin for the studies is not explicitly stated, but the company is based in China.

3. Number of Experts and Qualifications for Ground Truth

This type of submission (510(k) for a medical device that performs a physical action, like RF ablation) does not typically involve human expert readers establishing ground truth for diagnostic imaging. The "ground truth" here is based on physical and biological measurements.

• For the ex-vivo testing, results are likely analyzed by researchers with expertise in thermal tissue ablation and potentially a pathologist or histologist to assess ablation zones.
• For the in-vivo animal testing, the ground truth would be established through:
  • Direct observation (general observe).
  • Clinical laboratory tests (blood routine, blood biochemistry) interpreted by veterinary or medical lab experts.
  • Ultrasound monitoring interpreted by veterinary radiologists or sonographers.
  • Histopathological examination interpreted by veterinary pathologists.
  • These assessments would determine the "truth" of the device's effects on the animal models.

The specific number of experts and their detailed qualifications are not provided in the 510(k) summary.

4. Adjudication Method for the Test Set

Adjudication methods like "2+1" or "3+1" are relevant for expert consensus in diagnostic studies, particularly when there might be disagreement in image interpretation. This 510(k) summary does not indicate such a method, as the "ground truth" is derived from objective physical measurements and biological assessments rather than subjective expert interpretation of images.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done or reported. This type of study is typically conducted for AI-powered diagnostic devices where the AI assists human readers in interpreting images. The Zhejiang CuraWay device is an Endovenous Radiofrequency Generator and Catheter, a therapeutic device designed to perform an ablation procedure, not a diagnostic imaging interpretation tool. Therefore, a study comparing human readers with and without AI assistance is not applicable here.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

No standalone performance study for an algorithm without human-in-the-loop was done or reported. Similarly to the point above, this device performs a physical therapeutic action and is operated by a clinician. While it includes embedded software for monitoring parameters (power, time, impedance, temperature), its "performance" is inherently tied to its physical interaction with tissue under human control, not as an autonomous diagnostic algorithm. The software is part of the control system, not a standalone diagnostic tool.

7. Type of Ground Truth Used

• Ex-vivo testing: The ground truth for thermal spread and ablation effect was based on direct observation and measurement of the treated bovine liver tissue. This is a pathology/histology-based ground truth for the physical effect.
• In-vivo animal testing: The ground truth for the device's impact on living tissue was established through a combination of:
  • Clinical observation
  • Laboratory outcomes data (blood routine, blood biochemistry)
  • Imaging data and interpretation (Ultrasound Monitoring)
  • Pathology/histology (Histopathological examination, vascular wall thermal damage, vascular wall inflammation)
  • This represents a comprehensive outcomes-based and pathology-based ground truth from an animal model.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI algorithm development. The software in this device is described as "embedded software, which is written in C language and is developed on the Atollic TrueSTUDIO integrated development compilation software." This implies traditional software engineering and validation rather than statistical model training. If any internal parameters of the RF generator were optimized through data, that information is not provided.

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

As no "training set" in the context of machine learning is indicated, this question is not applicable. The software validation refers to compliance with IEC 62304:2015 and FDA Guidance Content of Premarket Submissions for Device Software Functions, which focus on rigorous software development lifecycle processes, risk management, and verification/validation, rather than data-driven model training and ground truth establishment for a predictive algorithm.

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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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