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ArtiSential Laparoscopic Instruments-Electrodes, Monopolar Series (Hand-controlled) are indicated for cutting and coagulation in endoscopic, gynecological, and general abdominal and thoracic and general laparoscopic procedures.

It uses the principle of applying high-frequency currents from the electrode to the human body to generate heat by bioimpedance when radio frequency (RF) energy from the electrosurgical unit applies an electric current to the electrode part, and using the generated heat to incise cellular tissues and cause coagulation. It is composed of a end-tip, Φ5, Φ8 diameter shaft, grip part, and electrosurgical unit connection electrode plug.

The provided text is a 510(k) summary for the ArtiSential Laparoscopic Instruments-Electrodes. This document describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria and study results for device performance related to a diagnostic or AI-powered medical device.

The document primarily focuses on the physical and functional aspects of the laparoscopic instruments. Specifically, it mentions:

• Principles of operation: How the device uses high-frequency currents for cutting and coagulation.
• Components: End-tip, shaft, grip part, electrosurgical unit connection electrode plug.
• Minor differences from predicate: COAG/CUT button, cable, and connector.
• Non-Clinical and/or Clinical Tests: Thermal spread testing (in accordance with FDA guidance) and Trocar Compatibility Testing (in accordance with FDA Usability guidance).

Because the device is an electrosurgical instrument and not an AI-powered diagnostic tool, the typical "acceptance criteria" and "study proving the device meets the acceptance criteria" as described in your prompt (e.g., related to sensitivity, specificity, human reader improvement with AI assistance, ground truth establishment) are not applicable to this type of medical device submission.

Therefore, I cannot extract the information requested in your prompt based on the provided text. The document confirms the device's classification as Class II, product code GEI (Electrosurgical Cutting And Coagulation Device And Accessories), and its substantial equivalence to a predicate device (K230498). The studies performed (thermal spread and trocar compatibility) are standard for this type of device to demonstrate safety and effectiveness for surgical use.

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ArtiSential Laparoscopic Instruments-Electrodes, Monopolar Series are indicated for cutting and coagulation in endoscopic, gynecological, and general abdominal and thoracic and general laparoscopic procedures.

This product is sterile, single-use, invasive instrument that used in laparoscopic surgery. There are two Version, one for Hook and Spatula. The two models are same except for jaw. This product is a specific component, but not the entire electrosurgical device. The device is not intended to be marketed with multiple components, accessories, and as part of a system.

The provided text is a 510(k) premarket notification for a medical device: "ArtiSential Laparoscopic Instruments-Electrodes." This document primarily focuses on establishing substantial equivalence to a predicate device, as required by the FDA. As such, it details physical and electrical performance characteristics of the device rather than the results of a clinical study involving human or AI interpretation of medical images.

Therefore, many of the requested points regarding acceptance criteria for AI/human reader performance in a clinical setting, sample sizes for test sets in a clinical study, expert adjudication, MRMC studies, standalone AI performance, and ground truth establishment for training sets in AI models are not applicable or find no direct mention in this document.

The document discusses engineering and safety tests for a physical instrument, not a diagnostic AI system or a comparative study of human readers.

However, I can extract and present the acceptance criteria and performance data that are relevant to the described device and its specified tests:

Acceptance Criteria and Reported Device Performance for ArtiSential Laparoscopic Instruments-Electrodes

The device under review is an electrosurgical instrument, not an AI or imaging device requiring human reader studies. Therefore, the "acceptance criteria" and "device performance" relate to physical, electrical, and mechanical integrity and function, rather than diagnostic accuracy or human interpretation.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:
The document does not refer to a "test set" in the context of clinical images or data provenance (e.g., country of origin, retrospective/prospective) because this device is a physical surgical instrument being evaluated for its engineering and safety characteristics. The tests described are laboratory and bench studies (e.g., measuring dimensions, tensile strength, electrical resistance) on samples of the manufactured device. Specific sample sizes for each test are not explicitly stated in this summary, but implied to be sufficient for engineering validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth and expert review in the context of diagnostic performance are irrelevant for the evaluation of this physical electrosurgical instrument. The "ground truth" for these tests is based on established engineering standards and physical measurements.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as this refers to adjudication of discrepancies in expert medical interpretation, which is not part of this device's evaluation.

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 surgical instrument, not an AI or diagnostic imaging tool. MRMC studies are used to assess the impact of AI on human diagnostic performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. There is no algorithm or AI component in this device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device's performance evaluation is based on engineering specifications, standardized test methods (e.g., ISO, IEC standards for biocompatibility and electrical safety), and objective physical measurements (e.g., dimensions, force, resistance, angles).

8. The sample size for the training set:
Not applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established:
Not applicable. There is no "training set" or "ground truth" in the AI sense for this device.

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ArtiSential Laparoscopic Instruments-Electrodes, Monopolar Series are indicated for cutting and coagulation in endoscopic, gynecological, and general abdominal and thoracic and general laparoscopic procedures.

This product is sterile, single-use, invasive instrument that used in laparoscopic surgery. There are two Version, one for Dissector and Scissors. The two models are same except for jaw. This product is a specific component, but not the entire electrosurgical device. The device is not intended to be marketed with multiple components, accessories, and as part of a system.

The provided text is a 510(k) premarket notification for a medical device, specifically ArtiSential Laparoscopic Instruments-Electrodes, Monopolar Series. It details the device's characteristics, intended use, and a comparison to a predicate device to establish substantial equivalence.

However, the document does not describe a study that proves the device meets specific acceptance criteria based on AI or an algorithm's performance. Instead, it focuses on the engineering and biocompatibility performance of surgical instruments. The "performance data" section details tests for biocompatibility, electrical safety, sterilization, shelf life, and functional performance of the physical instrument (e.g., appearance, dimensions, operational tests like bending/rotation, tensile strength, and electrical feedthrough).

Therefore, I cannot fulfill the request to describe the acceptance criteria and study proving an AI or algorithm's performance, as this information is not present in the provided text. The document is about physical surgical instruments, not an AI/algorithm-driven device.

If you are interested in the acceptance criteria and performance of the physical device as described in this document, I can extract that information. Please clarify if that is what you are looking for.

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Indications for use include electrosurgical coagulation, dissection, and grasping of tissue during the performance of laparoscopic and general surgical procedures.

The ArtiSential Laparoscopic Instruments – Electrodes, Bipolar series(four versions, ABF01 series, ABD01 series, ABD02 series and ABD04 series) are sterile, single-use, invasive instruments that used in laparoscopic surgery. There are four versions, ABF01 series, ABD01 series, ABD02 series and ABD04 series. Three versions are same except for jaw shape. This product is a specific component, but not the entire electrosurgical device. The device is not intended to be marketed with multiple components, accessories, and as part of a system.

The LivsMed Inc. ArtiSential Laparoscopic Instruments-Electrodes, Bipolar series (four versions) underwent a series of performance tests to demonstrate its safety and effectiveness.

Here's an overview of the acceptance criteria and study details:

1. Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes for each test within the performance data section (e.g., how many devices were tested for dimensions, tensile strength, etc.). However, the tests are laboratory-based and involve physical and electrical characterization of the device.

• Provenance: This is a premarket notification (510(k)) for a medical device. The tests described are laboratory studies conducted by the manufacturer, LivsMed Inc., based in the Republic of Korea. Therefore, the data provenance is likely from laboratory testing conducted in South Korea. The studies are prospective in the sense that they are conducted specifically to demonstrate the device's conformance to standards and claims for regulatory submission.

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

Since this is a physical medical device (laparoscopic instruments-electrodes) and the performance data primarily relates to physical, mechanical, and electrical characteristics, there is no mention of experts establishing a "ground truth" for a test set in the traditional sense of diagnostic accuracy studies. The "ground truth" for these tests is defined by the established engineering specifications, international standards (e.g., IEC, ISO), and performance requirements for electrosurgical instruments.

For the thermal effect study, histological analysis was performed. This would implicitly involve qualified personnel (e.g., pathologists or histotechnicians) to interpret the tissue samples, but the document does not specify their number or qualifications.

4. Adjudication Method for the Test Set

Not applicable. The tests are directly measuring physical and electrical properties against predefined numerical or qualitative criteria. This is not a scenario that typically requires an adjudication method as seen in diagnostic image interpretation.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (e.g., AI in radiology) where human readers interpret cases. The device in question is a surgical instrument.

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

No, a standalone (algorithm only) performance study was not done. This device is a manual surgical instrument, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for these performance tests is based on:

• Engineering specifications and design requirements: For appearance, dimension, operational tests (jaw movement, rotation), and tensile strength.
• International standards: For biocompatibility (ISO 10993-1), electrical safety (IEC 60601 series), and sterilization (ISO-11135).
• Physical laws/principles: For feedthrough (electrical resistance).
• Histological analysis: For thermal effects, where the "ground truth" would be the observed tissue changes interpreted by qualified personnel against expected outcomes for electrosurgical devices.

8. The Sample Size for the Training Set

Not applicable. This device is a physical instrument, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

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

Not applicable, as there is no training set.

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Indications for use include electrosurgical coagulation, dissection, and grasping of tissue during the performance of laparoscopic and general surgical procedures.

The ArtiSential Laparoscopic Instruments - Electrodes, Bipolar series are sterile, single-use, invasive instruments that used in laparoscopic surgery. There are three versions, ABF01 series and ABD02 series. Three versions are same except for jaw shape. This product is a specific component, but not the entire electrosurgical device. The device is not intended to be marketed with multiple components, accessories, and as part of a system.

This document concerns the 510(k) premarket notification for the ArtiSential Laparoscopic Instruments-Electrodes. This is a medical device for electrosurgical cutting and coagulation and is a Class II device. The document is a Special 510(k) Summary, indicating that the device has minor modifications compared to a previously cleared predicate device (K200875).

Here's an analysis of the acceptance criteria and study information provided, focusing on what's available in the document:

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

The document describes performance tests as having been conducted and met, but it does not provide specific quantitative acceptance criteria or detailed reported performance values in a table. Instead, it states that "The device had passed all performed tests" and "Based on these performance characteristics, the results demonstrate that the performance requirements were met, the device performs as intended and that the subject device has substantially equivalent performance characteristics to the predicate devices."

The types of performance tests mentioned are:

In addition, the following characteristics were declared the same as the predicate device (K200875):

• Biocompatibility: Same as predicate.
• Electrical Safety: Tested according to IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-18 and IEC 60601-2-2. Active accessory insulation, HF leakage, HF dielectric strength, and mains frequency dielectric strength, and feedthrough test were reportedly performed and are the same as the predicate.
• Sterilization: EO (Ethylene Oxide) sterilization, same as predicate.
• Shelf life: 2 years, same as predicate.

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

The document does not specify the sample size used for the performance tests. There is no information regarding the provenance of the data (e.g., country of origin, retrospective or prospective).

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

This information is not applicable and not provided. The device is a surgical instrument, and its performance tests are primarily objective physical, electrical, and mechanical evaluations, not diagnostic assessments requiring expert ground truth for interpretation.

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

This information is not applicable and not provided as the tests are objective engineering evaluations, not subjective assessments requiring 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:

This information is not applicable and not provided. This is a surgical instrument, not an AI-assisted diagnostic device, so MRMC studies or AI assistance effect sizes are not relevant.

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

This information is not applicable and not provided. This is a manually operated surgical instrument, not an algorithm.

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

This is not applicable in the sense of clinical ground truth for diagnostic accuracy since the device is a surgical instrument. The "ground truth" for the performance tests would be established by engineering specifications, regulatory standards (e.g., IEC standards for electrical safety), and industry best practices for mechanical and functional performance testing of such devices.

8. The sample size for the training set:

This information is not applicable and not provided as this is a physical medical device, not a machine learning algorithm requiring a training set.

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

This information is not applicable and not provided (see point 8).

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ArtiSential Laparoscopic Instruments-Electrodes, Monopolar Series are indicated for cutting and coagulation in endoscopic, gynecological, and general abdominal and thoracic and general laparoscopic procedures.

This product is sterile, single-use, invasive instrument that used in laparoscopic surgery. There are two Version, one for Dissector and Scissors. The two models are same except for jaw. This product is a specific component, but not the entire electrosurgical device. The device is not intended to be marketed with multiple components, accessories, and as part of a system.

The provided document is a 510(k) summary for the ArtiSential Laparoscopic Instruments-Electrodes, Monopolar Series. It describes the device, its indications for use, and a comparison to predicate and reference devices. The document does not contain acceptance criteria in the traditional sense of specific performance metrics (e.g., sensitivity, specificity, accuracy) that are typically used to evaluate the performance of diagnostic or AI-driven medical devices.

Instead, this document focuses on demonstrating substantial equivalence to a legally marketed predicate device (K200501) and a reference device (K201063) by ensuring the new device meets established safety and performance standards for electrosurgical instruments. The "tests" here are primarily engineering and biocompatibility tests to prove the device is safe and performs its intended function reliably, not clinical performance metrics against a "ground truth" as would be seen for a diagnostic AI.

Therefore, many of the requested sections regarding acceptance criteria, sample sizes for test/training sets, ground truth establishment, expert adjudication, and MRMC studies are not applicable to the information provided in this document as it pertains to a physical surgical instrument, not an AI/diagnostic software.

Here's an attempt to extract relevant information given the limitations:

1. Table of Acceptance Criteria and Reported Device Performance:

Since specific numerical acceptance criteria (like accuracy percentages for AI models) are not provided for this type of device, the "acceptance criteria" are implied by the standards and categories of tests performed, aiming to show compliance and functionally equivalent performance to the predicate device.

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 typically not provided for engineering and biocompatibility testing of physical medical devices. The "test set" here refers to the actual device units subjected to the various physical, electrical, and thermal tests mentioned. The number of units tested for each specific test is not detailed in this summary. Data provenance (country of origin, retrospective/prospective) is also not applicable in the context of these device verification studies.

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)

Not applicable. "Ground truth" in the context of diagnostic AI refers to a definitive correct answer for a medical condition. For a physical electrosurgical instrument, the "ground truth" is its ability to meet engineering specifications and functional performance (e.g., cutting and coagulating as intended), which is assessed through standardized tests and not by expert consensus on clinical cases. The thermal effects study likely involved technicians or engineers performing the tests and evaluating the tissue response according to predefined criteria.

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

Not applicable. Adjudication methods are used in clinical studies, particularly for diagnostic imaging, to resolve discrepancies among expert interpretations. For engineering tests, results are typically objective measurements or observations against predefined pass/fail criteria.

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 specific to diagnostic AI or imaging interpretation and are not relevant to the evaluation of a physical electrosurgical instrument.

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

Not applicable. This device is a physical surgical tool, not an algorithm, and its use inherently involves a human surgeon.

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

As explained above, traditional "ground truth" for diagnostic AI is not applicable. For this device, the "ground truth" is defined by adherence to established engineering standards (e.g., IEC 60601, ISO 10993, ISO 11135, ASTM F88, ASTM F1929) and successful demonstration of functional performance characteristics (cutting and coagulation on tissue samples).

8. The sample size for the training set

Not applicable. This device is not an AI model requiring a training set.

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

Not applicable. This device is not an AI model requiring a training set with established ground truth.

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Indications for use include electrosurgical coagulation, dissection, and grasping of tissue during the performance of laparoscopic and general surgical procedures.

The ArtiSential Laparoscopic Instruments - Electrodes, Bipolar series are sterile, single-use, invasive instruments that used in laparoscopic surgery. There are three versions, ABF01 series, and ABD02 series. Three versions are same except for jaw shape. This product is a specific component, but not the entire electrosurgical device. The device is not intended to be marketed with multiple components, accessories, and as part of a system.

The provided text describes a 510(k) premarket notification for a medical device, specifically the "ArtiSential Laparoscopic Instruments - Electrodes". This document asserts the substantial equivalence of the new device to a predicate device (K190909) and details various performance tests conducted.

However, it does not contain information related to acceptance criteria, reported device performance in those terms, sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for AI/ML device studies. The document describes a traditional medical device (surgical instruments) and its non-AI related testing for regulatory clearance.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study that proves an AI/ML device meets them based on the provided text. The document focuses on demonstrating substantial equivalence to a predicate device through manufacturing and basic performance testing, not on the validation of an AI/ML component.

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