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The Erbe APC 3 with accessories is intended to deliver argon gas for argon plasma coagulation and ablation of tissue as well as argon-assisted cutting of tissue when used in conjunction with a compatible Erbe VIO Electrosurgical Generator (ESU) and applicators or probes.

The Erbe Argon Plasma Coagulation Unit Model APC 3 is an APC unit for use in conjunction with an Erbe Electrosurgical Unit (ESU) compatible Model (currently Model VIO® 3). The APC 3 (as well as VIO 3) can be mounted/secured to a cart or on a ceiling mount using fastening sets, i.e. connecting cables and hardware. The APC 3 is connected to an argon gas source via a pressure reducer and connected to the VIO 3 which powers and controls the APC unit. The ESU further provides a touch-screen monitor (i.e., interactive display) with an onscreen tutorial, settings and operational information as well as safety features (i.e., audio and visual error system). When using the APC 3 together with the VIO 3, the user is offered various APC Modes as well as argon-supported Modes which can be adjusted by the physician via effect levels in order to achieve the desired tissue effect. The ESU VIO 3 provides the high-frequency (HF) current required for thermal coagulation. For argon plasma coagulation and ablation, the HF current is applied non-contact to the tissue to be coagulated through ionized and hence electrically conductive argon gas (argon plasma). The argon gas is ionized in the high-frequency electrical field between the electrode of the applicator and the tissue. For argon-assisted cutting, the ESU provides the regular cutting/coagulation Mode while the argon gas provided by the APC 3 circulates the active electrode. This application is with contact to tissue.

Applicators or probes connected to the APC 3 for coagulating tissue via argon plasma and/or for cutting tissue supported by argon gas may be activated via footswitches connected to the ESU or by use of applicators that have an activation finger switch.

The APC unit and its accessories (i.e. pressure reducer and fastening sets) are supplied non-sterile and are reusable. Cleaning and disinfections are provided in the APC user manual or notes on use of the involved accessory. The compatible applicators and probes are provided sterile as well as are single-use.

This document describes the Erbe Argon Plasma Coagulation Unit APC 3 with Accessories, and its substantial equivalence to a predicate device. It primarily focuses on the device's technological characteristics and safety standards rather than clinical performance or AI-driven improvements in human reading. Therefore, much of the requested information regarding AI acceptance criteria, clinical study specifics (sample size, expert involvement, MRMC studies, ground truth), and training set details for AI cannot be extracted from this document because it is about an electrosurgical device, not an AI/ML-driven diagnostic device.

Here's a breakdown of what can be extracted, and where limitations exist based on the provided text:

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

The document doesn't provide specific quantitative acceptance criteria or detailed performance metrics in a table format for clinical efficacy. Instead, it focuses on general safety, performance, and substantial equivalence to a predicate device based on technical specifications and adherence to recognized standards.

Acceptance Criteria (Implied from the document):

• Safety: Adherence to electrical safety standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2).
• Performance: Ability to deliver argon gas for argon plasma coagulation, ablation, and argon-assisted cutting as intended. This is assessed through "Output/Mode Comparison," "Tissue Testing," and "Capacitive Coupling" as listed in the "Performance Evaluations/Testing" section.
• Usability: Conformance to usability engineering standards (e.g., IEC 62366, IEC 60601-1-6).
• Compatibility: Operation with compatible Erbe VIO Electrosurgical Generators (ESU) and specific applicators/probes.
• Substantial Equivalence: Demonstrating that the new device has "essentially the same principles of operation, technological characteristics, as well as performance characteristics as the predicate APC unit."

Reported Device Performance:
The document states that "Validation and verification activities in design control that includes testing/certification to designated standards (including electrical safety standards) and performance testing of the proposed devices has demonstrated substantial equivalence to the predicate." However, specific numerical performance data (e.g., coagulation efficacy rates, ablation depth measurements, cutting speeds) are not provided. The "Output/Mode Comparison" and "Tissue Testing" are mentioned as performance evaluations, but their results are summarized qualitatively as proving substantial equivalence.

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

This document describes a medical device (an electrosurgical unit), not an AI/ML diagnostic algorithm tested on a dataset of patient data. Therefore, the concepts of "test set sample size" and "data provenance" in the context of clinical/imaging data are not applicable here. The testing involves engineering and performance validation of the device itself, rather than testing on a retrospective or prospective clinical dataset.

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

Not applicable. This is not an AI/ML diagnostic device requiring expert annotation of medical images or data to establish ground truth for a test set. The validation is technical and engineering-focused.

4. Adjudication method for the test set

Not applicable. As this is not a diagnostic device involving human interpretation of data, there is no need for adjudication of readings.

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 not an AI-assisted diagnostic tool, so an MRMC study and
assessment of human reader improvement with AI assistance is irrelevant.

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

Not applicable. This is not an algorithm. It is a hardware medical device.

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

The "ground truth" for this device's performance evaluation is based on engineering standards, physical measurements, and comparison to the predicate device's established performance characteristics. It relies on:

• Compliance with recognized consensus standards: e.g., electrical safety, electromagnetic compatibility, usability (IEC, ISO standards listed).
• Physical (in-vitro/bench) testing: "Output/Mode Comparison," "Tissue Testing," "Capacitive Coupling." These tests would compare the device's output and tissue effects to specifications and the predicate.
• Functional verification: Ensuring the device operates as intended when connected to compatible components.

It does not involve "expert consensus," "pathology," or "outcomes data" in the sense of clinical diagnostic accuracy.

8. The sample size for the training set

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

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

Not applicable. See point 8.

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The Easylnstruments are indicated for cutting, grasping, dissecting and coagulation of tissue in laparoscopic surgical procedures.

The A.M.I. EasyInstruments device is a modular instrument system for use in laparoscopic highfrequency (HF) surgery and is designed for monopolar application. The Easylnstruments system comprises three-part detachable instruments, which include 1) different functional handles (EasyHandle), 2) instrument shafts of various diameters and lengths (EasyShaft), and 3) a wide range of different, application-specific attachments (EasyTips). It is intended during laparoscopic procedures to mobilize, manipulate, grasp, hold, fix, retract, dissect, cut, and coagulate tissue.

This FDA 510(k) summary describes a medical device, the EasyInstruments, which are electrosurgical cutting and coagulation devices and accessories. The document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and performance against those criteria in a clinical study for a new AI/software component. Therefore, much of the requested information (like number of experts, adjudication methods, MRMC studies, ground truth for test/training sets, effect size of AI improvement) is not applicable or cannot be extracted from this document because it pertains to the evaluation of AI/software in a clinical context, which is not the subject of this 510(k) for electrosurgical instruments.

However, I can extract information related to the performance testing that was conducted to demonstrate safety and efficacy compared to predicate devices for these hardware instruments.

Here's an attempt to answer the questions based on the provided text, noting where the requested information is not present or applicable:

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

The document does not explicitly state acceptance criteria in precise numerical terms or detailed performance metrics in a table. It lists numerous tests performed to demonstrate safety and performance relative to predicate devices. The "reported device performance" is summarized as "The results of these tests indicate that the EasyInstruments are substantially equivalent to the predicate devices" and "it can be concluded that the subject device does not raise new issues of safety or efficacy compared to the predicate devices."

Below is a summary of the types of tests performed and the general outcome:

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

• Sample size for test set: Not explicitly specified for each test. For "Thermal effects on tissue," it mentions "ex vivo animal tissues (liver, kidney, and muscle)," implying a sample of tissue, but the quantity is not detailed. For bench performance, it refers to "disposable tips," "reusable tips," "EasyHandle," and "EasyShaft," suggesting multiple units were tested, but precise numbers are not provided.
• Data provenance: Not specified. The manufacturer is based in Austria, but the location where the tests were specifically conducted or the origin of the animal tissues is not stated. The tests are non-clinical (bench, ex vivo).

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. This document pertains to the 510(k) clearance of electrosurgical instruments (hardware), not an AI/software device that requires expert-established ground truth for image interpretation or diagnosis. The "ground truth" here related to performance testing (e.g., measurements of thermal damage, visual inspection criteria, electrical readings), not clinical diagnoses.

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

Not applicable, for the same reasons as #3. Adjudication methods are typically used in clinical studies involving interpretation of medical data, where there might be disagreement among experts.

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 not an AI/software device, so no MRMC study or AI assistance evaluation was performed.

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

Not applicable. This is not an AI/software device.

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

For the non-clinical performance and thermal effects testing, the "ground truth" would be established by:

• Engineering specifications and standards (e.g., for electrical safety, dimensions, opening angles, grasping strength, continuity checks).
• Histological assessment for thermal damage (directly observing tissue changes).
• Standardized methods for cleaning/sterilization efficacy.
• Biocompatibility test results against established safety limits.

8. The sample size for the training set

Not applicable. This is not an AI/software device that requires a training set.

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

Not applicable, for the same reasons as #8.

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The Veloxion System is intended for intrauterine use by trained gynecologists for endoscopically controlled tissue chip resection and coagulation, and removal of intrauterine polyps and myomas via suction channel under continuous flow conditions following resection using a bipolar resecting device. It is also intended to distend the uterus by filling with saline to facilitate viewing with a hysteroscope and to monitor the volume differential between into and out of the uterus.

The Veloxion System consists of the following components:

• Veloxion Controller (with Integrated Fluid Control)
  • Footswitch
• Veloxion Resecting Device Kit:
  • Veloxion Resecting Device
  • Sheath
  • Continuous Flow Optical Obturator
• Veloxion Fluid Control Set
• Veloxion Saline Pole
  The Veloxion System also includes the following Class I accessories for handling of waste collected from the patient (these items apply no aspiration to the patient, they only handle waste after it is already outside the patient), which includes:
• Waste Accessory Bag for collection of waste aspirated form the patient and from under patient's buttocks,
• Waste Accessory Tubing for collection of waste from under the patient's buttocks
• Waste Management Pump for moving the waste to the Waste Bag.
  The Veloxion System provides bipolar resection and coagulation of intrauterine tissue, it distends the uterus by filling with saline, it provides pressure control of the intrauterine cavity for insufflation to facilitate viewing with a hysteroscope and it monitors the fluid deficit (potential fluid absorbed by the patient's body) to the physician established limit.

The provided text describes a 510(k) premarket notification for the Veloxion System, a hysteroscopy device, and compares it to predicate devices. However, the document does not contain information related to acceptance criteria or a study proving the device meets specific performance metrics in the format requested, particularly for an AI/algorithm-based device.

The "Performance Data" section (Page 8 of the original document) lists various tests performed, but these are general engineering and functional validation tests for the hardware components of the hysteroscope system (e.g., software V&V, integrity, functional testing of aspiration/irrigation, dimensional inspection, simulated use, durability, electrical safety, usability). These tests are typical for a medical device's safety and effectiveness but do not detail specific acceptance criteria for device performance in a clinical context (e.g., sensitivity, specificity, accuracy for a diagnostic task), nor do they describe a study comparing the device's diagnostic or assistive capabilities against a specific ground truth, as would be expected for an AI/algorithm.

Therefore, many of the requested data points cannot be extracted from this document as they are not present. The document focuses on establishing substantial equivalence based on technological characteristics and general performance testing of the physical system, not on the performance of a specific algorithm or AI component in a diagnostic or interpretive task.

If the "Veloxion System" refers to a device with an AI component for interpretation, that information is not detailed within this 510(k) summary. The summary describes fluid control, tissue resection, and coagulation functions.

Based on the information provided in the document:

1. A table of acceptance criteria and the reported device performance: Not available in a format detailing clinical performance metrics (e.g., sensitivity, specificity, accuracy) for an AI or algorithm. The document lists general performance data for the physical device, such as "Software Verification and Validation Testing," "Integrity: System withstands operating pressures," "Functional Testing: Cut and coagulation, aspiration, irrigation, pressure control," etc. These are not quantifiable metrics that can be presented in a table against acceptance criteria for an AI's diagnostic or interpretive performance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable or not provided. The testing described is for the hardware system's functionality and safety, not for an algorithm's diagnostic performance on a dataset.

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 or not provided, as there is no mention of a diagnostic performance study with ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable or not provided.

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 or not provided. The document describes a medical device for hysteroscopy, not an AI-assisted diagnostic tool for interpretation by human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable or not provided. The device described performs physical actions (resection, coagulation, fluid control) and monitoring, not standalone image analysis or diagnostic tasks.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable or not provided, as there is no diagnostic performance study described.

8. The sample size for the training set: Not applicable or not provided. This would be relevant for an AI/machine learning model, which is not the focus of this 510(k) summary.

9. How the ground truth for the training set was established: Not applicable or not provided.

Summary of available performance data (from section VII "Performance Data") related to the device's functional performance:

The document indicates that the following performance data were provided in support of substantial equivalence:

• Software Verification and Validation Testing performed per IEC 62304 and FDA guidance.
• Integrity testing (system withstands operating pressures).
• Functional Testing (Cut and coagulation, aspiration, irrigation, pressure control).
• Dimensional Inspection and Testing.
• Simulated Use (Tissue resection and spot coagulation, regulation of cavity pressure).
• Durability Testing (Electrode durability for tissue resection and coagulation).
• Fluid deficit testing.
• Comparative testing to predicate for electrode durability, pressure control, and fluid control.
• Electrical Safety & EMC per IEC 60601-1:2005, IEC 60601-1-2:2014, IEC 60601-2-18:2009, and IEC 60601-2-2:2009.
• Usability Testing (Use related risk evaluation).

Conclusion from the document:
Based on these performance tests, the Veloxion System is considered substantially equivalent, safe, and effective as the predicate systems. The document confirms that the differences between the Veloxion System and predicate devices (e.g., dual pump system, programmed flow rates, single-use patient-contacting components) were evaluated through performance testing to demonstrate safety and effectiveness.

In essence, the document confirms the device meets acceptance criteria related to its mechanical, electrical, software, and functional performance, but not for AI/algorithm-based diagnostic or interpretive capabilities, as those are not described as functions of this device.

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