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The flexible FiAPC probes are intended for argon plasma coagulation and ablation of tissue.

The FiAPC® plus probes are sterile, single-use flexible probes intended for argon plasma coagulation (APC) and ablation of tissue. The probes have a plug on the proximal end that enables the connection to the compatible electrosurgical unit (ESU) and APC unit. The plug is ergonomically designed and contains a filter that isolates the device side from the patient side. The plug also contains an instrument recognition which ensures that the instrument can only be operated with the compatible parent devices. The connector is followed by a long tube so that the probe can be inserted into the working channel of an endoscope. At the distal end there is an opening through which the argon plasma is released. The flexible FiAPC® plus probes are available in different variants. All variants have the same outer diameter but differ in their length and distal opening.

This FDA 510(k) summary describes a device (FiAPC plus probes) that is an electrosurgical accessory, not an AI/ML powered device. As such, it does not involve acceptance criteria related to algorithmic performance, ground truth, expert opinions, sample sizes for training/test sets, or MRMC studies that are typically associated with AI/ML devices.

The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical bench testing. The evaluation is centered on the physical and functional characteristics of the probes, particularly a new variant with a modified tip design.

Here's an analysis of the provided information within the context of hardware/electrosurgical accessory evaluation:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are primarily related to its physical and functional performance, safety, and equivalence to predicate devices. These criteria are established through adherence to various international and FDA-specific guidance documents and standards.

• Equivalent ignition distances: Confirmed through side-by-side tissue testing.
  Compliance with FDA Guidance "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery", issued on March 9, 2020. |
  | Design Controls | - Verification of design change: Performed in compliance with 21 CFR 820.30 to ensure safety and effectiveness of the device. |
  | Sterilization | - Sterilization validation: Complied with ISO 11135.
• Sterility Assurance Level (SAL): Documented at 10^-6, aligning with FDA Guidance "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile".
• EO residual testing: Complied with ISO 10993-7. |
  | Packaging and Shelf-life | - Packaging and shelf-life validation: Complied with ISO 11607-1.
• Accelerated aging: Performed using ASTM F 1980, demonstrating safety and effectiveness for the defined shelf-life. |
  | Biocompatibility | - Biocompatibility testing: Complied with ISO 10993-1 and FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
• No toxicologically relevant released substances: Chemical characterization showed no such substances.
• No cytotoxic, sensitizing, irritating, or acute systemic toxic properties: Demonstrated by testing.
• Absence of pyrogens: Fulfilled criteria.
• Biocompatible over entire life cycle: Conclusion based on tests. |
  | Electromagnetic Compatibility (EMC) & Electrical Safety | - Successful testing: Complied with IEC 60601-1, IEC 60601-2-2, IEC 60601-2-18, and IEC 60601-1-2, as applicable. |
  | Software Impact (of parent device) | - Software documentation: Complied with IEC 62304 and FDA Guidance "Content of Premarket Submissions for Device Software Functions".
• Probe recognition and mode limitation: Software updates in the parent device allow for this.
• No impact on safety/performance: User interface updates do not affect safety or performance.
• No changes to mode parameters, gas flow, or performance-relevant specifications: Confirmed. |

Given that this is a hardware device (electrosurgical probes) and not an AI/ML software device, the following points are not applicable or interpreted differently:

2. Sample size used for the test set and the data provenance: Not applicable in the context of an AI/ML test set. For physical testing (e.g., tissue testing, sterilization), sample sizes would be determined by relevant engineering standards for statistical significance and regulatory compliance, but are not specified in this summary. The data provenance would be from internal lab studies and external testing facilities.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Tissue effects are assessed by objective measurements (e.g., coagulation depth, area) rather than expert consensus on a 'truth' dataset.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are relevant for subjective interpretations of data (e.g., image review), which is not the case here.
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, as this is not an AI-assisted diagnostic or therapeutic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this device does not involve an algorithm. The probes are medical instruments used by human operators.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For physical performance aspects like tissue effects, the "ground truth" would be the objective measurements obtained from laboratory testing (e.g., histological analysis of tissue for coagulation depth) and instrumental measurements for ignition distance.
8. The sample size for the training set: Not applicable, as there is no training set for an AI/ML model.
9. How the ground truth for the training set was established: Not applicable.

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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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