(30 days)
The ERBE VIO APC with Accessories is intended to deliver argon gas for argon plasma coagulation of tissue when used in conjunction with a compatible ERBE VIO Electrosurgical Generator (ESU) and applicators or probes.
The ERBE Model APC 2 with Accessories is an argon plasma coagulation system and is used in conjunction with an ERBE VIO Electrosurgical Unit (ESU). The ESU provides high frequency (hf) voltage to electrically charge argon gas from the APC unit to form plasma in the gas stream when in close proximity to tissue. Current density upon arrival at the tissue surface from an APC instrument (applicator or probe) causes coaculation. The APC with the ESU has a color monitor display that provides the user with an onscreen tutorial as well as setting and operational information. The VIO APC/ESU system has various argon as well as argon assisted coagulation and cut modes. These modes have defined effect levels to provide the physician flexibility in interventional applications. Software in the ESU controls the microprocessor chip in the APC unit and APC Handles. The VIO ESUIAPC system is programmable and has error monitoring features. There is an ERBE Communications Bus (ECB) Cable for the ESU to communicate with the APC unit. A Pressure Reducer with Sensor is provided to requlate the argon gas going into the APC unit. Two types of APC Handles are available to activate the system. One of the Handles has a "ReMode" feature so that the physician can change between two pre-programmed modes via the Handle instead of having to touch the display screen. Specific technical information on the APC and Accessories can be found in Section IV. The APC unit and these accessories are supplied non-sterile and are reusable. Cleaning/Disinfection and as applicable sterilization instructions are provided in the respective User Manual or Notes on use. See Device Labeling in Section V. Attachment 2. An APC Membrane Filter is also apart of the system. A Filter is to be used for each case/interventional application. The Filter is connected between the APC unit (at the argon gas port) and an APC Handle or Connector Hose. The Filter creates a barrier to protect the APC unit from potential contamination. Filters are supplied sterile by means of ethylene oxide and are disposable (single use). They are contract manufactured and the sterilization cycle has been validated. See specific technical information in Section IV and general use information in the Notes on use in Section V, Attachment 1 for the Filter (Note: It is the same Filter used on the predicate device.).
The provided text does not describe acceptance criteria and a study to prove a device meets those criteria, as understood in the context of AI/ML medical devices.
Instead, the document is a 510(k) premarket notification for an ERBE VIO APC (Model APC 2) with Accessories, an electrosurgical cutting and coagulation device. The focus of this submission is to demonstrate substantial equivalence to a previously cleared predicate device, not to establish performance against specific acceptance criteria through a clinical or algorithmic performance study in the way AI/ML devices typically require.
Here's a breakdown of why an AI-focused answer cannot be fully provided based on the input:
- No AI/ML Component: The device described is a physical electrosurgical unit that uses argon gas and high-frequency voltage for coagulation. It does not employ artificial intelligence or machine learning.
- No "Algorithm Performance" or "Human Reader" Evaluation: Since there's no AI component, there are no algorithms to evaluate, no human readers whose performance is being augmented, and no need for concepts like ground truth, test sets, or training sets in the context of AI.
- Regulatory Pathway: The 510(k) pathway for this device relies on demonstrating that the modified device (ERBE VIO APC 2) has the "same intended use, principles of operation, and technological characteristics" as the predicate (ERBE Argon Plasma Coagulator Model APC 300) and that any changes "did not raise safety or efficacy concerns nor adversely affect safety or effectiveness." This is a comparison to a predicate, not an independent performance study against set criteria.
Therefore, an AI/ML-centric response table and study description cannot be generated from this document.
However, I can extract information relevant to the device's verification and validation in general, which is the closest equivalent to "proving the device meets acceptance criteria" in this context.
Summary of Device Verification and Validation (Non-AI/ML Context):
For this electrosurgical device, the "acceptance criteria" are implied by compliance with recognized consensus standards and the demonstration that modifications do not negatively impact safety or effectiveness compared to the predicate. The "study" involves engineering tests and adherence to software validation principles.
1. Table of "Acceptance Criteria" and "Reported Device Performance" (Interpreted for a Non-AI/ML Device):
| Acceptance Criteria (Implied by Standards & Predicate Comparison) | Reported Device Performance (as stated in 510(k) Summary) |
|---|---|
| Electrical Safety & Performance: | |
| - Electrosurgical Devices Standard Compliance | Met AAMI/ANSI HF 18 |
| - General Safety of Medical Electrical Equipment | Met EN 60601-1/IEC 60601-1 |
| - Electromagnetic Compatibility (EMC) | Met EN 60601-1-2/IEC 60601-1-2 |
| - Safety of High-Frequency Surgical Equipment | Met EN 60601-2-2/IEC 60601-2-2 |
| - Degrees of Protection Provided by Enclosures (Ingress Protection) | Met EN 60529 (IP Code) |
| Software Functionality & Safety: | |
| - Software Validation Principles Adherence | Followed "General Principles of Software Validation; Final Guidance for Industry and FDA Staff. 01/11/02" and "Guidance for FDA Reviewers and Industry. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, 05/29/98." |
| - Safety of Programmable Electrical Medical Systems (PEMS) | Met EN 60601-1-4/IEC 60601-1-4 |
| - Software Level of Concern | Determined to be a "moderate level of concern." |
| - All features/functions performed as intended by upgraded software (Revision 1.1.2) | Software was "upgraded to perform all the features/functions of the any compatible equipment." |
| Risk Management: | |
| - Risk Management System | Followed EN 1441: 1998 "Medical Devices Risk Management" for assessing the impact of modifications. |
| - Changes did not introduce new safety/efficacy concerns. | "All of the changes were verified or validated. The changes did not raise safety or efficacy concerns nor adversely affect safety or effectiveness. That is the modified device is as safe and effective as the predicate device." |
| Functional Equivalence to Predicate after modifications: | |
| - Maintain intended use, principles, materials, size, protective circuits, performance characteristics, etc. | "The ERBE VIO APC (Model APC 2) with Accessories has the same intended use, principles of operation, and technological characteristics as the predicate APC... materials, size, protective circuits, performance characteristics, packaging, and labeling (except in the descriptions of the specific user instructions) are the same or similar." |
| - Modified gas flow rate and purge time still safe and effective. | "gas flow rate range was made slightly lower with a one second shorter purge time." (Implied to be safe and effective through validation and risk analysis) |
| - New modes and effect levels provide flexibility without compromising safety/efficacy. | "Modifications to the APC unit also include slight variations to existing modes and more effect levels over larger voltage ranges. All of the APC unit changes were done to have a user-friendlier platform... provide the physician more flexibility in interventional applications." (Implied to be safe and effective through validation and risk analysis, detailed in Comparison Table and User Manual not provided here) |
| - Accessories (sensor, ReMode button) perform as intended. | "The Sensor provides the VIO ESU/APC system with in-put gas pressure data. The 'ReMode' button on the VIO APC Handle allows the physician to change between modes without having to touch the monitor..." (Implied to perform as intended and not introduce new hazards) |
Note: The 510(k) summary provides a high-level overview. The detailed test reports and validation documentation would contain the specific acceptance criteria and results for each test.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This device is not an AI/ML device, so there is no "test set" in the context of image data or patient data for algorithmic evaluation.
- The validation involves electrical measurements, software testing, and adherence to engineering standards. The "sample size" would refer to the number of devices tested, number of software test cases, or environmental conditions simulated. This information is not provided in the 510(k) summary.
- Data provenance for this type of device is typically from engineering labs and manufacturing facilities, not clinical sources or specific countries of origin related to patient data.
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 as this is not an AI/ML device and does not involve "ground truth" establishment by medical experts for a test set. Ground truth, in this context, might refer to expert verification of engineering specifications or clinical utility, but this is not discussed in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There is no "test set" of clinical cases or images that would require adjudication for this device type.
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 an electrosurgical tool, not an AI-assisted diagnostic or therapeutic tool that would involve human "readers."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device does not have a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the AI/ML sense. The "ground truth" for this device's performance would be engineering specifications, compliance with international standards, and functional equivalence to the predicate device in terms of safety and effectiveness, established through engineering tests, risk analysis, and software validation.
8. The sample size for the training set
- Not applicable. This device does not use a training set as it is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. This device does not use a training set.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.