(29 days)
The CONMED HelixAR ABC System is intended to deliver argon gas as well as high frequency electrical current for the cutting and/or coagulation of tissue.
The HelixAR ABC System is composed of an electrosurgical generator with argon beam coagulation (ABC) and a mobile pedestal. The generator is designed with a graphic user interface (GUI) display which allows the user to select monopolar, bipolar, and ABC modes of operation, choose power and argon flow settings, adjust user settings options, and create, edit, or delete user programs. The HelixAR mobile pedestal (cart) houses two D-size argon gas cylinders and provides connection ports for the use of wired footswitches. The mobile pedestal is designed with an argon tank capacity monitor that provides the user with feedback on the argon gas cylinder pressure.
This document is a 510(k) premarket notification from the FDA, specifically concerning the CONMED HelixAR ABC System, an electrosurgical device for cutting and coagulating tissue. As an electrosurgical device, it's not an AI/ML-driven diagnostic tool, which is typically where the detailed acceptance criteria and study designs (like MRMC studies) you've requested are relevant.
Therefore, many of the specific questions you've asked regarding AI/ML models (e.g., sample size for test/training sets, ground truth establishment, expert adjudication, MRMC studies) are not applicable to this type of medical device submission.
However, I can extract information related to the device's performance and the general "acceptance criteria" presented in the context of device safety and effectiveness.
Here's a breakdown based on the provided document:
Device: CONMED HelixAR ABC System (Electrosurgical Cutting and Coagulation Device and Accessories)
Type of Device: Electrosurgical Generator with Argon Beam Coagulation
1. Acceptance Criteria and Reported Device Performance (as interpreted for an electrosurgical device):
For an electrosurgical device, "acceptance criteria" revolve around demonstrating that the device is safe and effective for its intended use, and performs comparably to a predicate device. This is primarily established through compliance with recognized standards and bench testing.
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance / Evidence of Meeting Criteria |
|---|---|---|
| Safety | Risks associated with use are mitigated to an acceptable level. Compliance with electrical safety and electromagnetic compatibility standards. | "Risk management activities in accordance with ISO 14971 demonstrate the risks associated with the use of the HelixAR ABC System are mitigated to an acceptable level." "Design verification testing demonstrates the modified HelixAR ABC System complies with the electrical safety requirements of IEC 60601-1:2012 and IEC 60601-2-2:2009 and electromagnetic compatibility per IEC 60601-1-2:2007." |
| Performance | Meets design specifications. Performs for cutting and/or coagulation of tissue. | "Benchtop testing and software verification validation demonstrate the modified HelixAR ABC System meets design specifications." The device is cleared for its intended use: "cutting and/or coagulation of tissue." |
| Substantial Equivalence | No new risks of safety or efficacy compared to the predicate device. Substantially equivalent in design, intended use, principals of operation, and technical characteristics to the predicate. | "The differences between the predicate and modified device do not raise any new risks of safety or efficacy. Supporting information per this premarket submission confirms that the modified ConMed HelixAR ABC System is safe and effective for its intended use and is substantially equivalent in design, intended use, principals of operation, and technical characteristics to the CONMED HelixAR ABC System cleared under K152860." |
Study Proving Device Meets Acceptance Criteria:
The document describes the studies and activities undertaken to demonstrate substantial equivalence and meet the acceptance criteria. These are primarily benchtop testing, software verification and validation, and risk management activities.
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2. Sample size used for the test set and the data provenance: This is not an AI/ML device dealing with data sets of patient images/records. "Test sets" in this context refer to specific tests performed on the physical device and its software. The document does not specify the "sample size" in terms of number of patients or cases, as it's not a clinical study in that sense. The provenance would be internal laboratory testing by the manufacturer (ConMed Corporation). It's benchtop and software testing, not patient data.
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3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an electrosurgical device's performance is established through engineering and safety standards compliance, and verified through direct measurements or functional testing, not expert interpretation of patient data.
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4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This refers to clinical expert review for diagnostic AI, not electrosurgical device testing.
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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 question for AI/ML diagnostic devices, not an electrosurgical device.
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6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an electrosurgical tool, not an algorithm that performs a task autonomously. It is designed for human-in-the-loop operation during surgery.
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7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for this device's performance is based on established engineering and safety standards (e.g., IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2) and the device's design specifications. Its function (cutting/coagulation) is directly observable and measurable through bench testing, not derived from complex clinical outcomes or expert consensus on interpretations.
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8. The sample size for the training set: Not applicable. This device does not use machine learning, so there is no "training set."
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9. How the ground truth for the training set was established: Not applicable, as there is no training set for a machine learning model. For the device itself, "ground truth" (i.e., correct operation and safety parameters) is established by adherence to recognized national and international electrical safety and performance standards for electrosurgical equipment.
§ 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.