(90 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 describes the CONMED HelixAR ABC System, an electrosurgical generator with argon beam coagulation (ABC). The information provided is primarily for a 510(k) premarket notification, focusing on demonstrating substantial equivalence to predicate devices, rather than a detailed clinical study demonstrating specific performance metrics against pre-defined acceptance criteria for a new clinical claim. Therefore, much of the requested information regarding detailed acceptance criteria and a study proving those specific criteria cannot be fully extracted.
However, based on the provided text, here's an attempt to answer the questions within the context of substantial equivalence:
1. A table of acceptance criteria and the reported device performance
The document does not present explicit, quantifiable acceptance criteria with corresponding device performance values for specific clinical outcomes (e.g., coagulation time, depth of penetration, adverse event rates). Instead, the "acceptance" is focused on demonstrating that the device is substantially equivalent to predicate devices. The performance testing section mentions compliance with several standards.
| Acceptance Criteria (Implied by Substantial Equivalence and Standards Compliance) | Reported Device Performance (Summary) |
|---|---|
| Safety and Effectiveness (equivalent to predicate devices) | "CONMED HelixAR ABC System is safe and effective for its intended use" |
| Intended Use (equivalent to predicate devices) | "Substantially equivalent in design, intended use, principals of operation, and technical characteristics to the CONMED System 7550 and CONMED System 5000." |
| Materials (equivalent to predicate devices) | Demonstrated to be substantially equivalent. |
| Technology (equivalent to predicate devices) | Demonstrated to be substantially equivalent. |
| Performance (equivalent to predicate devices) | "Performance testing ... demonstrate the HelixAR ABC System is substantially equivalent" |
| Compliance with AAMI/ANSI ES60601-1 (General requirements for basic safety and essential performance of medical electrical equipment) | Devices comply with applicable sections. |
| Compliance with IEC 60601-2-2 (Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories) | Devices comply with applicable sections. |
| Compliance with IEC 60601-1-2 (Electromagnetic compatibility - Requirements and tests) | Devices comply with applicable sections. |
| Risk Mitigation (ISO 14971) | "Risks associated with the use of the HelixAR ABC System are mitigated to an acceptable level. Analyses ... conclude the benefits ... outweigh the residual risks." |
| Generation of New Risks | "The differences between the predicate devices and the proposed device do not raise any new risks of safety or efficacy." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Benchtop and ex-vivo comparison testing as well as in-vivo simulated use testing." However, it does not specify sample sizes for these tests (e.g., number of ex-vivo tissue samples, number of in-vivo simulated use observations) nor does it provide details on the data provenance (country of origin, retrospective/prospective). The focus is on the equivalence rather than a clinical trial with a defined test set sample size.
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)
This information is not provided in the document. Given that the testing appears to be primarily benchtop, ex-vivo, and simulated in-vivo, it's unlikely that external medical experts were used to establish a "ground truth" in the way they would be for image-based diagnostic devices or clinical outcomes. The "ground truth" for electrosurgical performance would typically be based on quantifiable physical measurements and established scientific principles rather than expert consensus on subjective observations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials, especially for endpoints requiring subjective assessment, to resolve discrepancies among multiple reviewers. Since no such clinical test set or expert review process is described, an adjudication method is not mentioned.
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/provided. The HelixAR ABC System is an electrosurgical device, not a diagnostic imaging device with an AI component for interpretation. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. The HelixAR ABC System is a physical electrosurgical device that requires human operation. It does not have a standalone algorithm for performance assessment in the way AI/ML software devices do.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the performance testing mentioned (benchtop, ex-vivo, in-vivo simulated use), the "ground truth" would likely be based on:
- Physical measurements: For parameters like power output, argon flow rates, temperature, current, etc.
- Observed tissue effects: For ex-vivo and in-vivo tests, comparison to known and accepted electrosurgical tissue effects validated by established scientific methods.
- Compliance with standards: Verification against the requirements of AAMI/ANSI ES60601-1, IEC 60601-2-2, and IEC 60601-1-2.
The document does not explicitly state the type of ground truth used, but it would not be expert consensus, pathology, or outcomes data in the context of a clinical trial.
8. The sample size for the training set
This information is not applicable/provided. The HelixAR ABC System is a hardware medical device; it is not an AI/ML device that requires a training set in the computational sense. The "training" for such a device would involve engineering design, prototyping, and iterative testing, not a dataset for algorithm training.
9. How the ground truth for the training set was established
This information is not applicable/provided for the reasons stated in point 8.
§ 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.