(62 days)
General-purpose electrosurgical generator used in conjunction with an electrosurgical accessory hand piece for delivery of RF (radio frequency) electrosurgical content through an accessory electrode for the cutting and coagulation at the operative site.
The CONMED® Sabre Genesis™ and CONMED® HyfreSurg™OP Electrosurgical Generators are electrosurgical generators with the basic modes of operational electrosurgical cutting and coagulation. The devices consist of a single electrosurgical generator unit for each model to supply high frequency (HF) electrosurgical current to accessory hand pieces to produce the clinical effect. When cutting, the subject device provides the energy to the active electrode which is drawn across the tissue while electrosurgical energy is being applied. When coagulating, the subject device provides the energy to the active electrode which may be held in contact with the tissue for desiccation or separated from the tissue by distance for fulguration to achieve the desired result.
The subject devices (Sabre Genesis and HyfreSurg OP) are of the same construction in components and assembly. The difference is the HyfreSurg OP does not have the Pulse Cut functionality and the control panel is altered accordingly.
Use of these products for unintended applications could lead to an unsafe condition.
The device utilizes previously cleared/marketed and required accessories.
The provided text describes a 510(k) summary for the CONMED® Sabre Genesis™ and CONMED® HyfreSurg OPTM Electrosurgical Units. However, it does not include specific acceptance criteria for the device performance in terms of metrics like sensitivity, specificity, accuracy, or other performance characteristics typically associated with AI/software devices. Instead, it focuses on demonstrating substantial equivalence to predicate devices and adherence to medical device standards.
Therefore, many of the requested elements for describing acceptance criteria and a study proving device adherence cannot be fully answered from the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: Device operates safely, provides alarms for risks, and complies with safety standards (e.g., IEC 60601-1, IEC 60601-2-2). | "The device provides alarms for conditions that could pose a risk to the patient." "Specific testing performed was in conformance with the requirements of [listed IEC standards]." |
| Effectiveness/Functionality: Delivers RF electrosurgical current for cutting and coagulation as intended. Performance characteristics are equivalent to predicate devices. | "Performance characteristics of the subject devices are equivalent to the subject devices and have been verified to meet the requirements above as well as performance requirements defined in design inputs." "Design verification and validation activities demonstrated the subject devices to be equivalent where applicable to the predicate devices." |
| Electromagnetic Compatibility: Meets EMC standards (IEC 60601-1-2). | "IEC 60601-1-2: 2005, Medical Electrical Equipment -- Part 1-2 General Requirements for Safety – Collateral Standard: Electromagnetic Compatibility - Requirements and Tests." (Implies compliance) |
| Usability: Complies with usability standards (IEC60601-1-6). | "IEC60601-1-6: 2004, Medical electrical equipment - Part 1-6: General requirements for safety -Collateral standard: Usability." (Implies compliance) |
| Biocompatibility: No direct patient contact, thus no biocompatibility concern. | "The subject devices do not have direct patient contact." |
| Substantial Equivalence: Demonstrated to be substantially equivalent to predicate devices (CONMED® System 2450™, CONMED® System 5000™). | The entire 510(k) submission and FDA clearance letter confirm substantial equivalence. |
Missing Information/Not Applicable (N/A) from the Text:
- Quantitative Performance Metrics: The document does not provide specific numerical targets (e.g., accuracy > 90%, sensitivity > 85%) for clinical or analytical performance. This is typical for electrosurgical units, which are hardware devices, not AI/software.
- Study Design for "Proving Device Meets Acceptance Criteria": The document refers to "Performance Testing" and "Design verification and validation activities" but does not detail a specific clinical or analytical study designed to prove these criteria in a statistical sense, as would be expected for an AI/software device. Instead, it relies on adherence to established standards and comparison to predicate devices.
2. Sample Size for Test Set and Data Provenance
- Sample Size: Not applicable/Not mentioned. The testing described is primarily focused on engineering and electrical safety standards for a hardware device, not a performance test on a specific dataset like an AI model.
- Data Provenance: Not applicable/Not mentioned. There is no "data" in the sense of patient records or images being used.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not applicable. There is no ground truth establishment in the context of an AI/software device for an electrosurgical unit.
- Qualifications of Experts: Not applicable.
4. Adjudication Method
- Adjudication Method: Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. This document describes an electrosurgical unit (a hardware device), not an AI-assisted diagnostic or clinical support tool where human reader performance would be a relevant metric.
6. Standalone Performance Study (Algorithm Only)
- Standalone Study: No. This is a hardware device; there is no "algorithm only" performance separate from the device's function.
7. Type of Ground Truth Used
- Type of Ground Truth: Not applicable. For this type of device, "ground truth" generally refers to adherence to engineering specifications and safety standards, as verified through physical testing, rather than a clinical ground truth like pathology or outcome data.
8. Sample Size for Training Set
- Sample Size for Training Set: Not applicable. This is a manufactured hardware device, not an AI model that undergoes a "training" phase with a dataset.
9. How Ground Truth for Training Set Was Established
- How Ground Truth Was Established: Not applicable.
In summary: The provided 510(k) summary is for a traditional electrosurgical unit, not an AI/software device. Therefore, the concepts of "acceptance criteria," "study," "test set," "ground truth," "experts," and "training set" as they relate to AI/software performance evaluation are not applicable or described in this document. The device's "performance" is demonstrated through compliance with recognized medical device standards and substantial equivalence to previously cleared predicate devices, focusing on safety and basic functional effectiveness.
§ 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.