(132 days)
The CROMA Electrosurgical Generator is intended to provide Radiofrequency (RF) and microwave (MW) energy for cutting, coagulation, and ablation of soft tissue, when used in conjunction with compatible electrosurgical instruments and accessories.
The Creo Medical Electrosurgical System is not intended for use in cardiac procedures.
The Reusable Interface Cable is for connection only of a compatible Creo Medical Instrument (Surgical Accessory) to the CROMA Electrosurgical Generator to deliver Radiofrequency (RF) and/or Microwave (MW) energy for the cutting, coagulation and ablation of tissue via endoscopic access.
The CROMA Electrosurgical Generator is an Electrosurgical unit (ESU) to be used with compatible electrosurgical instruments and accessories.
The CROMA Electrosurgical Generator is a tabletop, non-network connected, mains powered ESU. It comprises two distinct energy sources for the independent generation of bipolar radiofrequency (RF) and microwave (MW) energies, intended to supply electrosurgical power for cutting, and ablation of soft tissues, when connected to compatible instruments via the interface cable.
The CROMA Electrosurgical Generator incorporates proprietary software developed by Creo Medical Ltd.
The CROMA Electrosurgical Generator subject of this submission incorporates a new front panel, which has been updated from a Vacuum Fluorescent Display (VFD) in the predicate device to a Liquid Crystal Display (LCD) screen in the subject device.
The provided text describes a 510(k) premarket notification for the CROMA Electrosurgical Generator. This document is a regulatory submission to the FDA demonstrating substantial equivalence to a predicate device, rather than a study designed to prove the device meets specific acceptance criteria in the context of an AI-powered diagnostic. Therefore, many of the requested sections are not applicable.
Here's the information that can be extracted or derived from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative, measurable sense for a diagnostic device's performance. Instead, it focuses on demonstrating substantial equivalence to a predicate electrosurgical generator by comparing technological characteristics and compliance with electrical safety and software standards.
| Characteristic / Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1 Ed. 3.2, IEC 60601-2-2 Ed. 6.0, IEC 60601-2-6 Ed. 2.1 | Device complies with standards |
| EMC | Compliance with IEC 60601-1-2:2014 | Device complies with standards |
| Software V&V | Compliance with IEC 62304 Ed. 1.1 | Software developed, verified, and validated with IEC 62304 Ed. 1.1 |
| Mechanical & Usability Testing | Satisfactory performance in power on/off, initialization, standby, timeout, settings, language, accessory selection, connection/reconnection | Tests performed, usability assessment of UI changes |
| Indications for Use | Same as predicate (with rewording for clarity) | Stated Indications for Use are substantially equivalent to predicate |
| Technological Characteristics | Substantially equivalent to predicate in terms of energy inputs/outputs, principles of operation, control console functionalities | Device has same energy inputs/outputs, principles of operation, and functionalities with minor differences in display (LCD vs VFD) and associated software |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This device is an electrosurgical generator, not an AI-powered diagnostic or a device that uses a "test set" of patient data in the way implied by the question. The testing described is primarily engineering and software verification/validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. As noted above, this device is not an AI-powered diagnostic, and therefore, the concept of "ground truth" established by experts for a test set of data does not apply in this context.
4. Adjudication Method for the Test Set
Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document explicitly states: "Animal & Clinical Studies: Not Applicable." An MRMC study would fall under clinical studies.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, an electrosurgical generator does not have a "standalone algorithm" in the context of AI performance. The software mentioned is for controlling the device's functions and user interface.
7. The Type of Ground Truth Used
Not applicable. The ground truth concept, as it pertains to diagnostic accuracy, is not relevant here. The "truth" for this device relates to its adherence to engineering specifications, safety standards, and functional performance.
8. The Sample Size for the Training Set
Not applicable. This device does not employ machine learning or AI that would require a "training set" of data in the common sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 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.