(35 days)
The CardioVations Optical Bipolar Device is intended to be used for endoscopic and open dissection, bipolar coagulation, and transection of vessels.
The CardioVations Optical Bipolar Device is indicated for endoscopic and open dissection, bipolar coagulation, and transection of vessels.
The CardioVations Optical Bipolar is a sterile, single patient use, bipolar electrosurgical instrument with features to dissect, coagulate, and transect tissue with a knife blade. The instrument will be indicated for endoscopic and open tissue dissection bipolar coagulation and transection of vessels. For example like the predicate device, the instrument will be used in vessel harvesting for side branch management (e.g., dissection, coagulation, cutting). The working end of the instrument is composed of the inline jaws for clamping tissue (vessels), the electrode surface for bipolar coagulation and the knife for vessel transection. A cannula port is included in the modified device design for endoscope insertion and a CO2 luer connection. The instrument is 50 cm (19.6 inches) in length, and utilizes bipolar energy from a standard bipolar electrosurgical generator (ESG).
This document describes the CardioVations Optical Bipolar Device, a surgical instrument for tissue dissection, coagulation, and transection.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document states: "Results of verification testing indicates that the product meets the established performance requirements." However, it does not explicitly list specific numerical acceptance criteria or detailed performance metrics in a table format. The study primarily relies on demonstrating substantial equivalence to a predicate device.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" or its sample size. The evaluation appears to be based on "verification testing" rather than a clinical trial with a defined test set of patients or cases. The data provenance (country of origin, retrospective/prospective) is not mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not provided. The study does not describe a process for establishing ground truth involving multiple experts for a test set.
4. Adjudication Method for the Test Set
No adjudication method is described, as the document does not detail a test set requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No MRMC comparative effectiveness study is mentioned. This device is a surgical instrument, not an AI or imaging diagnostic tool where such studies are typically performed. The document focuses on performance requirements for the instrument itself.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The CardioVations Optical Bipolar Device is a physical surgical instrument, not an algorithm, and therefore does not have a "standalone" algorithmic performance. It is used with a human operator.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically applied to diagnostic algorithms (e.g., pathology, outcomes data) does not directly apply to the evaluation of a surgical instrument for substantial equivalence in this context. The "ground truth" for the device's performance would be its ability to perform its intended functions (dissection, coagulation, transection) safely and effectively, as demonstrated through verification testing and comparison to a predicate device. The document states that the modified device has the same technological characteristics as the predicate device (Clearglide Precision Bipolar Device), implying that its performance is benchmarked against the known performance of the predicate device.
8. The Sample Size for the Training Set
This information is not applicable. Surgical devices do not typically have "training sets" in the context of machine learning or AI algorithms.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons mentioned above.
§ 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.