(66 days)
Bovie® Cautery Devices are used for stopping small bleeders in hemostasis and other similar uses.
Bovie Cauteries are single use, battery operated devices. The device is activated by pressing the green button on the cautery body and is deactivated by releasing the button (in the default position, the cautery does not operate). Once the button is pressed, an internal circuit is completed that directs power from an internal battery to the cautery tip which in turn heats. The heated tip is introduced to the surgical site and the heat vaporizes the water component in blood/tissue, causing a clot that halts the bleeding.
The provided text is a 510(k) summary for the Bovie® Cautery Device. It mostly focuses on describing the device, its intended use, and comparing it to predicate devices, particularly highlighting safety enhancements. It does not contain information about specific acceptance criteria or a study that proves the device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity.
Therefore, most of the requested information regarding acceptance criteria and performance studies cannot be extracted from the provided text. The device is a cautery device, not an AI/algorithm-based diagnostic tool, so many of the questions related to AI performance metrics, ground truth, and expert studies are not applicable in this context.
Here's a breakdown of what can be inferred or directly stated from the text, and where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided document. The document describes the device, its function, technology, and intended use, and compares its characteristics (materials, energy source, design for safety, disposal instructions, sterility) to predicate devices. It does not provide specific performance metrics (e.g., specific coagulation time, temperature output, or other quantitative performance benchmarks) or acceptance criteria for those metrics.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is a medical device submission for a physical, battery-operated cautery device, not a software algorithm tested on a dataset. There is no "test set" in the context of diagnostic data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. See point 2.
4. Adjudication Method for the Test Set
Not applicable. See point 2.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
Not applicable. This is not an AI-assisted diagnostic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm.
7. The Type of Ground Truth Used
Not applicable. See point 2.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
Summary of what is available in the document regarding the device validation:
The submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, as required for 510(k) clearance. This means the manufacturer is asserting that the new device is as safe and effective as existing devices on the market.
The primary method of "proving" the device meets criteria (implicitly, the criteria of safety and effectiveness similar to predicates) is through:
- Comparison of Device Characteristics: The document provides a detailed comparison table (Page 3 of 3 in the 510(k) summary) showing that the Bovie® Cautery Device shares indications for use, sterilization method, materials (patient-contacting tips and handle), and energy source with predicate devices.
- Safety Enhancements: The submission highlights design changes made for enhanced safety, specifically:
- Easily removable battery pack (allowing for easy battery recycling and prevention of device activation after disposal).
- Recessed activation button (to prevent inadvertent activation).
- Unchanged Core Technology: The document explicitly states that the "Cautery device technology remains mostly unchanged" and that "Apart from the added safety features, these cautery devices remain mostly unchanged from those previously cleared" (Page 2 of 3). The patient-contacting tip component, cautery handle materials, and cautery tip configurations are also stated to be unchanged.
In essence, the "study" proving the device meets criteria is the detailed technical and functional comparison to already cleared predicate devices, asserting that the new device performs its intended function (stopping small bleeders in hemostasis) at least as safely and effectively, with added safety features. There are no clinical trial results or performance statistics presented in this 510(k) summary for a "test set" in the context of data analysis.
§ 886.4115 Thermal cautery unit.
(a)
Identification. A thermal cautery unit is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by heat conducted through a wire tip.(b)
Classification. Class II.