(64 days)
The DeRoyal Industries, Inc. Disposable Bipolar Electrosurgical Cable is indicated for use during electrosurgical procedures to provide transmission of electrical power from an electrosurgical generator to a bipolar instrument.
The DeRoyal Industries, Inc. Disposable Bipolar Electrosurgical Cable functions in the same manner as predicate devices in that it is intended to be used in electrosurgical procedures to provide transmission of electrical power from an electrosurgical generator to a bipolar instrument.
Device Design/ Materials Used/Physical Properties: The DeRoyal Industries, Inc. Disposable Bipolar Electrosurgical Cable is made of materials commonly used for their purpose. The primary material components are made of polyvinyl chloride.
This is a 510(k) premarket notification for a disposable bipolar electrosurgical cable. Such submissions for devices of this nature typically do not include detailed studies on performance metrics like accuracy, sensitivity, or specificity, as they are not AI/algorithm-driven devices with diagnostic or predictive functions. Instead, the focus is on demonstrating substantial equivalence to predicate devices through design, material, and intended use comparisons, often supported by bench testing to ensure basic functionality and safety.
Therefore, the provided text does not contain information on acceptance criteria related to accuracy, sensitivity, or specificity, nor does it detail a study proving device performance in that regard. The "study" here is essentially the comparison to predicate devices and the inherent understanding that the device will function as expected given its materials and design, similar to existing products on the market.
However, I can extract the relevant information that is present or implied by the nature of such a submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Implied by Predicate Devices) | Reported Device Performance (DeRoyal Device) |
|---|---|---|
| Length of Cable | 12 ft. (366 cm.) | 12 ft. (366 cm.) |
| Material of Outer Cable Insulation | PVC | PVC |
| Disposable | Yes | Yes |
| Sterility | Sterile | Sterile |
| Intended Use | To provide transmission of electrical power from an electrosurgical generator to a bipolar instrument. | To provide transmission of electrical power from an electrosurgical generator to a bipolar instrument. |
| Function | Functions in the same manner as predicate devices. | Functions in the same manner as predicate devices. |
| Materials | Commonly used for their purpose. | Made of materials commonly used for their purpose. |
Explanation: The "acceptance criteria" for a device like this in a 510(k) submission are typically not explicitly stated as numerical targets for accuracy, but rather as meeting the established characteristics and performance profile of legally marketed predicate devices. The "reported device performance" demonstrates that the DeRoyal cable matches these characteristics, establishing substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This device is a disposable electrosurgical cable, not an AI/algorithm-driven device requiring a test set of data (e.g., medical images, patient records). The "test" for this type of device involved comparing its physical and functional specifications to those of existing devices. The data provenance is the design and manufacturing specifications of the DeRoyal device and the characteristics of the predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth, in the context of AI/algorithm performance, refers to independently verified labels for data. For this device, "ground truth" relates to existing standards for electrosurgical cables. Establishing this would involve engineering and regulatory expertise, not medical experts for a "test set" of cases.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" of cases or "adjudication method" in the AI sense for this device. The evaluation is based on engineering specifications and comparison to predicate devices.
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
Not applicable. This is not an AI-assisted device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm-driven device.
7. The Type of Ground Truth Used
The "ground truth" for this type of device is the established safety, functionality, and performance of existing, legally marketed predicate electrosurgical cables. This is based on:
- Engineering design principles and material specifications.
- Compliance with general controls for medical devices (e.g., good manufacturing practices).
- The history of use and regulatory acceptance of similar devices.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" for this type of device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. If a comparison to predicate devices can be considered a form of "training" for regulatory review, the "ground truth" for such a comparison is based on the known, accepted characteristics of these predicate devices, established through their own regulatory pathways and market experience.
§ 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.