(29 days)
The Ellusa Reusable Bipolar Cable is intended to transfer power from an RF Generator to Bipolar Electrodes.
The subject device, Ellusa Reusable Bipolar Cable is a bipolar accessory designed to transfer the electrosurgical power to the Bipolar electrode. It is connected to a High Frequency Generator via the male end and the female end termination connects to the standard Bipolar instrument. The cable is made of Silicone material and Polypropylene H1500 which is flexible and autoclavable. The length of the cable is 3 meters, and it is provided non-sterile.
This document is a 510(k) summary for the Ellusa Reusable Bipolar Cable. It primarily focuses on demonstrating substantial equivalence to a predicate device through comparison of intended use, technological characteristics, and performance, rather than presenting a study demonstrating that the device meets specific performance acceptance criteria from a clinical or diagnostic standpoint.
Based on the provided text, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in terms of clinical or diagnostic performance (e.g., sensitivity, specificity, accuracy). Instead, the "acceptance criteria" are implied by compliance with established medical device standards and demonstrating performance equivalent to the predicate device.
| Test / Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Basic Safety & Essential Performance of High Frequency Surgical Equipment and Accessories | Compliance with IEC 60601-2-2:2017 | "The following tests were successfully performed: IEC 60601-2-2: 2017 Medical electrical equipment Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories" |
| Sterilization Validation (Moist Heat) | Compliance with ISO 17665-1:2006 | "-ISO 17665-1:2006 - Sterilization of health care products Moist heat Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices" (Note: Document lists ISO 17665-5 in text, but ISO 17665-1 in the table on page 4, assuming ISO 17665-1:2006 is the correct reference as it is the more general standard for moist heat sterilization). |
| Substantial Equivalence | Equivalence in intended use, technological characteristics, operating principle, and performance characteristics compared to the predicate device (Ellusa Disposable Bipolar Cables, K202558). | "The Ellusa Reusable Bipolar Cables are substantially equivalent in intended use, technological characteristics, operating principle, and performance characteristics to the predicate device by Ellusa (K202558)." |
The comparison table on page 4 details the similarities (e.g., Product Code, Device Classification, Functions, Operating principle, Energy Source, Cable Length, Activation Method). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence." Therefore, there is no test set sample size, data provenance, or associated study as typically understood for AI/diagnostic devices. The testing performed was non-clinical (laboratory/engineering) to confirm compliance with safety and performance standards relevant to the device's function as an electrosurgical accessory.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no clinical performance study involving ground truth established by experts was conducted or relied upon.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical performance study involving adjudication of ground truth was conducted or relied upon.
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 device is an electrosurgical cable, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical performance study requiring ground truth was conducted or relied upon. The "ground truth" for this device's performance relies on engineering measurements and compliance with recognized standards (IEC, ISO) for electrical safety, functional performance, and sterilization effectiveness.
8. The sample size for the training set
Not applicable, as this device does not involve a training set (e.g., for machine learning).
9. How the ground truth for the training set was established
Not applicable, as this device does not involve a training set.
§ 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.