(28 days)
The Ellusa Reusable Neutral Plate provides a safe return path for electrosurgical current and is designed for use with Ellusa Generators for minor surgical applications. The Reusable Neutral Plate is provided nonsterile and intended for use only in nonsterile environments.
The Ellusa Reusable Neutral Plates will be provided as a flexible plate made of silicone rubber and will be supplied with a 10-foot cable and is non-sterile. There are no differences in the functionality of a reusable neutral plate as compared to the disposable neutral plate. They are both used to provide a safe return path for electrosurgical current.
This submission is for an Ellusa Reusable Neutral Plate, which is an electrosurgical accessory. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific clinical performance acceptance criteria. Therefore, most of the requested information regarding clinical studies, ground truth, expert consensus, and multi-reader multi-case studies is not applicable to this document.
The acceptance criteria provided here are related to non-clinical testing and engineering standards for the device's safety and performance with respect to its function as an electrosurgical accessory.
Here's the breakdown of the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard / Test) | Reported Device Performance | Comments |
|---|---|---|
| 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 | "Testing was conducted for the following standard and resulted in passing results." | This blanket statement indicates all sub-elements of this standard were met. Specific sub-elements tested include: |
| - Cl. 201.8.7.3.101: Thermal effects of HF Leakage Currents | Passing results | Ensures the plate does not cause excessive heating due to leakage currents. |
| - Cl. 201.8.8.3.103: ACTIVE ACCESSORY HF dielectric strength | Passing results | Tests the insulation integrity under high-frequency voltage. |
| - Cl. 201.8.8.3.104: ACTIVE ACCESSORY mains frequency dielectric strength | Passing results | Tests the insulation integrity under mains frequency voltage. |
| - Cl. 201.15.101.2: NE cord attachment | Passing results | Ensures the cord is securely attached. |
| - Cl. 201.15.101.4: NE cord insulation | Passing results | Tests the insulation of the neutral electrode cord. |
| - Cl. 201.15.101.6: NE contact impedance | Passing results | Measures the resistance of the contact between the plate and the patient/generator to ensure efficient current return. |
| Biocompatibility Requirements | "All tests resulted in passing results." | This blanket statement indicates all biocompatibility tests were met. Specific tests include: |
| - In-Vitro Cytotoxicity ISO 10993-5:2010 | Passing results | Assesses potential for the device materials to be toxic to cells. |
| - Sensitization ISO 10993-10:2010 | Passing results | Assesses potential for the device materials to cause allergic reactions. |
| - Irritation ISO 10993-10:2010 | Passing results | Assesses potential for the device materials to cause skin irritation. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not provided in the document. The document describes non-clinical engineering and biocompatibility testing, which typically uses a specified number of device units or material samples for testing rather than a "test set" in the context of clinical data. The provenance of such testing data is usually from accredited testing laboratories, but specific details are absent.
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):
This information is not applicable as there was no clinical test set requiring expert ground truth establishment for this type of device (electrosurgical neutral plate). The "ground truth" for non-clinical testing is adherence to established engineering and biocompatibility standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable as there was no clinical test set requiring adjudication in this context. The "adjudication" for non-clinical testing involves the interpretation of test results against predefined pass/fail criteria of the standards.
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:
This information is not applicable. This document is for an electrosurgical neutral plate, which is a hardware accessory, not an AI-enabled diagnostic tool. Therefore, an MRMC study or AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable. The device is an electrosurgical neutral plate, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the non-clinical testing described is based on the pass/fail criteria defined within the referenced international standards (IEC 60601-2-2 and ISO 10993 series). These standards themselves are developed through expert consensus within their respective fields to ensure safety and performance.
8. The sample size for the training set:
This information is not applicable. As a hardware device, there is no "training set" in the context of machine learning. The device design and manufacturing processes are likely informed by engineering principles and previous device experience, but not a dataset used for training an algorithm.
9. How the ground truth for the training set was established:
This information is not applicable for the reasons stated 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.