(119 days)
AED Monopolar Lap Accessories are reusable devices (forceps and electrodes) intended to be used in general laparoscopic surgical procedures requiring the use of electrosurgical cutting and/or coagulation.
AED Monopolar Lap Accessories consist of Standard insulated monopolar handles Insulated Shafts Class I inserts (forceps, scissors, biopsy cups, needle holders) Electrodes The device is reusable and provided non-sterile. It must be cleaned and sterilized before use.
The provided text describes AED Monopolar Lap Accessories, focusing on their substantial equivalence to predicate devices rather than reporting on a study with specific acceptance criteria and performance metrics in the way one might expect for a novel AI/software medical device.
Therefore, for many of your requested points, the information is not directly available in the provided text. The device is a physical surgical accessory, and the "study" referred to is a comparison to predicate devices and adherence to performance standards, not a clinical trial or performance evaluation with human readers or AI.
Here's the information based on the provided text, with notes where information is not applicable or not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Standard/Predicate) | Reported Device Performance |
|---|---|---|
| Safety | Substantially equivalent to predicate devices (Dan Monopolar Lap Accessories, Gyrus Open Forceps) in basic functional characteristics, raising no new safety issues. | Confirmed substantial equivalence in basic functional characteristics. |
| Effectiveness | Substantially equivalent to predicate devices in basic functional characteristics, raising no new effectiveness issues. | Confirmed substantial equivalence in basic functional characteristics. |
| Electrical Safety | IEC 60601-2-2: Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment (Fourth Edition, 2006). | Implicitly met as part of substantial equivalence and performance standards. No specific performance values are given. |
| Sterilization | ISO 14937:2000 Sterilization of health care products – General Requirements for Characterization of a Sterilizing Agent and the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices. | Implicitly met as part of substantial equivalence and performance standards. No specific performance values are given. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable or not provided as this is not an AI/software device that uses a "test set" in the traditional sense of data or images. The evaluation is based on design analysis and comparison to predicate physical devices, and adherence to established performance standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as there is no "test set" of data requiring expert ground truth establishment for this physical device. The evaluation relies on engineering and regulatory assessment.
4. Adjudication Method for the Test Set
This information is not applicable as there is no "test set" or diagnostic assessment requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that analyze medical images or data interpreted by human readers, often with AI assistance. The AED Monopolar Lap Accessories are physical surgical tools.
6. Standalone (Algorithm only without human-in-the-loop performance) Study
No. A standalone performance study of an algorithm was not done. This device is a physical surgical instrument, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for this device's evaluation is based on established engineering standards (IEC 60601-2-2, ISO 14937:2000) and the demonstrated safety and effectiveness of legally marketed predicate devices (Dan Monopolar Lap Accessories, Gyrus Open Forceps). The evaluation confirms that the new device's design and functional characteristics are substantially equivalent, meaning it performs similarly to what is already accepted as safe and effective.
8. Sample Size for the Training Set
This information is not applicable as this is not an AI/software device that uses a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" for this physical device.
§ 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.