(20 days)
The Endolap Resectoscope Roller Electrode device is a monopolar electrode designed to deliver radio frequency energy that is supplied by an electrical generator cleared for medical use. The Endolap Resectoscope roller electrode device is indicated for ablation and coagulation of the soft tissue and is intended for use with compatible resectoscopes.
The Endolap Resectoscope Roller Electrode device is a monopolar electrode designed to deliver radio frequency energy that is supplied by an electrical generator cleared for medical use.
The provided document is a 510(k) clearance letter from the FDA for a medical device called the "ENDOlap™ Resectoscope Roller Electrode." This type of document does not typically contain the detailed information requested about acceptance criteria, study data, ground truth establishment, or multi-reader multi-case studies, as it is a regulatory clearance based on substantial equivalence to a predicate device, rather than a presentation of a full de novo study.
Therefore, most of the requested information cannot be extracted from this document. However, I can infer some general points related to the device and its intended use.
Here's what can be stated based on the provided text, and what cannot be provided:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not describe specific acceptance criteria (e.g., performance thresholds for sensitivity, specificity, accuracy, etc.) or report detailed device performance metrics from a study.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Cannot be provided. The document does not refer to a test set or study data in this context.
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)
- Cannot be provided. The concept of "ground truth" as it relates to clinical study data for algorithm evaluation is not applicable here. This device is a surgical instrument, not an AI or diagnostic algorithm.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Cannot be provided. Not applicable to this type of device clearance.
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
- Cannot be provided. This is not an AI-powered device, so an MRMC study comparing human readers with and without AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Cannot be provided. This is not an algorithm, so standalone performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. The concept of ground truth in the context of diagnostic or AI performance is not applicable to an electrosurgical device like this. For a surgical instrument, "ground truth" might relate more to the physical properties, safety, and functionality of the device as tested against engineering and biocompatibility standards, rather than clinical diagnostic accuracy.
8. The sample size for the training set
- Cannot be provided. This is not an AI or machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Cannot be provided. This is not an AI or machine learning device.
What the document does tell us:
- Device Name: ENDOlap™ Resectoscope Roller Electrode
- Regulatory Class: Class II
- Product Codes: 78 FAS (Resectoscope, Electrosurgical) and 78 FDC (Electrosurgical Unit, General & Plastic Surgery)
- Indications for Use: The ENDOlap™ Resectoscope Roller Electrode device is a monopolar electrode designed to deliver radio frequency energy. It is indicated for ablation and coagulation of soft tissue and is intended for use with compatible resectoscopes.
- Regulatory Mechanism: 510(k) Pre-market Notification, cleared on the basis of substantial equivalence to predicate devices marketed before May 28, 1976. This means the device met the FDA's requirements by demonstrating it is as safe and effective as a legally marketed predicate device, rather than submitting extensive de novo clinical trial data. The clearance focuses on general controls provisions, good manufacturing practices, and labeling.
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).