(20 days)
The Endolap Resectoscope Cutting Loop Device is a momopolar electrode designed to deliver radiofrequency energy that is supplied by and electrical generator cleared for medical use. The Endolap Resectoscope Cutting Loop device is inicated for ablation and coagulation of the soft tissue and is intlended for use with compatlible resectoscopes,
Resectoscope Cutting Loop
The provided text is a 510(k) clearance letter from the FDA for a medical device called the "ENDOlap™ Resectoscope Cutting Loop Electrode". This document, like many 510(k) clearances from 1997, does not contain detailed information about specific performance studies, acceptance criteria, or the methodology usually associated with contemporary AI/ML device evaluations.
Therefore,Based on the provided document, I cannot answer the question as it pertains to acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from 1997, which focuses on substantial equivalence to a predicate device rather than detailed performance study results that would typically include acceptance criteria, sample sizes, ground truth establishment, or AI/ML specific details like MRMC studies or standalone algorithm performance.
Here's why each specific point cannot be addressed from the given text:
- A table of acceptance criteria and the reported device performance: The letter states the device is "substantially equivalent" to predicate devices, but it does not specify any quantitative acceptance criteria or report performance metrics (e.g., accuracy, sensitivity, specificity, or device-specific functional parameters) from studies.
- Sample sized used for the test set and the data provenance: There is no mention of a test set, its sample size, or data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment and expert involvement are not discussed.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Adjudication methods are not mentioned.
- 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 is a pre-AI/ML era device. No MRMC study or AI-assisted performance is mentioned.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: As this is not an AI/ML device, a standalone algorithm performance study is not applicable and not mentioned.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): No ground truth type is specified.
- The sample size for the training set: There is no mention of a training set as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable, as there's no training set for an AI/ML model.
In summary, the provided document is a regulatory approval letter based on substantial equivalence, not a detailed technical report of a device performance study with specific criteria and results.
§ 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).