(109 days)
This instrument has been designed to be used with an Olympus endoscope to electrosurgically collect tissue, to electrosurgically cauterize or to perform electrosurgical hemostasis within the urinary organs.
The Single Use Hot Biopsy Forceps FD-231 consists of a handle and insertion portion. Fenestrated cups in the distal end of insertion are activated in the open and closed position by maneuvering the slider in the handle.
During operation, insertion will be inserted into endoscopes. Once the tissue is held by the cups, the tissue is subjected to high frequency electric current transmitted from plug which allows for collecting tissue. Once the tissue is touched by closed cups, the tissue is subjected to high frequency electric current transmitted from plug which allows for cauterization and hemostasis.
By means of high frequency electric current passing through the tissues between electrical plate attached on patient`s skin and the cups, heat will be produced from electricity resistance by the tissue and the heat will be utilized for collecting tissue, cauterization and hemostasis.
The provided document describes a medical device, the "Single Use Hot Biopsy Forceps FD-231," and its premarket notification for FDA clearance (K171916). However, the document does not contain information about acceptance criteria and a study proving that the device meets those criteria, specifically in the context of AI/algorithm performance or a multi-reader multi-case study as requested in the prompt.
The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing of performance specifications, material biocompatibility, electrical safety, and sterilization. It lists various tests performed to ensure the safety and effectiveness of the device as a physical medical instrument, not an AI or software-based diagnostic tool.
Therefore, I cannot provide the requested information for acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth details because these are not present in the provided text.
The closest information relating to "acceptance criteria" not directly tied to AI/algorithm performance is mentioned in the "Summary of non-clinical testing" section:
- Risk Analysis: "Finally, risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971 Second edition 2007-03-01. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment."
- Sterilization Residuals: "The EO residual and ECH residual were measured after sterilization of the device to meet the criteria defined in ISO 11135 Second edition 2014 and AAMI/ANSI/ISO 10993-7:2008(R)2012."
These references describe general acceptance criteria for risks and sterilization, which are standard for medical devices but do not relate to the performance metrics of an AI system or clinical study outcomes.
§ 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).