(238 days)
These instruments (sphincterotomes and guidewires) have been designed to be used with an Olympus endoscope for papillotomy using high-frequency current. The preloaded guidewire is used for guiding and exchanging endoscopic accessories for biliary duct, including but not limited to the common bile, cystic, pancreatic and right and left hepatic ducts.
The subject sphincterotome consists of sphincterotome and preloaded guidewire. It is used in combination with endoscope and electrosurgical unit for papillotomy. The subject sphincterotome is composed of handle section and insertion tube. The preloaded guidewire is used for insertion and exchange of endotherapy accessories including the subject sphincterotome.
The provided text is a 510(k) summary for a medical device (Single Use Preloaded Sphincterotome V) seeking substantial equivalence to predicate devices. It describes the device, its intended use, technological characteristics, and non-clinical testing performed.
However, the document does not contain information about acceptance criteria or a study proving that the device meets specific performance metrics in a way that aligns with the requested format (e.g., sensitivity, specificity, accuracy, or similar quantitative performance outcomes compared against expert-established ground truth).
The "Summary of Non-clinical Testing" section states that:
- "Performance testing was conducted to demonstrate the initial performance of the subject device and confirmed that the subject device works as intended."
- "Basic safety and performance testing was performed in accordance with !EC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-2 and IEC 60601-2-18. In addition, verification was conducted to evaluate the mechanical and functional performance."
- "Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verifications tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment."
This language indicates that internal testing was done against established acceptance criteria, but it does not provide the specifics of those criteria or the results in a quantifiable, comparative manner (e.g., a table of acceptance criteria vs. device performance with specific metrics).
The document is primarily focused on demonstrating substantial equivalence based on technological characteristics and compliance with recognized safety and performance standards for an electrosurgical accessory, rather than reporting on a clinical or AI-driven performance study with detailed metrics against a ground truth.
Therefore, it is not possible to fill out the requested table and provide the specific details about a study proving the device meets acceptance criteria as typically found in submissions for AI/ML-driven devices. The provided text describes compliance with general safety and performance standards and risk analysis-driven design verification, not a study evaluating diagnostic performance against a ground truth.
§ 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).