(492 days)
The nephroscopy accessory set is intended for minimally invasive procedures in nephroscopy. The shaft is a reusable, surgically invasive device for shortterm use. It is designed to bring instruments, telescopes, and fluids to the surgical site. The Dilator is a reusable, surgically invasive device for temporary use. It is designed to widen existing surgically invasive openings.
The TROKAMED GmbH Mini PCNL-System consists of shaft and dilator. The diameter is specified directly on the shaft and dilator. This ensures that the instrument can be assigned easily and only suitable components are used. The instruments cannot be disassembled. The puncture is expanded with the dilator at the beginning of surgery. The procedure, during which kidney stones can be destroyed, is then performed via the shaft. The kidney stones are automatically transported out of the proximal end of the shaft as a result of the cleaning pressure and by the irrigation fluid. The nephroscope may not be fully mounted on the shaft here.
The provided document is a 510(k) Premarket Notification for a medical device called the "Mini PCNL-System" by TROKAMED GmbH. It details a comparison to a predicate device and non-clinical performance testing. The document does not contain information about acceptance criteria and device performance in the context of a clinical study, human-in-the-loop performance, or AI assistance.
Instead, the document focuses on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical testing of the physical characteristics, reprocessing, life expectancy, biocompatibility, and mechanical properties of the device components.
Therefore, I cannot provide the requested information regarding:
- A table of acceptance criteria and reported device performance related to diagnostic accuracy or clinical outcomes.
- Sample size used for a test set (in a clinical context).
- Data provenance (country of origin, retrospective/prospective) for a clinical test set.
- Number of experts used or their qualifications for establishing ground truth in a clinical setting.
- Adjudication method for a clinical test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study or effect size of AI assistance.
- Standalone (algorithm-only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data) for a clinical study.
- Sample size for a training set (as this is not an AI/ML device).
- How ground truth for a training set was established (as this is not an AI/ML device).
The document is about demonstrating the safety and effectiveness of a surgical instrument (an endoscope accessory set) through engineering and biological testing, not a diagnostic or AI-powered device.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.