(26 days)
The KARL STORZ Pediatric Cysto-Urethro-Fiberscope and accessories are intended for use by a physician in the visual examination and treatment of a variety of urological endoscopic procedures for pediatric patients.
The KARL STORZ Pediatric Cysto-Urethro-Fiberscope and Accessories consists of a flexible fiber endoscope (Model Number: 11274BCU1) which can be used standalone or connected to compatible FDA-cleared camera heads which transfer images to compatible FDA-cleared Computer Control Units (CCUs) for the purposes of visual examination and treatment of a variety of urological endoscopic procedures for pediatric patients.
The provided text is a 510(k) Summary for the KARL STORZ Pediatric Cysto-Urethro-Fiberscope. It outlines the characteristics of the device and establishes its substantial equivalence to a predicate device. However, it does not contain acceptance criteria or a study that proves the device meets specific performance criteria in the context of AI/ML or diagnostic accuracy.
The document details non-clinical performance data, primarily focusing on compliance with various international standards for biocompatibility, reprocessing validation, and bench performance testing for mechanical, optical, and thermal/photobiological safety.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance related to diagnostic accuracy or AI/ML.
- Sample size and data provenance for a test set (as no such test set for diagnostic performance is described).
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone (algorithm only) performance.
- Type of ground truth (as no ground truth for diagnostic performance is mentioned).
- Sample size for the training set.
- Ground truth establishment for the training set.
The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence to the predicate device." This confirms that there was no study conducted to assess the device's diagnostic performance against specific acceptance criteria using patient data, which is what your questions are geared towards.
The "Non-Clinical Performance Data" section lists various standards the device complies with, but these are related to the physical and functional safety of the endoscope itself, for example:
- Biocompatibility Testing: ISO 10993 series for biological evaluation of medical devices.
- Reprocessing Validation: Standards like ISO 14937, ISO 17665-1, AAMI ST98 for cleaning and sterilization.
- Bench Performance Testing: IEC 60601-2-18, IEC 62471, ISO 8600-3, ISO 8600-5 for mechanical, optical, and thermal/photobiological performance.
These are not acceptance criteria or performance metrics related to diagnostic accuracy or the performance of an AI/ML component. The device is a flexible fiber endoscope, and the regulatory filing focuses on its substantial equivalence to another endoscope based on engineering specifications and safety standards, rather than any AI-driven diagnostic capabilities.
§ 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.