(78 days)
The KSEA Xenon-100 SCB Light Source is intended for use in combination with Karl Storz video-endoscopes for gastro-enterology or with Karl Storz endoscopes for general purpose endoscopy by qualified surgeons and is equipped with the SCB-feature which provides remote control of the light source for central operation, central display, automatic initial setting and interlocking operation to the Karl Storz SCB Control Computer (Karl Storz Communication Bus), to relay functions and controls on the SCB monitor.
The Karl Xenon-100 SCB is a Light Source unit for Karl Storz video gastro-endoscopes.
The provided text describes a 510(k) summary for the Karl Storz Xenon-100 SCB Light Source. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study. Substantial equivalence is a regulatory pathway in the US that avoids the need for extensive clinical trials by showing a new device is as safe and effective as a legally marketed predicate device.
Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of a clinical performance study with AI (like multi-reader multi-case studies, standalone performance, ground truth, sample sizes, etc.) is not present in the provided document.
Here's why and what information is available:
- No acceptance criteria or study results for device performance are listed. The document states: "The minor differences between the Karl Storz Xenon-100 SCB Light Source and the predicate device raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or general intended use of these devices." This implies that extensive comparative performance testing (as would be done for a novel AI device) was not required for this 510(k) submission.
- The focus is on "Substantial Equivalence." The entire submission hinges on demonstrating that the new device is functionally similar to an already approved device.
- The device is a "Light Source unit," not an AI-powered diagnostic or therapeutic device. The nature of the device (a light source for endoscopes) does not typically require the types of performance studies involving human readers, ground truth establishment, or AI algorithms as outlined in your request.
Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, deep learning studies, multi-reader multi-case studies, and ground truth in the way you've requested, as this information is not part of this 510(k) submission document.
However, based on the document, I can provide the following relevant details about the submission process:
- Device Name: Xenon-100 SCB Light Source
- Intended Use: For use in combination with Karl Storz video-endoscopes for gastro-enterology or with Karl Storz endoscopes for general purpose endoscopy by qualified surgeons. It features remote control, central operation, central display, automatic initial setting, and interlocking operation to the Karl Storz SCB Control Computer.
- Regulatory Pathway: 510(k) Premarket Notification, demonstrating Substantial Equivalence to a predicate device.
- Predicate Device: A legally marketed device with similar basic features and intended uses, but not explicitly named in the provided text.
- Date Submitted: September 30, 2008
- Date Received by FDA: October 1, 2008
- FDA Clearance Date: December 18, 2008
To reiterate, the provided document does not contain the specific information you've asked for regarding acceptance criteria, study design, datasets, or AI performance because it's a 510(k) for a light source, not an AI-enabled device requiring such validation studies.
§ 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.