(77 days)
The KSEA DCI Endoscope is indicated for use during endoscopic plastic, reconstructive and aesthetic procedures.
The KSEA DCI Endoscope is comprised of a rigid, panoramic telescope which utilizes rod lens technology. The body contact portions of the KSEA DCI Endoscope are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use,
The provided text is a 510(k) summary for the Karl Storz DCI Endoscope, which is a traditional medical device (an endoscope) rather than a software-based AI/ML device. Therefore, the questions regarding acceptance criteria and studies that prove the device meets these criteria in the context of AI/ML performance metrics are not applicable to this document.
The document focuses on demonstrating substantial equivalence to predicate devices. This means the manufacturer is asserting that their device is as safe and effective as a legally marketed device and does not raise new questions of safety or effectiveness.
Here's how the information provided relates to a traditional device clearance, rather than an AI/ML study:
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Acceptance Criteria and Reported Device Performance: For a traditional medical device like an endoscope, acceptance criteria would typically relate to physical characteristics, material biocompatibility, sterilization efficacy, and functional performance (e.g., image clarity, field of view, illumination, mechanical integrity). This document does not report specific performance metrics in the way an AI/ML study would (e.g., sensitivity, specificity, AUC). Instead, it states that "The minor differences between the KSEA DCI Endoscope and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no affect on the performance, function or intended use of the devices." This is the core claim for substantial equivalence.
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Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): These detailed questions are designed for AI/ML performance evaluation studies. They are not relevant to the 510(k) submission for this endoscope. The 510(k) pathway for this type of device typically relies on design comparisons, materials testing, and functional testing to established standards, rather than clinical efficacy trials involving "ground truth" established by experts on a dataset in the way a diagnostic AI would require.
In summary, based on the provided text, it is not possible to answer the questions you posed because the document describes a 510(k) submission for a non-AI/ML medical device where the primary goal is demonstrating substantial equivalence, not reporting AI performance metrics from a dedicated study.
§ 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.