(85 days)
The Endoscopic Camera TC804/C4 is intended to attach to standard endoscopes to permit visualization of body cavities, hollow organs and canals during endoscopic procedures. It also may be attached to a microscope. The endoscopic image can be displayed on any standard video monitor.
The Endoscopic Camera TC804/C4 is a 3-CCD camera, which consists of a camera control unit (CCU), a camera head, various connecting objectives, cables and adapters. The Endoscopic Camera TC804/C4 takes the image through standard endoscopes that would be normally seen with the naked eye, and displays it on any standard video monitor. The camera head is supplied with a standard 30 mm endofocus objective but may also be used with a 25 mm or zoom objective. The device is programmable by two head key bottons and is equipped with a ring-focus for both right-handed and left-handed users.
The provided text describes a 510(k) summary for the Endoscopic Camera TC804/C4. It outlines the device's intended use and design but does not contain information regarding specific acceptance criteria, performance data from a study, or details about ground truth establishment or sample sizes as would be expected for an AI/ML device.
The section titled "VIII. Performance Data" states: "The Endoscopic Camera TC804/C4 complies with the International Standard IEC 601-1. IEC 601-1-2. the European Standard EN 55011 and conforms to the Medical Device Directive 93/42 EEC. The device will be tested in accordance with UL2601-1." This indicates compliance with general electrical safety and EMC standards, and a plan for UL testing, but not a study evaluating its "performance" in the context of image quality or diagnostic accuracy, which would be relevant for devices that AI/ML systems typically enhance.
Therefore, I cannot populate the requested table and answer many of the questions because the document does not contain the necessary information about acceptance criteria, specific device performance metrics, study design, ground truth, or expert involvement as outlined in the prompt. The device described appears to be a standard endoscopic camera, not one incorporating AI/ML, and its regulatory submission focuses on substantial equivalence to predicate devices based on design and intended use, rather than detailed performance studies against specific acceptance criteria.
Analysis of Provided Information vs. Requested Details:
- Table of acceptance criteria and reported device performance: Not available. The document only mentions compliance with general medical device standards (IEC, EN, UL). It does not provide specific performance metrics like resolution, sensitivity, specificity, or image quality against defined acceptance criteria.
- Sample size for test set and data provenance: Not available. No test set or study validating specific performance claims is described.
- Number of experts and qualifications for ground truth: Not available. No ground truth establishment is described for a performance study.
- Adjudication method: Not available.
- MRMC comparative effectiveness study: Not applicable/not available. The document does not describe an AI-assisted device.
- Standalone performance study: Not available in the context of AI/ML or image quality metrics.
- Type of ground truth used: Not available.
- Sample size for training set: Not applicable/not available. No AI/ML model training is mentioned.
- How ground truth for training set was established: Not applicable/not available.
In summary, the provided 510(k) summary is for a traditional endoscopic camera, and its "Performance Data" section refers to compliance with safety and electrical standards, not to clinical or image quality performance studies that would typically have acceptance criteria, ground truth, and expert evaluation described.
§ 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.