(259 days)
The HOPKINS Telescopes are intended to provide visualization during laparoscopy and general surgery in adults and pediatrics.
The HOPKINS Telescopes are rigid telescopes that utilize the rod lens technology. At the distal end of the telescope's shaft is the lens and the other end of the shaft is attached to the eyepiece. Throughout the central lumen of the HOPKINS Telescopes, optical glass rods are used to transmit and magnify the image received from the lens. The HOPKINS Telescopes are available with 0°, 25° and 45° direction of view, 5mm diameter and 29cm working lengths.
The provided text is a 510(k) summary for the KARL STORZ HOPKINS Telescopes. This document is a premarket notification for a medical device to demonstrate substantial equivalence to a legally marketed predicate device. As such, it focuses on comparing the new device to an existing one based on technical characteristics, rather than establishing acceptance criteria and proving performance through a clinical study for an AI/ML-driven device.
The document discusses the physical and optical characteristics of the endoscope, reprocessing methods, and non-clinical performance data (e.g., adherence to ISO standards, biocompatibility, thermal safety, reprocessing validation). It explicitly states: "There are no performance standards or special controls developed under Section 514 of the FD&C Act for endoscopes." This indicates that the regulatory pathway for this device does not require the kind of performance validation typically seen for AI/ML devices, which would involve acceptance criteria for metrics like sensitivity, specificity, or AUC, and detailed clinical study designs.
Therefore, the document does not contain the information required to answer the prompt questions regarding acceptance criteria for an AI/ML device. The HOPKINS Telescopes are a traditional optical medical device, not an AI/ML product.
To reiterate, the provided text does not contain any information about:
- Acceptance criteria or reported device performance for AI/ML metrics.
- Sample sizes for test sets or data provenance (as it's not an AI/ML study).
- Number and qualifications of experts for ground truth establishment.
- Adjudication methods.
- MRMC comparative effectiveness studies or effect sizes.
- Standalone algorithm performance studies.
- Type of ground truth (as it's not a diagnostic AI/ML device).
- Sample size for training sets (no AI/ML training is mentioned).
- How ground truth for a training set was established.
§ 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.