(25 days)
The TELE PACK + is an all-in-one Imaging System, which comprises a light source for illumination, Camera Control Unit (CCU) for use with compatible camera heads or video endoscopes for image processing, as well as a monitor for image display, intended for the visualization of endoscopic and microscopic procedures.
The Telepack + is a portable and compact all-in-one imaging system that includes a 18.5 inch screen display, a camera control unit and internal LED light source, that is intended to be connected to a compatible device (camera head or videoendoscope) for the purpose of visualization and documentation of endoscopic and microscopic procedures as well as stroboscopy. The Telepack + includes a LED illumination light source to illuminate the intended area and a 18.5 inch monitor for display. It also allows the users to redefine the functions that take place when a button is pressed. The Telepack + is a non-patient contacting and require only wipe down as needed.
The provided text is a 510(k) Summary for the Telepack + imaging system. It describes the device, its intended use, and the non-clinical performance data used to demonstrate substantial equivalence to a predicate device. However, it does not contain information about:
- Acceptance criteria in the context of an AI/algorithm-driven device's performance metrics (e.g., sensitivity, specificity, AUC).
- A study proving the device meets these acceptance criteria through a comparison of algorithm performance against a ground truth dataset, or human reader performance.
- Sample sizes for test sets where ground truth is established by experts.
- The number or qualifications of experts used for establishing ground truth.
- Adjudication methods for ground truth.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Effect sizes of human reader improvement with AI assistance.
- Standalone algorithm performance studies.
- Specific types of ground truth (e.g., pathology, outcomes data for a disease).
- Sample size for training sets.
- How ground truth for training sets was established.
The "Performance Testing" section within the "Non-Clinical Performance Data" discusses basic image quality characteristics like "Minimum Illumination," "Spatial Resolution," "Color Performance," "Latency," "White Balance," and "AE Step Response," along with "Head Button Functionality." These are engineering performance metrics for an imaging system, not performance metrics for an AI/algorithm diagnosing or assisting in diagnosis.
The document explicitly states: "Clinical performance is not required to demonstrate substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish substantial equivalence." This indicates that the Telepack + is a hardware imaging system, and its approval was based on demonstrating that its image quality and functionality are comparable to its predicate, rather than on the diagnostic performance of an embedded AI algorithm.
Therefore, I cannot provide the requested information based on the given text.
In summary, the provided document does not contain the information required to answer your prompt because the device is an imaging system, not an AI/algorithm-driven diagnostic aid.
§ 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.