(71 days)
The Tru-Cable™ endoscopic fiber optic cable is designed to transmit light for illumination purposes from a remote source to an endoscope or similar surgical instrument. It can be adapted to be compatible with a variety of illuminators.
The Truphatek Tru-Cable™ endoscopic fiber optic cables are:
- . Lengths of 10 feet (3.5m)
- Diameters 3.5mm and 5.0mm .
- The fiber optic cable is hermetically sealed in a closed system so that it can be . sterilized or high level disinfected using most common methods.
- The cables are sold non-sterile. .
The fiber optic cables are designed for use with all the most popular light source illuminators and surgical instruments that are equipped with standard endoscopic adapters. They are designed for user high level disinfection and / or sterilization by autoclave or high level disinfection may be done via Steris® or Liquid Chemicals, i.e. Cidex OPA®. The cable is rated for 100 uses when processed via autoclave.
This document is a 510(k) Pre-Market Notification for the Tru-Cable™ endoscopic fiber optic cables. It focuses on demonstrating substantial equivalence to predicate devices and does NOT contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of human readers improving with AI vs. without AI assistance
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
This device is a physical medical instrument (fiber optic cable), not an AI/software device. The 510(k) summary provided is for a traditional medical device submission, which typically focuses on bench testing, biocompatibility, sterilization validation, and comparison to legally marketed predicate devices, rather than performance metrics typically associated with AI/ML diagnostic or prognostic tools.
§ 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.