(138 days)
The Syntec, Inc. Disposable Endo Illuminators is used to illuminate with visible spectrum light the intraocuiar portion of the eye for improved visualization during vitreo-retinal surgery.
The Endo Illuminator is comprised of five basic components. The handpiece handle. The handpiece tube. The fiberoptic cable. The fiber optic cable sheath and the connector.
The provided text describes a medical device called the Syntec, Inc. Tru Light Endo Illuminator. However, the document is a 510(k) summary of safety and effectiveness, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed performance metrics as you've requested.
Therefore, I cannot provide the information in the requested format because the input document does not contain the details of a study with acceptance criteria, specific performance metrics, sample sizes, expert qualifications, or ground truth methods.
The document states:
- "The Syntec, Inc. Tru Light Endoilluminator and the Grieshaber & Co. Disposable Standard Light Pipe are substantially equivalent since they both are used to for the same clinical purpose..."
- "Both devices are of a similar design and are made using the exact same materials."
- "The device is biocompatible with the body tissue and fluids that it comes in contact with as it is made of the same materials as the predicate device."
- "The light output intensity and spot size is the same as the predicate device. The only device differrences are cosmetic."
These statements indicate that the device's safety and effectiveness were demonstrated by showing it is essentially identical to a previously cleared device, not through an independent study with defined acceptance criteria and performance measurements.
§ 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.