(91 days)
The Unimax Anti-Fog Solution is intended to be used to prevent "fogging" (caused by condensation) on the lenses of endoscopic/laparoscopic instruments which are likely to fog during use.
The Unimax Anti-Fog Solution is a clear / colorless, water soluble solution. The model with alcohol is comprised of DPGMME (=2%), Isopropyl alcohol (=6%), and Deionized water (=92%), while the model without alcohol is comprised of DPGMME (=2%) and Deionized water (=98%). Unimax Anti-Fog Solution functions by reducing the surface tension of water, thus preventing water droplets (fog) from forming on the lenses of endoscopic / laparoscopic instruments during use. This solution is bottled in a volume of 6cc's in a 10cc clear plastic dropper bottle. Included in the tyvek pouch packaging of this product is a 4.54.50.5 (LWH) adhesive backed, non-abrasive, x-ray detectable radiopaque/nonradiopaque, polyurethane foam pad for applying the product to endoscopic / laparoscopic lenses. This product is sold sterile to healthcare professionals only.
The provided text describes a 510(k) premarket notification for the "Unimax Anti-Fog Solution." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving new acceptance criteria for an AI device. Therefore, the requested information about AI device acceptance criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, and standalone performance is not available in the given text.
The document states that a series of safety and effectiveness tests were performed to assess the Unimax Anti-Fog Solution. The results of these tests demonstrate that the device meets its predefined acceptance criteria and intended uses.
1. A table of acceptance criteria and the reported device performance
The document mentions that all test results demonstrate Unimax Anti-Fog Solution meets the requirements of its pre-defined acceptance criteria and intended uses. However, it does not explicitly list the acceptance criteria or specific performance values for the fog resistance test, cleaning ability test, extractable test, or prolonged fog resistance test. It only states that the results indicate the new device is "as safe and effective as the predicate device."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document as it refers to a medical device's physical properties, not an AI model requiring ground truth from experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not provided in the document. This is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not provided in the document. This is not an AI device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not provided in the document. This is not an AI device. The tests performed are laboratory standard tests.
8. The sample size for the training set
This information is not provided in the document. This is not an AI device and does not involve training sets.
9. How the ground truth for the training set was established
This information is not provided in the document. This is not an AI device and does not involve training sets.
§ 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.