(142 days)
The KnoxFog Anti-fogging Device is a temporary anti-fog coating and therein inhibits fogging on optical lenses. It is a laparoscopic accessory intended to facilitate intraoperative defogging of laparoscope lenses, thereby maintaining visualization of the surgical site and closed body cavity.
KnoxFog™ is intended for use as an anti-fog solution applied to rigid endoscope lenses prior to insertion into the body to maintain optical clarity during endoscopic procedures.
KnoxFog™ is a semi-sol gel anti-fog coating designed to prevent condensation on endoscopic lenses during surgical procedures. The device is supplied as a sterile solution in single-use containers for application immediately prior to endoscopic procedures. When applied to the endoscope lens, KnoxFog™ forms a transparent hydrophilic coating that prevents fog formation by maintaining optical clarity in high-humidity environments. The product is terminally sterilized using gamma radiation to ensure safety for use in surgical environments.
The provided FDA 510(k) clearance letter for the KnoxFog Anti-fogging Device focuses on the device's technical specifications and substantial equivalence to a predicate device, VitreOx™. However, it does not contain information typically associated with studies proving a device meets acceptance criteria for an AI/ML medical device, which would involve aspects like expert ground truth, multi-reader studies, or large data sets.
The document describes bench testing for an anti-fogging solution, not an AI/ML algorithm. Therefore, many of the requested points regarding AI/ML device studies (e.g., ground truth establishment, training sets, MRMC studies, standalone performance) are not applicable to the information provided.
I can, however, extract the acceptance criteria and performance data for the anti-fogging device based on the provided text.
Acceptance Criteria and Device Performance (KnoxFog Anti-fogging Device)
Based on the provided document, the "acceptance criteria" appear to be implicitly defined by the comparative performance against the predicate device, VitreOx™, specifically in terms of time-to-fog. Other tests (transportation, accelerated aging, biocompatibility) are also performance indicators but without explicit numerical acceptance thresholds provided beyond general "stability," "shelf-life claims," and "biocompatible."
Here's the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance (KnoxFog™) |
|---|---|
| Time-to-Fog: Equivalent or superior to predicate device (VitreOx™) which lasted 62 ± 5.5 minutes fog-free. | Time-to-Fog: Averaged 71.6 ± 3 minutes fog-free (117% relative performance compared to predicate). |
| Transportation Stability: Device remains stable under various transportation conditions. | Transportation Stability: Verified product stability under various transportation conditions. |
| Accelerated Aging/Shelf-Life: Product maintains claimed shelf-life. | Accelerated Aging/Shelf-Life: Six-month accelerated aging studies confirmed product shelf-life claims. |
| Biocompatibility: Device is biocompatible for intended use and addresses previous cytotoxicity concerns. | Biocompatibility: Tested in accordance with ISO 10993 standards and demonstrated biocompatibility, addressing previous cytotoxicity concerns. |
Note on "Acceptance Criteria": The document doesn't explicitly state numerical acceptance criteria for "Transportation Stability," "Accelerated Aging," or "Biocompatibility." Instead, it states that the tests verified stability, confirmed shelf-life claims, and demonstrated biocompatibility in accordance with standards. The time-to-fog analysis is the most quantitative comparative criterion mentioned.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for any of the tests (Time-to-Fog, Transportation, Accelerated Aging, Biocompatibility). The text just mentions "comparative testing" and "studies."
- Data Provenance: Not specified (e.g., country of origin). The studies appear to be bench testing performed by the manufacturer, UV ONE Hygienics, Inc. The document does not indicate if the data was retrospective or prospective in the medical context, as it's a materials science/engineering evaluation rather than a clinical study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not Applicable. This device is an anti-fogging solution, not an AI/ML diagnostic or image interpretation device. The "ground truth" would be objective measurements of fogging, material stability, and biological reactions, not expert consensus on medical images.
4. Adjudication Method for the Test Set
- Not Applicable. As above, this is for assessment of an anti-fogging solution, not human interpretation of data requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study is relevant for evaluating the impact of AI on human reader performance, typically in interpreting medical images. This device is a topical anti-fogging agent. The "Performance Data" section details bench testing comparing the device's technical performance (time-to-fog, stability) to a predicate, not how it affects human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This is not an algorithm. The performance data presented (time-to-fog, stability, biocompatibility) are inherently "standalone" in the sense that they measure the physical properties of the device itself.
7. The Type of Ground Truth Used
- Objective Measurements/Material Science:
- For "Time-to-Fog Analysis": The ground truth is the measurable time until fog formation on the endoscope lens under specific conditions.
- For "Transportation Testing": The ground truth relates to the physical integrity and continued functionality of the product after simulated transport.
- For "Accelerated Aging": The ground truth is the product's stability and efficacy over time, extrapolated from accelerated conditions.
- For "Biocompatibility Testing": The ground truth is established through standardized in vitro and in vivo biological tests (e.g., cytotoxicity, irritation) according to ISO 10993 standards.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As above, no training set for an AI/ML algorithm is involved.
§ 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.