(107 days)
The Avantis Medical Systems, Inc. Third Eye is indicated for use in the instrument channel of a conventional colonoscope to provide retrograde illumination and visualization of the colon for diagnostic purposes.
The Third Eye System consists of both disposable portions and facility equipment. The disposable portions include the Third Eye Retroscope and Caps. The facility equipment portions of the device include the Third Eye Video Processor and accessories. The Third Eye is designed as an auxiliary device for use during a colonoscopy procedure. After a colonoscope has been advanced to the cecurn, the Third Eye Retroscope is inserted through the instrument channel of the colonoscope. As the Third Eye Retroscope emerges from the distal tip of the instrument channel of the colonoscope, it automatically bends 180 degrees to form a "J" shape. The Third Eye then provides a continuous retrograde image of the colon throughout the process of withdrawal of the colonoscope. The Third Eve Video Processor is a piece of electrical equipment that acts as an interface for the Third Eye Retroscope, the video output signals, and user input controls. The output video signals from the Video Processor are displayed on a monitor for viewing by the physician. Application software that runs on the Video Processor allows the user to adjust the light intensity and various picture settings of the Third Eve Retroscope image.
Here's a breakdown of the acceptance criteria and study information based on the provided text for the Avantis Medical Systems' Third Eye Retroscope Auxiliary Endoscopy System:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Safety: Device modifications do not raise new or unresolved safety issues. Adherence to general controls provisions (registration, labeling, GMP). | "Modifications made to the device and accessories did not change the fundamental scientific technology of the device. The testing described demonstrates that the differences in the device components and accessories do not raise any new or unresolved issues for safety and efficacy." "Risks to patients in terms of adverse events are comparable to those reported in the literature for traditional screening colonoscopies. Use of the Third Eye did not increase the risks to the patients..." |
| Effectiveness/Performance: Device performs as intended. | "Bench verification testing was conducted to verify that the modified device meets the design inputs and intended performance characteristics. Results demonstrate that modifications made to the Third Eye design performs as intended." "Results from a prospective, multi-center post-market study demonstrate that retrograde viewing of the colon with the Third Eye improves the detection of polyps and adenomas compared to traditional colonoscopy alone. Results were statistically significant." |
| Clinical Benefit: Improves detection of polyps and adenomas. | "Avantis Medical Systems, Inc. has determined, based on clinical data, that the Third Eye improves the detection of polyps and adenomas in patients for whom colonoscopies are indicated." "Use of the Third Eye did not increase the risks to the patients but offered a statistically significant benefit of improved detection." |
| Substantial Equivalence: To the predicate device (K070330) despite modifications. | "The Avantis Third Eye is substantially equivalent in operation and fundamental scientific technology to its previous version, cleared under K070330." "The modified device is substantially equivalent to the cleared predicate device in fundamental design materials, processes, sterile barrier packaging, and sterilization. All changes have been subjected to risk analysis and have been verified to meet current design specifications." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in terms of a specific number of patients or cases. The document refers to a "multi-center post-market study."
- Data Provenance:
- Country of Origin: Not specified.
- Retrospective or Prospective: Prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not provided in the document. The document states that the Third Eye "improves detection of polyps and adenomas," implying a comparison, but it does not detail how the ground truth for "polyps and adenomas" was established in the clinical study (e.g., standard colonoscopy findings, pathology, or a panel of experts).
4. Adjudication Method 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, and Effect Size
- It states that a clinical study "demonstrate(s) that retrograde viewing of the colon with the Third Eye improves the detection of polyps and adenomas compared to traditional colonoscopy alone." This indicates a comparative effectiveness study, however, it's not explicitly labeled as an MRMC study and the specific effect size quantifying "how much human readers improve with AI vs without AI assistance" is not provided. The document only states that the results were "statistically significant." The device itself is an auxiliary endoscope, not an AI, so the framing of "human readers improve with AI vs without AI assistance" isn't directly applicable in this context. It's about improved detection with the device vs. without.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- No, this was not done. The device is an auxiliary endoscopic system designed for human use during a colonoscopy to provide additional visualization. It is not an algorithm that operates independently.
7. The Type of Ground Truth Used
- The document states the study measured "detection of polyps and adenomas." While not explicitly defined as pathology, in the context of colonoscopy clinical trials, pathology from biopsied or resected lesions is the generally accepted gold standard for confirming polyps and adenomas. However, the document does not definitively state that pathology was the sole or primary ground truth method.
8. The Sample Size for the Training Set
- This information is not applicable/not provided. The Third Eye Retroscope is a medical device, not an AI algorithm that requires a "training set" in the machine learning sense. The clinical study described is for validation of the device's performance.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable/not provided for the same reason as point 8.
§ 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.