(20 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 with a colonoscope during a colonoscopy procedure. After a colonoscope has been advanced to the cecum, 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 Eye 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 Eye Retroscope image.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Avantis Medical Systems, Inc. Third Eye® Retroscope® Auxiliary Endoscopy System, structured to answer your specific questions.
Based on the provided document, this is a Special 510(k) submission, which means the device is a modified version of an already cleared device (K083180). Special 510(k)s typically focus on demonstrating that modifications do not adversely affect safety and effectiveness, rather than proving initial efficacy. Therefore, a comprehensive de novo clinical study demonstrating efficacy against specific acceptance criteria is not expected or presented here.
1. Table of Acceptance Criteria and Reported Device Performance
No specific, quantified acceptance criteria or detailed device performance metrics (e.g., sensitivity, specificity, accuracy for diagnostic purposes) are provided in this Special 510(k) summary. The document states:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Design inputs and intended performance characteristics for the modified device (change in hydrophilic coating on camera polarizer) | "Results demonstrate that the modified Third Eye Retroscope Auxiliary Endoscopy System performs as intended." (Paragraph 510(k) Summary h)) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. No clinical or diagnostic performance test set (e.g., images for diagnostic accuracy) is described.
- Data Provenance: Not applicable. The "test dataset" described is limited to "Bench verification testing."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. No expert-based ground truth establishment is described, as the testing was limited to bench verification.
4. Adjudication Method for the Test Set
Not applicable. No test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No. An MRMC comparative effectiveness study was not done or described in this document. The submission is a Special 510(k) for a device modification, focusing on engineering verification.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, in a conceptual sense. The "testing" mentioned is "Bench verification testing." This means the device itself (the modified Retroscope and its components) was tested to ensure it met design inputs and performed as intended without human intervention in the diagnostic interpretation process. However, this is for the device's functionality (e.g., image quality, mechanics, material compatibility) and not for its diagnostic accuracy in identifying pathologies.
7. The Type of Ground Truth Used
For the bench verification testing, the "ground truth" would be the engineering specifications and design requirements for the device components. The testing aimed to verify that the modified components (specifically the hydrophilic coating) still met these pre-defined standards.
8. The Sample Size for the Training Set
Not applicable. This device is an endoscope system, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device is an endoscope system, not an AI/ML algorithm that requires a training set.
Summary of the Study Presented (Special 510(k) Context):
The submission is a Special 510(k) for a minor modification to an already cleared device (K083180). The modification involved changing the hydrophilic coating on the camera polarizer from one manufacturer to another.
The study presented is "Bench verification testing." The purpose of this testing was to confirm that the modified device still met its original "design inputs and intended performance characteristics." The results, as stated, "demonstrate that the modified Third Eye Retroscope Auxiliary Endoscopy System performs as intended." This implies that physical and functional tests were conducted to ensure the new coating did not negatively impact the device's operation, sterility, or mechanical properties, thus confirming it remained substantially equivalent to the predicate device. No clinical efficacy study or diagnostic performance study was conducted or required for this type of submission.
§ 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.