(27 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 Eve 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 Eve 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 Eve 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 Eye Retroscope image.
The provided document is a 510(k) summary for the Avantis Medical Systems, Inc. Third Eye® Retroscope® Auxiliary Endoscopy System. This submission is a "Special 510(k)" indicating modifications to a previously cleared device (K091783).
Therefore, the primary focus of this document is to demonstrate that the modifications made to the device do not raise new issues of safety or effectiveness and that the modified device remains substantially equivalent to its predicate. The study described is bench verification testing rather than a clinical study assessing diagnostic performance against a ground truth.
Because this is a Special 510(k) for modifications to an existing device, a full clinical study with specific acceptance criteria related to diagnostic performance (like sensitivity, specificity, accuracy) using a human-in-the-loop or standalone algorithm performance on a clinical test set is not typically required or presented in such a submission. The focus is on demonstrating that the changes do not negatively impact safety or effectiveness.
Based on the provided information, I can extract the following:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from 510(k) Summary) | Reported Device Performance (from 510(k) Summary) |
|---|---|
| Modified device meets design inputs and intended performance characteristics. | "Results demonstrate that the modified Third Eye Retroscope Auxiliary Endoscopy System performs as intended." |
| Modifications do not change the fundamental scientific technology of the device. | "Modifications made to the device and accessories did not change the fundamental scientific technology of the device." |
| Modifications do not raise any new or unresolved issues for safety and efficacy. | "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." |
| Support both standard and High Definition (HD) colonoscopes. | The modified Video Processor (VP) expands function to support both standard and HD colonoscopes. |
| Display standard and HD colonoscope images on a HD monitor. | The modified VP displays standard and HD colonoscope images on a HD monitor. |
| Smaller chassis to decrease footprint and improve aesthetics. | The VP was upgraded with a smaller chassis. |
| No changes in the function or capability of the VP result from chassis changes. | "No changes in the function or capability of the VP result from these changes." |
| No changes to disposable portions. | "No changes have been made to the disposable portions of the Third Eye system." |
| Substantially equivalent to the cleared predicate device in fundamental design, materials, processes, sterile barrier packaging, and sterilization. | "The modified device is substantially equivalent to the cleared predicate device in fundamental design, materials, processes, sterile barrier packaging, and sterilization." |
| All changes subjected to risk analysis and verified to meet current design specifications. | "All changes have been subjected to risk analysis and have been verified to meet current design specifications." |
| Minor changes to IFU as a result of VP modifications. | "Minor changes have been made to the IFU as a result of the modifications to the Video Processor." |
| Differences between modified and predicate have no impact on safety and effectiveness. | "Differences between the modified Third Eye System and the predicate device have no impact on safety and effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
The document describes "Bench verification testing." This typically involves laboratory-based tests of the device's hardware and software specifications, rather than clinical data from human subjects. Therefore, there is no human "test set" in the traditional sense of clinical data reported in this document. The testing is of the device's components and system functionality. If any data was used, it would likely be synthetic or internal test data generated to assess performance against engineering specifications. Data provenance is not applicable as this is not a study using retrospective or prospective patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable as the testing described is bench verification testing against engineering specifications, not a clinical study requiring expert-established ground truth on patient data.
4. Adjudication Method for the Test Set
This is not applicable as there is no clinical test set requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or reported in this 510(k) summary. The document focuses on demonstrating substantial equivalence of the modified device through bench testing, not on assessing the improvement of human readers with AI assistance. The device itself is an auxiliary endoscopy system providing visualization, not an AI-assisted diagnostic tool in the typical sense of interpreting images.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is an auxiliary endoscopy system, not an AI algorithm performing standalone interpretation. Therefore, a standalone algorithm performance study was not done or reported. The device provides images to a physician, who then performs the interpretation.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
As this was bench verification testing, the "ground truth" would be the design specifications and engineering requirements for the device's performance (e.g., video quality, illumination, mechanical movement, electrical functionality).
8. The Sample Size for the Training Set
This is not applicable as the device is not an AI algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as the device is not an AI algorithm that requires a training set with established ground truth.
In summary: The provided 510(k) summary for the Third Eye® Retroscope® Auxiliary Endoscopy System describes modifications to a previously cleared device. The "study" mentioned is bench verification testing aimed at confirming that the modified device still meets its design specifications and intended performance, and that the changes do not introduce new safety or efficacy concerns, thus maintaining substantial equivalence to its predicate. It is not a clinical study involving human subjects or AI algorithm performance assessment.
§ 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.