(78 days)
The Avantis Medical Systems, Inc. Third Eye Retroscope Auxiliary Endoscopy System is intended for use in the instrument channel of a standard colonoscope to provide retrograde illumination and visualization of the colon for diagnostic purposes.
The Third Eye Retroscope Auxiliary Endoscopy System is designed as an auxiliary device for use during a colonoscopy procedure. After a colonoscope has been advanced to the cecum, the Third Eye Retroscope auxiliary Endoscopy device is inserted through the instrument channel of the colonoscope. As the auxiliary device emerges from the distal tip of the instrument channel of the colonoscope, the auxiliary device automatically bends 180 degrees to form a "J" shape. The device then provides a continuous retrograde image of the colon throughout the process of withdrawal of the colonoscope. The Third Eye Retroscope is deployed through the instrument channel of a colonoscope in what is commonly referred to as a mother-daughter configuration. As a result, only approximately 4 cm of the distal tip of the device protrudes from the distal end of the colonoscope's instrument channel except for a few seconds during insertion and removal, when up to 9 cm of the distal tip extends beyond the end of the colonoscope. Any contact of the device with the colonic mucosa is transitory. The system consists of both disposable portions, and facility equipment. The disposable portions include the Third Eye Retroscope and Cap. The Third Eye Retroscope is an endoscope that consists of a distal section, flexible insertion tube and proximal section. The distal section houses an imaging sensor, light source and related circuitry. The flexible insertion tube consists of a standard braided catheter with electrical wires located inside the lumen. These wires carry signals from the distal region to the proximal region. The proximal section includes a torquing knob, flexible wire extension region, and electrical connector. The Third Eye Cap with polarizing filter is placed on the distal end of the colonoscope. The facility equipment portions of the device include the Third Eye Retroscope Video Processor and accessories. The video processor is a piece of electrical equipment that acts as an interface box for the Third Eve 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 various picture settings of the Third Eye Retroscope image and adjust the light intensity of the Retroscope. Additionally, the software facilitates the capture of still images, the export of these still images, and allows a user to save system settings under a profile name.
This document is a 510(k) summary for the Avantis Medical Systems, Inc. Third Eye™ Retroscope™ Auxiliary Endoscopy System. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study design with performance metrics typically associated with AI/ML device evaluations.
Therefore, many of the requested data points (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set sample size, and ground truth for training set) are not applicable or not provided in this type of regulatory submission. This document predates the widespread use of sophisticated AI/ML in medical devices and the associated regulatory expectations for performance studies.
However, I can extract the available information related to performance and create a table for what is provided.
Here's the breakdown of the information based on the document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. Instead, it relies on demonstrating substantial equivalence to predicate devices in terms of intended use, operation, materials, and safety through in vitro bench testing.
| Feature/Parameter | Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (as per submission) |
|---|---|---|
| Intended Use | "Indication for use" similar to predicate devices. | "Intended for use in the instrument channel of a standard colonoscope to provide retrograde illumination and visualization of the colon for diagnostic purposes." This is deemed similar to the combined intended uses of the predicate devices for colonoscopy, with the difference being a retrograde view. |
| Operation | Similar operation to predicate devices (e.g., insertion method, image generation, control via video processor). | The Retroscope is inserted into the colonoscope's instrument channel similar to biopsy forceps. It provides images of the colon similar to a colonoscope, but with a retrograde view. Controlled by the Third Eye Video Processor similar to how a colonoscope is controlled by a Video System Center. |
| Materials | Similar materials to predicate devices. | (Not explicitly detailed in this summary, but presumed to be comparable to materials used in similar endoscopes/accessories to ensure biocompatibility and function). |
| Safety | Similar safety profile to predicate devices. | The device is evaluated through in vitro bench testing to demonstrate safety. Contact with colonic mucosa is described as transitory. |
| Imaging Performance | Equivalent "Imaging Performance" to predicate colonoscopes. | Provides retrograde illumination and visualization. The software allows adjustment of picture settings and light intensity. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document only mentions "in vitro bench testing" without providing details on participants or specific datasets.
- Data Provenance: Not specified. Given it's "in vitro bench testing," it likely refers to laboratory testing and not human or animal study data.
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)
- Number of Experts/Qualifications: Not applicable/not specified. The testing described is "in vitro bench testing," which typically does not involve expert readers establishing ground truth for diagnostic accuracy in the way AI/ML systems are evaluated.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable/none specified. This type of adjudication is relevant for studies involving human interpretation and ground truth establishment, which isn't described here.
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
- MRMC Study: No. This document is for a traditional medical device (an auxiliary endoscope system), not an AI/ML diagnostic system. Therefore, an MRMC comparative effectiveness study regarding "human readers improve with AI vs without AI assistance" was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. The Third Eye Retroscope is an auxiliary endoscopy system used by a physician (human-in-the-loop). It's a visual aid, not an autonomous diagnostic algorithm. While it has "application software that runs on the video processor," this software adjusts picture settings and light intensity, and facilitates image capture, rather than providing autonomous diagnostic interpretations. The document refers to "in vitro bench testing" for performance evaluation, which is likely about image quality, functional integrity, and safety attributes of the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not explicitly stated or required for this type of 510(k) submission which relies on substantial equivalence based on physical and functional characteristics of the device tested via "in vitro bench testing." For imaging performance, the "ground truth" would likely be objective measurements of image resolution, clarity, field of view, illumination, and mechanical reliability, compared against expected performance or established standards.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This device is not an AI/ML product developed using training datasets in the conventional sense. Its "application software" serves control and display functions, not machine learning.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable for the reasons mentioned above.
§ 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.