(181 days)
Fuse Colonoscopy System: The Fuse Colonoscope with FuseBox Processor is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. The system consists of EndoChoice camera heads, endoscopes, video system, light source and other ancillary equipment. Fuse Colonoscopes, in conjunction with the FuseBox® processor, are indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) for adult patients. The system includes Lumos, a digital post processing inage enhancement technology. Lumos is intended to be used as an optional adjunct following white light endoscopy and is not intended to replace histopathological sampling as a means of diagnosis.
Fuse 1G Gastroscopy System: The Fuse 1G Gastroscope with FuseBox Processor is intended for diagnostic visualization of the digestive tract. The system also provides access for therventions using standard endoscopy tools. The system consists of EndoChoice camera heads, endoscopes, video system, light source and other ancillary equipment. The Fuse 1G Gastroscope, in conjunction with the FuseBox processor, is indicated for use within the upper digestive tract (including the esophagus, stomach and duodenum). The system includes Lumos, a digital post processing image enhancement technology. Lumos is intended to be used as an optional adjunct following white light endoscopy and is not intended to replace histopathological sampling as a means of diagnosis.
The Fuse Endoscopy System is a GI platform indicated for diagnostic visualization and therapeutic intervention of the digestive tract. The system labeled for healthcare facilities/hospitals enables physicians to view a high-resolution wide field of view. The FuseBox is responsible for image processing, transferring video signals from the endoscope, pneumatic control, and outputting high definition (HD 1080p) video signal. The current FuseBox version, unlike the version used with the two predicate devices, includes image post processing algorithm as an adjunct tool to white light visualization.
The feature provides real-time enhancement and will be used as an adjunctive tool. to supplement the white light endoscopic examination. The new feature may enhance appearance of surface vessels, visualization of the mucosal surface texture and visibility of borders of areas of interest when present.
The provided text describes the Fuse® Endoscopy System with FuseBox® Processor, which includes a digital post-processing image enhancement technology called Lumos. The information primarily focuses on establishing substantial equivalence to predicate devices for regulatory approval, rather than detailed acceptance criteria and a specific study proving it meets those criteria.
However, I can extract the available information and structure it as requested, making note of where specific details are not provided in the document.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria for the Lumos feature. Instead, it refers to overall device safety and effectiveness. The performance characteristics mentioned are comparisons to predicate devices for the white light aspects of the system. For Lumos, it states its function as an "enhancement feature."
| Characteristic / Acceptance Criteria (Implied) | Reported Device Performance (Lumos Feature) |
|---|---|
| Intended Use | Same as predicates: Diagnostic visualization of the digestive tract and access for therapeutic interventions. Lumos is an adjunct to white light endoscopy and not intended to replace histopathological sampling for diagnosis. |
| Enhancement Mechanism | Image processing of local contrast enhancement of intensity and tone, resulting in modification of the combination of RGB components for each pixel. Allows retaining the neutral color of the tissue for human observers. |
| Number of Enhancement Levels | 2 graduating enhancement modes for each intended use: Low gastro, high gastro; Low colono, high colono. |
| Safety and Effectiveness | All test results demonstrated that the device is safe and effective in comparison with the predicate device. The impact of the differences (Lumos) is insignificant in terms of device safety and effectiveness for the device's intended use. |
| Image Quality (General) | Image quality testing (spatial resolution, field of view, depth of field, uniformity, geometric distortion, noise properties and color performance) was performed. Results demonstrated the device is safe and effective. |
| Clinical Survey Impact | Clinical Survey on videos with Lumos compared to white light was performed, indicating satisfactory performance. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Clinical Survey on videos with the Lumos compared to white light" was performed. However, it does not provide any details regarding:
- The sample size of videos or cases used in this clinical survey.
- The provenance of the data (e.g., country of origin).
- Whether the data was retrospective or prospective.
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)
The document does not specify the number of experts or their qualifications used to establish ground truth for the "Clinical Survey on videos." It only states that a clinical survey was conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not provide any information about the adjudication method used for the "Clinical Survey on videos."
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
The document mentions a "Clinical Survey on videos with the Lumos compared to white light." While this implies a comparison, it does not explicitly state that it was a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. Furthermore, it does not provide any effect size or quantitative measure of how much human readers improve with AI (Lumos) vs. without AI assistance. It only broadly states that the feature "may enhance appearance of surface vessels, visualization of the mucosal surface texture and visibility of borders of areas of interest."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes Lumos as an "optional adjunct" and an "adjunctive tool to supplement the white light endoscopic examination." This strongly suggests that it is not intended for standalone performance but rather for human-in-the-loop use. No standalone algorithm performance study is described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the type of ground truth used for the "Clinical Survey on videos." Given the context of "diagnostic visualization" and "adjunct following white light endoscopy," it's plausible that expert interpretation/consensus of standard white light imagery or potentially pathological findings serve as an implicit ground truth, but this is not mentioned. It specifically states that Lumos "is not intended to replace histopathological sampling as a means of diagnosis."
8. The sample size for the training set
The document does not provide any information regarding the sample size for a training set. The descriptions focus on the device's function and comparison to predicate devices, not on the development or training of the Lumos algorithm.
9. How the ground truth for the training set was established
Since no training set details (including sample size) are provided, the document does not describe how ground truth for a training set was established.
§ 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.