(119 days)
Processor VP-7000
The VP-7000 unit is used for endoscopic observation, diagnosis, treatment, and image recording.
It is intended to process electronic signals transmitted from a video endoscope (a video camera in an endoscope). This product may be used on all patients requiring endoscopic examination and when using a Fujinon/FUJIFILM medical endoscope and light source together with monitor, recorder and various peripheral devices.
BLI (Blue Light Imaging), LCI (Linked Color Imaging) and FICE (Flexible spectral-Imaging Color Enhancement) are adjunctive tools for gastrointestinal endoscopic examination which can be used to supplement Fujifilm white light endoscopy.
BLI, LCI and FICE are not intended to replace histopathological sampling as a means of diagnosis.
Light Source BL-7000
The BL-7000 Light Source is used for endoscopic observation, diagnosis, treatment, and image recording, If is intended to provide illumination to an endoscope.
The light source also functions as a pump to supply air through the endoscope while inside the obtaining clear visualization to facilitate diagnostic examination.
This product may be used on all patients requiring endoscopic examination and when using a Fujinon/FUJIFILM medical endoscope and video processor together with monitor, recorder and various peripheral devices.
VP-7000 and BL-7000 are intended to be used in conjunction with Fujinon/FUJIFILM endoscopes for endoscopic observation, diagnosis, treatment, and image recording. The description for each of the components of the subject device is below:
The VP-7000 Video Processor:
The Processor relays the image from the endoscope to a video monitor. Projection can be either analog or digital at the user's preference. The Processor incorporates internal digital storage capacity. The Processor also controls the light projected to the body cavity. The Processor provides for optional structural enhancement through user modes FICE. BLI. BLI-bright and LCI. Spectral and structural enhancements are achieved through proprietary software. The device is AC operated at a power setting of 100-240V/50-60Hz/0.8-0.5A. The Processor is housed in a steelpolycarbonate case measuring 390x110x485mm.
The DK-7000E Keyboard is a standard accessory of VP-7000. It is used to enter pertinent procedural information (patient, physician, date, etc.) for display on the video monitor and digital/analog storage systems. The Keyboard is also used to control operational features of the VP-7000 Processor. The Keyboard resembles a standard computer keyboard, and is provided with an instruction label attached to it.
The BL-7000 Light Source:
The Fujinon/FUJIFILM endoscope employs fiber bundles to transmit light from the light source and subsequently to the body cavity. The Light Source employs 79.2W 4 LED lamps. Brightness control is performed by the user. The device is AC operated at a power setting of 100-240V/50-60Hz/1.2-0.7A. The Light Source is housed in a steel-polycarbonate case measuring 390x155x485mm.
The provided document describes the FUJIFILM Processor VP-7000 and Light Source BL-7000 and its substantial equivalence to predicate devices, particularly focusing on the performance data for its new imaging features (BLI and BLI-bright).
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" with quantitative metrics for the clinical performance of the device's enhanced imaging modes (BLI, BLI-bright). Instead, it states that "All testing criteria were met" for non-clinical functional tests and for clinical evaluation, "The clinical study established that BLI and BLI-bright demonstrated substantial equivalence of diagnostic visualization (e.g. image quality) to the predicate FICE."
The primary goal of the clinical study was to demonstrate substantial equivalence of diagnostic visualization (image quality) compared to the FICE predicate. While a specific numerical acceptance criterion isn't given, the statement implies that the image quality was not worse than FICE, which was already a cleared device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Non-clinical: | |
| Software validation (IEC 62304) | All testing criteria were met. |
| Electrical safety (IEC 60601) | All testing criteria were met. |
| Functional testing of FICE, BLI-bright, LCI image processing features (Contrast Enhancement, Resolving Power, Noise, Artifact Creation, Color Reproduction) | All testing criteria were met, and in all instances the device functioned as intended. |
| Clinical: | |
| Substantial equivalence of diagnostic visualization/image quality to predicate FICE (for BLI and BLI-bright) | BLI and BLI-bright demonstrated substantial equivalence of diagnostic visualization (e.g. image quality) to the predicate FICE. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact number of subjects (patients) or images in the clinical study's test set. It mentions each subject underwent an endoscopic examination using the VP-7000, BL-7000, and FUJIFILM's video endoscopes.
- Data Provenance: The study was a "prospective clinical trial." The country of origin for the data is not explicitly stated, but given the FDA filing, it is likely that parts, if not all, of the data were collected in the United States or under similar clinical standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: The clinical study involved "multiple blinded investigators." The exact number is not specified.
- Qualifications of Experts: The qualifications of these "investigators" are not detailed in the provided text. It can be inferred they are medical professionals qualified to interpret endoscopic images, but specific credentials (e.g., gastroenterologists, radiologists) or years of experience are not mentioned.
4. Adjudication Method for the Test Set
- The study design was a "reader concurrence study." Images were "analyzed independently by multiple blinded investigators." It is not explicitly stated how discrepancies among readers were resolved or if a formal adjudication process (e.g., 2+1, 3+1) was used to establish a final ground truth for each image, beyond simply analyzing reader agreement (concurrence).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
- An MRMC-like study was performed in the sense that multiple readers evaluated multiple cases. However, this study was not a comparative effectiveness study designed to assess how much human readers improve with AI vs. without AI assistance.
- The BLI, LCI, and FICE features are described as "adjunctive tools for gastrointestinal endoscopic examination which can be used to supplement Fujifilm white light endoscopy." They are image processing features, not necessarily "AI" in the modern sense (e.g., providing diagnostic suggestions).
- The study's goal was to establish "substantial equivalence of diagnostic visualization (e.g. image quality) to the predicate FICE," not an improvement in human reader performance or diagnostic accuracy per se. Therefore, no effect size for human reader improvement with AI assistance is reported.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
- No standalone performance was reported in this document. The BLI, LCI, and FICE features are image processing enhancements intended to be used by a "licensed medical practitioner (user)" as "adjunctive tools" to "supplement" white light endoscopy. They are not presenting a standalone diagnostic output that would require a separate "algorithm only" performance evaluation.
7. The Type of Ground Truth Used
- The document states that the clinical study evaluated "overall image quality" and "diagnostic visualization."
- The images were analyzed independently by multiple blinded investigators using a "4-point Likert scale." This suggests that the ground truth for image quality/diagnostic visualization was established through expert consensus/opinion based on their scoring.
- The document explicitly states: "BLI, LCI and FICE are not intended to replace histopathological sampling as a means of diagnosis." This indicates that histopathology was not the ground truth against which the image enhancements were directly evaluated for diagnostic accuracy outcomes.
8. The Sample Size for the Training Set
- The document does not specify a separate training set. The BLI, LCI, and FICE enhancements are described as "achieved through proprietary software" and based on "signal processing" and manipulation of LED light intensity ratios. This suggests these are pre-defined image processing algorithms rather than machine learning models that require a distinct training set in the typical sense of AI development.
9. How the Ground Truth for the Training Set Was Established
- As no explicit training set for a machine learning model is mentioned, the concept of "ground truth for the training set" does not directly apply in the context of the information provided for these specific image processing features. The development of these enhancements would likely have involved engineering and optical principles to achieve desired visual effects, rather than a data-driven training process with established clinical ground truth labels.
§ 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.