(30 days)
Endoscope Model EG-580UT
FUJIFILM Endoscope Model EG-580UT is intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis, and endoscopic treatment. This product is intended to be used with a FUJIFILM ultrasonic processor. This product is not intended for use on children and infants.
Endoscope Model EG-580UR
FUJIFILM Endoscope Model EG-580UR is intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis, and endoscopic treatment. This product is intended to be used with a FUJIFILM ultrasonic processor. This product is not intended for use on children and infants.
Endoscope Models EG-580UT and EG-580UR are comprised of three general sections; a control portion. an insertion portion, and an umbilicus. The control portion controls the angulation of the endoscope. This portion also controls the flexibility of the distal end in the endoscope. The insertion portion contains class fiber bundles, several channels, and a charge-coupled device (CCD) image sensor in its distal end. The channels in the insertion portion assist in delivering air/suction as well as endoscope accessories, such as forceps. The qlass fiber bundles allow light to travel through the endoscope and emit light from the tip of the insertion portion to illuminate the body cavity. This provides enough light to the CCD image sensor to capture an image and display it on the monitor. The umbilicus consists of electronic components needed to operate the endoscope when plugged into the video processor, light source, and ultrasonic processor. The endoscopes are used in combination with FUJIFILM's video processors, light sources, ultrasonic processors or diagnostic ultrasound systems, and peripheral devices such as monitor, printer, foot switch, and cart.
Based on the provided text, the document is a 510(k) summary for FUJIFILM Endoscope Models EG-580UT and EG-580UR. It describes the devices and compares them to a predicate device (K183433). The primary purpose of this document is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove the device meets specific performance criteria for AI assistance in image analysis.
The document discusses acceptance criteria for two endoscopic specifications: "Resolution" of the endoscope's camera, not an AI-driven image analysis technology. Therefore, many of the requested details regarding AI-specific studies (e.g., sample size for test/training sets, expert adjudication, MRMC studies, ground truth for AI) are not applicable here as this document does not describe the validation of an AI/ML medical device.
However, I can extract the information related to the device's optical performance criteria as presented.
Here's the breakdown of the information that is available in the document:
1. Table of acceptance criteria and the reported device performance (for Endoscopic Resolution, not AI performance):
| Acceptance Criteria (Resolution) | Reported Device Performance |
|---|---|
| At 5mm of working distance: 0.08mm of line pair on the square wave chart is readable. | Implied to meet the criteria, as it is presented as a characteristic of the "Proposed device" and no deviation is noted in the comparison to the predicate. |
| At 100mm of working distance: 1.4mm of line pair on the square wave chart is readable. | Implied to meet the criteria, as it is presented as a characteristic of the "Proposed device" and no deviation is noted in the comparison to the predicate. |
Important Note: The document presents these "Acceptance Criteria" under the "Resolution" characteristic of the proposed device, directly implying that the device meets these specifications, as it's part of the substantial equivalence claim. There isn't a separate section detailing the "reported performance" against these, beyond stating them as the device's characteristic.
Study Type and Details (Based on available information in the document):
-
Type of Device: This document describes Endoscope Models EG-580UT and EG-580UR, which are physical medical devices (endoscopes) used for ultrasonic imaging of the upper GI tract. It is not an AI/ML-driven diagnostic or assistive device.
-
Study Purpose: The studies mentioned are primarily for demonstrating the safety and effectiveness of the endoscopes by showing substantial equivalence to a predicate device, focusing on reprocessing, biocompatibility, EMC, ultrasonic safety, and acoustic output. The document explicitly states: "The proposed devices share the same intended use, physical characteristics, and principle of operation as the predicate device. The differences have been evaluated for the EMC, ultrasound endoscopic safety, and acoustic output. There remains no new concern regarding the safety and effectiveness of the proposed device."
-
AI/ML Application: There is no mention of an AI/ML component in these endoscopes or in their validation. Therefore, questions related to AI-specific study designs (test/training sets, experts, MRMC, standalone performance, ground truth for AI) are not applicable to the information provided in this document.
Here are the answers to the other questions based only on the provided text, noting their applicability:
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
* Not applicable for AI/ML performance testing. The document describes performance testing for the endoscope's physical specifications (e.g., resolution, bending capability, acoustic output). It does not specify sample sizes for these tests in terms of patient data or clinical images. Data provenance is also not mentioned for these engineering/performance tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable for AI/ML performance testing. Ground truth, in the context of diagnostic performance (especially for AI), would typically involve expert interpretations or pathological findings. The "ground truth" for the device's resolution (e.g., 0.08mm line pair readable) is an objective engineering specification, not established by human experts in the way clinical ground truth is.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not applicable for AI/ML performance testing. Adjudication methods are relevant for resolving discrepancies in expert opinions, typically in diagnostic studies involving human readers or AI. This document does not describe such a study.
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:
* No. Not applicable as this is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* No. Not applicable as this is not an AI/ML algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
* For the endoscopic resolution, the ground truth is based on physical measurement against a standardized test chart (square wave chart). For other performance tests like reprocessing, biocompatibility, EMC, and acoustic output, the ground truth is established by adherence to specific international standards (ISO, IEC) and FDA guidance documents.
8. The sample size for the training set:
* Not applicable. There is no mention of a training set as this is not an AI/ML device.
9. How the ground truth for the training set was established:
* Not applicable. There is no mention of a training set.
In summary, this FDA 510(k) summary focuses on demonstrating that new endoscope models are substantially equivalent to a previously cleared device based on their physical and operational characteristics, and compliance with various engineering and safety standards. It does not pertain to the validation of an AI-driven image analysis device.
§ 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.