(175 days)
FUJIFILM Endoscope Model EG-740N is intended for the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum. The device can be inserted orally or transnasally.
FUJIFILM Endoscope Model EG-740N is 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 glass fiber bundles, several channels and a complementary 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 glass 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 in to the video processor and the light source. The endoscope is used in combination with FUJIFILM's video processors, light sources and peripheral devices such as monitor, printer, foot switch, and cart.
The provided document is a 510(k) premarket notification for a medical device, the FUJIFILM Endoscope Model EG-740N. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical efficacy or superiority through extensive clinical studies, especially those involving AI algorithms or human reader performance.
Therefore, much of the requested information regarding AI algorithm performance, multi-reader multi-case studies, and detailed ground truth establishment methods for large datasets is not applicable to this specific submission. The document primarily reports on bench testing, electrical safety, and biocompatibility to demonstrate that the new device performs similarly and is as safe as the predicate devices.
Here's a breakdown of the requested information based on the provided text, highlighting what is and is not present:
1. A table of acceptance criteria and the reported device performance
The document states that the subject device met performance specifications in various tests. While it lists the categories, it does not provide specific numerical acceptance criteria or reported performance values in a table format. It simply states that the device "met performance specifications" or that "bench testing data demonstrated that the subject device is substantially equivalent in performance to the predicate devices."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Electrical safety | Met specifications (eval. using ANSI/AAM ES 60601-1:2012, IEC 60601-1-2:2007, IEC 60601-1-6:2013, and IEC 60601-2-18:2009) |
| Biocompatibility | Met specifications (eval. using ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010; in accordance with FDA guidance, June 16, 2016) |
| Endoscope specific testing | Met specifications (eval. using ISO 8600-1:2015, ISO 8600-3:1997, and ISO 8600-4:2014) |
| Software specific testing | Met specifications (eval. using ANSI/AAM//EC 62304:2006; in accordance with FDA Guidance, May 11, 2005) |
| Cleaning, high-level disinfection, and sterilization | Met specifications (eval. using AAMI TIR12:2010, AAMI TIR30:2011; in accordance with FDA guidance, March 17, 2015) |
| Field of view | Met performance specifications |
| Bending capability | Met performance specifications |
| Rate of air supply | Met performance specifications |
| Rate of water supply | Met performance specifications |
| Rate of suction | Met performance specifications (Comparative bench testing with primary predicate device conducted) |
| Working length | Met performance specifications |
| Diameter of forceps channel | Met performance specifications |
| Viewing direction | Met performance specifications |
| Resolution | Met performance specifications |
| LG output | Met performance specifications |
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 refers to "bench testing" and "comparative bench testing" without specifying a sample size in terms of number of patients or images. These tests would involve physical testing of the device prototypes. Data provenance and whether it's retrospective or prospective are not relevant for this type of physical device testing.
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)
This is not applicable. The "ground truth" for this device's testing relates to engineering specifications (e.g., does the endoscope bend to the correct angle, is the resolution within specification, does it pass the electrical safety tests). It does not involve human expert interpretation of medical images or clinical outcomes data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are used to establish ground truth in clinical data interpretation, typically in studies involving human readers or AI algorithms assessing medical conditions. This submission focuses on engineering and safety performance.
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
This is not applicable. This submission is for a physical endoscope, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or reported.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. This device is a physical endoscope, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this submission are the engineering specifications, consensus standards (e.g., ISO, IEC, AAMI), and regulatory guidance documents used for electrical safety, biocompatibility, software validation, and reprocessing validation. For example, the device must meet the specified lumens for light output or specific angles for bending capability, which are objective engineering parameters.
8. The sample size for the training set
This is not applicable. This is a 510(k) for a physical endoscope, not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of data used for algorithm development.
9. How the ground truth for the training set was established
This is not applicable for the same reasons as #8.
§ 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.