(207 days)
FUJIFILM Endoscope Model EG-760CT is intended for the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
FUJIFILM Endoscope Models EC-760P-V/L and EC-740T/L are intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.
FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L are comprised of three general sections: a control portion, an insertion portion and an umbilicus. The 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 either a complementary metal-oxide-semiconductor (CMOS, in 760 series models) or charged-coupled device (CCD, in EC-740T/L) 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 CMOS or 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 and the light source. The endoscopes are used in combination with FUJIFILM's video processors, light sources and peripheral devices such as monitor, printer, foot switch, and cart. All of these combinations were previously cleared in K172916.
This document is a 510(k) summary for FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L, and EC-740T/L. It does not describe a study proving the device meets acceptance criteria related to AI or algorithm performance. Instead, it focuses on demonstrating substantial equivalence to predicate devices through various non-clinical performance tests and adherence to regulatory standards.
Therefore, many of the requested details about acceptance criteria for AI algorithms, sample sizes for test sets, expert involvement, and MRMC studies are not applicable to the information provided.
However, I can extract the information related to the performance data presented to support substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table with specific quantitative acceptance criteria or reported device performance for clinical outcomes. Instead, it lists various types of engineering and safety tests and states that the device "met performance specifications" or "are substantially equivalent in performance."
| Category of Testing | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with ANSI/AAM ES 60601-1:2012, IEC 60601-1-2:2007, IEC 60601-1-6:2013, and IEC 60601-2-18:2009. | Evaluated and met these standards. |
| Biocompatibility | Compliance with ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010, and FDA guidance on ISO 10993-1. | Evaluated and successfully conducted in accordance with standards and guidance. Differences in materials from predicate were validated. |
| Endoscope Specific Testing | Compliance with ISO 8600-1:2015, ISO 8600-3:1997, and ISO 8600-4:2014. | Evaluated and met these standards. |
| Software Specific Testing | Compliance with ANSI/AAM//EC 62304:2006 and FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. | Software validation activities performed in accordance with standards and guidance. |
| Cleaning, High-level Disinfection, and Sterilization | Compliance with AAMI TIR12:2010, AAMI TIR30:2011, and FDA guidance "Reprocessing Medical Devices in Health Care Settings." | Validation of cleaning, disinfection, and sterilization instructions according to standards and guidance. |
| Bench Testing (Features) | Validation of "Advanced Force Transmission" and "Adaptive Bending" features. | Conducted and features were validated. |
| Bench Testing (Comparison) | Substantial equivalence in the "rate of suction" compared to the predicate device. | Comparative bench testing conducted, showing substantial equivalence in the rate of suction. |
| Additional Performance Testing | Meeting performance specifications for: Field of view, Bending capability, Rate of air supply, Rate of water supply, Working length, Diameter of forceps channel, Viewing direction, Resolution, LG output. | Device met performance specifications for all listed items. |
2. Sample size used for the test set and the data provenance
Not applicable. The document describes engineering and bench testing, not clinical studies with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This document pertains to device engineering and safety testing, not clinical evaluation requiring expert ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically for clinical study outcomes and expert consensus, which are not 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
No. This document does not mention any MRMC studies or AI assistance. The devices are endoscopes, and the evaluation focuses on their physical and functional characteristics.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No. The devices are physical endoscopes, not standalone algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the bench and engineering tests, the "ground truth" was established by technical specifications, consensus standards (e.g., ISO, AAMI, IEC, ANSI/AAMI), and established testing protocols. For comparative tests, the predicate device's performance served as a reference for substantial equivalence.
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not an AI-driven device being evaluated for a machine learning model.
9. How the ground truth for the training set was established
Not applicable. As there is no training set mentioned, this question is not relevant.
§ 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.