(63 days)
ED-530XT is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
FUJIFILM Duodenoscope Model ED-530XT 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.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Characteristic | Reported Device Performance |
|---|---|---|
| Electrical Safety | ANSI/AAM ES 60601-1:2012 | Met standard |
| IEC 60601-1-2:2007 | Met standard | |
| IEC 60601-1-6:2013 | Met standard | |
| IEC 60601-2-18:2009 | Met standard | |
| Biocompatibility | ISO 10993-1:2009 | Met standard (adopted from predicate device testing) |
| ISO 10993-5:2009 | Met standard (adopted from predicate device testing) | |
| ISO 10993-10:2010 | Met standard (adopted from predicate device testing) | |
| Functional Performance | Field of view | Met pre-defined acceptance criteria |
| Bending capability | Met pre-defined acceptance criteria | |
| Air supply rate | Met pre-defined acceptance criteria | |
| Water supply rate | Met pre-defined acceptance criteria | |
| Suction rate | Met pre-defined acceptance criteria | |
| Working length | Met pre-defined acceptance criteria | |
| Forceps standing angle | Met pre-defined acceptance criteria | |
| Forceps standing tension | Met pre-defined acceptance criteria | |
| Forceps channel diameter | Met pre-defined acceptance criteria | |
| Viewing direction | Met pre-defined acceptance criteria | |
| Resolution | Met pre-defined acceptance criteria | |
| LG output | Met pre-defined acceptance criteria | |
| Transport & Storage Conditions | Temperature range (-20°C to 60°C) | Supported (expansion of conditions) |
| Humidity range (10 to 85% RH) | Supported (expansion of conditions) |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly state the sample size for the test set regarding the functional performance tests (e.g., field of view, bending capability, etc.). It only mentions that Fujifilm conducted "performance testing on the proposed device ED-530XT." Also, the provenance of the data (e.g., country of origin, retrospective or prospective) is not specified.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The provided document does not mention the use of experts to establish ground truth for the performance tests. The nature of the tests (e.g., measuring field of view, bending capability) suggests objective measurements rather than expert interpretation.
4. Adjudication Method for the Test Set
Since experts are not mentioned in the establishment of ground truth for performance tests, an adjudication method is not applicable and not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The device in question is an endoscope, and the performance tests focus on its physical and functional attributes, not on its assistance to human readers in interpretation. Therefore, an effect size of human readers improving with AI vs. without AI assistance is not relevant or reported here.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is a physical medical device (an endoscope), not an AI algorithm. Therefore, a standalone performance study in the context of "algorithm only without human-in-the-loop performance" is not applicable and not mentioned. The tests performed are on the device itself.
7. Type of Ground Truth Used
The ground truth used for the performance tests appears to be objective measurements against pre-defined engineering and performance specifications. For electrical safety and biocompatibility, the ground truth is established by the relevant international consensus standards (e.g., IEC, ISO).
8. Sample Size for the Training Set
Since this is a physical medical device and not an AI algorithm, the concept of a "training set" in the context of machine learning is not applicable and not mentioned.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an AI algorithm, this information is not applicable. The "ground truth" for the device's performance is established by its adherence to specified engineering parameters and relevant safety and performance standards.
§ 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.