(711 days)
The Fujifilm Duodenoscope Model 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.
The Fujifilm Duodenoscope Model ED-530XT is comprised of three main sections: an operation section, an insertion portion, and an umbilicus. The operation section controls the angulation (up/down/left/right) of the distal end of the endoscope. The insertion portion contains glass fiber bundles, several channels and a CCD image sensor. 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 sensor to capture an image and display it on the monitor. The endoscope also contains several channels to deliver air/water and provide suction, as well as a forceps channel. The forceps channel is used to introduce endoscope accessories such as biopsy forceps during the procedure. The umbilicus section consists of electronic components needed to operate the endoscope when plugged in to the video processor and the light source.
The provided text is a 510(k) summary for a medical device called the Fujifilm Duodenoscope Model ED-530XT. It primarily focuses on demonstrating substantial equivalence to a predicate device (Fujinon G5 Duodenoscope ED-450XT5 / ED-250XT5) rather than detailing specific acceptance criteria and a study proving device performance against those criteria in a typical clinical or AI context.
Therefore, many of the requested categories (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance with AI, and specific ground truth types) are not applicable or not explicitly detailed in this document, as the submission relies on bench testing and comparison to an existing predicate device rather than a clinical trial demonstrating new performance metrics against specific acceptance thresholds.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a formal table of specific acceptance criteria with quantifiable metrics (e.g., sensitivity, specificity, accuracy) that are typically seen for diagnostic devices or AI algorithms. Instead, the performance is demonstrated through various engineering and safety tests, with the implied "acceptance criterion" being that the device meets the standards and performs comparably to the predicate.
| Test Category | Implied Acceptance Criterion / Standard Met | Reported Device Performance |
|---|---|---|
| Safety & Regulatory Compliance | ||
| EMC & Electrical Safety | IEC 60601-1-2:2007, ANSI/AAMI ES60601-1:2005, IEC 60601-2-18:2009 | Device met performance specifications. |
| Biocompatibility | ISO 10993 | Device was evaluated in accordance with ISO 10993. |
| Cleaning, Disinfection, Sterilization | AAMI TIR12:2010, AAMI TIR30:2011, FDA guidance "Reprocessing Medical Devices..." (March 2015) | Validation performed, indicating instructions are effective. |
| Endoscope Specific Testing | ISO8600-1:2013 | Device met performance specifications. |
| Device Functionality | ||
| Field of View | Performance specifications | Met performance specifications. |
| Bending Capability | Performance specifications | Met performance specifications. |
| Rate of Air Supply | Performance specifications | Met performance specifications. |
| Rate of Water Supply | Performance specifications | Met performance specifications. |
| Rate of Suction | Performance specifications | Met performance specifications. |
| Resolution | Performance specifications | Met performance specifications. |
| Light Guide (LG) Output | Performance specifications | Met performance specifications. |
| Elevator Wire Channel Seal | Safety and effectiveness analysis | Demonstrated safety and effectiveness. |
| Distal End Cap Seal Strength & Integrity | Safety and effectiveness analysis | Demonstrated safety and effectiveness. |
| Overall Equivalence | Substantial equivalence to predicate device (ED-450XT5) | "As safe and effective, and performs as well or better, than the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The performance data described are primarily from bench testing of the device itself and its components, rather than a "test set" of patient data or clinical cases.
- Data Provenance: Not applicable in the context of clinical data. The tests are lab-based, engineering performance tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. The ground truth for these engineering and safety tests is established by adherence to industry standards, measurement protocols, and physical testing, not by expert medical interpretation of images or clinical outcomes.
4. Adjudication Method for the Test Set
- Not applicable. This concept is relevant for studies involving human interpretation or clinical endpoints, not for bench testing of physical device performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not reported. This type of study is typically done for diagnostic aids or AI algorithms where human reader performance is a key outcome. This 510(k) submission focuses on the safety and functional equivalence of an endoscope.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable. This device is an endoscope, which is a physical medical instrument, not an AI algorithm. Therefore, "standalone" performance in the AI sense is not relevant.
7. The Type of Ground Truth Used
- The "ground truth" for the tests described is based on engineering specifications, established consensus standards (e.g., ISO, AAMI, IEC), and documented test methods for device performance, safety, and biocompatibility.
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI algorithm that undergoes "training."
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this type of device submission.
§ 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.