(225 days)
ENDORAIL is an accessory to an endoscope and is intended to ensure positioning of a standard endoscope (i.e. an endoscope with an instrument channel that is at least 3.7mm diameter and is used for standard endoscopic visualization) during endoscopy of the large intestine.
ENDORAIL is a colonoscopy add-on device developed to be used without any modification to colonoscopes and peripheral devices currently utilized. It is an accessory for colonoscopy aimed at facilitating progression of the endoscope in the large intestine. The device works as a magnetic anchor that allows the operator to guide the colonoscope and to straighten colon curves and loops. ENDORAIL includes a Balloon Guide that can be introduced, when needed, through the endoscope instrument channel during the colonoscopy, if this procedure becomes challenging. The system does not require to be premounted and does not interfere with the normal colon examination process. The Balloon Guide is advanced beyond the colonoscope tip where the balloon is filled with a ferromagnetic fluid and magnetically anchored to a magnetic Handpiece placed on the patient's abdomen. Once anchored, the colonoscope can be easily straightened and guided along the device, allowing a fast and safe inspection of the entire colon. Once the challenging segment of the colon is resolved, or the colonoscopy procedure is completed, the Balloon Guide can be retrieved.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Primary Endpoints) | Reported Device Performance (ENDORAIL) |
|---|---|
| Efficacy: Colonoscopy incompletion rate ≤ 10% in long-lasting colonoscopies. | 0% colonoscopy incompletion rate. All 100% of patients successfully completed the colonoscopy. |
| Safety: No increase in colonoscopy serious adverse events (SAEs) (i.e., absence of any device-related SAEs). | No AE/SAE, no abnormal findings, and no overall change in the health status of any patient undergoing colonoscopy with ENDORAIL were observed in the study. |
Study Details
2. Sample Size and Data Provenance
- Test Set Sample Size: 38 patients were enrolled and included in the statistical analysis.
- Data Provenance: Prospective, multi-center clinical trial conducted in Italy, Germany, and Belgium.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
The document does not explicitly state the number of experts used to establish the ground truth for the test set cases or their specific qualifications beyond being "specialized medical staff" and "Principal Investigators" at the trial centers. However, the study involved:
- Principal Investigator: Prof. Alessandro Repici (IRCCS Humanitas Research Hospital, Milan, Italy)
- Principal Investigator: Prof. Helmut Neumann (GastroZentrum Lippe, Germany, affiliated with Universität Mainz)
- Principal Investigator: Prof. Raf Bisschops (University Hospitals Leuwen, Belgium)
These individuals are implied to be highly qualified gastroenterologists or endoscopists.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method for the test set cases, such as "2+1" or "3+1." The evaluation of outcomes (completion rate, adverse events) was directly reported as observed during the clinical study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study was a single-arm interventional study.
6. Standalone Algorithm Performance
This section is not applicable as ENDORAIL is a physical accessory to an endoscope, not a software algorithm or AI-driven device intended for standalone performance.
7. Type of Ground Truth Used
The ground truth for the acceptance criteria (colonoscopy completion and adverse events) was based on clinical observation and outcomes data from the prospective clinical trial. Colonoscopy completion was defined as caecal intubation being achieved. Adverse events were observed and classified by medical staff.
8. Sample Size for the Training Set
This section is not applicable. As ENDORAIL is a physical medical device accessory and not a machine learning algorithm, there is no "training set" in the context of AI/ML. The device's design and functionality were developed and validated through non-clinical testing and then evaluated in a clinical trial.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable as there is no training set for a physical 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.