(137 days)
The Aer-O-Scope Colonoscope System is intended to provide panoramic (3600) visualization (via a video monitor) and visual access to the adult lower gastrointestinal tract, (including but not limited to, the anus, rectum, sigmoid colon, colon, cecum and ileocecal valve) for endoscopy.
The Aer-O-Scope Disposable Scanner (colonoscope component of the Aer-O-Scope Colonoscope System) is a single use disposable device. An Aer-O-Scope TM Scanner cannot be reprocessed.
The Aer-O-Scope Colonoscope System is a flexible, operator-controlled, colonoscope that utilizes a propulsion mechanism to provide visualization and visual (diagnostic) access to the colon. It is comprised of two major components, the Controlling Work Station and the Aer-O-Scope Disposable Scanner (the colonoscope component). The work station system console contains all internal components and subsystems required for operation and control of the Aer-O-Scope Colonoscope System, including a joystick component for controlling scope tip deflection. The Aer-O-Scope Disposable Scanner includes a soft narrow multilumen tube with channels for irrigation, insufflation, suction, CO2 delivery to the balloons and colon, soft balloons for the propulsion system and an optical imaging head with a CMOS chip and lenses for both forward visualization and a 360° panoramic omni view. All commands are controlled by the operator and regulated through the Controlling Work Station.
Similar to the predicate device, the Aer-O-Scope Colonoscope System utilizes a propulsion system for colonic intubation and scanning. The propulsion system relies on CO2 gas and soft pliable balloons that allow the Aer-O-Scope scanner to travel through the colon without the need for pushing force. A rectal balloon that sits at the base of the rectum and acts as a sealer prevents gas from escaping via the rectum. Two other balloons at the tip of the scope act as driving balloons. The space between the rectal balloon and the driving balloons is filled with low pressured CO2 gas via the rear channel through the rectal introducer that helps move the optical imaging head forward. For retraction, the gas behind the driving balloons is vented via the two-way rear channel in the rectal introducer. The space between the cecum and the driving balloons is filled with low pressure CO2 gas via the front channel, easing the driving balloons back towards the rectum. The tip of the scope with the optical imaging head can be deflected in any direction to ensure full visualization.
The Aer-O-Scope Disposable Scanner is a single use device and cannot be reprocessed. The main materials that come in contact with the patient are polyurethane and Pebax™ that are coated with a hydrophilic coating. The Aer-O-Scope Disposable Scanner has been demonstrated to be biocompatible according to the ISO 10993 harmonized and FDA consensus standard.
The provided document describes the Aer-O-Scope Colonoscope System and a clinical study conducted to demonstrate its safety and effectiveness.
Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Primary Efficacy Endpoint) | Reported Device Performance (Clinical Study) |
|---|---|
| Cecal intubation in 90% of all study cases. | 98.2% (Lower boundary of 95% confidence interval: 90.4%) in the pooled sample size of 56 subjects. |
| Primary Safety Endpoint: Frequency and severity of adverse device effects (ADEs). | No reportable adverse events or adverse device effects during the study. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: A total of 56 patients. This was further divided into an 18-patient training cohort and a 38-patient study cohort.
- Data Provenance: Prospective. The clinical study was carried out in the Tel Aviv Medical Center.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts used to establish the ground truth or their qualifications. The "ground truth" for assessing cecal intubation and pathologies was likely determined by the performing physicians themselves during the procedures (both Aer-O-Scope and conventional colonoscopy) and potentially confirmed by subsequent conventional colonoscopy for mucosal damage.
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method for the test set. The study involved a "tandem colonoscopy" setup where an Aer-O-Scope colonoscopy was followed by a conventional colonoscopy. This design inherently provides a comparison, where the conventional colonoscopy can serve as a reference or confirmation for findings, including mucosal damage. However, a formal adjudication panel or process is not mentioned for conflicting findings or interpretation.
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 explicitly described. The study compared the Aer-O-Scope to conventional colonoscopy by performing both procedures on the same patients, but it focused on device performance (intubation rates, safety, visualization) rather than comparing human reader performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The Aer-O-Scope Colonoscope System is a medical device that provides visualization for human operators. It is not an AI algorithm performing diagnostic tasks independently. Therefore, a standalone (algorithm-only) performance study is not applicable and was not performed. The device's performance is intrinsically linked to its use by a human operator.
7. The Type of Ground Truth Used
The ground truth for the clinical study appears to be a combination of:
- Clinical Observation/Physician Assessment: Cecal intubation success was determined by the performing physician.
- Tandem Colonoscopy: The conventional colonoscopy performed immediately after the Aer-O-Scope procedure served as a robust comparison to monitor for any mucosal damage caused by the Aer-O-Scope and potentially confirm pathologies or visualization quality.
- Pathology: The "tertiary objective was to document the number of pathologies visualized during procedures." While this was an observational endpoint, the confirmation of these pathologies would typically involve histopathological examination of biopsies, implicitly.
8. The Sample Size for the Training Set
The document mentions an "18 training cohort" within the total of 56 patients. This refers to a group of patients used for initial training with the device during the clinical study, not a distinct dataset for training an artificial intelligence algorithm. The device itself (the Aer-O-Scope) does not appear to involve AI or machine learning algorithms that require a separate training dataset in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
The "training cohort" refers to a group of patients where operators gained proficiency with the device. The ground truth for this cohort would be established in the same manner as the study cohort: through real-time physician assessment during the procedure and comparison with subsequent conventional colonoscopy. There isn't an AI-specific training set ground truth to establish here.
§ 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.