(43 days)
The Aer-O-Scope Colonoscope System is intended to provide panoramic (3600) visualization (via a video monitor) and diagnostic/therapeutic access to the adult lower gastrointestinal tract, (including but not limited to, the anus, rectum, sigmoid colon, transverse 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 Scanner cannot be reprocessed.
The Aer-O-Scope 2 is a flexible, operator-controlled, colonoscope that utilizes a propulsion mechanism to provide visualization and therapeutic access to the colon. It is comprised of two major components, the Controlling Work Station and the Aer-O-Scope 2 Disposable Scanner (the colonoscope component). The work station system console contains all 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 2 Disposable Scanner includes a soft narrow multi-lumen tube with channels for irrigation, insufflation, therapeutic access and suction, CO2 delivery to the balloons and colon and the soft balloons for the propulsion system. The Disposable Scanner also includes an optical imaging head with a CMOS sensor 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.
The Aer-O-Scope 2 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 2 scanner to travel through the colon without the need for pushing force. The tip of the scope with the optical imaging head can be deflected in any direction to ensure full visualization. This propulsion system is identical to the Aer-O-Scope 1 Colonoscope System.
The Aer-O-Scope 2 Colonoscope System contains optional post processing spectral filtering capabilities that assist the physician in examining features captured in standard white light colonoscopy images.
The Aer-O-Scope 2 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 2 Disposable Scanner is biocompatible according to the ISO 10993 harmonized and FDA consensus standard.
The provided text is related to the FDA 510(k) clearance for the Aer-O-Scope Colonoscope System and details the substantial equivalence to predicate devices, particularly focusing on mechanical and biocompatibility aspects, rather than detailed performance criteria for an AI/CADe device. Therefore, a direct answer to the request regarding acceptance criteria and study proving performance for an AI/CADe device cannot be fully formulated from the given text.
The text does not include information about:
- A table of acceptance criteria and reported device performance (in terms of clinical efficacy metrics like sensitivity, specificity, PPV, NPV).
- Sample size for the test set or its provenance for clinical performance evaluation.
- Number and qualifications of experts for ground truth establishment.
- Adjudication method for a test set.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
- Standalone (algorithm only) performance.
- The type of ground truth used for clinical performance.
- Sample size for the training set.
- How ground truth for the training set was established.
The provided document describes the Aer-O-Scope Colonoscope System and focuses on its substantial equivalence to predicate devices based on bench testing and pre-clinical in vivo tests. It explicitly states that no clinical data is needed for the determination of substantial equivalence for this device, as the propulsion system is identical to a previously cleared device. Therefore, the questions related to clinical performance metrics, ground truth, expert review, and AI assistance are not addressed by this document.
The document highlights:
- Bench tests to measure forces, biocompatibility, and safety.
- Ex-vivo studies to demonstrate therapeutic access.
- Pre-clinical in vivo tests in swine for overall safety and efficacy.
These are general device safety and performance criteria, not specific clinical performance metrics (e.g., sensitivity/specificity for disease detection) that would be expected for an AI/CADe 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.