FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Aer-O-Scope Colonoscope System is intended to provide 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 colonoscope is a single use disposable endoscope and cannot be reprocessed.

Device Description

The Aer-O-Scope 3 Colonoscope System is a flexible, operator-controlled, colonoscope that provides visualization and therapeutic access to the colon. It is comprised of two major components, the Video Controller and the Aer-O-Scope 3 Disposable Colonoscope. The Video Controller contains all components and subsystems required for operation and control of the Aer-O-Scope 3 Colonoscope System. The Aer-O-Scope 3 Disposable Colonoscope includes channels for irrigation, insufflation, lens wash, therapeutic access, and suction. The disposable colonoscope includes an optical imaging head with a CMOS sensor and lenses for visualization with a 200° panoramic omni field of view. All commands are controlled by the operator and regulated through the Video Controller. The Aer-O-Scope 3 Disposable Colonoscope is a single use device and cannot be reprocessed. The main material that comes in contact with the patient is polyurethane that is coated with a biocompatible hydrophilic coating. The Aer-O-Scope 3 Disposable Colonoscope is biocompatible according to the ISO 10993 harmonized and FDA consensus standard.

AI/ML Overview

The provided text describes the regulatory clearance of a medical device (Aer-O-Scope Colonoscope System) but lacks the specific details required to fully address all aspects of your request regarding acceptance criteria and the study that proves the device meets them. The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed performance study with acceptance criteria.

However, based on the available information, here's an attempt to extract and infer what's possible:

There is no explicit table of acceptance criteria and reported device performance provided in the document. The document states that "GI View Ltd. conducted packaging and shelf-life testing which met all the criteria," "Biocompatibility tests were performed and met all the required criteria," "EMC and Electrical safety were tested... and found compliant with the applicable standards," and "Bench tests to measure the safety and effectiveness of device components were performed. Bench tests to measure optical parameters and safety such as photobiological safety, resolution and geometric distortion were performed. In all instances the Aer-O-Scope 3 Colonoscope System functioned as intended and met the individual test specifications and/or FDA consensus standards." For clinical performance, it states, "The data demonstrated that the Aer-O-Scope 3 Colonoscope System (with a wider field of view (200°) compared to the predicate) successfully allows cecal intubation in the intended use population and provides therapeutic access to the lower gastrointestinal tract for screening, diagnostic and surveillance endoscopy (colonoscopy) as the predicate devices."

Given the information, a table like the one requested cannot be constructed precisely as acceptance criteria values are not explicitly stated for each performance aspect, nor are the quantitative results. The text only confirms that criteria were "met" or "functioned as intended."

Here's an attempt to answer the other questions based on the provided text:

1. A table of acceptance criteria and the reported device performance:
As mentioned above, an explicit table is not provided. The document generally states that "all criteria were met" for various tests.

Acceptance Criteria (Inferred from text)	Reported Device Performance (Summary from text)
Packaging and Shelf-life standards	Met all the criteria
Biocompatibility standards	Met all the required criteria
EMC and Electrical safety standards	Found compliant with the applicable standards
Device component safety & effectiveness	Functioned as intended; met individual test specifications
Optical parameters (photobiological safety, resolution, geometric distortion)	Functioned as intended; met individual test specifications and/or FDA consensus standards
Cecal Intubation Success Rate	Successfully allows cecal intubation
Therapeutic Access to lower GI tract	Provides therapeutic access to the lower gastrointestinal tract for screening, diagnostic, and surveillance endoscopy
Overall Safety and Efficacy (in vivo)	Demonstrated overall safety and efficacy

2. Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: The document mentions "Pre-clinical in vivo tests in swine" and a "clinical investigation" in humans.
  - For the clinical investigation, the number of human subjects is not specified.
  - For the in vivo tests, the number of swine is not specified.
- Data Provenance: The document does not explicitly state the country of origin for the clinical investigation data. Given the "Owner" (GI View Ltd.) is based in "Ramat Gan, Israel," it implies the clinical study could have been conducted in Israel or elsewhere, but this is not confirmed. The document refers to "GI View Ltd. conducted" studies.
- Retrospective or Prospective: The clinical investigation is described as being performed "to demonstrate safety and effectiveness," which strongly suggests a prospective study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The text does not elaborate on how ground truth was established for "cecal intubation" or "therapeutic access" during the clinical or pre-clinical studies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No, an MRMC comparative effectiveness study involving human readers with and without AI assistance is not mentioned. The document focuses on the device's performance for visualization and therapeutic access, primarily in comparison to a predicate device's functionality, not on AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This device is an endoscope system (hardware) for visualization and access, not a standalone AI algorithm. Therefore, the concept of "standalone (algorithm only)" performance without human-in-the-loop is not applicable to this device's description. The system provides visualization to a human operator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not explicitly detailed. For the clinical investigation, "cecal intubation" success and "therapeutic access" would likely be determined by direct observation by the participating endoscopists. The document does not specify if additional ground truth like pathology reports for lesions found or long-term outcomes data were used to evaluate the device's diagnostic or therapeutic efficacy.
8. The sample size for the training set:
This device is a hardware system, not an AI model that requires a "training set" in the traditional machine learning sense. Therefore, the concept of a "training set" sample size is not applicable.
9. How the ground truth for the training set was established:
As above, this question is not applicable as the device is not an AI model with a training set.

Summary

Regulation Number and Section

§ 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.