(99 days)
Air Assist is intended to slide over the outer surface of an endoscope to facilitate endoscopic therapy by providing a manual, reversible method to control the insufflation (air/CO2) so the physician can better maintain an appropriate field of view.
The Gastro Concepts Air Assist Device is a single-use device that is used to aid in maintaining air/CO2 and insufflation during a colonoscopy. The Air Assist, a single-use device, comprises a cylindrical body with a conical-shaped tip and an open channel for endoscope insertion. Positioned against the anus (not inserted into the rectum), it forms a temporary seal, maintaining air/CO2 insufflation leading to adequate colonic distension for enhanced visualization.
The provided text describes a 510(k) premarket notification for the "Gastro Concepts Air Assist" device. However, it does not contain the detailed acceptance criteria and study results typically found in a comprehensive study report for a device relying on artificial intelligence or complex statistical analysis.
The document focuses on demonstrating substantial equivalence to a predicate device through bench testing rather than detailed performance metrics against specific acceptance criteria for AI-driven insights. It explicitly states, "No Clinical Testing was required for this product."
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions related to sample sizes for test or training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, as these items are not present in the provided text.
The available information about "performance testing" is limited to bench tests.
Here's what I can extract regarding the performance testing:
Performance Testing (Bench)
The following bench tests were performed:
- Dimensional Testing
- Simulated Use
- Mechanical Properties: Structural integrity, compression and tension strength
- Leak Rate and Sealing Capability
Summary of Study Results:
- The bench testing demonstrated that the Air Assist device was able to withstand forces greater than expected during clinical use.
- The device was successful in reducing the leak rate during simulated colonic insufflation.
- The device meets the requirements of ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within A Risk Management Process."
Key Missing Information (Based on your request categories):
- Table of acceptance criteria and reported device performance: Not provided. The text only states that the device "meets the requirements" and "was successful" without quantifiable acceptance criteria or specific performance values.
- Sample size used for the test set and data provenance: Not applicable/Not provided, as no clinical or specific dataset testing is detailed beyond general bench tests.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/Not provided.
- 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: Not applicable/Not provided. This is not an AI-driven device described in the document.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/Not provided. This is not an AI-driven device.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable, as the performance evaluation relies on physical properties and simulated use, not diagnostic "ground truth."
- The sample size for the training set: Not applicable/Not provided.
- How the ground truth for the training set was established: Not applicable/Not provided.
In essence, the provided document describes a medical device where substantial equivalence is demonstrated through engineering bench tests and compliance with recognized standards, not through studies involving AI, human readers, or clinical data with expert-established ground truth.
§ 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.