(209 days)
The G-EYE® colonoscope is intended to be used with a compatible video processor (including light source), documentation equipment, monitor, endotherapy device such as a biopsy forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower gastrointestinal tract including the anus, rectum, sigmoid colon, colon and ileocecal valve. It incorporates a balloon at the colonoscope to maintain central positioning within the lumen and help control the endoscope's view field and/or endoscope positioning.
The G-EYE® System comprises the G-EYE® Colonoscope and the NaviAid™ SPARKC ("SPARKC") inflation pump. The G-EYE® Colonoscope includes a reprocessable, reusable balloon (the G-EYE® balloon) that is attached to a standard, commercially available colonoscope which is remanufactured by Smart Medical to include the balloon at its bending section. The balloon onto the standard colonoscope is considered remanufacturing of the standard colonoscope by Smart Medical, which assumes responsibility for the final device including the G-EYE® balloon and the remanufactured colonoscope. The G-EYE® balloon is inflated by the dedicated SPARKC inflation system, which enables automatic control of the required balloon pressure in one of several user-selected, system-controlled pressure levels such that the balloon conforms to the colonic lumen diameter. The G-EYE® Colonoscope is advanced by the endoscopist with the balloon deflated, which essentially preserves the standard colonoscope's diameter and insertion technique. At the cecum, the balloon is inflated to engage the colon walls, and the colonoscope is then withdrawn by the endoscopist using standard withdrawal technique. Withdrawal of the inflated balloon mechanically straightens the colonic folds and anatomic flexures, centers the colonoscope optics within the colonic lumen, and minimizes uncontrolled bowel slippage during withdrawal, therefore maintaining the endoscope's field of view
The provided text (FDA 510(k) summary for the G-EYE® System) does not contain detailed information about acceptance criteria and a study proving the device meets these criteria in the format requested. Specifically, it lacks:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for a test set specifically for evaluating the AI component (as the device described is not an AI/software as a medical device in the typical sense but rather a physical colonoscope system with a balloon).
- Data provenance for a test set.
- Details on expert involvement, ground truth establishment, or adjudication methods for a test set.
- Information on MRMC studies or effect sizes of human reader improvement with AI assistance.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for a training set or how its ground truth was established.
The document discusses performance data in the context of demonstrating substantial equivalence to a predicate device, focusing on verification bench testing, reprocessing validation, biocompatibility, software verification/validation, and electrical safety/EMC. It also mentions three clinical studies conducted outside the United States that further support safety and performance, but these are noted as "not required to demonstrate substantial equivalence" and are presented at a high level.
Therefore, many of the requested points cannot be answered from the provided text because the device is a hardware system, not an AI software, and the document focuses on regulatory clearance via substantial equivalence rather than a detailed AI performance study.
However, I can extract the information that is present regarding performance and its acceptance:
Acceptance Criteria and Device Performance (as inferred from the text)
The document doesn't explicitly list quantitative "acceptance criteria" for a study in a table, but it states that various tests "met its acceptance criteria, supporting substantial equivalence to the predicate."
Here's a summary of the performance "studies" and what they aimed to achieve in terms of acceptance:
| Category of Performance Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Reprocessing Validation | Consistent with FDA guidance, proving safe and effective reprocessing. | Performed; results met acceptance criteria, demonstrating reprocessing validity. |
| Biocompatibility | In accordance with ISO 10993-1, assuring patient safety from materials. | Established; results met acceptance criteria, confirming material safety. |
| Software Verification & Validation | Software performs as intended. | Performed; demonstrated software performs as intended and met acceptance criteria. |
| Electrical Safety & Electromagnetic Compatibility (EMC) | Passing in accordance with IEC 60601-1 and IEC 60601-1-2. | Conducted; results were passing and met acceptance criteria. |
| Verification Bench Testing (SPARKC & G-EYE® Colonoscope) | Operational and functional performance as designed. (Specific metrics not detailed). | Included operational and functional testing; results met acceptance criteria. |
| Clinical Studies (Outside US) | Device functions as intended; no serious device-related adverse events; facilitates visualization of colonic mucosa. | Three studies, over 1000 subjects; demonstrated device functioned as intended with no serious device-related adverse events, and facilitated visualization. |
Other Requested Information:
Since this is a filing for a physical medical device (colonoscope system) and not an AI/software device, much of the requested information (especially points 2-5, 8-9) is not applicable or not provided in the context of an AI performance study.
- Sample size used for the test set and the data provenance: Not applicable in the context of an "AI test set." For the clinical studies (which were supplementary and not primary for 510(k) clearance): "over 1000 subjects" combined across three studies. Data provenance is "outside the United States." It's not specified if they were retrospective or prospective, but clinical studies are typically prospective.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is not an AI/diagnostic imaging device requiring expert ground truth in this manner for its 510(k). The clinical studies involved medical professionals using the device.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for this type of device and regulatory submission.
- 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. This device is not an AI assistance tool for human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the clinical studies, the "ground truth" was essentially the observed performance of the device in facilitating procedures, absence of adverse events, and aiding visualization. These are clinical outcomes rather than a "ground truth" for an AI diagnostic task.
- The sample size for the training set: Not applicable. This is not an AI device trained on data.
- How the ground truth for the training set was established: Not applicable.
§ 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.