(104 days)
The NeoGuide Endoscopy System is intended to provide visualization and diagnostic / therapeutic access to the adult lower gastrointestinal tract (including, but not limited to, the anus, rectum, sigmoid colon, colon, cecum and ileocecal valve) for endoscopy and endoscopic surgery.
The NeoGuide Endoscopy System has many features in common with currently marketed colonoscopes. The colonoscope is manually inserted and withdrawn by the physicial, who manually steers and controls it using up/down and left/right steering control knobs on a handle. The colonoscope distal tip is equipped with a CCD camera and fiber optic illumination bundles for procedural illumination. A standard tool channel is incorporated for therapeutic procedures, as well as valves to control insuflation air, water irrigation, and suction.
The NeoGuide Colonoscope differs from currently marketed colonoscopes in that it incorporates fifteen active electro-mechanically controlled segments designed to allow the shape of the insertion tube to conform to the path defined by the physician as the colonoscope tip is manually steered through the colon lumen. The active segments are similar to conventional colonoscope steerable tips, as they each employ four control cables to articulate in the up/down and left/right directions. In order to determine the path selected by the physician during a procedure, the NeoGuide endoscopy system incorporates transducers that measure the angle of articulation of the steerable tip and the depth of insertion of the colonoscope into the patient. Software is required to create an anatomical map and interpret, monitor, and control the insertion tube segments.
Here's a breakdown of the requested information based on the provided text. Unfortunately, the provided text does not contain detailed acceptance criteria or the specific study details that "prove" the device meets them. The document is primarily a 510(k) summary and an FDA clearance letter, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a detailed clinical study report.
Therefore, many sections below will indicate that the information is not available in the provided text.
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Available | Not Available |
| (e.g., specific metrics like insertion success rate, procedure time reduction, diagnostic accuracy for specific pathologies are not provided in this document.) | (The document states the device has been shown to be "substantially equivalent" to currently marketed predicate devices based on in vitro bench, in vivo animal, and clinical studies, but does not detail the results of these studies against specific performance metrics.) |
Explanation: The 510(k) summary and FDA letter do not list explicit acceptance criteria for performance metrics. The clearance is based on substantial equivalence, implying that the device's performance is expected to be comparable to its predicates, but no specific numerical targets or results are presented in this document.
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not available in the provided text. The document mentions "clinical study" but does not specify the sample size for a test set.
- Data Provenance: Not available in the provided text. The document mentions "clinical study" but does not specify the country of origin of the data or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not available in the provided text.
- Qualifications of Experts: Not available in the provided text.
4. Adjudication method for the test set
- Adjudication Method: Not available in the provided text.
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
- MRMC Study: Not applicable. The NeoGuide Endoscopy System is a colonoscope with electro-mechanically controlled segments, not an AI-based diagnostic tool that assists human readers in interpreting images. Therefore, the concept of human readers improving with AI assistance does not apply to this device. The document describes a colonoscope that is "manually inserted and withdrawn by the physician, who manually steers and controls it."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. As noted above, this is a physical medical device (colonoscope) operated by a physician, not an algorithm, so standalone performance in the context of AI is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not available in the provided text. The document refers to "in vitro bench, in vivo animal and clinical study" but does not describe how ground truth was established within these studies. For a colonoscope, relevant ground truth might involve successful navigation, lesion detection (confirmed by pathology), or safety outcomes.
8. The sample size for the training set
- Sample Size (Training Set): Not applicable in the traditional sense of machine learning. The NeoGuide Endoscopy System is a hardware device with software to control its segments. There's no indication of a "training set" used for an AI algorithm in the context typically understood for diagnostic AI. The software "creates an anatomical map and interpret, monitor, and control the insertion tube segments," which implies control algorithms rather than a trained classification model.
9. How the ground truth for the training set was established
- Ground Truth (Training Set): Not applicable for the reasons stated above. If the software involved any form of learned control, the "training" would likely refer to engineering calibration and testing against design specifications, not a ground truth labeled for a diagnostic AI.
§ 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.