(90 days)
The CAD 12 is indicated for use with a flexible endoscope to aid endoscopic insertion and advancement during diagnostic and therapeutic lower gastrointestinal endoscopy.
The CAD 12 is an endoscopic accessory device configured as an overtube to aid insertion and advancement of an endoscope. The CAD 12 utilizes a rotating membrane tube to advance the endoscope in the lower GI tract. The rotating membrane tube is driven by two mechanical rotating drive wires.
The provided document does not contain details about specific acceptance criteria, study design, or performance metrics in a structured way that would allow for the filling of the requested table and detailed description. The document states:
"An extensive collection of tests has been conducted and successfully completed, including functional performance, safety, biocompatibility and sterility testing. All testing indicates that CAD 12 meets its specification requirements."
However, it does not elaborate on what those "specification requirements" or "acceptance criteria" are, nor does it provide performance data, sample sizes, ground truth establishment methods, or details about expert involvement in a study. The focus of this 510(k) summary is on demonstrating substantial equivalence to predicate devices rather than providing a detailed performance study report against pre-defined acceptance criteria.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can and cannot be answered from the provided text:
1. Table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not specified in the document.
- Reported Device Performance: Not specified in terms of quantitative metrics or individual test results. The document only states "All testing indicates that CAD 12 meets its specification requirements."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
| Not specified | Not specified |
| Not specified | Not specified |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
- The document only mentions "extensive collection of tests" including "functional performance, safety, biocompatibility and sterility testing," but no details on study participants, data sources, or cohorts.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document does not describe any study involving experts to establish a "ground truth" for colonoscopy assistance device performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified. Without a study involving ground truth establishment by multiple experts, an adjudication method is not applicable or mentioned.
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 MRMC or comparative effectiveness study involving human readers with/without AI assistance is mentioned. The device is a mechanical "Colonoscopy Assist Device" (overtube with rotating membrane), not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device is a physical, mechanical endoscopic accessory, not an algorithm. Therefore, a "standalone algorithm performance" study is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable as no specific "ground truth" for a performance study is described. The "testing" mentioned refers to functional, safety, biocompatibility, and sterility tests against internal specifications, not clinical outcomes or expert consensus for diagnostic accuracy.
8. The sample size for the training set:
- Not applicable. The device is a mechanical overtube, not an AI/machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established:
- Not applicable. (See #8)
§ 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.