(15 days)
The Endoscope is indicated for use in general endoscopic procedures and other minimally invasive surgical procedures to visualize a surgical working cavity.
The Essex Endoscope consists of a shaft that houses glass fibers for light delivery and an optical lens system for image return. The distal shaft has a window for viewing. The proximal hub has a light guide post for attachment of light guides and an eyepiece with a clear viewing window for attachment of medical camera couplers. The Endoscope provides illumination and visualization of the working space during surgical procedures.
The provided text is a 510(k) summary for the Guidant Essex Endoscope. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert involvement, or ground truth establishment.
The document is a regulatory submission for premarket notification, where the manufacturer asserts substantial equivalence to a previously cleared device. This type of submission generally doesn't include detailed performance studies with acceptance criteria in the same way a new, innovative device might. The "performance" in this context is often demonstrated through a comparison of technological characteristics to the predicate device to show that it performs "as safely and effectively."
Therefore, based solely on the provided text, I cannot complete a table of acceptance criteria or describe a study that proves the device meets such criteria because that information is not present.
Here's what I can extract based on the lack of the requested information:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No information regarding a "test set" or data provenance for performance evaluation is provided. The submission focuses on substantial equivalence to a predicate device based on design and materials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
No information about experts establishing ground truth for a test set is provided. The device is an endoscope for visualization during surgery, and its "performance" is implicitly tied to its ability to provide clear illumination and visualization, which is asserted through design similarity to a predicate.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
No information about adjudication methods for a test set is provided.
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 information about an MRMC study is provided. This device is an endoscope directly used by a surgeon for visualization, not an AI-powered diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device (an endoscope), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
No explicit ground truth is mentioned. The device's function (visualization) is inherent to its design, and its safety and effectiveness are established through substantial equivalence, not detailed performance metrics against a defined ground truth in the context of this 510(k) summary.
8. The sample size for the training set:
Not applicable. This is a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established:
Not applicable. This is a physical medical device, not a machine learning model.
§ 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.