(29 days)
The Ahmed Glaucoma Valve Model FP8 is indicated for the management of refractory glaucomas where previous surgical treatment has failed or by experience is known not to provide satisfactory results. Such refractory glaucomas can include neovascular glaucoma, primary open angle glaucoma unresponsive to medications, congenital or infantile glaucoma and refractory glaucomas resulting from aphakia or uveitis.
The Ahmed® is comprised of a silicone drainage tube that is connected to a valve mechanism. This valve mechanism is the same in the predicate AGV-FP8 (Original). The valve mechanism consists of a silicone sheet folded and pressed between two complimentary polypropylene plates. The valve mechanism is securely positioned in a pocket inside of a silicone endplate that serves to distribute the aqueous humor from the anterior chamber of the surface of the endplate. The valve in the AGV-FP8 (Modified) behaves like a variable resistor, decreasing resistance to allow more flow when intraocular pressure is high. When pressure is low, the resistance to fluid outflow is high and the valve closes, thereby preventing hypotony. By means of the valve mechanism, the AGV-FP8 (Modified) maintains intraocular pressure within the appropriate physiological range.
In both the AGV-FP8 (Original) and AGV-FP8 (Modified), the silicone sheet is folded and pressed between two polypropylene plates. In both the predicate devices and the AGV-FP8 (Modified), the polypropylene bottom plate is separate from the silicone endplate material. The valve mechanism is inserted into a pocket in the silicone endplate to fixate the valve components to the endplate. Both the predicate devices and AGV-FP8 (Modified) have the same curvature as the average human eye at its equator and also protects the valve from blockage by fibrous tissue
The provided text does not contain information about acceptance criteria and a study proving a device meets them in the context of AI/ML performance. Instead, it is a 510(k) summary for a medical device called the Ahmed® Glaucoma Valve Model FP8.
The document discusses a change in the endplate material of the glaucoma valve from one grade of silicone to another. The "testing" section (h) describes biocompatibility, physical, chemical, and aging tests conducted to support this material change, not the performance of an AI/ML system.
Therefore, I cannot extract the requested information regarding:
- A table of acceptance criteria and the reported device performance (for AI/ML).
- Sample size and data provenance for an AI/ML test set.
- Number and qualifications of experts for AI/ML ground truth.
- Adjudication method for an AI/ML test set.
- MRMC comparative effectiveness study results.
- Standalone AI performance.
- Type of AI ground truth.
- Sample size for AI training set.
- How ground truth for the AI training set was established.
This document pertains to the regulatory submission for a physical medical device, not a software device or AI algorithm, and thus does not describe the types of studies that would provide the requested information.
§ 886.3920 Aqueous shunt.
(a)
Identification. An aqueous shunt is an implantable device intended to reduce intraocular pressure in the anterior chamber of the eye in patients with neovascular glaucoma or with glaucoma when medical and conventional surgical treatments have failed.(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(2) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),” and
(3) “Aqueous Shunts—510(k) Submissions.”