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The Ahmed™ Glaucoma Valve 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™ Glaucoma Valve Model FP7 (AGV-FP7) is a valved aqueous drainage implant designed to regulate intraocular pressure in eyes suffering from intractable glaucoma. The Ahmed™ device is comprised of a silicone drainage tube that is connected to a valve mechanism. This valve mechanism is the same in the AGV-FP7 and the predicate AGV-S2. 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 eye over the surface of the endplate. The valve in the AGV-FP7 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-FP7 maintains intraocular pressure within the appropriate physiological range.

In both the AGV-S2 and AGV-FP7, the silicone sheet is folded and pressed between two polypropylene plates. In the AGV-S2, the bottom polypropylene plate is comprised of the polypropylene endplate body. In the AGV-FP7, 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. Additional differences include stiffening ribs in the posterior half of the AGV-FP7 to add stiffness to the flexible endplate, The other predicate device, the Baerveldt Glaucoma Implant (BGI) also consists of a flexible silicone endplate which shares some features with the AGV-FP7, though the BGI endplate is larger in area. The AGV-FP7 endplate has the same curvature as the average human eye at its equator and also protects the valve from blockage by fibrous tissue. The endplate is made of flexible silicone. Inflammation and scarring around flexible silicone implants in animal ocular tissue was less pronounced than that found around rigid polypropylene.

The provided text is a Premarket Notification [510(k)] Summary for the Ahmed™ Glaucoma Valve Model FP7. It describes the device, its intended use, and claims substantial equivalence to existing predicate devices. However, this document does not contain the detailed study information needed to fill out all the fields requested in your prompt.

Here's what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions that the AGV-FP7 has "similar IOP and complication rates to the predicate devices." Specifically, it states, "compared to the AGV-S2, the IOP of the AGV-FP7 groups was lower (within the acceptable physiological range) and fewer complications were reported."

However, explicit acceptance criteria (e.g., "IOP must be reduced by X mmHg" or "complication rate must be < Y%") are NOT provided in this document. Therefore, a table with specific criteria and numerical performance cannot be fully constructed from the given text.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document references several clinical studies:

• The Ahmed Baerveldt Comparison Study:
  • Design: "multicenter, prospective, randomized, controlled clinical trial"
  • Sample Size: Not explicitly stated in this summary.
  • Provenance: "multicenter" implies multiple locations, but specific countries are not mentioned.
• Comparison of Polypropylene and Silicone Ahmed Glaucoma Valves (Ishida K. et al.):
  • Design: "prospective, multicenter, comparative study"
  • Sample Size: Not explicitly stated in this summary.
  • Provenance: "multicenter," but specific countries are not mentioned.
• Comparison of silicone and polypropylene Ahmed glaucoma valves: two-year follow-up (Mackenzie PJ et al.):
  • Design: "single surgeon, retrospective, consecutive case series."
  • Sample Size: Not explicitly stated in this summary.
  • Provenance: Not specified, but "single surgeon" suggests a single institution.

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):

This information is not provided in the document. The studies listed are clinical trials, where patient outcomes (IOP, complications) are typically objectively measured or clinically observed, rather than adjudicated by experts in the context of establishing a 'ground truth' for an AI device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not provided. As these are clinical trials of a medical device (glaucoma valve) rather than, for example, an image analysis AI, the concept of "adjudication method for the test set" in the context of expert consensus on data interpretation doesn't directly apply here in the way it would for an AI performance study.

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, a MRMC comparative effectiveness study was not done. The device in question is an implanted glaucoma valve, not an AI-assisted diagnostic tool for human readers. Therefore, there is no discussion of human readers or AI assistance in this context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No, this is not an AI algorithm. This is a physical medical device (an aqueous shunt). The "testing" described is non-clinical (physical, chemical, sterilization, biocompatibility) and clinical (patient outcomes after surgical implantation).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the clinical studies, the "ground truth" (or outcome measures) were:

• Intraocular Pressure (IOP): This is a direct, measurable physiological parameter, which can be considered objective outcomes data.
• Complication Rates: These are clinically observed events, also considered outcomes data.

8. The sample size for the training set:

Not applicable. This document describes a physical medical device, not a machine learning model. Therefore, there is no "training set."

9. How the ground truth for the training set was established:

Not applicable. There is no "training set" or "ground truth" established for it, as this is not an AI device.

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