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The Ahmed™ Glaucoma Valve is indicated for the management of refractory qlaucomas, 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 medication, congenital or infantile dlaucoma, and refractory glaucomas resulting from aphakia or uveitis.

The Ahmed™ Glaucoma Valve (AGV) S3 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 membrane. The valve membrane is sandwiched between a top plate made of polyprolylene and a complementary bottom plate made of polypropylene. The bottom plate is extended to provide for aqueous distribution and drainage. The valve body conforms to the shape of the globe at its equator and protects the valve from blockage by fibrous tissue growth.

The Ahmed Valve Model M4 valve system is exactly the same as the Models S2 and S3. The M4 valve system is enclosed within a porous material (MEDPOR®) made of polyethylene (MEDPOR® is well established as a safe material and has been approved by the FDA for ocular use).

The provided text describes a 510(k) premarket notification for the Ahmed Glaucoma Valve Model M4. The primary goal of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to prove specific performance against detailed acceptance criteria using a clinical study with quantifiable metrics like sensitivity or specificity for an AI device.

Therefore, the following information is extracted based on the context of a 510(k) for a medical device that is not an AI algorithm. The device, an Ahmed Glaucoma Valve Model M4, is a physical implant, and the "study" referred to is biocompatibility and comparative physical/biological effects, not an AI performance study.

Here's the breakdown based on the provided text, adapted to reflect that this is not an AI device:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission for a non-AI medical device, the "acceptance criteria" are related to demonstrating substantial equivalence to a predicate device, particularly concerning safety and effectiveness through biocompatibility and functional comparison. Specific performance metrics like sensitivity/specificity for AI are not applicable here.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size (Animal Study): Not explicitly stated. The text only mentions "An animal study comparing the AGV™-S3 and AGV™-M4 was conducted."
• Data Provenance: The study was an "animal study" conducted at "Duke University." It lasted "for over six months." It is a prospective study in an animal model.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This is not applicable to a non-AI medical device animal study. Ground truth, in the context of an animal study for a physical implant, would be derived from objective measurements (e.g., histology for collagen synthesis and vascularization, pressure measurements for outflow resistance, direct observation of biocompatibility).

4. Adjudication Method for the Test Set

Not applicable to a non-AI medical device animal study. Adjudication methods like 2+1 or 3+1 are typically used for human expert review in diagnostic studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (often AI-assisted) where human readers interpret cases. The study mentioned is an animal study evaluating the physical and biological characteristics of a glaucoma implant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. This device is a physical medical implant, not an algorithm.

7. The Type of Ground Truth Used

For the animal study comparing the AGV™-M4 and AGV™-S3, the ground truth would be based on:

• Histopathology/Biological Markers: For "decreased collagen synthesis and increased vascularization."
• Physiological Measurements: For "resistance to outflow."
• Clinical Observation/Pathology: For "biocompatibility."

8. The Sample Size for the Training Set

Not applicable. This is a physical implant, not an AI algorithm. There is no concept of a "training set" in this context.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for a physical implant.

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