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The Ahmed® Glaucoma Valve Model FP7 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) (Modified) 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 predicate AGV-FP7 (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 eye over the surface of the endplate. The valve in the AGV-FP7 (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-FP7 (Modified) maintains intraocular pressure within the appropriate physiological range.

This FDA 510(k) Premarket Notification is for the Ahmed® Glaucoma Valve Model FP7, which is a medical device and not an AI/ML product. Therefore, it does not involve the typical acceptance criteria and study designs pertinent to AI/ML devices, such as performance metrics like sensitivity, specificity, AUC, or the involvement of human readers for ground truth establishment.

Instead, the submission focuses on non-clinical performance data to demonstrate substantial equivalence to a predicate device after a material change.

The core information relevant to the provided query, adjusted for a physical medical device, is as follows:

The proposed device, Ahmed® Glaucoma Valve Model FP7 (Modified), is a modification of the previously cleared Ahmed® Glaucoma Valve Model FP7 (K162060). The change involves modifying the endplate material from one grade of silicone (NuSil MED 4840) to a slightly firmer grade of silicone (NuSil MED 4850).

1. A table of acceptance criteria and the reported device performance

The document states that the testing "utilized well-established methods to evaluate the proposed change, all testing methods and acceptance criteria are the same as the proposed predicate devices." While specific numerical acceptance criteria are not tabulated in the provided text, the types of tests and their reported outcomes are:

The overarching acceptance criterion is that the modified device's performance in these non-clinical tests should not introduce new questions of safety or effectiveness compared to the predicate device. The reported performance is that this criterion was met for all tested aspects.

2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes for each specific test (Cytotoxicity, Sensitization, etc.) nor the detailed provenance of the data (e.g., country of origin, retrospective/prospective). This information would typically be detailed in the full submission, but is summarized here. The tests are non-clinical (laboratory/bench testing) rather than human clinical trials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable in the context of this device and testing. The "ground truth" for non-clinical performance of a material change is established by adherence to recognized testing standards and methods (e.g., ISO standards for biocompatibility) and comparison against established performance benchmarks for the original material or predicate device. There isn't a direct "expert interpretation" of test results in the same way as an AI/ML diagnostic output.

4. Adjudication method for the test set
Not applicable. This refers to consensus methods for expert interpretation, which is not relevant for standardized non-clinical material testing.

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
Not applicable. This is not an AI/ML device, and no human-in-the-loop study was conducted or required for this type of 510(k) submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.

7. The type of ground truth used
The "ground truth" for the non-clinical tests listed (Cytotoxicity, Sensitization, Irritation, Pyrogenicity, Physical Stability, Chemical Testing, Aqueous Aging) is based on established scientific and regulatory standards for biocompatibility and material performance. For instance, biocompatibility tests like cytotoxicity would be evaluated against ISO 10993 series standards, where specific cell responses or material properties indicate acceptability.

8. The sample size for the training set
Not applicable. This concept applies to AI/ML models, not physical medical devices undergoing material changes.

9. How the ground truth for the training set was established
Not applicable. This concept apples to AI/ML models, not physical medical devices undergoing material changes.

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