(83 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 medication, congenital or infantile glaucoma, and refractory glaucomas resulting from aphakia or uveitis.
The Ahmed® Glaucoma Valve Model FP8 (AGV-FP8) 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. 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-FP8 and the predicate 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-FP8 and the predicate AGV-FP7 maintain intraocular pressure within the appropriate physiological range.
The provided text is a 510(k) Summary of Safety and Effectiveness for the Ahmed® Glaucoma Valve Model FP8. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a study with the common structure of an AI/ML device study.
Therefore, many of the requested elements (e.g., sample size for test set, number of experts, adjudication method, MRMC comparative effectiveness study, standalone performance, training set size, ground truth for training set) are not applicable or cannot be extracted directly from this type of medical device submission.
However, I can extract information related to performance testing in general and clinical study results that compare the device to others, which somewhat aligns with the spirit of the request.
Here's an analysis based on the provided text, while acknowledging its limitations for an AI/ML context:
1. Table of Acceptance Criteria and Reported Device Performance
Strictly speaking, the document doesn't present "acceptance criteria" in the format one might expect for statistical performance metrics of an AI/ML model (e.g., "sensitivity >= X%"). Instead, it focuses on demonstrating that the performance of the new device (AGV-FP8) is equivalent to legally marketed predicate devices.
The "performance" described is in terms of clinical outcomes, specifically success rates, IOP reduction, and reduction in glaucoma medications, adverse effects, and complications. The "acceptance criteria" are implied to be achieving outcomes that are not statistically significantly different from the predicate devices or showing effectiveness in specific patient populations.
| Acceptance Criteria (Implied) | Reported Device Performance (Summary from Clinical Studies) |
|---|---|
| Equivalence to Predicate Devices (FP7) | No statistically significant differences between AGV-FP8 and AGV-FP7 in preservation of vision, IOP reduction, or decrease in the number of glaucoma medications. (Study 1) |
| Effectiveness in Refractory Primary Congenital Glaucoma | AGV-FP8 was found to be an effective treatment in this difficult-to-treat group. (Study 2) |
| Similar long-term IOP reduction, decrease in number of glaucoma medications, and success rates compared to combined trabeculotomy-trabeculectomy for refractory primary congenital glaucoma. (Study 3) | |
| Effectiveness After Failed Glaucoma Drainage Device Implantation | AGV-FP8 implantation was described as a good choice for surgical treatment when the first glaucoma drainage device failed. (Study 4) |
| Safety Profile (Complications/Adverse Events) | In Study 3, a higher rate of hyphema was reported in the combined trabeculotomy-trabeculectomy group, with other complication rates similar between the two groups. In Study 4, corneal decompensation was found in some cases, but no other serious complications were reported. Absence of serious complications were not explicitly linked to specific thresholds. |
| Physical and Chemical Stability | Device maintains performance characteristics and structural integrity after aqueous exposure. Chemical analysis and aqueous aging chemical testing assess hazards and stability. (Non-clinical testing) |
| Biocompatibility | Satisfactory biocompatibility. (Non-clinical testing) |
2. Sample Size Used for the Test Set and Data Provenance
This information is typically for AI/ML model validation, which is not the primary focus here. Instead, the document refers to human clinical studies:
- Study 1 (Koh et al., 2013): Retrospective review of records from adult refractory glaucoma patients. The exact number of patients undergoing AGV-FP8 or AGV-FP7 implantation is not explicitly stated in this summary but is implied to be a comparison between two groups. Provenance: Single center (details not provided, but the journal implies South Korea).
- Study 2 (Dave et al., 2015): Retrospective noncomparative case series of eyes with refractory primary congenital glaucoma. The number of cases is not specified in the summary. Provenance: Not explicitly stated, but the journal implies India.
- Study 3 (Helmy, 2016): Randomized, prospective, single-surgeon, comparative study including 66 eyes with refractory primary congenital glaucoma. Half underwent AGV-FP8 implantation. Provenance: Egyptian patients.
- Study 4 (Ko et al., 2016): Retrospective review of clinical histories of 23 refractory glaucoma patients, 21 of whom underwent AGV-FP8 implantation. Provenance: Not explicitly stated, but the journal implies South Korea.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This concept of "ground truth" established by experts for a test set is not directly applicable to the clinical studies referenced in this 510(k) summary. These studies are clinical outcomes studies where the "ground truth" is typically the observed patient outcome (e.g., actual IOP, preserved vision, occurrence of complications) as assessed by the treating clinicians, not an independent panel establishing a "ground truth" for an AI model.
- Study 1: "two surgeons at a single center" performed the implantations and likely contributed to follow-up data. Their specific qualifications (e.g., number of years of experience) are not stated.
- Study 2: "a single surgeon" implanted the AGV-FP8. Qualifications not stated.
- Study 3: "a randomized, prospective, single-surgeon, comparative study." Qualifications not stated.
- Study 4: "Surgical outcomes of additional Ahmed glaucoma valve implantation in refractory glaucoma." Implies treating ophthalmic surgeons. Qualifications not stated.
4. Adjudication Method for the Test Set
As this is not an AI/ML diagnostic or prognostic study requiring ground truth consensus on images or other data, adjudication methods (like 2+1 or 3+1) are not typically used or reported in this context. Clinical outcomes are generally determined by treating physicians and medical records.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
No MRMC study comparing human readers with and without AI assistance was done or is applicable here. The device is a physical implant (Ahmed Glaucoma Valve), not an AI-powered diagnostic or assistive tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. The device is a physical medical implant, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" in these clinical studies refers to the actual clinical outcomes observed in patients, such as:
- Intraocular Pressure (IOP) measurements
- Visual acuity
- Number of glaucoma medications
- Occurrence and type of adverse events/complications (e.g., hyphema, corneal decompensation)
- Success rates (as defined by each study, e.g., defined IOP range without further surgical intervention for glaucoma).
This is clinical outcomes data, as assessed and recorded by the surgical teams and clinicians in the respective studies.
8. The Sample Size for the Training Set
Not applicable. The device is a physical implant, not an AI/ML model that requires a training set. The clinical "studies" are observational/comparative for the device's performance, not for training an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set for an AI/ML model is involved.
§ 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.”