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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.

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.

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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

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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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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 medication, congenital or infantile glaucoma, and refractory glaucomas resulting from aphakia or uveitis.

The Ahmed™ Glaucoma Valve Bi-plate is a modification of an already approved device called the Ahmed™ Glaucoma Valve (AGV™) Ref. 510 (k) 925636 dated November 12, 1993. The Ahmed™ Glaucoma Valve (AGV™) is an ophthalmic implant for use in intractable Glaucoma. The device features a specially engineered, one way silicone membrane valve system designed to prevent collapse of the anterior chamber (AC) due to hypotony (abnormally low intraocular pressure) and to reduce excessive intraocular pressure by venting aqueous out of the anterior chamber through this control one way valve. The AGV™ implant consists of a silicone drainage tube, a polypropylene valve body to house the valve membrane, and to protect it from occlusion due to fibrosis. All materials used in the manufacturing of this device are of medical grade quality. No metallic or toxic substances are used in the manufacturing of this device. The AGV™ is terminally sterilized by gamma radiation. The AGV™ has a surface area of 184mm².

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Ahmed Glaucoma Valve Bi-plate:

Disclaimer: The provided text is a 510(k) summary (K991072) for a medical device seeking substantial equivalence, not a detailed clinical study report with explicit acceptance criteria. Therefore, the "acceptance criteria" discussed below are inferred from the safety and effectiveness claims and comparisons to the predicate device. The "reported device performance" is the performance of the predicate device (Ahmed Glaucoma Valve, single plate) and the general claims made about the new device (Ahmed Glaucoma Valve Bi-plate) based on literature about double-plate implants.

Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for substantial equivalence, the primary "acceptance criteria" are demonstrating that the Ahmed Glaucoma Valve Bi-plate is as safe and effective as a legally marketed predicate device (Molteno Double Plate Implant, K875099, and the original Ahmed Glaucoma Valve, K925636). The performance metrics revolve around:

• Intraocular Pressure (IOP) Reduction: The device should effectively lower IOP in refractory glaucoma patients.
• Maintenance of IOP within normal range: After surgery, IOP should be maintained at a healthy level.
• Prevention of Hypotony: A key feature of the Ahmed Glaucoma Valve (and claimed for the Bi-plate) is its ability to prevent abnormally low IOP.
• Safety Profile: The device should have an acceptable complication rate.
• Biocompatibility: The materials used should be non-toxic and biocompatible.

Since the submission specifically states, "AGV Bi-plate and Molteno Double Plate are substantially equivalent," and refers to the existing Ahmed Glaucoma Valve, the performance of these devices serves as the benchmark.

Study Details Proving Acceptance Criteria

The document refers to several studies and prior 510(k) submissions rather than presenting a single, new clinical trial for the Ahmed Glaucoma Valve Bi-plate. The main approach is through demonstrating substantial equivalence to existing devices, supported by:

1. Prior Approval of the Single-Plate Ahmed Glaucoma Valve (K925636): This forms the foundation of the device's safety and effectiveness.
2. Literature Review of Double-Plate Implants (especially Molteno Double Plate): This supports the safety and effectiveness of increasing surface area.
3. Comparisons of Technological Characteristics: Demonstrating similarity in materials, design, and function between the AGV Bi-plate and the predicate Molteno Double Plate.

Here's a breakdown based on the provided text:

1. Sample sizes used for the test set and the data provenance:

   • Ahmed Glaucoma Valve (single plate) - Huang et al. (1999):
     • Sample Size: 159 eyes (144 patients).
     • Data Provenance: Multi-center, retrospective clinical follow-up. Country of origin not specified, but the journal "Am J Ophthal." is a US-based publication.
   • Ahmed Glaucoma Valve (single plate) - K925636 Clinical Testing (50 patients):
     • Sample Size: 50 patients.
     • Data Provenance: Clinical study performed at five centers for six months. Retrospective or prospective not explicitly stated for this particular summary, but prior 510(k)s often involve prospective data collection. This data would be from the US, as it's a US FDA submission.
   • Molteno Double Plate - Molteno (1981) paper:
     • Sample Size: 12 patients for the double plate group.
     • Data Provenance: Clinical study. Country of origin not specified, but Molteno is associated with New Zealand.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This information is not provided directly within the 510(k) summary. For the studies cited (Huang et al., Molteno 1981, and the initial 50-patient study), the "ground truth" (e.g., IOP measurements, complication assessments) would have been established by the clinicians participating in those studies (presumably ophthalmologists or glaucoma specialists), but their specific number or qualifications are not detailed here. For 510(k) submissions of this nature, the "ground truth" often comes from standard clinical practice and validated measurement techniques rather than an independent expert panel for the submission itself.

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

   • This information is not provided in the 510(k) summary for any of the cited clinical studies. Clinical studies typically have internal review processes, but formal adjudication methods like "2+1" or "3+1" are not mentioned.

4. 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, an MRMC comparative effectiveness study was not done. This device is a physical implant, not an AI or imaging diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.

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

   • Not applicable. This is a physical medical device. The "standalone performance" would relate to its physical function (e.g., fluid flow, pressure regulation), which was assessed via in vitro and in vivo animal studies.

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

   • Clinical Outcomes Data: This is the primary type of ground truth used. It includes:
     • Intraocular Pressure (IOP) measurements.
     • Number of anti-glaucoma medications.
     • Visual acuity.
     • Incidence and type of complications (e.g., hypotony, tube obstruction, iritis).
     • Success rates (based on predefined clinical criteria like target IOP without severe complications).
   • In vitro and In vivo (animal) studies: For biocompatibility and physical function.

7. The sample size for the training set:

   • This term "training set" is typically used in the context of machine learning or AI models. It is not applicable here as the device is a physical implant. The development of the original Ahmed Glaucoma Valve would have involved iterative design and testing, but not in the framework of training sets.

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

   • Not applicable, as there is no "training set" in the AI/ML sense. The "ground truth" for the device's performance claims comes from clinical data and scientific literature on similar devices, as described above.

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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 medication, congenital or infantile glaucoma, and refractory glaucomas resulting from aphakia or uveitis.

The Ahmed™ Glaucoma Valve (AGV™) is a ophthalmic implant for use in intractable glaucoma. The device features a specially engineered, one-way silicone membrane valve system designed to prevent collapse of the anterior chamber (AC) due to hypotony, abnormally low intraocular pressure, and a build-up of excessive intraocular pressure, by venting aqueous humor from the eye. The AGV™ implant consists of a silicone drainage tube and polypropylene valve body to house the valve membrane and protect it from occlusion by fibrosis. All materials used in the manufacture of the device are of medical grade quality. No toxic substances are used in the manufacturing process. The AGV is terminally sterilized by gamma ray radiation.

The Acceptance Criteria and Device Performance for the Ahmed™ Glaucoma Valve Model S3 are based on a clinical study of its predicate device, the Ahmed™ Glaucoma Valve Model S2. The S3 model was deemed substantially equivalent to the S2 model.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: 50 subjects.
• Data Provenance: Prospective clinical study conducted at six (6) institutions. The country of origin is not explicitly stated, but the submission is to the US FDA, implying it was likely conducted in the US or under US regulatory standards.

3. Number of Experts and Qualifications for Ground Truth:

• The document does not explicitly state the number of experts used to establish the ground truth for the test set or their specific qualifications. For medical device studies of this nature, clinical investigators (ophthalmologists, for this device) at the participating institutions would be responsible for patient assessments and data collection, which inherently forms the basis of the "ground truth." The study involved monitoring by medical professionals.

4. Adjudication Method:

• The document does not explicitly detail an adjudication method (e.g., 2+1, 3+1) for the test set. Clinical trials typically involve multiple investigators and a study monitor following a pre-defined protocol. The results presented are the aggregated outcomes from the participating institutions.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is a clinical trial evaluating the performance of a medical device (Ahmed™ Glaucoma Valve) in human subjects, not an assessment of human readers' performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study:

• No, a standalone (algorithm only) performance study was not done. The device is a physical implant, not an AI algorithm. The studies focused on the performance of the physical device after implantation.

7. Type of Ground Truth Used:

• The ground truth was established through clinical outcomes data collected directly from patients after device implantation. This included measurements of intraocular pressure (IOP), assessment of visual acuity, and monitoring for post-operative complications, evaluated by medical professionals.

8. Sample Size for the Training Set:

• This information is not applicable. The device is a physical implant, not an AI algorithm that requires a "training set" in the computational sense. The "training" or development of the device would involve engineering, material science, and pre-clinical testing, not a data-based training set.

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

• This information is not applicable for the same reason as above. The "ground truth" for the development of the physical device would be derived from physiological principles, material properties, and pre-clinical models (in vitro and animal studies) that guide its design and demonstrate its intended function.

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