Search Results

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.

Ask a specific question about this device

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

The Ahmed® is comprised of a silicone drainage tube that is connected to a valve mechanism. This valve mechanism is the same in the predicate AGV-FP8 (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 surface of the endplate. The valve in the AGV-FP8 (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-FP8 (Modified) maintains intraocular pressure within the appropriate physiological range.

In both the AGV-FP8 (Original) and AGV-FP8 (Modified), the silicone sheet is folded and pressed between two polypropylene plates. In both the predicate devices and the AGV-FP8 (Modified), 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. Both the predicate devices and AGV-FP8 (Modified) have the same curvature as the average human eye at its equator and also protects the valve from blockage by fibrous tissue

The provided text does not contain information about acceptance criteria and a study proving a device meets them in the context of AI/ML performance. Instead, it is a 510(k) summary for a medical device called the Ahmed® Glaucoma Valve Model FP8.

The document discusses a change in the endplate material of the glaucoma valve from one grade of silicone to another. The "testing" section (h) describes biocompatibility, physical, chemical, and aging tests conducted to support this material change, not the performance of an AI/ML system.

Therefore, I cannot extract the requested information regarding:

1. A table of acceptance criteria and the reported device performance (for AI/ML).
2. Sample size and data provenance for an AI/ML test set.
3. Number and qualifications of experts for AI/ML ground truth.
4. Adjudication method for an AI/ML test set.
5. MRMC comparative effectiveness study results.
6. Standalone AI performance.
7. Type of AI ground truth.
8. Sample size for AI training set.
9. How ground truth for the AI training set was established.

This document pertains to the regulatory submission for a physical medical device, not a software device or AI algorithm, and thus does not describe the types of studies that would provide the requested information.

Ask a specific question about this device

The iStent infinite® Trabecular Micro-Bypass System Model iS3 an implantable device intended to reduce the intraocular pressure (IOP) of the eye. It is indicated for use in adult patients with primary open-angle glaucoma in whom previous medical and surgical treatment has failed.

The iStent infinite Trabecular Micro-Bypass System Model iS3 is a sterile, single-use injector system that is pre-loaded with three G2-W stents, and is designed to deliver the stents into Schlemm's canal. The G2-W stents are manufactured from implant grade titanium (Ti6Al4V ELI per ASTM F136) and are coated with stearalkonium heparin. An area of reduced outside diameter, midway along the device, is designed to provide retention within the trabecular meshwork, while multiple outlet lateral lumens (4 outflow orifices) are designed to provide an exit route for aqueous from the anterior chamber. The stent has a single piece design, is 360 um in diameter, 360 um in height, and the central inlet and outlet lumen has a diameter of 80 um. The head of the stent has four side outlets that each have a diameter of 50 um.

Here's a breakdown of the acceptance criteria and study information for the iStent infinite Trabecular Micro-Bypass System, as presented in the provided FDA 510(k) summary, structured to answer your questions:

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

Please note that for the clinical effectiveness endpoints, explicit "acceptance criteria" are not stated as pass/fail thresholds in the provided text. Instead, the study reports the observed performance, and the FDA determined this performance supports substantial equivalence. For bench testing, direct pass/fail results against implicit or explicit criteria are mentioned.

Ask a specific question about this device

The AHMED® ClearPath glaucoma drainage device is indicated for the management of refractory glaucoma where previous surgical treatment has failed or is not expected to provide satisfactory results. Such refractory glaucoma may include but is not limited to: neovascular glaucoma, congenital or infantile glaucoma, and refractory glaucoma resulting from aphakia or uveitis.

The AHMED® ClearPath Glaucoma Drainage Device is a non-valved drainage device designed to shunt aqueous in eyes suffering from refractory glaucoma. Two models CP250 are available covering surface areas of approximately 250mm². The implant consists of a medical grade silicone tube secured to a medical grade silicone episcleral plate near the anterior suture points. The anterior suture points are located on the anterior side of the plate, flanking each side of the tubing track. The silicone plate is barium impregnated to increase ultrasound resolution and identification with CT scan, MRI and plain skull films. The plate conforms to the shape of the globe at its equator and provides a surface from which fluid can be dispersed. Each AHMED® ClearPath is supplied with a 23-gauge hypodermic needle and a 2-inch polypropylene ripcord (pre-loaded in the lumen of the tube) in a sterile, sealed double- pouch. The supplied needle and ripcord are for optional use and are available to be incorporated into the implantation procedure per the surgeon's usual routine. The device is for single use only.

The provided document is a 510(k) summary for a medical device (AHMED® ClearPath Glaucoma Drainage Device), which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study proving that the device meets specific acceptance criteria as would be done for an AI/ML medical device.

Therefore, many of the requested elements (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable (N/A) because this is a submission for a physical medical device (an aqueous shunt) and not a software/AI medical device. The "acceptance criteria" here refers to the device meeting its design specifications and demonstrating equivalence to a predicate, not performance metrics like sensitivity/specificity for an AI model.

However, I can extract and present the relevant information provided in the document:

Acceptance Criteria and Study for AHMED® ClearPath Glaucoma Drainage Device

This 510(k) submission demonstrates substantial equivalence of the AHMED® ClearPath Glaucoma Drainage Device to a legally marketed predicate device (Baerveldt Glaucoma Implant), rather than proving the device meets specific acceptance criteria through a clinical performance study as would be typical for an AI/ML device. The "acceptance criteria" for this device are its ability to meet design specifications and perform comparably to the predicate device in bench testing, and its biocompatibility.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set (Bench Testing Sample Size): Not explicitly stated how many devices or samples were tested for each bench test. The document refers to "the AHMED® ClearPath glaucoma drainage device was evaluated" and "results establish that the AHMED® ClearPath glaucoma drainage device meets the defined specifications." These are laboratory tests, not clinical studies with patients.
• Data Provenance: The bench testing was conducted internally or by validated labs as part of the device development process.
• Retrospective/Prospective: N/A (Bench testing, not clinical data)

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

• Number of Experts: N/A (Ground truth established by standardized test methods and comparisons to a physical predicate device, not by expert consensus on clinical images/data).
• Qualifications of Experts: N/A

4. Adjudication Method for the Test Set

• Adjudication Method: N/A (No human interpretation requiring adjudication for bench tests).

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

• MRMC Study: N/A (This is a physical medical device, not an AI/ML software).
• Effect Size of Human Reader Improvement: N/A

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

• Standalone Performance: N/A (This is a physical medical device, not an algorithm).

7. The type of Ground Truth Used

• Ground Truth:
  • Bench Testing: Engineering specifications, functional requirements, and direct comparison to the physical predicate device (Baerveldt Glaucoma Implant) for "pressure/flow characterization and effectiveness of tube occlusion utilizing a ripcord." Standards such as ANSI Z80.27 and ISO 11137-1/2, ISO 10993-1 were used as references for test methodologies and acceptance criteria.
  • Clinical Efficacy/Safety: Substantial equivalence is supported by reference to published clinical literature on the predicate device (Budenz et al. 2015, 2016) and other relevant literature for specific design features (Kahook et al. 2006 for placement, Sherwood & Smith 1993, An et al. 2018 for ripcord use). The device itself did not undergo a de novo clinical trial.

8. The Sample Size for the Training Set

• Training Set Sample Size: N/A (This is a physical medical device. No "training set" in the AI/ML sense).

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

• Ground Truth Establishment for Training Set: N/A (No training set for this type of device).

Ask a specific question about this device

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.

Ask a specific question about this device

The XEN Glaucoma Treatment System is indicated for the management of refractory glaucomas, including cases where previous surgical treatment has failed, cases of primary open angle glaucoma, and pseudoexfoliative or pigmentary glaucoma with open angles that are unresponsive to maximum tolerated medical therapy.

The XEN Glaucoma Treatment System consists of the XEN45 Gel Stent preloaded into the XEN Injector. The XEN45 Gel Stent is composed of a gelatin derived from porcine dermis, formed into a tube, and then cross-linked with glutaraldehyde. The inside diameter of the tube is approximately 45 um, its outside diameter is approximately 150 um, and it has a length of approximately 6 mm. The XEN45 Gel Stent creates a permanent channel through the sclera allowing aqueous flow from the anterior chamber to the subconjunctival space.

The XEN45 Gel Stent is preloaded into an injector designed to place the XEN45 Gel Stent in the intended position. The injector with the preloaded implant is sterilized via gamma irradiation and is provided sterile. The injector is discarded after a one-time use.

The document provided is a 510(k) summary for a medical device (XEN Glaucoma Treatment System) and details the performance data used to demonstrate substantial equivalence to predicate devices, rather than formally outlining acceptance criteria for AI/ML-based device performance and a study proving it meets those.

Therefore, many of the requested elements (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth types for test/training, training set build) are not applicable or cannot be extracted from this document, as they relate to AI/ML device validation, which is not the subject of this 510(k) summary.

However, I can extract information related to the clinical effectiveness and safety evaluation of the XEN Glaucoma Treatment System, which serves as its "performance data" in this context.

Here's an attempt to structure the available information relevant to "acceptance criteria" and "device performance" as per the document provided, interpreting "acceptance criteria" as the measures of effectiveness and safety used to demonstrate equivalence.

Device: XEN Glaucoma Treatment System

Study Type: K161457 510(k) Premarket Notification - demonstrating substantial equivalence to predicate devices.

Interpretation of "Acceptance Criteria" for this device: For this type of medical device (an aqueous shunt), acceptance criteria are primarily demonstrated through clinical effectiveness in lowering intraocular pressure (IOP) and an acceptable safety profile, comparable to legally marketed predicate devices. The "performance data" presented is the evidence that these clinical objectives were met.

1. Table of "Acceptance Criteria" (Effectiveness and Safety Measures) and Reported Device Performance

Ask a specific question about this device

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

Ask a specific question about this device

The Molteno3 S-Series glaucoma implant is intended to reduce intraocular pressure in neovascular glaucoma or glaucoma where medical and conventional surgical treatments have not been successful to control the progression of disease.

The Molteno3 S-Series Glaucoma Implant comes in two sizes and consists of a fine bore, flexible silicone translimbal tube attached to the upper surface of an injection molded polypropylene episcleral plate with a surface area of either 185mm² (size: SS) or 245mm² (size: SL). The function of the translimbal tube is to deliver aqueous humor ("aqueous") from within the anterior chamber of the eye onto the upper surface of the episcleral plate. The function of the plate is, when the device is implanted below the Tenon's capsule, to initiate the formation of a large circular bleb which develops a specialized fibrovascular bleb lining and becomes distended by aqueous fluid.

The Molteno3 devices have an oval pressure ridge on the upper surface of the episcleral plate that divides the upper surface of the plate into a small, primary and a large, secondary drainage chamber. The S-Series device has a lower ridge profile and the two front suture holes have been moved to a more anterior position than the predicate G-Series device.

The Molteno3 implants may be inserted between the sclera and the Tenon's tissue, so that the device would lie below both the Tenon's tissue and the overlying conjunctiva. However, other surgical techniques may be employed during the placement of a Molteno Implant, consistent with the surgeon's judgment.

The device is intended for single use, is packaged individually in polypropylene presentation boxes, and is sold sterile.

The provided text describes the Molteno3 S-Series Glaucoma Implant and its comparison to the predicate Molteno3 G-Series implant for 510(k) clearance. The document focuses on demonstrating substantial equivalence rather than defining and proving acceptance criteria with specific performance metrics against a predetermined threshold for a novel device.

Therefore, the acceptance criteria are implicitly defined by the demonstrated substantial equivalence to the predicate device, meaning the new device performs "as safe and effective" as the predicate device. The study aims to show that there is "no clinically significant difference in outcome" between the new and predicate device.

Here's an attempt to extract the requested information based on the provided text, acknowledging that some details, particularly specific performance acceptance criteria with numerical thresholds, are not explicitly stated in this type of substantial equivalence document.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are not explicit numerical thresholds defined for the new device's performance but rather the demonstration that its performance is equivalent to the predicate device. The "reported device performance" refers to the outcomes observed in the clinical study for the S-Series device and the comparison to the predicate.

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

• Sample Size for Test Set: Data from 70 patients receiving the S-Series implant.
• Data Provenance:
  • S-Series Data: Clinical data developed in the United States.
  • Predicate (G-Series) Data: Published historical data from the Otago Glaucoma Surgery Outcome study (country not explicitly stated, but Otago is in New Zealand) and a Finnish study, along with additional unpublished data from the Otago study.
• Retrospective or Prospective: Not explicitly stated for either dataset. The S-Series data "developed using both the G-Series implants" then specifying "clinical data from the use of the Molteno3 S-Series device in the United States were compared to published historical data" suggests the S-Series data might be prospective or a compiled registry, while the predicate data is explicitly historical.

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

The text does not describe a ground truth established by experts in the context of interpreting data for the study. Instead, the "ground truth" (or reference for comparison) for the S-Series device's performance is the clinical outcome data (IOP, visual acuity, adverse events) reported for both the S-Series patients and the historical predicate device cohorts. The assessment of "no clinically significant difference" would likely have been performed by clinical researchers or statisticians, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

The document does not mention an adjudication method (like 2+1 or 3+1) for the clinical outcome data. This type of method is more common in studies where subjective assessments (e.g., image interpretation) need consensus. Here, the outcomes are objective clinical measurements (IOP, visual acuity, adverse events).

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

An MRMC study was not performed. The study described compares clinical outcomes of a medical device in patients, not the performance of human readers with or without AI assistance. The device itself is an implant, not an AI diagnostic tool.

6. Standalone Performance Study

This is not applicable as the Molteno3 S-Series Glaucoma Implant is a medical device for implantation, not an algorithm. Its "performance" is measured by its clinical effect in vivo (reduce intraocular pressure, maintain visual acuity, safety profile), as opposed to an algorithm's standalone diagnostic accuracy. The clinical study described in Section VII.B is effectively the standalone performance study for the device's clinical impact.

7. Type of Ground Truth Used

The "ground truth" used for assessing the device's performance comprises clinical outcome data including:

• Intraocular Pressure (IOP) measurements
• Visual acuity measurements
• Post-operative reductions (other unspecified clinical parameters)
• Adverse event rates

This outcome data is used to determine if the device is "safe and effective."

8. Sample Size for the Training Set

The document describes a clinical comparison study, not the training of an algorithm or AI model. Therefore, there is no training set in the context of machine learning. The clinical data serves as evidence for device performance.

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

As there is no training set for an algorithm, this question is not applicable.

Ask a specific question about this device

The Molteno3 glaucoma implants is intended to reduce intraocular pressure in neovascular The Molten.> Elawoma where medical and conventional surgical treatments have not been successful to control the progression of disease.

The Molteno3 Glaucoma implant consists of a flexible silicone translimbal tube attached to a polypropylene episcleral plate. This third generation design is intended to maximize single quadrant bleb performance and simplify insertion and postoperative management.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Molteno3 Glaucoma Implant:

Limitations of the Provided Information:

It's crucial to note that the provided documents (a 510(k) summary and the FDA's clearance letter) are extremely limited in their detail about the study and acceptance criteria. They are focused on establishing substantial equivalence for regulatory purposes, not on providing a comprehensive scientific publication of a study. As such, many of the requested details are not present in the given text.

Acceptance Criteria and Study Details for the Molteno3 Glaucoma Implant

Based on the provided K062252 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criterion/Performance Metric (Implied)	Reported Device Performance
   Clinical Equivalence (Overall Patient Outcomes)	"The outcomes through 22 months are substantially equivalent" to the original Double Plate Molteno Implant.
   Safety Profile	(Not explicitly stated as a separate metric, but implied by "substantially equivalent clinical performance").
   Intraocular Pressure (IOP) Reduction	(Not numerically stated, but the primary function for which it's compared).
   Device Material Composition	"Identical in material composition to predicate Molteno Implant devices."

   Note: The 510(k) process for substantial equivalence does not typically require predefined, specific numerical acceptance criteria in the same way a PMA or clinical trial for a novel device would. The "acceptance criterion" here is largely demonstrating equivalence to a predicate device.

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

   • Sample Size: "Current data of 44 patients receiving the GS-175mm2".
   • Data Provenance: Not specified (e.g., country of origin, specific clinics). The data is described as "current data," implying it's new data collected for this submission, which typically aligns with a prospective or concurrently collected retrospective study. However, without more information, it's impossible to definitively state if it was purely prospective. It's compared to "historical data," which by definition is retrospective.

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

   • Not mentioned. The document does not provide any information about "ground truth" establishment by experts for the clinical outcomes data. Clinical outcomes in this context (IOP reduction, success/failure of the implant) are usually objective physiological measurements or predefined clinical endpoints (e.g., meeting target IOP, avoiding reoperation).

4. Adjudication Method for the Test Set:

   • Not mentioned. There is no indication of an adjudication method in the provided text.

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

   • No. This type of study is specifically relevant to image-based diagnostic devices where multiple readers interpret cases. The Molteno3 Glaucoma Implant is a therapeutic device, so an MRMC study is not applicable here.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

   • N/A. The Molteno3 Glaucoma Implant is a physical medical device, not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used:

   • Clinical Outcomes/Patient Data: The "ground truth" implicitly refers to the actual clinical performance and outcomes in patients who received the Molteno3 Glaucoma Implant, particularly regarding its ability to reduce intraocular pressure and control disease progression. This is measured directly from patient follow-up. It's compared against the "historical data" of the predicate device for equivalence.

8. Sample Size for the Training Set:

   • Not applicable/Not mentioned. Since this is a physical medical device and not an AI/machine learning algorithm, there is no "training set." The Molteno3 is a "third generation design" based on prior engineering and clinical experience with earlier Molteno implants, so fundamental design principles would have been "trained" by years of experience, but not in the computational sense.

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

   • Not applicable/Not mentioned. As there is no training set in the computational sense, this question is not relevant. The device design would have evolved based on clinical feedback and performance of previous generations of the implant.

Ask a specific question about this device

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.

Ask a specific question about this device