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The VIA360™ Surgical System is indicated for delivery of controlled amounts of viscoelastic fluid during ophthalmic surgery. It is also indicated to cut trabecular meshwork tissue during trabeculotomy procedures.

The VIA360™ Surgical System is a manually operated surgical instrument used by ophthalmologists to deliver controlled amounts of ophthalmic viscoelastic fluid into the anterior segment of the eye. The VIA360™ Surgical System is comprised of a surgical-grade stainless steel cannula and a nylon microcatheter. The cannula is attached to a nose piece that can be rotated to a desired position for use in either eye. The microcatheter is advanced and retracted up to 40 mm per cycle by rotating the scroll wheel. The microcatheter has patterned markings every 10 mm to help measure the extended length. A controlled amount of viscoelastic fluid is dispensed through multiple outlets located on the microcatheter's distal tip by depressing the scroll wheel or the surrounding button. An external reservoir is included for the purpose of priming the device. The device is single-use only.

The provided text describes the 510(k) submission for the VIA360™ Surgical System. This device is a manually operated surgical instrument for ophthalmic procedures, specifically for delivering viscoelastic fluid and cutting trabecular meshwork tissue.

Based on the document, it's clear that this is not a submission for an AI/ML medical device. The device is a physical, manually operated surgical instrument. Therefore, the questions related to AI/ML device performance (such as sample size for test/training sets, expert ground truth establishment, MRMC studies, standalone algorithm performance, etc.) are not applicable to this submission.

The acceptance criteria and device performance evaluation detailed in the document are for a physical medical device, not a software or AI/ML product.

Here's a breakdown of the acceptance criteria and study information provided for the VIA360™ Surgical System, as it pertains to a physical device:

Acceptance Criteria and Reported Device Performance

Study Details (Non-AI/ML Device):

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

   • The document does not specify a numerical sample size for "test sets" in the context of typical AI/ML validation datasets. Instead, it refers to "samples" or "units" for each specific non-clinical test (e.g., "All samples met the acceptance criteria" for visual inspection). The number of samples for each test is not detailed.
   • Data provenance is not explicitly mentioned (e.g., country of origin, retrospective/prospective), as this is non-clinical performance and biocompatibility testing of a physical device.

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

   • Not applicable. This is a physical device; ground truth in the AI/ML sense (e.g., for image annotations) is not relevant. The "ground truth" here is compliance with engineering specifications, material properties, and biological safety standards.

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

   • Not applicable. This is not a human-in-the-loop diagnostic study requiring adjudication.

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:

   • Not applicable. This is a physical surgical device, not an AI-assisted diagnostic tool.

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

   • Not applicable. Again, this is not an algorithm. The "performance" is the physical function and safety of the device itself, evaluated through non-clinical bench testing.

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

   • For this physical medical device, the "ground truth" is defined by established engineering standards (ASTM, ISO), biocompatibility guidelines (ISO 10993 series), and the functional requirements of the device (e.g., accurate fluid dispense, sufficient joint strength). Compliance with these defined standards and specifications forms the basis of "truth."

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of an AI/ML model for this physical device. Device design and manufacturing processes are iterative but not "trained" in this manner.

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

   • Not applicable for the same reason as point 7.

Key takeaway from the document: The applicant demonstrates substantial equivalence for the VIA360™ Surgical System by comparing its design, materials, and non-clinical performance data to a legally marketed predicate device (OMNI Surgical System). The 510(k) summary explicitly states: "Clinical data is not included in this submission and is not required. Substantial equivalence is based on technological comparison." This further confirms that no AI/ML specific evaluations (which often require clinical data or extensive simulation/test data for model validation) were conducted or needed.

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The Kahook Dual Blade Glide is indicated to surgically remove a strip of trabecular meshwork to reduce intraocular pressure in adult patients with primary open angle glaucoma.

The Kahook Dual Blade (KDB) Glide is a single-use, ophthalmic knife for use in adults. It is intended to remove a strip of trabecular meshwork tissue to allow for fluid outflow in glaucoma patients. The device is designed for ease of use and easy access to the structures within the eye. The blades are made of surgicalgrade stainless steel. The tip of the knife is pointed and allows for easy piercing of tissue. The ramp that the tip is attached to lifts tissue and exposes it to two parallel dual blades of the instrument, effectively remove a narrow strip of tissue.

Here's a summary of the acceptance criteria and study information for the Kahook Dual Blade Glide, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance document does not explicitly present a table of quantitative acceptance criteria with corresponding performance directly within the "Performance Data" section for each specific test in the same way a software validation might. However, it states that "Results of the non-clinical bench testing demonstrate that the Kahook Dual Blade Glide meets the defined specifications and functions as intended." It broadly indicates that "All samples met the acceptance criteria" for tests like corrosion, endotoxin, visual inspection, bubble leak, tensile test, and non-cytotoxicity, non-sensitizer, non-irritant, and non-toxic for biocompatibility.

For clinical effectiveness, the primary endpoint was used as an acceptance criterion, and device performance is reported against it.

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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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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.

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The Streamline® Viscoelastic Injector is intended to deliver small amounts of viscoelastic fluid during Ophthalmic Surgery.

The Streamline® Surgical System is a single-use disposable cannula for use during ophthalmic surgical procedures to deliver small amounts of viscoelastic fluid.

The Streamline® Viscoelastic Injector is a single use disposable device designed to deliver small amounts of viscoelastic fluid.

The device consists of a single-use disposable device comprised of a surgical grade stainless steel cannula and a polymer handset, actuator button and priming port (Figure 1). The cannula is comprised of a long thin neck with an outer sleeve at its tip and allows access through a minimum 1.8 mm clear corneal incision. The cannula is long enough to reach across the eye 180 degrees from the clear corneal incision.

The device outer sleeve is transparent which allows the dispensing cannula with a clearly identifiable color to be visible at 12X magnification.

The priming port allows interfacing with commonly used viscoelastic containers used during priming and filling of the device.

The actuator button is located at the top of the handset and is colored for easy identification and incorporates a slight depression giving the user a tactile feel and correct finger placement. Each actuation of the actuator button causes an internal mechanical cam to rotate causing a snap action which rapidly retracts the outer sleeve at the device's distal tip. This action allows the cannula to dispense viscoelastic fluid through opposing side outlets located at an acute angle from the perpendicular plane of tip (Figure 2).

The length of the gear assembly allows for up to eight (8) total activations of the device. Each activation of the delivers approximately 7 µL of OVD and approximately 56 µL of OVD for the total maximum 8 activations allowed by the device. Once all activations are completed the gear assembly will have reached the end of travel and cannot be reset. Additionally, activation of the actuator button causes the priming port to disengage from the fluid pathway, to prevent re-priming of the device. This prevents the device from further priming preventing re-use.

Materials used to manufacture the Streamline® Viscoelastic Injector are of medical grade quality and no toxic substances are used in the manufacturing process. The materials used in the Streamline® Viscoelastic Injector were selected from materials safe for use in a clinical setting. These materials include stainless steel, polycarbonate, ABS polymer and silicone.

The provided document is a 510(k) premarket notification for the Streamline® Viscoelastic Injector. It details the device's technical characteristics, intended use, and provides a comparison to a predicate device. It also lists performance testing conducted to demonstrate conformance to design specifications and applicable standards.

However, the document does not contain specific acceptance criteria values or detailed results of a study that directly proves the device meets those criteria in a quantitative sense as typically presented with metrics like sensitivity, specificity, or F1-score. The "Performance Testing" section describes what types of tests were performed but does not provide the numerical acceptance criteria or the reported performance outcomes beyond qualitative statements (e.g., "assuring cannula integrity", "Qualitatively verify activation").

Furthermore, the document does not describe a study involving human readers or comparative effectiveness studies (MRMC) as it is a medical device for injecting viscoelastic fluid, not an AI/imaging diagnostic device.

Here's an attempt to answer your questions based only on the provided document, highlighting where information is unavailable:

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, specific numerical acceptance criteria and reported performance values (e.g., precise strength values, exact force measurements, or quantitative pass/fail rates for functional tests) are not detailed in this document. The document lists the types of tests performed to ensure the device meets design specifications and conformance to standards.

2. Sample size used for the test set and the data provenance

The document does not specify exact numerical sample sizes for most of the performance tests (e.g., "100% of units during sample build" is mentioned for drivetrain motion, but no number of units is given). For Human Factors Engineering, "15 surgeons" were used.

Data provenance (e.g., country of origin, retrospective/prospective) is not stated. These tests are likely laboratory-based functional and material tests.

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 the provided document. The ground truth for functional engineering tests, material science tests, and biological safety is established by adherence to recognized international and national standards, and by engineering specifications, rather than expert consensus on diagnostic interpretations. The "experts" involved would be the engineers, test technicians, and possibly medical professionals (for cadaver evaluation and human factors) conducting these specific tests. For the Human Factors Engineering evaluation, 15 surgeons were used. Their specific qualifications beyond being "surgeons" are not detailed.

4. Adjudication method for the test set

This is not applicable as the tests described are primarily objective engineering and material science evaluations against predefined mechanical, biological, and material specifications, not subjective assessments requiring adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or AI-assisted diagnostic tools, not for a surgical instrument like the Streamline® Viscoelastic Injector.

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

No, this is not applicable. The Streamline® Viscoelastic Injector is a manually operated surgical device, not an algorithm.

7. The type of ground truth used

The ground truth for the performance testing is based on:

• Established engineering specifications (e.g., required force for actuation, dispensed volume).
• Compliance with recognized international and national standards (e.g., ISO 10993 series for biocompatibility, ISO 80369-7 for Luer fittings, ISO 9626 for cannulas, ASTM standards for packaging).
• Qualitative assessment by trained personnel during functional checks (e.g., visual verification of drivetrain motion, qualitative verification on cadaver eyes).

8. The sample size for the training set

This is not applicable. The Streamline® Viscoelastic Injector is a mechanical surgical device, not an AI or machine learning model that requires a training set.

9. How the ground truth for the training set was established

This is not applicable for the reasons stated in point 8.

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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).

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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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