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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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