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510(k) Data Aggregation
(214 days)
The Ex-Press™ Miniature Glaucoma Implant is intended to reduce intraocular pressure in patients with glaucoma where medical and conventional surgical treatments have failed.
The Ex-PRESS™ Miniature Glaucoma Implant device is a stainless steel tube with a blunt needle shaped penetrating tip at one end and a flat, angled flange at the opposite (distal) end. The device is 2.96mm in length and 0.4mm in diameter. The device consists of a tube whose purpose is to capture aqueous fluid from the anterior chamber of the eve and transport the fluid to the distal end and out of the device from which the fluid then moves into a conjunctival bleb. There are three transverse reserve openings near the proximal end of the device to serve as ports for aqueous fluid in case of occlusion of the primary opening. The flange at the distal end of the device serves as a reservoir and prevents intrusion into the eye. The spur along the bottom of the device prevents extrusion of the device and serves as an anchor. The material of the device is a medical grade stainless steel composition similar in characteristics to other medical implant devices for different indications for use. The device has a stainless steel wire embedded in the tube transverse to the shaft. The purpose of the wire is to restrict the flow passing through the tube. The device drains aqueous humor from the anterior chamber to relieve excessive intraocular pressure associated with glaucoma. The devices available are the R-30 and R-50 versions that represent different flow characteristics created by different wire diameters welded inside the device. The higher the R- number, the lower the resistance of the device to flow.
Here's a summary of the acceptance criteria and study details for the Ex-PRESS™ Miniature Glaucoma Implant, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Definition of Success) | Reported Device Performance (1-year follow-up, Per Protocol Cohort, n=58) |
|---|---|
| IOP reduction > 20% from baseline with or without medications | Cumulative probability of success: 77% |
| IOP < 21 mmHg with or without medications | Cumulative probability of success: 83% |
| IOP reduction > 20% from baseline with or without medications (Overall Success) | Overall success: 80.4% (weighted mean) |
| IOP < 21 mmHg with or without medications (Overall Success) | Overall success: 75.9% |
| Significant reduction in average number of glaucoma medications | Dropped from 1.55 pre-operation to 0.52 one-year post-operation |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Per-Protocol cohort for effectiveness): 58 patients
- Sample Size (Intention-to-treat cohort for safety): 113 patients
- Data Provenance: Prospective, multi-center study conducted at 14 international sites in 8 countries outside of the United States.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not explicitly state the number of experts or their specific qualifications for establishing ground truth related to the clinical patient outcomes (e.g., IOP reduction, medication use). Clinical assessments like tonometry, gonioscopy, and slit-lamp examinations were conducted by practitioners at the study sites; these are standard clinical procedures.
4. Adjudication Method for the Test Set
The document does not describe a specific adjudication method (e.g., 2+1, 3+1). The study was described as an "open-label" clinical study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not explicitly described. The study compared the device's efficacy results to "other glaucoma drainage devices based on the literature," indicating an indirect comparison rather than a direct MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is a medical device (implant) and not an algorithmic software device. Therefore, the concept of a "standalone algorithm" performance study is not applicable here. The device itself is the intervention.
7. The Type of Ground Truth Used
The ground truth for effectiveness was based on objective clinical measurements and patient outcomes:
- Intraocular Pressure (IOP) measurements.
- Number of glaucoma medications used.
- Clinical examinations (tonometry, gonioscopy, slit-lamp examination) to assess safety and success directly.
8. The Sample Size for the Training Set
The document describes a clinical study to evaluate the device. There is no mention of a "training set" as this device is not an AI/ML algorithm that requires training data. The "training" for the device would be its manufacturing and design, which is supported by preclinical information.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this is a medical device, not an AI/ML algorithm.
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