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510(k) Data Aggregation
(38 days)
The Blunt Tip Ex-PRESS Mini Glaucoma Shunts are indicated for use in reduction of intraocular pressure in patients with glaucoma where medical and conventional surgical treatments have failed.
The blunt tipped Ex-PRESS Mini Glaucoma Shunts capture aqueous fluid from the anterior chamber of the eye and transport it distally into a conjunctival bleb.
The blunt tipped Ex-PRESS shunts are comprised of a surgical grade stainless steel tube with a rounded tip at the proximal end and a flat angled flange at the distal end. Three transverse reserve openings near the proximal end of the device serve as ports for aqueous fluid in case of occlusion of the primary opening. The flange at the distal end of the devices serves as a reservoir and prevents intrusion into the eye. The external spur in the middle of the implant serves as an anchor and prevents extrusion from the eye.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text describes a medical device, the Optonol Ex-PRESS™ Mini Glaucoma Shunt, and its substantial equivalence to a predicate device. However, it does not explicitly state specific quantitative acceptance criteria for performance metrics. Instead, the basis for equivalence is primarily qualitative and comparative, focusing on manufacturing, materials, and functional similarity.
The performance section merely states: "Bench testing was conducted per the guidance document 'Guidance for Industry and for FDA Reviewers/Staff Aqueous Shunts - 510(k) Submissions' - November 16", 1998." Without access to this specific guidance document or details of the bench testing results, we cannot populate a table with numerical acceptance criteria and reported device performance.
If we infer acceptance criteria based on the substantial equivalence claim, they would be:
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Functional Equivalence: Device must perform the same function as the predicate device (diverting aqueous humor from anterior chamber to subconjunctival space to reduce intraocular pressure). | "Bench testing demonstrates that the devices are functionally equivalent." (Direct statement comparing the blunt tip Ex-PRESS with the predicate Ex-PRESS, implying similar flow characteristics and pressure reduction capabilities as assessed by bench testing.) |
| Material Equivalence: Must be manufactured from the same materials as the predicate device. | "The devices are manufactured from the same materials..." (Direct statement of equivalence.) |
| Process Equivalence: Must use the same manufacturing processes as the predicate device. | "...using the same processes." (Direct statement of equivalence.) |
| Indication for Use Equivalence: Must have the same indication for use as the predicate device. | "Both devices have the same indication for use, 'reducing intraocular pressure in patients with glaucoma where medical and conventional surgical treatments have failed'..." (Direct statement of equivalence.) |
| Flow Restriction Mechanism Equivalence: Must have identical flow restriction mechanisms as the predicate device. | "The flow restriction mechanisms are identical." (Direct statement of equivalence.) |
2. Sample Size Used for the Test Set and the Data Provenance
The document mentions "Bench testing" but does not provide any details about the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). Bench testing typically refers to laboratory-based evaluations, not clinical studies with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable and not provided in the document. The study described is bench testing, which does not involve human experts establishing ground truth in the way a clinical study or image interpretation study would. Ground truth in this context would likely be based on physical measurements and engineering specifications, not expert consensus on patient data.
4. Adjudication Method for the Test Set
This information is not applicable and not provided in the document for the reasons stated above. Adjudication methods are relevant for studies involving human interpretation or clinical endpoints, not for bench testing of a physical device's characteristics.
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
This information is not applicable and not provided in the document. The device is a physical glaucoma shunt, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable and not provided in the document. The device is a physical implant, not an algorithm. Standalone performance refers to the performance of an AI algorithm without human involvement, which is not relevant here.
7. The Type of Ground Truth Used
For the bench testing mentioned, the "ground truth" would be established by:
- Engineering Specifications: Predefined design parameters, material properties, and functional performance targets.
- Physical Measurements: Data obtained from instruments measuring flow rates, pressure differentials, material integrity, dimensional accuracy, etc., under controlled laboratory conditions.
- Comparison to Predicate Device: The performance of the predicate device (Ex-PRESS Models R30 and R50) under similar bench test conditions would serve as a crucial reference point for establishing equivalence.
The document does not explicitly state these, but they are the standard types of ground truth for bench testing of medical devices.
8. The Sample Size for the Training Set
This information is not applicable and not provided in the document. The device is a physical implant, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided in the document, as there is no training set for a physical device.
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(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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