(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.
§ 886.3920 Aqueous shunt.
(a)
Identification. An aqueous shunt is an implantable device intended to reduce intraocular pressure in the anterior chamber of the eye in patients with neovascular glaucoma or with glaucoma when medical and conventional surgical treatments have failed.(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(2) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),” and
(3) “Aqueous Shunts—510(k) Submissions.”