(55 days)
The Molteno3 glaucoma implants is intended to reduce intraocular pressure in neovascular The Molten.> Elawoma where medical and conventional surgical treatments have not been successful to control the progression of disease.
The Molteno3 Glaucoma implant consists of a flexible silicone translimbal tube attached to a polypropylene episcleral plate. This third generation design is intended to maximize single quadrant bleb performance and simplify insertion and postoperative management.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Molteno3 Glaucoma Implant:
Limitations of the Provided Information:
It's crucial to note that the provided documents (a 510(k) summary and the FDA's clearance letter) are extremely limited in their detail about the study and acceptance criteria. They are focused on establishing substantial equivalence for regulatory purposes, not on providing a comprehensive scientific publication of a study. As such, many of the requested details are not present in the given text.
Acceptance Criteria and Study Details for the Molteno3 Glaucoma Implant
Based on the provided K062252 510(k) summary:
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Table of Acceptance Criteria and Reported Device Performance:
Acceptance Criterion/Performance Metric (Implied) Reported Device Performance Clinical Equivalence (Overall Patient Outcomes) "The outcomes through 22 months are substantially equivalent" to the original Double Plate Molteno Implant. Safety Profile (Not explicitly stated as a separate metric, but implied by "substantially equivalent clinical performance"). Intraocular Pressure (IOP) Reduction (Not numerically stated, but the primary function for which it's compared). Device Material Composition "Identical in material composition to predicate Molteno Implant devices." Note: The 510(k) process for substantial equivalence does not typically require predefined, specific numerical acceptance criteria in the same way a PMA or clinical trial for a novel device would. The "acceptance criterion" here is largely demonstrating equivalence to a predicate device.
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size: "Current data of 44 patients receiving the GS-175mm2".
- Data Provenance: Not specified (e.g., country of origin, specific clinics). The data is described as "current data," implying it's new data collected for this submission, which typically aligns with a prospective or concurrently collected retrospective study. However, without more information, it's impossible to definitively state if it was purely prospective. It's compared to "historical data," which by definition is retrospective.
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Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not mentioned. The document does not provide any information about "ground truth" establishment by experts for the clinical outcomes data. Clinical outcomes in this context (IOP reduction, success/failure of the implant) are usually objective physiological measurements or predefined clinical endpoints (e.g., meeting target IOP, avoiding reoperation).
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Adjudication Method for the Test Set:
- Not mentioned. There is no indication of an adjudication method in the provided text.
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If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. This type of study is specifically relevant to image-based diagnostic devices where multiple readers interpret cases. The Molteno3 Glaucoma Implant is a therapeutic device, so an MRMC study is not applicable here.
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If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- N/A. The Molteno3 Glaucoma Implant is a physical medical device, not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" is not relevant.
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The Type of Ground Truth Used:
- Clinical Outcomes/Patient Data: The "ground truth" implicitly refers to the actual clinical performance and outcomes in patients who received the Molteno3 Glaucoma Implant, particularly regarding its ability to reduce intraocular pressure and control disease progression. This is measured directly from patient follow-up. It's compared against the "historical data" of the predicate device for equivalence.
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Sample Size for the Training Set:
- Not applicable/Not mentioned. Since this is a physical medical device and not an AI/machine learning algorithm, there is no "training set." The Molteno3 is a "third generation design" based on prior engineering and clinical experience with earlier Molteno implants, so fundamental design principles would have been "trained" by years of experience, but not in the computational sense.
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How the Ground Truth for the Training Set Was Established:
- Not applicable/Not mentioned. As there is no training set in the computational sense, this question is not relevant. The device design would have evolved based on clinical feedback and performance of previous generations of the implant.
§ 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.”