(65 days)
The Molteno3 S-Series glaucoma implant is intended to reduce intraocular pressure in neovascular glaucoma or glaucoma where medical and conventional surgical treatments have not been successful to control the progression of disease.
The Molteno3 S-Series Glaucoma Implant comes in two sizes and consists of a fine bore, flexible silicone translimbal tube attached to the upper surface of an injection molded polypropylene episcleral plate with a surface area of either 185mm² (size: SS) or 245mm² (size: SL). The function of the translimbal tube is to deliver aqueous humor ("aqueous") from within the anterior chamber of the eye onto the upper surface of the episcleral plate. The function of the plate is, when the device is implanted below the Tenon's capsule, to initiate the formation of a large circular bleb which develops a specialized fibrovascular bleb lining and becomes distended by aqueous fluid.
The Molteno3 devices have an oval pressure ridge on the upper surface of the episcleral plate that divides the upper surface of the plate into a small, primary and a large, secondary drainage chamber. The S-Series device has a lower ridge profile and the two front suture holes have been moved to a more anterior position than the predicate G-Series device.
The Molteno3 implants may be inserted between the sclera and the Tenon's tissue, so that the device would lie below both the Tenon's tissue and the overlying conjunctiva. However, other surgical techniques may be employed during the placement of a Molteno Implant, consistent with the surgeon's judgment.
The device is intended for single use, is packaged individually in polypropylene presentation boxes, and is sold sterile.
The provided text describes the Molteno3 S-Series Glaucoma Implant and its comparison to the predicate Molteno3 G-Series implant for 510(k) clearance. The document focuses on demonstrating substantial equivalence rather than defining and proving acceptance criteria with specific performance metrics against a predetermined threshold for a novel device.
Therefore, the acceptance criteria are implicitly defined by the demonstrated substantial equivalence to the predicate device, meaning the new device performs "as safe and effective" as the predicate device. The study aims to show that there is "no clinically significant difference in outcome" between the new and predicate device.
Here's an attempt to extract the requested information based on the provided text, acknowledging that some details, particularly specific performance acceptance criteria with numerical thresholds, are not explicitly stated in this type of substantial equivalence document.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are not explicit numerical thresholds defined for the new device's performance but rather the demonstration that its performance is equivalent to the predicate device. The "reported device performance" refers to the outcomes observed in the clinical study for the S-Series device and the comparison to the predicate.
| Acceptance Criterion (Implicit) | Reported Device Performance (S-Series vs. Predicate) |
|---|---|
| Safety and Effectiveness equivalent to predicate device | Clinical comparison established "no clinically significant difference in outcome" between the S-Series and the predicate G-Series implant. |
| IOP (Intraocular Pressure) reduction | Outcome data for IOP reduction evaluated; found to be not clinically significantly different from predicate. |
| Post-operative reductions (other relevant parameters) | Outcome data evaluated; found to be not clinically significantly different from predicate. (Specific parameters not detailed beyond IOP) |
| Visual Acuity | Outcome data for visual acuity evaluated; found to be not clinically significantly different from predicate. |
| Adverse Events | Data on relevant adverse events evaluated; found to be not clinically significantly different from predicate. |
| Material composition and manufacturing process | Identical to predicate device. |
| Sterilization effectiveness (Bacterial Endotoxin Testing) | In conformity with FDA's recommended limit of ≤0.2 EU/device. (This is a specific, explicitly stated acceptance criterion met by bench testing.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Data from 70 patients receiving the S-Series implant.
- Data Provenance:
- S-Series Data: Clinical data developed in the United States.
- Predicate (G-Series) Data: Published historical data from the Otago Glaucoma Surgery Outcome study (country not explicitly stated, but Otago is in New Zealand) and a Finnish study, along with additional unpublished data from the Otago study.
- Retrospective or Prospective: Not explicitly stated for either dataset. The S-Series data "developed using both the G-Series implants" then specifying "clinical data from the use of the Molteno3 S-Series device in the United States were compared to published historical data" suggests the S-Series data might be prospective or a compiled registry, while the predicate data is explicitly historical.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The text does not describe a ground truth established by experts in the context of interpreting data for the study. Instead, the "ground truth" (or reference for comparison) for the S-Series device's performance is the clinical outcome data (IOP, visual acuity, adverse events) reported for both the S-Series patients and the historical predicate device cohorts. The assessment of "no clinically significant difference" would likely have been performed by clinical researchers or statisticians, but their number and specific qualifications are not detailed.
4. Adjudication Method for the Test Set
The document does not mention an adjudication method (like 2+1 or 3+1) for the clinical outcome data. This type of method is more common in studies where subjective assessments (e.g., image interpretation) need consensus. Here, the outcomes are objective clinical measurements (IOP, visual acuity, adverse events).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study was not performed. The study described compares clinical outcomes of a medical device in patients, not the performance of human readers with or without AI assistance. The device itself is an implant, not an AI diagnostic tool.
6. Standalone Performance Study
This is not applicable as the Molteno3 S-Series Glaucoma Implant is a medical device for implantation, not an algorithm. Its "performance" is measured by its clinical effect in vivo (reduce intraocular pressure, maintain visual acuity, safety profile), as opposed to an algorithm's standalone diagnostic accuracy. The clinical study described in Section VII.B is effectively the standalone performance study for the device's clinical impact.
7. Type of Ground Truth Used
The "ground truth" used for assessing the device's performance comprises clinical outcome data including:
- Intraocular Pressure (IOP) measurements
- Visual acuity measurements
- Post-operative reductions (other unspecified clinical parameters)
- Adverse event rates
This outcome data is used to determine if the device is "safe and effective."
8. Sample Size for the Training Set
The document describes a clinical comparison study, not the training of an algorithm or AI model. Therefore, there is no training set in the context of machine learning. The clinical data serves as evidence for device performance.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an algorithm, this question is not applicable.
§ 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.”