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510(k) Data Aggregation
(179 days)
XEN Glaucoma Treatment System
The XEN Glaucoma Treatment System is indicated for the management of refractory glaucomas, including cases where previous surgical treatment has failed, cases of primary open angle glaucoma, and pseudoexfoliative or pigmentary glaucoma with open angles that are unresponsive to maximum tolerated medical therapy.
The XEN Glaucoma Treatment System consists of the XEN45 Gel Stent preloaded into the XEN Injector. The XEN45 Gel Stent is composed of a gelatin derived from porcine dermis, formed into a tube, and then cross-linked with glutaraldehyde. The inside diameter of the tube is approximately 45 um, its outside diameter is approximately 150 um, and it has a length of approximately 6 mm. The XEN45 Gel Stent creates a permanent channel through the sclera allowing aqueous flow from the anterior chamber to the subconjunctival space.
The XEN45 Gel Stent is preloaded into an injector designed to place the XEN45 Gel Stent in the intended position. The injector with the preloaded implant is sterilized via gamma irradiation and is provided sterile. The injector is discarded after a one-time use.
The document provided is a 510(k) summary for a medical device (XEN Glaucoma Treatment System) and details the performance data used to demonstrate substantial equivalence to predicate devices, rather than formally outlining acceptance criteria for AI/ML-based device performance and a study proving it meets those.
Therefore, many of the requested elements (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth types for test/training, training set build) are not applicable or cannot be extracted from this document, as they relate to AI/ML device validation, which is not the subject of this 510(k) summary.
However, I can extract information related to the clinical effectiveness and safety evaluation of the XEN Glaucoma Treatment System, which serves as its "performance data" in this context.
Here's an attempt to structure the available information relevant to "acceptance criteria" and "device performance" as per the document provided, interpreting "acceptance criteria" as the measures of effectiveness and safety used to demonstrate equivalence.
Device: XEN Glaucoma Treatment System
Study Type: K161457 510(k) Premarket Notification - demonstrating substantial equivalence to predicate devices.
Interpretation of "Acceptance Criteria" for this device: For this type of medical device (an aqueous shunt), acceptance criteria are primarily demonstrated through clinical effectiveness in lowering intraocular pressure (IOP) and an acceptable safety profile, comparable to legally marketed predicate devices. The "performance data" presented is the evidence that these clinical objectives were met.
1. Table of "Acceptance Criteria" (Effectiveness and Safety Measures) and Reported Device Performance
| "Acceptance Criteria" Aspect (as inferred from effectiveness/safety goals) | Reported Device Performance (XEN Glaucoma Treatment System) |
|---|---|
| Effectiveness: | |
| IOP Reduction (> 20% from baseline) | 76.3% of subjects achieved a 12-month mean diurnal IOP reduction of > 20% from baseline on the same or fewer IOP-lowering medications. |
| Mean Diurnal IOP Reduction (at 12 months) | -6.4 ± 1.1 (SE) mmHg mean diurnal IOP reduction from baseline at the 12-month visit. |
| Mean Diurnal IOP at 12 Months | 15.9 (± 5.2) mmHg (for 52 subjects with observed data) from a baseline of 25.1 (± 3.7) mmHg. |
| Mean Number of IOP-Lowering Medications at 12 Months | 1.7 (± 1.5) medications (from a baseline of 3.5 ± 1.0 medications). |
| Safety: | |
| Adverse Event Profile Comparison to Predicates | The adverse event profile of the XEN45 Gel Stent is comparable to publicly available data on legally marketed predicate devices. |
| Most Common Adverse Events | Additional glaucoma surgery (with/without device explant), hypotony ( |
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