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510(k) Data Aggregation
(179 days)
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 (< 6 mmHg), IOP increase ≥ 10 mmHg from baseline, needling procedures. |
| Overall Safety Conclusion | As safe as the predicates and does not raise any different or unanticipated safety questions. |
2. Sample Size and Data Provenance
- Clinical Study Sample Size: 65 subjects were implanted with the XEN45 Gel Stent.
- Data Provenance:
- Clinical Study: Prospective, multi-center, single-arm, open-label clinical trial conducted at 12 sites in the U.S.
- Additional Data Considered: OUS (Outside U.S.) data, including an abstract (Grover et al, 2016 AGS abstract "Describing the Development of a Minimally Invasive Collagen Stent for Treating Glaucoma: First 975 Eyes Treated with the XEN Gel Stent," p. 86) and post-market surveillance data from the European Union and Canada.
3. Number of Experts and Qualifications for Ground Truth
- Not applicable to this device submission. This is a medical device for implantation, not an AI/ML diagnostic or image analysis tool requiring expert radiologists for ground truth establishment. The "ground truth" is the clinical outcome (IOP change, adverse events observed in patients).
4. Adjudication Method for the Test Set
- Not applicable for a clinical trial evaluating device performance. Clinical trial data collection follows predefined protocols and statistical analysis plans.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not applicable. This is a clinical trial for an implantable medical device, not a comparative study of AI assistance for human readers.
6. Standalone Performance (Algorithm Only)
- Not applicable. This is a physical medical device (implant), not an algorithm or AI. Its performance is inherent to its physical function within the patient.
7. Type of Ground Truth Used
- Clinical Outcomes Data: For effectiveness, the "ground truth" was objective measurements of intraocular pressure (IOP) and number of IOP-lowering medications over time, as well as observed adverse events for safety. This is direct patient outcome data from a clinical trial.
8. Sample Size for the Training Set
- Not applicable. This is not an AI/ML device that undergoes a "training" phase with data. The clinical trial serves as the primary dataset for demonstrating safety and effectiveness for regulatory approval.
9. How the Ground Truth for the Training Set Was Established
- Not applicable (as above). The "ground truth" (clinical outcomes) was established through direct observation and measurement in the prospective clinical trial.
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