(247 days)
The MASTERKA® is a silicone intubation device indicated for use in the treatment of congenital lacrimal duct obstructions (stenosis of the valve of Hasner) in patients 12 months and older.
The MASTERKA® is a monocanalicular intubation device with self-retaining punctal fixation for the treatment of stenoses that require intubation. The device consists of a silicone tube molded to a fixation head and pre-mounted on an introducer facilitates insertion of the MASTERKA and is completely removed once the intubation of the lacrimal passages has been completed. The MASTERKA® comes in three different lengths (30, 35, or 40 mm depending on the model) and is provided as a sterilized product.
The MASTERKA® Stent, a monocanalicular lacrimal stent, demonstrated its clinical safety and effectiveness through a literature-based study to support its 510(k) clearance by the FDA. The study referenced was a published series by Fayet et al. (2011) that included 68 pediatric cases of congenital lacrimal duct obstructions.
Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from study context) | Reported Device Performance (MASTERKA®) |
|---|---|
| No postoperative epistaxis | 0/68 cases (0%) |
| No intraoperative or postoperative systemic complications | None reported |
| Overall success rate (absence of epiphora and mucous discharge for simple nasolacrimal intubation at the valve of Hasner) | 89.4% (60/66 cases successful; 2 cases lost to follow-up) |
| Complication rate | 13.2% (9/68 cases) |
| Most common complication: Early tube loss | 11.8% (8/68 cases) |
| Other complication: Keratitis | 1.5% (1/68 cases) |
| Similar efficacy and safety to predicate devices | Concluded by authors and FDA as similar |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 68 cases of congenital lacrimal duct obstructions in patients 12 months and older.
- Data Provenance: The study was a retrospective analysis of clinical data published in the Journal Français d'Ophtalmologie (2011) by Fayet et al. The country of origin of the data is not explicitly stated in the provided text, but the journal name suggests French origin.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications for this retrospective study. It references a published clinical study by Fayet et al., implying that the clinical outcomes were assessed by ophthalmologists/surgeons involved in the cases. The reference lists four authors: Fayet B, Racy E, Ruban J-M, Katowitz J, who likely served as the experts assessing the outcomes.
4. Adjudication Method for the Test Set
The document does not describe a specific adjudication method (e.g., 2+1, 3+1). As a retrospective published study, the clinical outcomes would have been determined by the treating physicians and reported in the publication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study was a single-arm series evaluating the performance of the MASTERKA® device, with a comparison to predicate devices being made qualitatively based on similar complication types and rates in literature.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable to the MASTERKA® Stent. This is a medical device (stent), not an AI algorithm. Therefore, no standalone algorithm performance was assessed.
7. The Type of Ground Truth Used
The ground truth was based on clinical outcomes data, specifically defined as "absence of epiphora and mucous discharge" for success, and reported complications like "early tube loss" and "keratitis." These outcomes were observed and documented by clinicians in the course of patient care.
8. The Sample Size for the Training Set
This is not applicable as the clinical evaluation was based on a published study assessing the device's performance, not training a machine learning model.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as the clinical evaluation was based on a published study assessing the device's performance, not training a machine learning model.
N/A