(81 days)
The Lacriflow CL is indicated in treatments of epiphora in patients 12 months and older, in cases of:
- Canalicular pathologies (stenosis, obstruction, lacerations),
- During Dacryocystorhinostomy (conventional or laser),
- Congenital nasolacrimal duct obstruction.
The LACRIFLOW CL is intended for the treatment of epiphora due to conditions including the obstructions of lacrimal punctum, lacrimal canaliculus, or nasolacrimal duct. The LACRIFLOW CL consists of the Lacrimal duct tube and the Bougie. The Lacrimal duct tube is intended to be inserted and placed inside the lacrimal canaliculus or other sites to dilate the lacrimal duct, and the Bougie is intended to be used for the Lacrimal duct tube and removed after insertion of Lacrimal duct tube. Lacrimal duct is dilated by insertion of the Lacrimal duct tube into the obstructed site.
The provided document is a 510(k) premarket notification for the Lacriflow CL device. It outlines the device's characteristics, indications for use, and a comparison to a predicate device (Lacriflow K120886). The primary focus of the document is to demonstrate "substantial equivalence" to the predicate device, especially considering modifications made.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The concept of "acceptance criteria" in this document is implicitly defined by demonstrating that the modified Lacriflow CL device performs comparably to the predicate Lacriflow (K120886) and that the modifications do not introduce new safety or effectiveness concerns. The performance is assessed through specific verification tests rather than against explicit numerical thresholds for clinical outcomes (e.g., sensitivity, specificity, accuracy).
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Penetration Test of Tip with Bougie (following elimination of stainless steel rings) | Performed (stated to meet verification tests). |
| Simulated Insertion Test (following change in tip shape) | Performed (stated to meet verification tests). |
| Bending Test for Tip (following change in tip shape) | Performed (stated to meet verification tests). |
| Inserting Load Measurement (following change in hydrophilic coating area) | Performed (stated to meet verification tests). |
| Visual Inspection for Extraneous Matter, Abnormality, Coating Droplet (following change in hydrophilic coating area) | Performed (stated to meet verification tests). |
| Overall substantial equivalence to predicate device (K120886) | Concluded that Lacriflow CL is substantially equivalent to Lacriflow (K120886) based on identical indications for use and satisfactory design verification tests. |
2. Sample Size for Test Set and Data Provenance
The document describes design verification tests. These are engineering/performance tests conducted on the device components or the device itself, not clinical studies involving human patients.
- Sample Size for Testing: For the "Tensile Strength of the Tube," the predicate device's performance is listed as "14.2 N (Average of 9 samples)." This is the only explicit sample size mentioned in relation to a performance characteristic. For the other "Performance tests" listed in Table 2, specific sample sizes are not provided in this document.
- Data Provenance: Not applicable as these are laboratory/engineering tests described, not clinical data from patients.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. The "ground truth" here is defined by engineering specifications and comparative performance to the predicate device, verified through laboratory testing. There is no mention of experts establishing ground truth for a test set in the context of clinical, diagnostic, or interpretive performance.
4. Adjudication Method for Test Set
Not applicable. This is a technical performance assessment, not a clinical study requiring adjudicated interpretations of results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in this document. This device is a lacrimal stent, and the evaluation focuses on its physical and functional equivalence to a predicate device, not on diagnostic accuracy improvements with AI assistance for human readers.
6. Standalone (Algorithm Only) Performance Study
No, a standalone (algorithm only) performance study was not conducted or described. This device is a physical medical device, not an AI/algorithmic diagnostic tool.
7. Type of Ground Truth Used
The "ground truth" for the evaluation described in this document is based on:
- Engineering Specifications and Performance Standards: The device's physical properties and functional performance (e.g., tip penetration, insertion load, bending strength, visual integrity) are evaluated against established engineering parameters and expectations for medical devices of this type.
- Predicate Device Performance: Comparison to the known performance and characteristics of the legally marketed predicate device (Lacriflow K120886) serves as a benchmark for substantial equivalence.
8. Sample Size for Training Set
Not applicable. This is a physical medical device, not an AI/machine learning system that requires a training set.
9. How Ground Truth for Training Set Was Established
Not applicable. As there's no training set for an AI/machine learning model, this point is irrelevant.
N/A