(269 days)
The LACRIFLOW 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 is intended for the treatment of epiphora due to conditions including the obstructions of lacrimal punctum, lacrimal canaliculus, or nasolacrimal duct. The LACRIFLOW 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 insertion of 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.
This document is a 510(k) summary for the KANEKA LACRIFLOW lacrimal stent. It establishes substantial equivalence to predicate devices and focuses on bench testing and biocompatibility rather than performance metrics from clinical studies.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not provide a comparative table of quantitative performance metrics for the device (e.g., success rates, complication rates) against specific acceptance criteria. Instead, it focuses on demonstrating that the device meets in-house standards and comparing physical characteristics with predicate devices.
The bench testing section mentions two specific tests:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Tensile Strength of the Lacrimal duct tube: Met acceptable minimum force until breakage according to in-house standard. | 14.2 N (Average of 9 samples) (Compared to predicate: 3.56 N and 1.98 N) |
| Stiffness of the Bougie: Met acceptance criteria according to in-house standard. | Specific numerical values are not provided, only a statement of conformance. |
It's important to note that "in-house standard" implies internal benchmarks, not necessarily publicly defined or clinically validated thresholds. The document asserts that "Result of the all performance tests showed that the LACRIFLOW was compliant with in-house standards and the test result did not raise any new safety and effectiveness concern."
2. Sample Size Used for the Test Set and Data Provenance
This information is not explicitly stated in the provided document.
- For the Tensile Strength of the Lacrimal duct tube, a sample size of "9 samples" is mentioned.
- For the Stiffness of the Bougie, no sample size is given.
- The document describes bench testing, which typically does not involve human data or data provenance like country of origin or retrospective/prospective collection methods.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the document discusses bench testing and not clinical studies that would require expert-established ground truth.
4. Adjudication Method for the Test Set
This information is not applicable as the document describes bench testing and not clinical studies requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this 510(k) summary. The submission focuses on device characteristics and basic performance, not on comparing human reader performance with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone performance study of an algorithm is not applicable here, as the device is a physical medical device (stent), not an AI algorithm.
7. Type of Ground Truth Used
For the bench tests, the "ground truth" was established by in-house standards and direct measurement of physical properties. This is not clinical ground truth like pathology, expert consensus, or outcomes data.
8. Sample Size for the Training Set
This information is not applicable. As the device is a physical stent and the evaluation is based on bench testing and material properties, there is no "training set" in the context of an algorithm or model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as #8.
N/A