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The lacrimal duct catheter is indicated for use during dilation of the obstructed nasolacrimal duct in the following populations:

a. The 2MM catheter is indicated for use during dilation of the obstructed nasolacrimal duct obstruction in patients over 12 months of age and under 30 months of age.

b. The 3 mm catheter is indicated for use during dilation of the obstructed nasolacrimal duct in children over 30 months of age.

c. The 5mm catheter is indicated for use in adults during dilation of a lacrimal duct obstruction or blocked dacryocystorhinostomy ostium as a result of the following: functional or complete nasolacrimal duct obstruction, dacryocystitis, or failed dacryocystorhinostomy.

The lacrimal duct catheter is a sterile, single use, non-pyrogenic disposable balloon catheter consisting of a semi-flexible stainless steel hypotube core and nylon balloon tubing. The balloon is designed to inflate to a known diameter and length at the specific pressure. Markings are present 10 and 15 mm proximal to the beginning of the working portion of the balloon, which helps indicate when the balloon is placed correctly in the lacrimal system. The overall length of the catheter is 6 inches (15.24 cm) long. There is an opening on the distal end of the catheter hypotube to accommodate irrigation solutions. The Y-hub on the proximal end of the catheter has a luer port for inflation of the balloon catheter (labeled "inflation" with a red band) and a second luer port for irrigation through the balloon catheter (labeled "irrigation"). The balloon catheter is available in a 2 mm and 3 mm inflated diameter. The 3 mm balloon has a length Of 15 mm and a deflated profile of approximately 1.1 mm. The 2 mm balloon has a length Of 15 mm and a deflated profile of approximately 1.0 mm. The balloon has a 5 mm inflated diameter and a length of 10 mm. The deflated profile of the 5 mm balloon is approximately 1.2 mm.

This document describes the DacryoCATH, a lacrimal duct balloon catheter, and its substantial equivalence to a predicate device based on non-clinical performance tests. It does not contain information about a study proving the device meets acceptance criteria related to AI or algorithm performance, as it is a physical medical device.

Therefore, many of the requested categories related to AI/algorithm studies cannot be filled from the provided text.

Here's a breakdown of the available information based on the provided text, and where gaps exist for the requested AI/algorithm-specific details:

Acceptance Criteria and Device Performance (as inferred from the non-clinical tests):

Instead of 'acceptance criteria' in the context of an AI-driven device, the document focuses on the safety and performance characteristics of a physical catheter. The "reported device performance" refers to the successful completion of these non-clinical tests, indicating the new design is substantially equivalent to the predicate.

Information not present for an AI/Algorithm Study:

1. Sample sizes used for the test set and data provenance (e.g., country of origin, retrospective/prospective): Not applicable for a physical device's non-clinical testing.
2. Number of experts used to establish ground truth for the test set and qualifications: Not applicable for a physical device's non-clinical testing. Ground truth in this context would implicitly be the physical standards met or not met during testing.
3. Adjudication method: Not applicable. Performance is determined by test results against established physical parameters.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable as this is a physical medical device, not an AI or imaging diagnostic tool that assists human readers.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the non-clinical tests would be the established engineering and ISO standards for biocompatibility and mechanical performance.
7. The sample size for the training set: Not applicable as this is a physical device.
8. How the ground truth for the training set was established: Not applicable.

Additional Information Available from the Document:

• Device Name: DacryoCATH
• Regulation Number: Unclassified (product code OKS)
• Regulatory Class: Class II
• Predicate Device: K113508, DacryoCATH
• Reason for 510(k) Submission (Special 510(k)): Change in patient contact materials and design.
• Material Changes:
  • Balloon Material: Changed from PET - polyethylene terephthalate to Nylon 12.
  • Hypotube: Changed from 304 stainless steel 24 gauge regular wall (OD .022" and ID .010") to 304 Stainless steel 24 gauge thin wall (OD .020" and ID .012").
  • Collar: Addition of a 304 stainless steel collar welded onto the proximal hypotube (previously none).
• Conclusion: After performing non-clinical performance studies, the data shows that the DacryoCATH (with the new design) is substantially equivalent to the predicate.

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The lacrimal duct catheter is intended for use during dilation of the obstructed nasolacrimal duct.

The lacrimal duct catheter is indicated for use during dilation of the obstructed nasolacrimal duct in the following populations:

• a. The 2mm catheter is indicated for use during dilation of the obstructed nasolacrimal duct obstruction in patients over 12 months of age and under 30 months of age.
• b. The 3 mm catheter is indicated for use during dilation of the obstructed nasolacrimal duct in children over 30 months of age.
• c. The 5mm catheter is indicated for use in adults during dilation of a lacrimal duct obstruction or blocked dacryocystorhinostomy ostium as a result of the following: functional or complete nasolacrimal duct obstruction, dacryocystitis, or failed dacryocystorhinostomy.

The lacrimal duct catheter is a sterile, single use, non-pyrogenic disposable balloon catheter consisting of a semi-flexible stainless steel hypotube core and polyethylene terephthalate balloon tubing. The balloon is designed to inflate to a known diameter and length at the specific pressure. Markings are present 10 and 15 mm proximal to the beginning of the working portion of the balloon, which helps indicate when the balloon is placed correctly in the lacrimal system. The overall length of the catheter is 6 inches (15.24 cm) long. There is an opening on the distal end of the catheter hypotube to accommodate irrigation solutions. The Y-hub on the proximal end of the catheter has a luer port for inflation of the balloon catheter (labeled "inflation" with a red band) and a second luer port for irrigation through the balloon catheter (labeled "irrigation"). The balloon catheter is available in a 2 mm and 3 mm inflated diameter. The 3 mm balloon has a length of 15 mm and a deflated profile of approximately 1.1 mm. The 2 mm balloon has a length of 15 mm and a deflated profile of approximately 1.0 mm. The balloon has a 5 mm inflated diameter and a length of 10 mm. The deflated profile of the 5 mm balloon is approximately 1.2 mm.

The provided text describes the DacryoCath Lacrimal Duct Balloon Catheter and its non-clinical performance testing for substantial equivalence to a predicate device. There is no clinical study or clinical performance data described in the provided document that would establish acceptance criteria or demonstrate the device meets such criteria in a clinical setting.

The document focuses on non-clinical performance tests to show similar technological characteristics and safety.

Here's a breakdown of the information requested, based only on the provided text:

1. A table of acceptance criteria and the reported device performance:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: The document does not specify the exact sample sizes for each individual test. It mentions "balloons of each diameter and length" for rupture testing, and "test article" for others. No specific numbers are provided for these non-clinical tests.
• Data Provenance: Not applicable for non-clinical lab tests. The tests refer to ISO and ASTM standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. These were non-clinical, laboratory-based engineering and biological safety tests. Ground truth in this context refers to the defined parameters and expected outcomes of the standardized tests, not expert interpretation of clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. Adjudication methods are typically used for clinical result interpretation, particularly when expert consensus or review is needed. These are objective engineering and biological tests with pass/fail criteria.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. This document does not describe an MRMC study or any clinical comparative effectiveness study involving human readers or AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No. This device is a physical medical device (balloon catheter) intended for manual use by a clinician, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For the non-clinical tests, the "ground truth" is defined by the specific requirements and methodologies of the international and national standards (ISO, ASTM, USP) referenced for each test. For example, for biocompatibility, the ground truth is the absence of cytotoxicity, sensitization, irritation, etc., as determined by the specified assays. For functional tests, it's meeting predefined performance specifications (e.g., burst pressure, inflation time).

8. The sample size for the training set

• Not applicable. This document describes the testing of a physical medical device. There is no mention of a "training set" as would be relevant for machine learning algorithms.

9. How the ground truth for the training set was established

• Not applicable, as there is no training set described.

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