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The OphtaCath® Unilateral Kits (2-mm and 3-mm) are intended for use during dilation of the obstructed nasolacrimal duct to treat epiphora. For patients older than 12 months but under 30 months, the recommended catheter is the 2 mm balloon diameter. For patients 30 months and older, the recommended catheter is the 3 mm balloon diameter.

The OphtaCath® lacrimal duct catheter is a sterile and single-use balloon catheter consisting of a semi-flexible stainless steel stylet covered by PBX tubing that ends with a nylon balloon. The balloon is covered by a protective polyethylene sleeve. The balloon is designed to be inflated to a known diameter and length at the specified pressure. Markings are placed at 10 mm and 15 mm · proximal to the working portion of the balloon. The overall length of the catheter is approximately 240 mm long. The catheter is available in a 2 mm inflated diameter. The 2 mm balloon has a length of 13 mm and a diameter of 0.90 mm before inflation. The 3 mm balloon has a length of 15 mm and a diameter of 1.0 mm before inflation. The Flamingo Inflation Device is an accessory to the OphtaCath®, and is a sterile, single-use inflation device for dilating the balloon catheter, monitoring balloon pressure, and deflating the balloon postoperatively. The OphtaCath® is sold as a unilateral kit that contains one 2 mm or 3 mm balloon catheter and an inflation device (OphtaCath® Unilateral Kits, 2-mm and 3-mm).

The provided text describes a 510(k) premarket notification for the OphtaCath® Unilateral Kit, a lacrimal balloon catheter. The submission focuses on demonstrating substantial equivalence to a predicate device (LacriCATH) through non-clinical testing. It does not contain information about studies involving human subjects or AI algorithms. Therefore, much of the requested information about acceptance criteria, device performance from clinical studies, expert-established ground truth, MRMC studies, or training/test set details cannot be extracted from this document.

Here's a breakdown of what can be inferred from the provided text, and what cannot:

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

The document mentions "established specifications for the device" for nonclinical tests, but it does not provide a table outlining these specific acceptance criteria. Instead, it offers a general statement that "All nonclinical test results met the established specifications for the device."

• Acceptance Criteria Mentioned (Implicit/General):

  • Manufacturability (manufacturing process validated)
  • Flexibility of the stylet (tested before and after sterilization)
  • Deflation time (tested before and after sterilization)
  • Compliance (tested before and after sterilization)
  • Burst strength of catheter and components (tested before and after sterilization)
  • Absence of leakages during inflation
  • Sufficient tensile strength of welds
  • Biocompatibility (tested to applicable standards)
  • Ethylene oxide sterilization effectiveness (validation studies performed)
  • Package integrity (studies performed, supports shelf-life)
  • Connectivity of kit components
  • Fluid fill volume of inflation device

• Reported Device Performance (General Statements):

  • "All nonclinical test results met the established specifications for the device."
  • "Test results demonstrate that the OphtaCath® catheter did not contain any leakages while being inflated and all welds were of sufficient tensile strength to resist breakage."
  • "The biocompatibility... met required specifications."
  • "The test results support the shelf-life and storage conditions for the device."
  • "Test results demonstrate the compatibility of the components."
  • "It can be concluded that the OphtaCath® lacrimal balloon catheter performs as intended without leakage or breakage; and that the assembled device performs as intended."

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

This document describes pre-market notification for a medical device (lacrimal balloon catheter) and focuses on non-clinical bench testing and substantial equivalence to a predicate device. It does not involve a "test set" in the context of clinical data or AI algorithms. The "samples" referred to are physical devices used for bench testing. The sample sizes for these bench tests are not specified. There is no data provenance related to patient data as it's not a clinical study or AI algorithm evaluation.

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)

This is not applicable. "Ground truth" in the context of expert consensus is relevant for diagnostic or AI-assisted devices that interpret patient data. This document describes a physical medical device (catheter) and its non-clinical performance.

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

This is not applicable for the same reasons as point 3.

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

This is not applicable. The document does not describe any MRMC studies, human readers, or AI assistance.

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

This is not applicable. The document does not describe any algorithms or AI performance studies.

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

For the non-clinical testing, the "ground truth" is defined by the technical specifications and standards (e.g., burst pressure, deflation time, tensile strength). This is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This is not applicable. There is no AI algorithm being trained.

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

This is not applicable. There is no AI algorithm being trained.

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