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K Number
K991238
Device Name
FCI CRAWFORD PROBE INTUBATION SETS
Manufacturer
FCI OPHTHALMICS, INC.
Date Cleared
1999-07-08

(87 days)

Product Code
OKS
Regulation Number
N/A
Type
Traditional
Panel
OP
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Epiphora in infants or adults, particularly in cases of canalicular pathologies (stenosis, obstruction or laceration) dacryocysorhinostomy (conventional or laser) imperforation of the nasolacrimal duct in an infant

Device Description

Not Found

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and study information:

Based on the provided FDA 510(k) letter (K991238) for the "FCI Crawford Probe Intubation Sets," it is not possible to extract information about acceptance criteria or a study proving device performance in the way typically expected for an AI/software device.

This document is a substantially equivalent (SE) letter for a physical medical device (FCI Crawford Probe Intubation Sets), not a software or AI device. The FDA's 510(k) pathway for physical devices primarily focuses on demonstrating substantial equivalence to a predicate device already on the market, rather than requiring extensive clinical trials or performance studies with specific statistical acceptance criteria as would be expected for a novel AI/software product.

Therefore, most of the requested information (like sensitivity, specificity, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, etc.) is not present and not applicable to this type of regulatory submission.

However, I can extract the following limited information:

1. Table of Acceptance Criteria and Reported Device Performance:

  • Acceptance Criteria: The document does not specify quantitative acceptance criteria for performance. The "acceptance" here is the FDA's determination of "substantial equivalence" to a predicate device.
  • Reported Device Performance: The document does not report specific performance metrics (e.g., success rates, complication rates, sensitivity, specificity). The justification for market clearance is that the device is substantially equivalent to a previously approved device.

2. Sample sized used for the test set and the data provenance:

  • Not applicable / Not provided. This 510(k) determination is based on a comparison to a predicate, not a clinical study with a defined test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

  • Not applicable / Not provided. Ground truth establishment, as typically understood for performance studies, is not part of this 510(k) submission type.

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

  • Not applicable / Not provided.

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:

  • Not applicable / Not provided. This is a physical device, not an AI-assisted diagnostic tool.

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

  • Not applicable / Not provided.

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

  • Not applicable / Not provided. The "ground truth" for a 510(k) submission of a physical device is its functional similarity and intended use matching that of a predicate device.

8. The sample size for the training set:

  • Not applicable / Not provided.

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

  • Not applicable / Not provided.

Summary of Document Context:

The provided document is an FDA 510(k) clearance letter for a physical medical device called "FCI Crawford Probe Intubation Sets." The core of a 510(k) submission for such a device is to demonstrate substantial equivalence to a predicate device that is already legally marketed. This process typically involves comparisons of design, materials, manufacturing processes, intended use, and sometimes non-clinical testing (e.g., biocompatibility, sterility) to show that the new device is as safe and effective as the predicate. It does not generally involve extensive clinical performance studies with acceptance criteria, ground truth establishment, or human-AI interaction studies as would be seen for a software as a medical device (SaMD) or AI-powered diagnostic tool.

N/A