MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE

• K Number: K061404
• Device Name: MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE
• Manufacturer: FCI OPHTHALMICS, INC.
• Date Cleared: 2006-08-07 ( 80 days)
• Product Code: OKS
• Regulation Number: N/A
• Type: Traditional
• Panel: OP
• Reference & Predicate Devices: N/A

Intended Use

Indicated in initial surgery in the treatment of monocanalicular lacerations and stenoses requiring intubation. Further indications are: Congenital lacrimal duct obstructions Canalicular lacerations After treatment of canaliculitis with concretions when curettage of a canaliculus has been performed. After clacryocystorhinostomy Epiphora

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a medical device called the "Mono-Crawford Naso-lacrimal Intubation Device." This type of document primarily focuses on establishing substantial equivalence to a predicate device based on indications for use and technological characteristics.

It is crucial to understand that 510(k) submissions typically do not involve the kind of rigorous performance studies or acceptance criteria that are described in the prompt's questions for AI/diagnostic devices. The clearance is based on the device being as safe and effective as a legally marketed predicate, not necessarily on a new, comprehensive study demonstrating meeting specific performance metrics with statistical rigor.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth are not present in this document because they are not typically part of a 510(k) premarket notification for a physical medical intubation device.

However, I can extract the information that is available:

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Acceptance Criteria and Study for Mono-Crawford Naso-lacrimal Intubation Device

Based on the provided 510(k) clearance letter (K061404), the "acceptance criteria" for a device applying for 510(k) clearance is primarily that it demonstrates substantial equivalence to a predicate device in terms of intended use, technological characteristics, and safety/effectiveness. This typically does not involve the quantitative performance metrics and statistical studies common for AI/diagnostic tools.

Here's a breakdown of the requested information, acknowledging the limitations of a 510(k) document for this type of device:

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criterion (for 510(k) equivalence)	Reported Device Performance (as implied by clearance)
   Substantial Equivalence to Predicate Device	Achieved (FDA issued substantial equivalence letter)
   Same Intended Use as Predicate	Yes (Indications for Use are similar to common intubation devices)
   Similar Technological Characteristics as Predicate	Implied (not detailed in this letter, but reviewed in 510(k) submission)
   Safety and Effectiveness at least equivalent to Predicate	Implied (FDA found device to be safe and effective)
   Biocompatibility	Implied (not detailed in this letter, but reviewed in 510(k) submission for sterility and materials)
   Sterility	Implied (not detailed in this letter, but reviewed in 510(k) submission)

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

   • Not Applicable. This document pertains to a physical medical intubation device, not a diagnostic or AI device that would utilize a "test set" in the context of performance evaluation with data. The 510(k) process involves a comparison to a predicate device, often through engineering analysis, material testing, and sometimes small clinical data if there are new safety/effectiveness questions that cannot be addressed by comparison alone. This letter does not mention any specific clinical study data in this regard.

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

   • Not Applicable. See point 2. The "ground truth" here is regulatory compliance and demonstrating equivalence to a predicate device, which is evaluated by FDA reviewers.

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

   • Not Applicable. See point 2.

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. This is a physical intubation device, not an AI or diagnostic tool.

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

   • Not Applicable. This is a physical intubation device, not an algorithm.

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

   • The "ground truth" for 510(k) clearance is that the device is substantially equivalent to a legally marketed predicate device in terms of safety and effectiveness for its stated indications for use. This "ground truth" is established through the FDA's regulatory review process, primarily based on documentation provided by the manufacturer (engineering drawings, materials specifications, comparisons to the predicate, sometimes non-clinical testing results, and very occasionally, limited clinical data if specific new questions arise).

8. The sample size for the training set:

   • Not Applicable. This is not an AI/machine learning device.

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

   • Not Applicable. This is not an AI/machine learning device.

Regulation Number and Section

N/A