(115 days)
The Crawford Bicanaliculus Intubation stents are intended for use for nasolacrimal intubation in patients 12 months of age and older. Indications for nasolacrimal intubation performed with the Crawford Bicanaliculus Intubation are:
- . Canalicular pathologies (e.g., congenital or acquired stenosis, lacerations)
- During dacryocystorhinostomy .
- Congenital lacrimal duct obstruction .
The Crawford Bicanaliculus Intubation is a bicanalicular intubation device that consists of a silicone tube that is attached at each end to a flexible metallic Crawford probe. The Crawford Bicanaliculus Intubation comes in a single length of 310 mm and is provided as a sterilized product.
The provided text describes a 510(k) Summary for the Crawford Bicanaliculus Intubation device. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study or AI-related metrics.
Therefore, many of the requested categories (e.g., acceptance criteria, reported performance, sample size for test set, ground truth methods, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of regulatory submission.
Here's a breakdown based on the information available:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Equivalence: Silicone tube and flexible metallic Crawford probes are identical or very similar in grade/construction to predicate devices. | The Crawford Bicanaliculus Intubation manufactured by FCI SAS and the Crawford Probe Intubation Set (primary predicate) have "slightly different grades of silicone tube and stainless steel," but the "Mono-Crawford Naso-Lacrimal Intubation Device is constructed of an identical silicone and stainless steel grade." All three have "identical medical grade silicone tube" or "very similar grade of silicone" for the stent body. |
| Intended Use Equivalence: Same indications for use as predicate devices. | Intended use for nasolacrimal intubation in patients 12 months and older for canalicular pathologies, during dacryocystorhinostomy, and congenital lacrimal duct obstruction is identical to predicate devices (implied by substantial equivalence claim). |
| Basic Design Concept Equivalence: Similar form and function. | Described as a bicanalicular intubation device consisting of a silicone tube attached to flexible metallic Crawford probes, which is consistent with the general description of the predicate devices. |
| Dimensions Equivalence: Similar size. | Comes in a single length of 310 mm, which is implied to be similar to predicate devices to maintain substantial equivalence. |
| Sterilization Methods Equivalence: Same sterilization method. | All three devices are ethylene oxide sterilized. |
| Biocompatibility Equivalence: Biocompatible materials. | Biocompatibility of silicone raw materials and finished device was tested to applicable standards and met required specifications, aligning with predicate device claims. |
| Nonclinical Test Performance: Met established specifications for material properties. | Tensile strength tests performed before and after sterilization met established specifications. Technology transfer was validated. |
| Shelf-life and Storage Validation: Supported by studies. | Ethylene oxide sterilization validation studies and package integrity studies were performed according to applicable standards, supporting shelf-life and storage conditions. |
2. Sample size used for the test set and the data provenance:
- Not applicable/Not provided. This submission relies on "substantial equivalence" to legally marketed predicate devices, not on a clinical test set with human subjects or data provenance in the way an AI/diagnostic device would. The "tests" mentioned are non-clinical (tensile strength, biocompatibility, sterilization validation).
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/Not provided. No clinical test set with ground truth established by experts is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. No clinical test set requiring adjudication is described.
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 medical device (stent/probe), not an AI diagnostic tool. No MRMC studies were conducted or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not provided. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical tests, the "ground truth" was established by engineering specifications and applicable standards for material properties (tensile strength, biocompatibility) and process validation (sterilization, package integrity). There is no "expert consensus," "pathology," or "outcomes data" in the clinical sense for these tests. The ultimate "ground truth" for regulatory approval is the demonstration of substantial equivalence to already approved predicate devices.
8. The sample size for the training set:
- Not applicable/Not provided. This is a physical medical device. The concept of a "training set" is not relevant here.
9. How the ground truth for the training set was established:
- Not applicable/Not provided. As above, no training set or corresponding ground truth is relevant for this device.
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