(62 days)
CELOX Vascular is indicated for the local management and control of surface bleeding from vascular access sites, perculaneous catheters or tubes utilizing introducer sheaths up to 16French
CELOX Vascular is a kit that consists of a hemostatic pad and an optional adhesive bandage. The adhesive bandage is a 3M Tegaderm 4" x 4-3/4" bandage (reference K973036), or equivalent self adhesive security bandage. The hemostatic pad is a CELOX Hemostatic Granules on Sheet cleared in K080079 on July 9, 2008.
The provided document describes the CELOX Vascular device and its substantial equivalence determination. Here's a breakdown of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" in a quantitative manner (e.g., minimum sensitivity, specificity, or specific hemostasis rates to be achieved in a clinical trial). Instead, it describes demonstrating hemostasis and performance as effectively as a predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Achieve hemostasis | Demonstrated hemostasis following the removal of percutaneous vascular access catheters in a pre-clinical porcine model. |
| Control bleeding | Successfully controlled all bleeding following 11 vascular access procedures when up to a 16French tissue dilator was used. |
| Equivalence to predicate device | CELOX Vascular dressing controlled bleeding as effectively as the D-Stat Dry (a predicate device). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 11 vascular access procedures.
- Data Provenance: Pre-clinical porcine model testing. (The country of origin for the testing is not specified, but the company is based in the UK.)
- Retrospective/Prospective: The nature of "pre-clinical porcine model testing" typically implies a prospective design for the animal study itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The document refers to the results of a "pre-clinical porcine model testing" and the observation of "demonstrated hemostasis" and "successfully controlling all bleeding." The methods for assessing hemostasis and whether experts were involved in defining "ground truth" for the success of these procedures are not detailed.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The study described is a pre-clinical animal (porcine) model assessing the device's ability to achieve hemostasis, not a study involving human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This question is not applicable as the CELOX Vascular is a physical medical device (hemostatic pad and adhesive bandage), not an AI algorithm or software. No standalone algorithm performance was assessed.
7. The Type of Ground Truth Used
The ground truth for the device's performance (i.e., hemostasis) was established through direct observation and measurement of bleeding control in a pre-clinical porcine model. This can be considered outcomes data in an animal model context – the direct outcome being the cessation of bleeding.
8. The Sample Size for the Training Set
This question is not applicable. The CELOX Vascular is a physical medical device, not a machine learning model. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no training set for a physical device.
N/A