(30 days)
The OUTBACK Elite Re-Entry Catheter is intended to facilitate placement and positioning of guidewires and catheters within the peripheral vasculature. The OUTBACK Elite Re-Entry Catheter is not intended for use in the coronary or cerebral vasculature.
The OUTBACK® Elite Re-Entry Catheter is a single-use device designed to facilitate placement and positioning of guidewires within the peripheral vasculature. The device consists of three primary elements: 1) Cannula, 2) Catheter shaft, and 3) Deployment handle with deployment control slide. The OUTBACK® Elite Re-Entry Catheter is supplied sterile and is available in two useable lengths.
The provided document is a 510(k) summary for the OUTBACK Elite Re-Entry Catheter. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study for a novel device. Therefore, much of the requested information regarding acceptance criteria, study design, and ground truth establishment, which are typical for studies validating AI/software-driven medical devices, is not available in this document.
However, I can extract the information provided about device performance testing:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance results in a quantitative manner as would be expected for an AI study. Instead, it states that "Design verification and validation testing demonstrate that the catheter continues to meet all previous performance specifications and that none of the critical clinical performance parameters have changed." and "The OUTBACK® Elite Re-Entry Catheter continues to meet all previous performance specifications and none of the critical clinical performance parameters have changed."
The performance data listed are primarily related to physical, chemical, and biological properties of the catheter, not diagnostic accuracy or clinical outcomes as would be relevant for devices with AI components. The types of testing performed, and the general statement of conformity, are:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility Testing | Compliant with U.S. FDA GLP regulations (21 CFR Part 58) and ISO 10993-1:2009/Cor 1:2010. Specific tests performed: In vitro Cytotoxicity MEM Elution, In vitro Hemolysis (ASTM Extract & Direct Contact), USP Containers - Plastics, Physicochemical Tests. |
| Device Dimensional and Functional Testing | All previous performance specifications met. Specific tests performed: Device Joint Tensile Strength, Catheter Torqueability, Device Joint Torque to Failure. |
| Packaging and Sterilization Testing | All previous performance specifications met. Specific tests performed: Sterilization Validation, Sterilization Loading Configuration Evaluation, Bioburden, EO residuals, Bacterial Endotoxin, NPRT, D-Value, Blue Dye Penetration, Peel Strength. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document as the study described is a device verification and validation study, not a clinical study involving a test set of patient data.
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 information is not applicable/provided as the study did not involve establishing ground truth from expert interpretation of a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable/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
This information is not applicable/provided. The device is a physical catheter, not an AI or software-driven diagnostic tool that would typically undergo an MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. This device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable/provided. For the physical and performance tests, the "ground truth" would be established by validated test methods and specifications, not by expert consensus or pathology on patient data.
8. The sample size for the training set
This information is not applicable/provided. This is a physical device, not an AI model, and therefore does not have a training set in the AI sense.
9. How the ground truth for the training set was established
This information is not applicable/provided.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).