(91 days)
The AlboSure Polyester Vascular Patch is indicated for cardiac and vascular patch grafting. The fabric is recommended for use in patients requiring systemic heparinization prior to, or during, surgery.
AlboSure Polyester Vascular Patch is a knitted polyester fabric, impregnated with bovine collagen and contains glycerol as softening agent.
The provided text describes a 510(k) premarket notification for the AlboSure™ Polyester Vascular Patch, which is a cardiovascular patch. The document focuses on demonstrating substantial equivalence to a predicate device, rather than elaborating on a study that proves the device meets specific acceptance criteria based on performance metrics like sensitivity, specificity, or accuracy—which would be typical for AI/ML-driven medical devices.
Therefore, the following information is not applicable or extractable from the provided text for this medical device, as it is a physical patch and not a software/AI device:
- Acceptance criteria and reported device performance (in the context of AI/ML metrics): The document lists "Summary of Product Testing" with tests like Tensile Strength, Burst Strength, Wall Thickness, Suture Retention Strength, and Water Permeability. However, it does not provide specific acceptance criteria (i.e., numerical thresholds) or reported performance values for these tests. The conclusion only states "LeMaitre Vascular has demonstrated that the AlboSure Polyester Vascular Patch is substantially equivalent to the predicate device based on its indications for use and fundamental scientific technology," implying these physical tests were satisfactory for equivalence.
- Sample size used for the test set and the data provenance: Not applicable as there isn't a "test set" in the context of an AI/ML study. The product testing mentioned would involve material samples.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable in the AI/ML sense. The "ground truth" for a physical device would be its objective physical and biological properties.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document primarily focuses on regulatory approval through substantial equivalence, which is a comparison to a legally marketed predicate device rather than an independent performance study against defined acceptance criteria (as would be typical for AI/ML submissions).
In summary, based on the provided text, the questions about acceptance criteria and study details (especially those pertaining to AI/ML device evaluation) cannot be answered because the device is a physical cardiovascular patch, and the submission is for substantial equivalence, not an AI/ML algorithm performance study.
§ 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
(a)
Identification. An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.(b)
Classification. Class II (performance standards).