(84 days)
The HEMASHIELD FINESSE™ Ultra-Thin, Knitted Cardiovascular Patch is indicated for cardiac and vascular patch grafting. The fabric is also recommended for use in patients requiring systemic heparinization prior to, or during, surgery.
The HEMASHIELD FINESSE™ Ultra-Thin, Knitted Cardiovascular Patch is a knitted polyester fabric, impregnated with bovine collagen and contains glycerol as a softening agent.
Here's an analysis of the provided text based on your request:
In this 510(k) summary, the device being described is a medical patch, not an AI/ML powered device, therefore many of the requested categories related to AI/ML studies are not applicable.
Acceptance Criteria and Study to Prove Device Meets Criteria
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What the device should do) | Reported Device Performance (What the device actually does) |
|---|---|
| Burst Strength - equivalent to marketed product | Equivalent to marketed product (Predicate: HEMASHIELD® Cardiovascular Fabrics) |
| Wall Thickness - equivalent to marketed product | Equivalent to marketed product (Predicate: HEMASHIELD® Cardiovascular Fabrics) |
| Suture Retention Strength - equivalent to marketed product | Equivalent to marketed product (Predicate: HEMASHIELD® Cardiovascular Fabrics) |
| Tensile Strength - equivalent to marketed product | Equivalent to marketed product (Predicate: HEMASHIELD® Cardiovascular Fabrics) |
| Water Permeability - equivalent to marketed product | Equivalent to marketed product (Predicate: HEMASHIELD® Cardiovascular Fabrics) |
| Suture Hole Elongation - equivalent to marketed product | Equivalent to marketed product (Predicate: HEMASHIELD® Cardiovascular Fabrics) |
| Biocompatibility - identical to predicate | Assumed identical due to identical materials, processing, packaging, and sterilization as predicate (HEMASHIELD® Cardiovascular Fabrics), which was shown safe by ISO 9000 testing. |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify the exact sample sizes used for each individual test (Burst Strength, Wall Thickness, etc.). It generally states that "Testing has been performed."
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). Given the nature of material testing for a medical device (polyester fabric), the data would likely be from laboratory testing of manufactured samples, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable, as the tests are for physical material properties of a medical device (patch) and do not involve human interpretation or subjective assessment that would require expert "ground truth." The "ground truth" here is the direct measurement of physical properties.
4. Adjudication method for the test set
- Not applicable for the type of physical material testing described. Adjudication methods are typically used in clinical studies or AI algorithm evaluations where human interpretation or consensus is required.
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
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic or interpretive AI devices, not for a cardiovascular patch.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done. This device is a physical medical implant, not an AI algorithm.
7. The type of ground truth used
- The "ground truth" for the material tests (Burst Strength, Wall Thickness, etc.) is direct measurement of physical properties. For biocompatibility, the ground truth is the demonstrated safety and biocompatibility of the predicate device based on ISO 9000 standards.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML model, so there is no concept of a "training set" in the context of its development and validation.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for this device.
§ 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).