(303 days)
The Cardio-Wrap Bioresorbable Sheet is intended for reconstruction and repair of defects of the pericardium.
MAST Biosurgery Cardio-Wrap Bioresorbable Sheet is a resorbable implant in sheet form manufactured from polylactic acid (PLA). MAST Biosurgery Cardio-Wrap Bioresorbable Sheet can be cut with scissors to the desired shape and size. The MAST Biosurgery Cardio-Wrap can be used either alone or in conjunction with soft tissue fixation devices such as resorbable sutures, which can also serve to fixate the MAST Biosurgery Cardio-Wrap and prevent dislocation. MAST Biosurgery Cardio-Wrap Bioresorbable Sheet is provided in various shapes such as rectangles, ovals, and circles and will be provided in other shapes and sizes as needed for particular surgical procedures. MAST Biosurgery Cardio-Wrap Bioresorbable Sheet is provided in sheets of 10mm x 10mm to 500mm x 500mm and will be provided in other shapes and sizes as needed for particular surgical procedures. The thickness of the MAST Biosurgery Cardio-Wrap Bioresorbable Sheet ranges from 0.02 mm to 1.0 mm according to the region to be treated. The MAST Biosurgery Cardio-Wrap is provided in solid sheets. The borders of the sheets may be aligned with holes to attach suture material.
The provided text describes a 510(k) premarket notification for the MAST Biosurgery Cardio-Wrap Bioresorbable Sheet. This type of filing aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than establishing de novo acceptance criteria through a specific clinical study with detailed performance metrics.
Therefore, many of the requested categories for acceptance criteria and study details are not applicable to this type of submission. The provided information focuses on demonstrating equivalence through design characteristics, material composition, and intended use compared to existing cleared devices, not on a standalone performance study with specific acceptance thresholds.
However, I can extract information related to the device description and the basis for its clearance:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Strength (Post-Aging) | Strong enough for the indications for use, substantially equivalent to predicate devices. |
| Safety and Efficacy (In Vivo) | Materials are safe and efficacious for the indications for use. |
| Material Composition | Fabricated from polylactic acid (PLA), free from human or animal materials. |
| Sterility | (Implied for an implantable device, not explicitly detailed as a performance metric here) |
| Bioresorbability | Bioresorbable (shared characteristic with several predicate devices). |
| Shapes and Sizes | Provided in sheets of 10mm x 10mm to 500mm x 500mm, thickness 0.02mm to 1.0mm. |
| Cuttable to Desired Shape | Can be cut with scissors. |
| Fixation Compatibility | Can be used alone or with soft tissue fixation devices (e.g., resorbable sutures). |
| Limited Adhesion Claim | Limitation: Safety and effectiveness for reducing post-operative adhesion formation not established. |
2. Sample size used for the test set and the data provenance
- Not Applicable. This submission relies on substantial equivalence to predicate devices, not a new clinical test set with a defined sample size for performance evaluation against specific criteria. The "In Vitro Testing" and "In Vivo Testing" sections mention "testing" and "studies" but do not provide specific sample sizes or data provenance relevant to a "test set" as typically understood in a performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. There is no mention of a "test set" and "ground truth" in the context of expert review for this 510(k) submission.
4. Adjudication method for the test set
- Not Applicable. As no specific "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. This device is a bioresorbable sheet, not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
- Not Applicable. The "ground truth" for this submission is effectively the established performance and safety profiles of the legally marketed predicate devices to which the Cardio-Wrap Bioresorbable Sheet claims substantial equivalence.
8. The sample size for the training set
- Not Applicable. This is a physical medical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
- Not Applicable. As above, this is not an AI/ML 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).