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MacroPore Cardio-Wrap (TS) is a resorbable implant in sheet form manufactured from poly lactic acid (PLA). MacroPore Cardio-Wrap (TS) can be cut with scissors to the desired shape and size. The MacroPore Power Pen can also be used to cut or shape the MacroPore Cardio-Wrap (TS) to the desired shape or size. MacroPore Cardio-Wrap (TS) Sheet is fully malleable when heated to approximately 55℃ (for example, by the use of sterile hot water), and thus can be conformed three dimensionally to most any anatomical orientation. The MacroPore Cardio-Wrap (TS) can be used either alone or in conjunction with soft tissue fixation devices such as resorbable sutures, which can also serve to fixate the MacroPore Cardio-Wrap (TS) and prevent dislocation. The MacroPore Cardio-Wrap (TS) may be used in conjunction with various MacroPore manual instruments. MacroPore Cardio-Wrap (TS) 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. MacroPore Cardio-Wrap (TS) is provided in sheets of 10mm to 500mm x 500mm and will be provided in other shapes and sizes as needed for particular surgical procedures. The thickness of the MacroPore Cardio-Wrap (TS) ranges from 0.05 mm to 1.0 mm according to the region to be treated. The MacroPore Cardio-Wrap (TS) is provided in solid sheets. The borders of the sheets may be aligned with holes to attach suture material.

AI/ML Overview

The provided text describes the MacroPore Cardio-Wrap (TS) device for 510(k) clearance, focusing on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a clinical study. Therefore, many of the requested elements for a study proving device meeting acceptance criteria (like sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) are not included in this type of submission.

However, I can extract the information provided regarding the testing and the basis for its equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Aspect	Reported Device Performance (Proxy for Acceptance)
Material Composition	Fabricated from polylactic acid (PLA) – Met (consistent with description)
Inherent Viscosity (after heating)	Viscosity stayed within an appropriate range over 120 minutes when heated to 60°C in saline. – Met
Aging (Strength)	Demonstrated to be strong enough for the indications for use. – Met
Mechanical Strength (Tensile & Suture Pull-out)	Substantially equivalent to the mechanical strengths of the predicate devices under indication for use conditions. – Met
Safety and Efficacy (In Vivo)	Animal studies demonstrated that the materials are safe and efficacious for the indications for use. – Met
Indications for Use (Equivalence)	Shares identical indications for use principles with predicate devices for the same surgical procedures. – Met
Physical Design (Equivalence)	Substantially equivalent to predicate devices (thin semi-rigid sheets, contourable when heated). – Met
Thickness (Equivalence)	Thinnest MacroPore Cardio-Wrap (TS) thickness (0.5mm) is virtually identical to predicate (1.0mm). – Met
Dimensions (Equivalence)	Comparable to predicate devices (rectangular sheets, several centimeters in size). – Met

2. Sample size used for the test set and the data provenance:

Test Set Sample Size:
- In Vitro Testing: Not specified for each specific test (e.g., how many viscosity samples, how many mechanical tests).
- Animal Study: Not specified how many animals were used.
Data Provenance: Not explicitly stated (e.g., country of origin), but implied to be conducted by the manufacturer for the 510(k) submission. These would be considered prospective tests conducted specifically for this regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable as this is a device for surgical repair, and the "ground truth" is based on physical and biological performance rather than expert interpretation of data. The ground truth for equivalence is established by direct comparison of physical and mechanical properties and biological response in animal models.

4. Adjudication method for the test set:

Not applicable for the types of in-vitro and in-vivo (animal) studies described, as these are objective measurements and observations rather than expert adjudication of clinical outcomes.

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 surgical implant, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a surgical implant; there is no "algorithm" in the sense of a software-driven process.

7. The type of ground truth used:

In Vitro Testing: Objective physical and chemical measurements (e.g., viscosity, mechanical strength, material composition).
In Vivo Testing (Animal Study): Safety and efficacy observations in an animal model, likely assessed by veterinarians/researchers.
Equivalence: Direct comparison to known properties and indications of established predicate devices.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI-driven device requiring a training set. The "training" here would be the scientific and engineering principles used to design and manufacture the device.

9. How the ground truth for the training set was established:

Not applicable for the reason stated in point 8.

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