Search Results

The MacroPore Surgi-Wrap MAST Bioresorbable Sheet is to be used wherever temporary wound support is required, to reinforce soft tissues where weakness exists, or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. The resorbable protective film minimizes tissue attachment to the device in case of direct contact with the viscera.

MacroPore Surgi-Wrap MAST Bioresorbable Sheet is a resorbable implant in sheet form manufactured from poly lactic acid (PLA). MacroPore Surgi-Wrap MAST Bioresorbable Sheet 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 Surgi-Wrap MAST Bioresorbable Sheet to the desired shape or size. MacroPore Surgi-Wrap MAST Bioresorbable Sheet is fully malleable when heated to approximately 55°C (for example, by the use of sterile hot water), and thus can be conformed three dimensionally to most any anatomical orientation. The MacroPore Surgi-Wrap MAST Bioresorbable Sheet 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 Surgi-Wrap MAST Bioresorbable Sheet and prevent dislocation. The MacroPore Surgi-Wrap MAST Bioresorbable Sheet may be used in conjunction with various MacroPore manual instruments.

MacroPore Surgi-Wrap MAST 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. MacroPore Surgi-Wrap MAST Bioresorbable Sheet is provided in sheets of 25mm x 25mm to 500mm and will be provided in other shapes and sizes as needed for particular surgical procedures. The thickness of the MacroPore Surgi-Wrap MAST Bioresorbable Sheet ranges from 0.02 mm to 1.0 mm according to the region to be treated. The MacroPore Surgi-Wrap MAST Bioresorbable Sheet is provided in solid sheets. The borders of the sheets may be aligned with holes to attach suture material.

The MacroPore Surgi-Wrap MAST Bioresorbable Sheet is a surgical mesh made from polylactic acid (PLA) intended for temporary wound support, soft tissue reinforcement, and repair of hernias or fascial defects.

Here's an analysis of its acceptance criteria and the study that proves it meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document describes several tests:

• In Vitro Testing (Inherent Viscosity): No specific sample size is provided, but it states "testing was performed." The data provenance is not specified, but it's an in-house lab test ("in vitro").
• In Vitro Testing (Strength): No specific sample size is provided, but it states "testing demonstrates." Data provenance is not specified.
• In Vitro Testing (Mechanical Strength): No specific sample size is provided, but it states "mechanical testing was performed." Data provenance is not specified.
• In Vivo Testing (Animal Studies): No specific species or number of animals are provided, only "Animal studies were conducted." Data provenance is typically internal to the manufacturer or a contract research organization. These are prospective studies on animals.
• Equivalence to Marketed Product: This is a comparison to previously cleared devices (K012025, K002699) and relies on their established performance, not a new test set of patients for the MacroPore Surgi-Wrap MAST Bioresorbable Sheet.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

The document does not mention the use of human experts to establish ground truth for a test set in the context of the device's performance. The "ground truth" for material properties and animal studies would be established by the results of the scientific tests and observations themselves, as interpreted by the researchers/scientists conducting those studies.

4. Adjudication Method for the Test Set:

No adjudication method is described for any test set, as this is not a study involving human interpretation of data where consensus or adjudication would be required.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size:

No MRMC comparative effectiveness study was conducted or described. This type of study is typically done for diagnostic imaging devices where human interpretation is a key factor. This device is a surgical implant.

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

Not applicable. This device is a physical surgical mesh, not a software algorithm.

7. The Type of Ground Truth Used:

The ground truth used for proving the device meets acceptance criteria is primarily based on:

• Empirical Measurement/Laboratory Data: For inherent viscosity, strength, and mechanical properties.
• Biological Observation/Pathology: For the animal studies assessing safety and efficacy in vivo.
• Established Performance of Predicate Devices: For demonstrating substantial equivalence, relying on the known performance and clearance of the MacroPore Surgi-Wrap (TS) and Sofradim Parietex Composite Mesh.

8. The Sample Size for the Training Set:

Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no training set mentioned for this type of device.

Ask a specific question about this device