Search Results
Found 2 results
510(k) Data Aggregation
(303 days)
CARDIO-WRAP
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.
Ask a specific question about this device
(86 days)
MACROPORE CARDIO-WRAP (TS)
The MacroPore Cardio-Wrap (TS) is indicated for use as a pericardium replacement device in patients that may require re-operation within six months.
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.
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.
Ask a specific question about this device
Page 1 of 1