(54 days)
BioBlanket™ Surgical Mesh is indicated for use in general surgical procedures for reinforcement of soft tissue where weakness exists and for the repair of ruptured or damaged soft tissues. The device is supplied sterile and is intended for one time use.
BioBlanket™ is comprised of a single layer porous, cross-linked collagen patch that is supplied sterile in the form of a pad. This pad will be available in 2 different sizes, 5 cm x 5 cm and 5 cm x 10 cm, both with a 1.0 mm ± 0.25 mm thickness.
The provided text describes a 510(k) submission for the BioBlanket™ Surgical Mesh. However, it does not contain specific acceptance criteria, detailed study designs, or performance data beyond a general statement that the device passed required tests.
Therefore, I cannot populate the table or answer most of your questions based on the provided input. The document is primarily focused on seeking clearance for the device by demonstrating substantial equivalence to a predicate device, rather than presenting detailed performance study results against specific criteria.
Here's what can be inferred and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | BioBlanket™ was subjected to biocompatibility, integrity and performance tests. The device passed the requirements of all tests. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable as this document does not describe a study involving expert-established ground truth for a test set in the way one would for diagnostic or AI-driven devices. The "performance data" mentioned refers to engineering and biocompatibility tests, not clinical studies with human review.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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 MRMC study was mentioned. This device is a surgical mesh, not an AI-driven diagnostic tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the "biocompatibility, integrity and performance tests," the ground truth would likely be established by pre-defined engineering standards, material specifications, and biological response criteria, rather than expert consensus on clinical images or pathology.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that would require a training set.
9. How the ground truth for the training set was established
- Not applicable.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.