(164 days)
GORE® ENFORM Biomaterial is indicated for use in the reinforcement of soft tissue. This includes use in patients requiring soft tissue reinforcement in plastic and reconstructive surgery. Examples of applications where GORE® ENFORM Biomaterial may be used include hernia repair as suture line reinforcement, muscle flap reinforcement, and general tissue reconstructions.
As packaged, GORE® ENFORM Biomaterial is a porous, three-dimensional sheet comprised of a bioabsorbable PGA:TMC copolymer in a matrix (scaffold) structure that functions to reinforce soft tissue during the phases of wound healing by filling softtissue deficits. The bioabsorbable, porous scaffold structure of the ENFORM device elicits a physiological response which fills the deficit with native tissue and gradually absorbs the device. There are two configurations of the GORE® ENFORM Biomaterial. One configuration will possess an added PGA:TMC film layer on one side of the device to provide visceral protection in soft tissue reinforcement applications requiring intraperitoneal contact with the viscera. Both ENFORM configurations are available in various sizes and can be trimmed to the desired shape by the surgeon at time of use. The GORE® ENFORM Biomaterial is supplied sterile for single use only.
The provided text describes a medical device, the GORE® ENFORM Biomaterial, and its FDA 510(k) premarket notification. However, it does not include acceptance criteria, specific device performance data in a table format, or details about a study that proves the device meets specific acceptance criteria in the way typically found for an AI/ML powered device.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices for a traditional medical product (surgical mesh).
Here's an attempt to answer your questions based solely on the provided text, highlighting what is and isn't available:
Since this document describes a traditional medical device (surgical mesh), not an AI/ML powered device, most of the requested information (like sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable or not provided in this type of submission.
Therefore, the table of acceptance criteria and reported device performance from an AI/ML perspective cannot be created as the data is not present. The "performance criteria established for the indicated uses of the device" are mentioned as having been met, but the specific criteria and results are not detailed.
Here's what can be extracted based on your desired headings:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The document states: "Results demonstrated that both configurations of the GORE® ENFORM Biomaterial met the performance criteria established for the indicated uses of the device." However, the specific quantitative acceptance criteria (e.g., minimum tensile strength, maximum stiffness, specific biological response thresholds) are not detailed in this document.
- Reported Device Performance: Similarly, the specific quantitative performance results are not detailed. The document broadly states that the device "met the performance criteria" and "demonstrated substantial equivalence" to predicate devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not specified. The document mentions "Bench study" and "Animal study" but does not provide sample sizes for these studies.
- Data Provenance: Not specified. Animal studies are mentioned, but details on the species, number of animals, or study design (e.g., retrospective/prospective) are absent.
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 / Not Provided. For a surgical biomaterial, "ground truth" would typically be established through histological analysis, physical testing, and clinical observations in animal models. The experts involved in evaluating these results (e.g., pathologists, surgeons, material scientists) are not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided. This concept is more relevant to AI model evaluation where multiple human readers assess cases. For a traditional device, testing focuses on physical properties, biocompatibility, and physiological response, which are typically measured objectively or evaluated by specialists without a "reader adjudication" process.
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. Not Applicable. This device is a biomaterial, not an AI/ML product designed to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. Not Applicable. This device is a biomaterial, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the Animal Study, the "ground truth" would implicitly be derived from observed physiological responses, tissue ingrowth, and visceral protection evaluations (likely through gross observation, histology/pathology, and potentially biomechanical assessments in the animals).
- For Bench Testing, the "ground truth" would be the measured physical properties against established material specifications or predicate device performance.
8. The sample size for the training set
- Not Applicable / Not Provided. This device is not an AI/ML product developed using training data.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided. This device is not an AI/ML product.
§ 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.