(40 days)
The Glycar Inc., Tissue Repair Patch family of products have the same intended uses as the predicate device, the Bio-Vascular Inc., Peri-Guard™ family of products, which are all tissue patches made from the same glutaraldehyde-treated bovine pericardium.
Already approved intended uses for the Glycar Tissue Repair Patch family of glutaraldehyde-tanned bovine pericardial tissue patches:
The Glycar Tissue Repair Patch (K942911) was deemed substantially equivalent to the Peri-Guard™ bovine pericardial tissue patch and received approval for U.S. marketing for the intended use of hernia and other intraabdominal soft tissue defect or deficiency repair in December, 1994.
An addition to the Glycar Tissue Repair Patch family of products, the Glycar Staple Strip (K954665) was deemed substantially equivalent to the Peri-Strips™ bovine pericardial surgical staple bolsters and received approval for U.S. marketing for the intended uses of surgical stapling of lung tissue, gastric staplings, rectal and vaginal prolapse, urethral sling, reconstruction of the pelvic floor, and hernias or defects of the diaphragm, thoracic and abdominal wall in October, 1995.
The Glycar Staple Strip uses the identical material as the Glycar Tissue Repair Patch with the addition of a synthetic suture material to assist placement of the device on the surgical stapling arm.
The Glycar Tissue Repair Patches are made of the same material as the predicate device, the Peri-Guard™ tissue patches, which are made from glutaraldehyde-treated bovine pericardium.
Glutaraldehyde-treated bovine pericardium is a strong, pliable, biocompatible material which is easy to handle surgically.
Glycar's glutaraldehyde-treated pericardium possesses tissue strength equaling that of the predicate device. It provides for a durable repair, replacement or reinforcement of natural soft tissue.
The manufacturing process for the Glycar Tissue Repair Patches involves the harvesting of bovine pericardium, fixation of the pericardium in glutaraldehyde, inspection and cleaning of the pericardium, selection of the pericardium for use in strip production, additional tanning of the bovine pericardium, and then cutting of the glutaraldehyde-treated bovine pericardium for the designated strip size, followed by sterilization in formaldehyde, followed then by treatment with Glycar's proprietary anti-inflammation treatment, XX.
Sterility is maintained by using aseptic fill under Clean Room 100 conditions, during transfer to antiinflammation treatment and to the final storage medium, 2% propylene oxide in water.
Sizes and shapes will be specific for product line reflecting different indications as appropriate for the use.
The provided text is a 510(k) summary for a medical device (Glycar Tissue Repair Patch) and does not describe a study involving acceptance criteria and device performance in the context of diagnostic accuracy, which is typically what the requested table and study details apply to.
Instead, this document focuses on demonstrating substantial equivalence to a predicate device (Peri-Guard™ product line, including Supple Peri-Guard™). The "acceptance criteria" here are essentially the demonstration that the Glycar Tissue Repair Patches are sufficiently similar to the predicate device in terms of material, intended use, sterilization, and other performance features. The "study" proving this is a comparison to the predicate device, not a diagnostic performance study.
Therefore, many of the requested fields are not applicable because the input describes a regulatory submission for a tissue repair patch, not a diagnostic AI device requiring a clinical performance study with human readers and ground truth.
However, I can extract the relevant information regarding the comparison made to establish substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (based on predicate device) | Reported Device Performance (Glycar Tissue Repair Patch) |
|---|---|---|
| Material Composition | Manufactured from glutaraldehyde-treated bovine pericardium | Manufactured from glutaraldehyde-treated bovine pericardium (same as predicate) |
| Intended Uses | Same intended uses as predicate device (e.g., hernia repair, soft tissue repair, reinforcement, reconstruction) | Same intended uses as predicate device, including previously approved uses for hernia repair and surgical staple bolsters. |
| Sterilization Assurance Level (SAL) | Sterilized to a minimum assurance against contamination of 10^-6 organisms | Sterilized to an SAL of 10^-6 organisms |
| Tissue Strength | Equates to predicate device's tissue strength, providing durable repair, replacement or reinforcement of natural soft tissue. | Possesses tissue strength equaling that of the predicate device. Provides for a durable repair, replacement or reinforcement of natural soft tissue. |
| Pyrogenicity | Negative pyrogenicity (as indicated for predicate, implied for substantial equivalence) | Found to have negative pyrogenicity. |
| Sterilization Method | Chemical sterilization method (formaldehyde and propylene oxide) | Chemical sterilization method (formaldehyde and propylene oxide) |
| Bovine Spongiform Encephalopathy (BSE) Status | Raw material from BSE-free certified cattle | Pericardium from Govenment approved abbatoirs in Transvaal, S. Africa; cattle certified free from BSE. |
| Manufacturing Process | (Implied to not adversely affect safety/efficacy compared to predicate, despite one proprietary difference) | Demonstrated no adverse effects on safety or efficacy from the proprietary manufacturing material XX. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable in the context of a diagnostic device performance study. The "test set" here refers to the Glycar device being compared against the predicate. The "data provenance" refers to the manufacturing process, material sourcing, and test results for the Glycar device itself to demonstrate its properties.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. Ground truth, in this context, would essentially be the validated performance and safety profile of the predicate device, against which the new device is compared. This is not established by a panel of experts for a specific diagnostic task.
4. Adjudication Method for the Test Set
Not applicable. This is not a study requiring adjudication of diagnostic findings.
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 is a comparison of a tissue repair patch to a predicate device, not a diagnostic AI system with human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this substantial equivalence claim is the established safety and effectiveness profile of the predicate device (Peri-Guard™ product line), as approved by the FDA (K923657). The Glycar device demonstrates that it meets essentially identical specifications and performance characteristics, thus proving it is "as safe and effective" as the predicate.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning model requiring 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.