(70 days)
Tissue repair patch, for the surgical repair of soft tissue deficiencies which include: defects of the abdominal and thoracic wall, gastric banding , rectal and vaginal prolapse, urethral sling, reconstruction of the pelvic floor, and hernias, or defects of the diaphragm, femoral, incisional, inguinal, lumbar, and umbilical hernia.
The Shelhigh No-React® Tissue repair patch/ UroPatch™ is made of glutaraldehyde fixed boyine pericardium. rinsed with the detoxification process No-React®. It is stored in 2% Benzyl alcohol like the Shelhigh No-React® pericardial patch. The material exhibits good tensile strength, shrink temperature, excellent biocompatibility and suture retention. It is soft and pliable making it convenient to implant. Bovine pericardial material has been used successfully as a tissue patch for pericardial closure. Glutaraldehyde processed bovine pericardium has a long history of success as a permanently implanted material.
The provided text describes a medical device, the Shelhigh No-React® UROPATCH™, and its substantial equivalence to predicate devices. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving the device meets those criteria.
Here's a breakdown of what can be inferred and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The submission highlights three key physical/mechanical properties used for comparison with the predicate device. These can be considered the de facto acceptance criteria addressed by the non-clinical testing.
| Acceptance Criterion (Implicit) | Reported Device Performance (vs. Predicate) |
|---|---|
| Suture Retention | Substantially equivalent |
| Tensile Strength | Substantially equivalent |
| Shrink Temperature | Substantially equivalent |
| Flexibility | Identical |
| Wall Thickness | Identical |
| Biocompatibility (cytocompatibility) | Higher level (vs. conventional glutaraldehyde treated and storage) |
Missing Information:
- Specific quantitative thresholds for "substantially equivalent" or "higher level" for most criteria. The document states they are "substantially equivalent physical/mechanical properties as measured by suture retention, tensile strength, and shrink temperature" and the UroPatch™ has a "higher level of cytocompatibility when compared with the conventional glutaraldehyde treated and storage."
2. Sample Size Used for the Test Set and Data Provenance
The document mentions an "animal study" to evaluate biocompatibility.
- Sample Size: Not specified.
- Data Provenance: Animal study. No country of origin is mentioned. Whether it was retrospective or prospective is not explicitly stated, but animal studies are typically prospective.
Missing Information:
- Specific number of animals used in the study.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided as the submission describes non-clinical/animal testing, not a study involving human experts establishing ground truth for diagnostic or interpretative tasks.
4. Adjudication Method for the Test Set
This information is not applicable as the described study is an animal study evaluating physical and biological properties of a patch, not a diagnostic device requiring adjudication of human readings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
This information is not provided and is not applicable to this type of device (a tissue repair patch). MRMC studies are typically for diagnostic imaging devices or AI tools that assist human interpretation.
6. If a Standalone (algorithm only without human-in-the-loop performance) was Done
This information is not provided and is not applicable to this type of device. The device is a physical tissue repair patch, not software or an algorithm.
7. The Type of Ground Truth Used
For the animal study:
- Ground Truth: "Higher level of biocompatibility" compared to a control group ("conventional glutaraldehyde treated patch"). This would likely involve histological assessment, cellular response markers, or other in-vivo biological endpoints. Specifics are not provided.
8. The Sample Size for the Training Set
This information is not applicable as the device is not a machine learning model or an algorithm that requires a training set. The "testing" involved non-clinical and animal studies to demonstrate physical properties and biocompatibility.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reasons as point 8.
In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence through comparison of physical/mechanical properties and an animal study for biocompatibility. It does not contain the detailed information typically found in submissions for AI/ML-driven diagnostic devices, which would include extensive data on human expert review, training sets, and specific performance metrics against clinical ground truth.
§ 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.