(280 days)
Tisgenx's Bovine Pericardial Tissue Patch is intended for use as a surgical patch for cardiac and vascular reconstruction and repair, soft tissue deficiency repair, and reinforcing the suture line during general surgical procedures.
The Tisqenx Bovine Pericardial Tissue Patch is a bovine pericardium that is chemically crosslinked using a glutaraldehyde solution to impart stability. The device is provided terminally sterile, packaged in a sterile barrier jar filed with a liquid chemical sterilant. The device is intended for single patient use as a surgical patch for cardiac and vascular reconstruction and repair, soft tissue deficiency reconstruction and repair, and reinforcing the suture line during general surgical procedures.
The provided text describes a 510(k) premarket notification for a medical device called the "Bovine Pericardial Tissue Patch." It primarily focuses on demonstrating substantial equivalence to a predicate device, not on proving the device meets specific acceptance criteria through a study with human expert review or AI performance metrics.
Therefore, many of the requested details, such as MRMC studies, AI performance metrics, sample sizes for training/test sets for AI, expert qualifications, and ground truth methodologies, are not applicable or not present in this type of submission. This document describes a traditional medical device premarket submission, not an AI/ML device submission.
Here's a breakdown based on the provided text, highlighting what is and isn't available:
Since this is a submission for a traditional medical device (a surgical mesh), not an AI/ML powered device, most of the questions relating to AI/ML specific performance studies (MRMC, standalone AI, training/test sets, expert adjudication for AI ground truth) are not relevant to this document. The "study" here refers to bench testing to demonstrate physical and chemical properties in comparison to a predicate device, not clinical performance studies involving human readers or AI.
1. A table of acceptance criteria and the reported device performance
The document does not provide a direct table of specific acceptance criteria with numeric performance values from the testing in the same way one would expect for an AI/ML or diagnostic device. Instead, it states that "Performance Testing" was conducted to demonstrate "substantial equivalence" to the predicate device. The acceptable performance is therefore implied to be similar enough to the predicate device for all the mentioned characteristics.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Ultimate Tensile Strength | Similar to the predicate |
| % Elongation | Similar to the predicate |
| Suture Retention Strength | Similar to the predicate |
| Crosslinking Validation (DSC, Histology) | Validated |
| Glutaraldehyde Residuals | (Implicitly within acceptable limits) |
| Packaging Validation (Leak Test) | Validated |
| Sterility Test | Validated |
| Biocompatibility | Conducted in accordance with FDA Guidance for the Use of International Standard ISO 10993-1 |
Explanation: The document states that these tests were conducted to show that the device's mechanical properties, processing, and safety aspects are "similar to the predicate" or "validated." The exact numerical values for "acceptance criteria" and "reported performance" are not detailed in this public summary, as is common for 510(k) summaries which focus on demonstrating equivalence rather than publishing full test reports.
2. Sample sizes used for the test set and the data provenance
- Sample Size for Test Set: Not specified in the provided summary. This would typically be detailed in the full test reports, not in the 510(k) summary.
- Data Provenance: Not applicable in the context of clinical data. The tests are bench tests of the physical device. Therefore, there's no "country of origin" or "retrospective/prospective" designation for the test data in the sense of patient data.
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. The ground truth for this device (surgical mesh) is established through bench engineering and chemical tests (e.g., tensile testing, chemical analysis, sterility testing), not through human expert review of clinical images or data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no human review or "adjudication" in the sense of interpreting outcomes for this type of device and its specific testing outlined.
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 not an AI/ML device, nor is it a diagnostic device that would 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 AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is based on established engineering and biological standards and test methods.
- Mechanical Properties: Defined by established ASTM/ISO standards for tensile strength, elongation, suture retention.
- Chemical Properties: Defined by methods for glutaraldehyde crosslinking validation and residuals (e.g., Differential Scanning Calorimetry, Histology).
- Biocompatibility: Established by ISO 10993-1.
- Sterility and Packaging: Established by relevant ISO/AAMI standards.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/ML device. Device development involves R&D and prototyping, but not in the sense of "training data."
9. How the ground truth for the training set was established
Not applicable. As there's no training set for an AI/ML model, there's no ground truth established in this context.
§ 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.