(251 days)
TiO2Mesh™ is a surgical mesh implant specifically indicated for repair of tissue defects of the abdominal wall, where a non-reabsorbable support material is required. Relevant applications include the repair of inguinal and incisional hernia in all common surgical methods. TiO2Mesh™ can be used for both laparoscopic and other open procedures.
TiO2Mesh™ is made from a monofilament polypropylene thread and has a large-pore structure with blue orientation stripes. The surgical mesh implant has a titanium dioxide coated surface. The fabric can be stretched in both directions and is highly flexible to react to body dynamics in terms of elasticity. TiO2Mesh™ is available in different shapes and sizes (product flyer TiO2Mesh™ ).
The Biocer Entwicklungs GmbH Traditional 510(k) Premarket Submission for TiO2Mesh™ does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in the way typically expected for an AI/ML device. This submission focuses on demonstrating substantial equivalence to predicate devices for a surgical mesh, not on the performance of a diagnostic or assistive AI system.
Here's a breakdown based on the provided text, highlighting what is present and what is absent:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not present in the provided document. The submission is for a physical surgical mesh and relies on comparing its technological characteristics and non-clinical testing results to predicate devices rather than setting and meeting specific performance metrics like sensitivity, specificity, or accuracy that would be relevant for an AI system.
The "Comparison Table" provided in the document compares the TiO2Mesh™ to predicate devices (TiMesh-TC and Soft Mesh) across various attributes like material, grammage, and pore size, as well as indications for use. However, these are characteristics for substantial equivalence, not acceptance criteria for performance in the context of an AI/ML device.
| Characteristic | TiO2Mesh™ (New Device) | TiMesh-TC (Predicate) | Soft Mesh (Predicate) |
|---|---|---|---|
| Manufacturer | Biocer Entwicklungs GmbH | GfE Medizintechnik GmbH | Bard |
| Trade Name | TiO2 Mesh | TiMesh-TC | Soft Mesh |
| 510(k) Number | Not Available yet | K031225 | K052155 |
| Product Code | FTL | FTL | FTL |
| Regulation Number | 878.3300 | 878.3300 | 878.3300 |
| Regulation Name | Surgical mesh. | Surgical mesh. | Surgical mesh. |
| Indications for use | Repair of tissue defects of the abdominal wall, where a non-reabsorbable support is required for inguinal and incisional hernia in all common surgical methods (laparoscopic and open procedures). | Reinforcement of tissue during surgical repair for inguinal, femoral, umbilical, and incisional hernias, rectal, vaginal, and apical prolapses, and parietal reinforcement of tissues and abdominal wall repair (laparoscopic and open surgery). | Reconstruction of soft tissue deficiencies, such as for the repair of hernias and chest wall defects; repair of inguinal hernia defects. |
| Material | PP + Titanium | PP + Titanium | PP |
| Grammage | 43 | 65 | 44 |
| Pore size (mm) | 2.8 | 1 | 2.5 |
| Biocompatible | Yes | Yes | Yes |
| Physical Properties | Comparable (FDA Guidance used) | Comparable (FDA Guidance used) | Comparable (unknown whether FDA Guidance was used) |
2. Sample size used for the test set and the data provenance
This information is not applicable as there is no "test set" in the context of AI/ML evaluation for this device. The submission relies on non-clinical (in vitro and in vivo animal) testing and comparison to predicate devices, not on a dataset used to evaluate an AI algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. Ground truth for an AI/ML test set is not relevant for this medical device submission. The safety and effectiveness are established through non-clinical biocompatibility and performance testing and comparison to legally marketed predicate devices, not through expert consensus on a diagnostic outcome.
4. Adjudication method for the test set
This information is not applicable. There is no test set or adjudication process for an AI/ML algorithm's output.
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
This information is not applicable. A MRMC study is relevant for evaluating the impact of AI on human diagnostic performance. This device is a surgical mesh, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is not an AI algorithm.
7. The type of ground truth used
For the non-clinical testing conducted for TiO2Mesh™, the "ground truth" would be the observed biological and physical responses in the laboratory and animal studies, and the established regulatory standards and guidance documents. For example:
- Biocompatibility: Observations of cellular reactions (cytotoxicity), tissue irritation, sensitization, systemic toxicity, and local effects after implantation in animal models. The "ground truth" here is the biological response relative to established safety thresholds and standards.
- Material properties: Measured physical characteristics (grammage, pore size) compared to predicate devices and acceptable ranges for surgical meshes.
8. The sample size for the training set
This information is not applicable. There is no training set for an AI/ML algorithm.
9. How the ground truth for the training set was established
This information is not applicable. There is no training set for an AI/ML algorithm.
Summary of the Study that Proves the Device Meets Acceptance Criteria (as per 510(k) for a physical device):
The submission demonstrates substantial equivalence through a combination of:
- Comparison of Technological Characteristics: A detailed comparison table (Section 8) outlines the similarities and differences between TiO2Mesh™ and two predicate devices (TiMesh-TC and Soft Mesh) across key attributes like material, grammage, pore size, and biocompatibility. The claim is that the characteristics are comparable, especially to TiMesh-TC which also uses PP+Titanium.
- Non-Clinical Testing (Section 9):
- Biocompatibility Studies: A series of in vitro and in vivo tests were conducted on TiO2Mesh™ extracts or the device itself to assess:
- Cytotoxicity (Cell Growth Analysis via BCA-Staining)
- Irritation (Intracutaneous Reactivity)
- Sensitization (Local Lymph Node Assay LLNA)
- Acute Systemic Toxicity (in the Mouse)
- Local Effects after Implantation (7-day and 90-day periods)
- Investigation of Extractable Organic Substances (GC/MS Fingerprint)
- Bacterial Endotoxins (LAL-Test Kinetic Turbidimetric Assay)
- Inhibition or enhancement of LAL-Test (KTA)
- Physical and Sterilization Validation:
- Transport simulation and packaging validation report.
- ETO Sterilization validation report.
- Biocompatibility Studies: A series of in vitro and in vivo tests were conducted on TiO2Mesh™ extracts or the device itself to assess:
Conclusion stated in the document (Section 11): The non-clinical testing results and the comparative analysis of technological characteristics led to the conclusion that TiO2Mesh™ is "substantially equivalent" to the referenced predicate devices, meaning it has the same intended use and either identical technological characteristics, or different characteristics that do not raise new questions of safety or effectiveness. No clinical testing was required or performed for this 510(k) submission to demonstrate "acceptance criteria" or "device performance" in a clinical setting, as the substantial equivalence argument was based entirely on non-clinical data and comparison to existing devices.
§ 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.