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510(k) Data Aggregation
(55 days)
The Symbotex™ Composite Mesh is intended for the reinforcement of soft tissue where a weakness exists such as the repair of the primary abdominal wall and incisional hernias.
Symbotex™ Composite Mesh is made out of a three-dimensional (3D) monofilament polyester textile, which is covered with an absorbable, continuous and hydrophilic film on one of its sides. This film is made up of collagen from porcine origin and glycerol. Symbotex™ Composite Mesh will be proposed in 3 configurations:
Symbotex™ Composite Mesh flat sheet (SYM): 3D textile mesh(s) of various sizes with a central green (dye D&C Green No6) marking to help surgeons center and orient the mesh.
Symbotex™ Composite Mesh flat sheet with sutures (SYMF): 3D textile mesh(s) of various sizes with a central green (dye D&C Green No6) marking and pre-placed Dermalon® sutures to help surgeons, place and fixate the mesh.
Symbotex™ Composite Mesh with flap (SYMOS): 3D textile mesh(s) of various sizes with a green (dye D&C Green No6) bi-dimensional (2D) monofilament polyester flap providing a dedicated fixation area.
The provided document ("K131969") describes the Symbotex™ Composite Mesh, a surgical mesh for soft tissue reinforcement. Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly list specific numerical acceptance criteria (e.g., "bursting strength must be > X N/cm"). Instead, it states that the results of the bench and preclinical tests demonstrate that the device is substantially equivalent to the predicate devices. This implies that the performance of the Symbotex™ Composite Mesh met or was comparable to the established performance characteristics of the predicate devices.
| Acceptance Criteria (Implied by Substantial Equivalence Goal) | Reported Device Performance (as demonstrated by testing) |
|---|---|
| Bench Testing Characteristics: | |
| Mesh thickness comparable to predicate | Assessed; results demonstrate substantial equivalence. |
| Pore size comparable to predicate | Assessed; results demonstrate substantial equivalence. |
| Surface density comparable to predicate | Assessed; results demonstrate substantial equivalence. |
| Bursting strength comparable to predicate | Assessed; results demonstrate substantial equivalence. |
| Bursting distension comparable to predicate | Assessed; results demonstrate substantial equivalence. |
| Breaking strength comparable to predicate | Assessed; results demonstrate substantial equivalence. |
| Elongation at break comparable to predicate | Assessed; results demonstrate substantial equivalence. |
| Tear strength comparable to predicate | Assessed; results demonstrate substantial equivalence. |
| Suturing strength comparable to predicate | Assessed; results demonstrate substantial equivalence. |
| Seam strength comparable to predicate | Assessed; results demonstrate substantial equivalence. |
| Suture assembly strength comparable to predicate | Assessed; results demonstrate substantial equivalence. |
| Trocar testing comparable to predicate | Assessed; results demonstrate substantial equivalence. |
| In-vivo Performance: | |
| Minimizing tissue attachment comparable to predicate | Demonstrated in a preclinical test on a representative animal model in comparison with PARIETEX™ Optimized Composite Mesh (K110663). |
| Biocompatibility: | |
| Meet ISO 10993-1 for a permanent implant | Evaluated; Symbotex™ Composite Mesh is comprised of materials that have been evaluated for biocompatibility in accordance with ISO 10993-1. |
| Shelf Life/Stability: | |
| Demonstrated adequate shelf life | Demonstrated by stability testing on materials and components. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated for bench tests. For the in-vivo preclinical test, the sample size is not specified beyond "a representative animal model."
- Data Provenance: The bench testing refers to "FDA's Guidance for the Preparation of a Premarket Notification for Surgical Mesh issued March 2, 1999." The in-vivo study was a "pre-clinical test." The document does not specify the country of origin for the data or if it was retrospective or prospective, though preclinical animal studies are inherently prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. This device is a surgical mesh, not a diagnostic AI system that requires expert interpretation for ground truth establishment. Performance is assessed through objective physical and biological tests.
4. Adjudication Method for the Test Set
Not applicable. As this is not a diagnostic AI system, expert adjudication for ground truth is not relevant.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No. This is a medical device (surgical mesh), not a diagnostic AI system. MRMC studies are typically performed for evaluating the impact of AI on human reader performance in diagnostic tasks.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device, not an algorithm or AI system.
7. The Type of Ground Truth Used
- Bench Testing: Ground truth is established through standardized physical and mechanical measurements according to recognized guidance documents (FDA's Guidance for Surgical Mesh). This is objective, quantitative data.
- In-vivo Pre-clinical Test: Ground truth for "minimizing tissue attachment" would be established through direct observation, histological analysis, and potentially various scoring systems in the animal model. This is empirical biological data.
- Biocompatibility: Ground truth is established by adherence to ISO 10993-1 standards for material compatibility with biological systems.
8. The Sample Size for the Training Set
Not applicable. This product is a physical device and does not involve machine learning or AI, and therefore no "training set" is used.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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