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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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(175 days)
The SURGIMESH®XB - Skirted mesh is intended for use in the reinforcement of tissues during surgical repair.
The SURGIMESH®XB-Skirted is indicated for the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects. The silicone layer minimizes the tissue attachment to the mesh in the case of direct contact with the viscera
The SURGIMESH®XB - Skirted surgical mesh is a non-absorbable, synthetic mesh, made of non-knitted, non-woven fibers of polypropylene, one surface of which is coated with silicone. The use of SURGIMESH®XB - Skirted mesh provides reinforcement of soft tissues. On the opposite side, the silicone layer minimizes tissue attachment to the mesh in case of direct contact with the viscera. The SURGIMESH®XB - Skirted mesh is supplied sterile and is available in anatomic forms in order to meet individual surgeons' needs.
More specifically, the SURGIMESH® XB - Skirted mesh is composed of a layer of non-woven, non-knitted material made from polypropylene (i.e., SURGIMESH®XB), a skirted part made from polypropylene (i.e., SURGIMESH®WN) linked with the first layer by sewing a PVDF thread into the two parts with a layer of silicone (equivalent to SURGIMESH® XB product material).
This document describes the premarket notification 510(k) for the SURGIMESH®XB - Skirted surgical mesh. The provided text outlines the device's characteristics, intended use, and the performance testing conducted to demonstrate substantial equivalence to predicate devices, rather than a study against a specific set of acceptance criteria with human readers or standalone algorithm performance.
Here's an analysis of the available information regarding acceptance criteria and supporting studies, formatted as requested, and noting where information is not present in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Not Explicitly Stated but Inferred from Testing Standards) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Device must be biocompatible according to ISO 10993-1 standards. | Device demonstrated biocompatibility per ISO 10993-1 standards. |
| Sterilization Validation | Device must be sterile according to ISO 10993-7, ISO 11137-1, ISO 14937, and USP 28 standards. | Device demonstrated sterility per listed standards. |
| Product Packaging | Packaging must have appropriate sealing characteristics according to ISO 11607. | Packaging demonstrated appropriate sealing characteristics per ISO 11607. |
| Device Structure & Material Characterization | Device specifications (mechanical and material characteristics) must be substantially similar to predicate devices based on ISO 5084, ISO 3801, ISO 9073-3, ISO 9073-4, ISO 9073-7, ISO 13934-1, and ISO 13938-1 standards. | SURGIMESH®XB - Skirted specifications are substantially similar to identified predicate device specifications. |
| Functionality/Intended Use | Device must function as intended. | In all instances, the SURGIMESH®XB - Skirted functioned as intended and the results observed were as expected. |
| Substantial Equivalence | Device must be substantially equivalent to identified predicate devices. | The device was determined to be substantially equivalent. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document states "Preclinical testing was conducted" but does not detail the number of units or samples tested for each criterion.
- Data Provenance: The studies were preclinical testing conducted by Aspide Medical. The location of these tests (e.g., country of origin) is not explicitly stated, but Aspide Medical is based in LA TALAUDIERE (FRANCE). The studies are retrospective as they summarize testing that has already been performed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to the provided document. The performance data focuses on technical and material characteristics of a surgical mesh, not on expert interpretations of medical images or clinical outcomes that typically require ground truth established by experts.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes where there might be disagreement in assessments. The reported tests are objective technical validations against established standards.
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. This document describes a medical device (surgical mesh), not an AI-powered diagnostic or assistive technology that would involve human readers or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. This document describes a medical device (surgical mesh), not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance testing cited are the established international standards (ISO, USP) for biocompatibility, sterility, packaging, and material characterization. The device's performance was compared against these universally recognized technical standards and against the specifications of predicate devices.
8. The Sample Size for the Training Set
This information is not applicable. This document describes a medical device (surgical mesh) testing and substantial equivalence, not the development or training of an AI model that would require a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As no AI model or training set is mentioned, there is no ground truth for a training set to be established.
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