(359 days)
SurgiLattice™ scaffold is indicated for use as a bioabsorbable scaffold for soft tissue support and to repair, elevate and reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome. This includes reinforcement of soft tissue in plastic and reconstructive surgery, and general soft tissue reconstruction. SurgiLattice scaffold is also indicated for the repair of hernia and other fascial defects that require the addition of a reinforcing material to obtain the desired surgical result.
SurgilLattice scaffold is a bioabsorbable surgical mesh manufactured from poly-butylene succinate (PBS). PBS is an absorbable polymer that is processed into monofilament fibers and knitted into a surgical scaffold. PBS degrades through the process of hydrolysis, is absorbed over time, and is ultimately eliminated as CO2 and H2O. It has been developed to optimize absorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue.
The provided text describes a 510(k) premarket notification for the SurgiLattice™ scaffold, a surgical mesh. The document focuses on demonstrating substantial equivalence to a predicate device (GalaFLEX® scaffold) rather than providing detailed acceptance criteria and a study report as one might find for a de novo device with novel performance metrics.
Therefore, the requested information in the form of a table of acceptance criteria and a description of a single study proving the device meets those criteria is not explicitly presented in this document. Instead, the document describes performance testing that establishes comparability to the predicate device to demonstrate substantial equivalence.
Here's an attempt to extract the relevant information based on the provided text, noting where specific details are not available or are framed in terms of comparability rather than predefined acceptance criteria for novel performance:
1. A table of acceptance criteria and the reported device performance
As mentioned, the document does not present explicit acceptance criteria in the typical sense for a new device's performance metrics. Instead, it aims to show comparability to a legally marketed predicate device. The "acceptance criteria" can be inferred as "comparable to the predicate device" for various characteristics.
| Acceptance Criteria (Inferred as Comparability to Predicate) | Reported Device Performance (SurgiLattice™ scaffold) |
|---|---|
| Indications for Use: Same as predicate (with exception of not including bridging repair) | Indications statement is the same as the predicate, with the exception of bridging repair, which is not included for the subject device. |
| Technological Characteristics & Principles of Operation: Same as predicate | The technological characteristics and principles of operation are the same. Minor technological difference (biomaterial composition) does not raise new issues of safety or effectiveness. |
| Degradation Pathway: Comparable to predicate | Hydrolytic degradation products of PBS (1,4-butanediol and succinic acid) are metabolized via Krebs Cycle, similar to the predicate's P4HB degrading to 4HB which is also metabolized via Krebs Cycle. |
| Physical & Mechanical Properties: Comparable to predicate (mesh thickness, density, pore diameter, mesh knit characteristics, burst strength, bending stiffness, tensile strength, suture pull-out, tear strength) | Results from performance testing (based on "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh", dated March 2, 1999) demonstrate comparable mesh thickness, density, pore diameter, mesh knit characteristics, burst strength, bending stiffness, tensile strength, suture pull-out, and tear strength. Both products have the same macroporous, monofilament warp knit construction. |
| Biocompatibility: Meets ISO 10993 requirements; comparable to predicate | Biocompatibility testing conducted per ISO 10993-1:2009 for an implant device (contact > 30 days). Passing results for cytotoxicity, irritation/intracutaneous reactivity, maximization, acute systemic toxicity, material-mediated pyrogenicity, genotoxicity, hemolysis, subacute/subchronic/chronic local toxicity, subcutaneous implantation with histology (4, 12, 26 weeks), subcutaneous implantation with histology using partially-degraded mesh (simulating 116 weeks), coupled with a toxicological assessment (ISO 10993-18). The rabbit study (4, 8, 12, 26 weeks) showed comparable dimensional, morphologic, and histological properties, and a study simulating 116 weeks showed minimal or no reaction comparable to the predicate. |
| Strength Retention Profile: Comparable to predicate | Pre-clinical implantation studies indicate approximately 88% strength retention at 12 weeks. Minimal residual strength at 78 weeks based on in vitro degradation. A rabbit study showed comparable initial strength, strength retention profile, and degradation profile to the predicate. |
| Degradation Profile: Comparable to predicate | A rabbit study showed comparable degradation profile to the predicate. |
| Local Tissue Reaction (Long-term): Minimal or no reaction; comparable to predicate | A second rabbit study, using accelerated degraded material (simulating 116 weeks), microscopically showed minimal or no reaction and was comparable to the predicate device. |
| Functional Performance (Hernia Repair Model): Comparable to predicate (burst strength, stiffness, morphologic properties, molecular weight, histology) | Evaluated in a functional porcine model of hernia repair. The results support substantial equivalence of SurgiLattice scaffold to the predicate in terms of repair site mechanics (burst strength and stiffness), morphologic properties (fiber diameter/surface roughness), molecular weight, and histology. |
| Shelf Life: Passing results | Bench testing of physical and mechanical characteristics, and shelf life studies using real-time and accelerated aging were performed with passing results. (Specific criteria for "passing" are not detailed, but imply stability over time). |
2. Sample sizes used for the test set and the data provenance
The document mentions several studies, primarily animal models:
- Rabbit Biocompatibility Study (Subcutaneous implantation):
- Sample Size: Not explicitly stated as a number of animals, but refers to implantation with histology at "4, 12 and 26 weeks" and "using partially-degraded mesh (representing 116 weeks)". This implies multiple time points, likely requiring multiple animals or sites per animal.
- Provenance: Pre-clinical, GLP rabbit studies, in vivo. Country of origin is not specified.
- Porcine Hernia Repair Model:
- Sample Size: Not explicitly stated.
- Provenance: Functional porcine model, in vivo. Country of origin is not specified.
- In Vitro Degradation Studies:
- Sample Size: Not explicitly stated (e.g., number of samples tested).
- Provenance: In vitro studies.
- Bench Testing:
- Sample Size: Not explicitly stated (e.g., number of mesh samples tested).
- Provenance: Bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The studies described are primarily animal model and bench tests, not human reader studies requiring expert consensus on image interpretation or clinical outcomes.
4. Adjudication method for the test set
This information is not provided in the document. Given the nature of the studies (animal models, bench tests), an adjudication method as typically used in human reader studies (e.g., 2+1, 3+1) would not apply. Results would likely be based on objective measurements, histological analysis by a pathologist, and possibly statistical comparisons.
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
No, an MRMC comparative effectiveness study involving human readers and AI assistance was not done or described in this document. This is a medical device (surgical mesh), not an AI diagnostic imaging tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. The device is a surgical mesh, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance evaluations described includes:
- Histology/Pathology: For biocompatibility, local tissue reaction, and tissue ingrowth in rabbit and porcine models.
- Objective Physical/Mechanical Measurements: For properties like mesh thickness, density, pore diameter, burst strength, bending stiffness, tensile strength, suture pull-out, and tear strength from bench testing.
- Chemical Analysis: For molecular weight in the porcine study and for in vitro degradation.
- Comparison to Predicate: The ultimate "ground truth" for demonstrating substantial equivalence is showing that the device performs similarly to the legally marketed predicate device across relevant metrics.
8. The sample size for the training set
This question is not applicable. This is a physical medical device (surgical mesh), not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This question is not applicable.
§ 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.