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510(k) Data Aggregation
(125 days)
The device is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. Indications for use include the repair of hernias and /or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome.
The device is intended for single patient use only.
The proposed device is an implantable surgical mesh comprised of non-crosslinked porcine dermis that has been processed, terminally sterilized and is stored hydrated and ready to use. The proposed device is designed to perform as a scaffold that allows for neovascularization and permits replacement of the device with host tissue. The device in its unopened, undamaged package is sterile.
The provided text describes a 510(k) summary for a surgical mesh device, Fortiva™ porcine dermis / Tutoplast® porcine dermis, which focuses on establishing substantial equivalence to a predicate device (Strattice®). The document does not outline specific acceptance criteria in a quantitative sense (e.g., a target sensitivity or specificity for a diagnostic device) or provide a study that explicitly demonstrates the device "meets" such criteria for clinical performance.
Instead, the performance data presented is focused on demonstrating equivalence to a predicate device through various in vitro and in vivo tests related to biomechanical properties, manufacturing process safety, and biocompatibility.
Here's a breakdown based on the information provided, addressing your specific points:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of quantitative acceptance criteria for clinical performance or any metrics like sensitivity, specificity, or AUC. Instead, it describes equivalence-based performance criteria:
| Characteristic | Acceptance Criteria (Implicit for Equivalence to Predicate) | Reported Device Performance |
|---|---|---|
| Biomechanical Properties (in vitro) | Equivalent to predicate device (Strattice®) in unimplanted tensile maximum load, burst strength, and suture pullout strength. | "Unimplanted tensile maximum load, burst strength and suture pullout strength were equivalent for the proposed and predicate devices." |
| Viral Inactivation (manufacturing process) | Demonstration of ability to inactivate model viruses with a wide range of characteristics (enveloped and non-enveloped, RNA and DNA, low resistance and high resistance). | "The results demonstrate the ability of the process to inactivate viruses with a wide range of characteristics (enveloped and non-enveloped, RNA and DNA, low resistance and high resistance) when used to process porcine dermis for the proposed device." |
| Pyrogenicity | Non-pyrogenic (rabbit pyrogen test) and endotoxin level <20 EU per device. | "The device did not elicit a response [in the rabbit pyrogen test]." "All device lots will be tested to ensure the endotoxin level is <20 EU per device." |
| Biocompatibility (in vitro & in vivo) | Pass all applicable FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing. Equivalent to predicate in structural and functional properties in an implantation study (maximum tensile strength at graft-host interface, burst strength, clinical and gross pathology, local effects of implantation). | "The device passed all applicable FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing for the biological evaluation of medical devices." "The structural and functional properties of the proposed and predicate devices were also evaluated in an implantation study. Maximum tensile strength at the graft-host interface, burst strength, clinical and gross pathology, and the local effects of implantation were assessed and results demonstrate the proposed and predicate devices are substantially equivalent." "Results from in vitro and animal studies demonstrate that the proposed device is biocompatible, and as safe and effective as the predicate..." |
2. Sample size used for the test set and the data provenance
The document mentions an "implantation study" (animal study) but does not provide a specific sample size for this or any other test set. It does not mention the country of origin of the data. The study appears to be prospective in nature, as it describes evaluations conducted for the purpose of the 510(k submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a surgical mesh, not a diagnostic AI system predicting outcomes. Ground truth in this context would likely refer to objective measurements and observations in the animal study rather than expert consensus on images or other diagnostic data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI-powered diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the biomechanical properties, the ground truth would be objective measurements from laboratory tests (tensile testers, burst strength testers, etc.).
For viral inactivation, the ground truth would be laboratory assays measuring viral titers after processing.
For pyrogenicity, the ground truth would be a validated rabbit pyrogen test result and endotoxin levels measured by specific assays.
For the implantation study, the ground truth would be:
* Objective measurements: Maximum tensile strength at the graft-host interface, burst strength.
* Pathology: Clinical and gross pathology assessments (likely by veterinary pathologists).
* Observation: Local effects of implantation (observed by researchers/veterinarians).
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that uses training sets.
9. How the ground truth for the training set was established
Not applicable.
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