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510(k) Data Aggregation
(89 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 reinforcement of soft tissues in plastic and reconstructive surgery.
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.
This document is a 510(k) premarket notification for the Fortiva™ porcine dermis and Tutoplast® porcine dermis surgical meshes. The purpose of this submission is to demonstrate that the proposed device is substantially equivalent to a legally marketed predicate device (K123356). The document describes the device's indications for use, technological characteristics, and performance data supporting its substantial equivalence.
Here's an analysis of the acceptance criteria and study information provided:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a numerical or target-based format. Instead, it demonstrates equivalence to a predicate device through various tests. Equivalence is the de-facto acceptance criteria in this context for a 510(k) submission.
| Characteristic / Test | Acceptance Criteria (Implied: Equivalence to Predicate K123356) | Reported Device Performance (Fortiva™ porcine dermis, Tutoplast® porcine dermis) |
|---|---|---|
| Intended Use | Equivalent to predicate (Surgical mesh scaffold to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes) | Proposed device is equivalent to predicate in intended use. |
| Material | Equivalent to predicate (Porcine Dermis) | Proposed device is equivalent to predicate in material. |
| Design | Equivalent to predicate (Terminally sterilized sheets in various sizes) | Proposed device is equivalent to predicate in design. |
| Function | Equivalent to predicate (Scaffold for soft tissue repair) | Proposed device is equivalent to predicate in function. |
| Processing | Equivalent to predicate (Proprietary tissue sterilization process) | Proposed device is equivalent to predicate in processing. |
| Chemical composition | Equivalent to predicate (Not applicable to these devices) | Proposed device is equivalent to predicate in chemical composition. |
| Energy Source | Equivalent to predicate (Not applicable to these devices) | Proposed device is equivalent to predicate in energy source. |
| In vitro Biomechanical Properties | Equivalent to predicate for: - Tensile maximum load - Burst strength - Suture pullout strength | Unimplanted tensile maximum load, burst strength and suture pullout strength were equivalent for the proposed and predicate devices. |
| Viral Inactivation | Demonstrated ability of process to inactivate model viruses with a wide range of characteristics. | 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). |
| Pyrogenicity | Device did not elicit a pyrogen response in rabbit test; 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 Testing | Passed all applicable FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing. | The device passed all applicable FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing. |
| Implantation Study (Structural & Functional Properties) | Equivalent to predicate for: - Maximum tensile strength at graft-host interface - Burst strength - Clinical and gross pathology - Local effects of implantation | Structural and functional properties of the proposed and predicate devices were equivalent for the evaluated implantation study. Results were equivalent. |
2. Sample size used for the test set and the data provenance
The document does not specify a distinct "test set" in the context of human subject data, as this is a 510(k) submission based on in-vitro and animal studies demonstrating substantial equivalence to a predicate, not a new clinical trial.
- For biomechanical properties (in vitro): The sample size for each test (tensile maximum load, burst strength, suture pullout strength) is not explicitly stated.
- For viral inactivation: The sample size involved testing "porcine dermis at the stage in the chemical processing applicable to the chemical being evaluated." Specific numbers are not given.
- For pyrogenicity: The standard rabbit pyrogen test involves a specific number of rabbits (typically 3, with provisions for additional rabbits if initial results are equivocal). The document states "the rabbit pyrogen test," implying adherence to a standard protocol, but doesn't give the exact number of rabbits used.
- For biocompatibility (ISO 10993-1 testing): This standard typically involves a battery of tests (e.g., cytotoxicity, sensitization, irritation, acute systemic toxicity), each with its own sample size, often using various cell lines or animal models. Specific sample sizes are not provided.
- For the implantation study (animal study): The sample size (number of animals or implants) is not explicitly stated. The provenance is animal data.
Data Provenance: The data comes from in-vitro lab testing and animal studies ("animals studies demonstrate that the proposed device is biocompatible"). There is no mention of human retrospective or prospective data.
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. The studies performed are not clinical studies relying on expert interpretation of images or symptoms to establish ground truth.
- Biomechanical tests: Ground truth is established by physical measurement according to validated test methods.
- Viral inactivation: Ground truth is established by laboratory assays measuring viral reduction.
- Pyrogenicity: Ground truth is established by physiological response (temperature change) in rabbits.
- Biocompatibility: Ground truth is established by standardized biological assays and observation in animal models.
- Implantation study: Ground truth is established by physical measurements (tensile strength, burst strength) and histological/pathological examination of animal tissues.
4. Adjudication method for the test set
This information is not applicable as there is no mention of human readers or subjective assessments requiring adjudication in the context of a "test set" for this type of submission.
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 a 510(k) submission for a surgical mesh, not an AI-powered diagnostic device. An MRMC study is not relevant to demonstrating substantial equivalence for this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used
The ground truth used for the various studies includes:
- Physical Measurements: For biomechanical properties (tensile strength, burst strength, suture pullout strength).
- Laboratory Assays: For viral inactivation (measuring viral reduction) and endotoxin levels.
- Physiological Response: For pyrogenicity (rabbit temperature response).
- Pathological/Histological Examination: For the implantation study, assessing clinical and gross pathology, as well as local effects of implantation in animal models.
- Validated Biocompatibility Tests: According to FDA Blue Book Memorandum G95-1 and ISO 10993-1 standards.
8. The sample size for the training set
Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set." The studies performed are for device characterization and equivalence to a predicate.
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
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(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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