(291 days)
The Hybrid Graft is for implantation to reinforce soft tissues where weakness exists. Indications for use include the repair of a hernia or body wall defect requiring the addition of a reinforcing or bridging material to obtain the desired surgical result. The graft is supplied sterile and is intended for one-time use.
The Hybrid Graft is composed of a bioabsorbable, extracellular collagen matrix (Small Intestinal Submucosa, SIS) and a polypropylene mesh. The collagen matrix is identical to the predicate SIS Hernia Repair Device (K974540, K062697), manufactured by Cook Biotech Incorporated. The polypropylene mesh is similar to the predicates PROCEED™ Ventral Patch (K061533) and ULTRAPRO® Mesh (K033337), both manufactured by Ethicon, Incorporated. The Hybrid Graft is similar to both PROCEED and ULTRAPRO in that all are made of a composite of a bioabsorbable or collagen-based and synthetic (polypropylene) component. The polypropylene mesh in the Hybrid Graft is layered between six (6) layers of SIS on the side facing the viscera and two (2) layers of SIS on the side facing the body wall. The device is packaged in a vacuum pressed (dried), laminated state and supplied sterile in a sealed double pouch system.
This document is a 510(k) premarket notification for a medical device called the "Hybrid Graft." It's important to note that a 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets new acceptance criteria through extensive clinical studies as one might find for novel AI/software devices.
Instead, the "acceptance criteria" here refer to meeting standards for mechanical performance and biocompatibility to demonstrate that the new device is as safe and effective as existing, legally marketed devices. The "study that proves the device meets the acceptance criteria" refers to bench testing and biocompatibility testing.
Here's the information broken down as requested, with the caveat that the prompt's structure is more aligned with AI/software performance studies, which is not the primary focus of this type of medical device submission.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria (Implicit from equivalence) | Reported Device Performance |
|---|---|---|---|
| Mechanical Performance | Suture retention | Adequate for the application (similar to predicates) | "Finished devices were tested for mechanical performance... The mechanical performance of the Hybrid Graft is adequate for the application." (Specific numerical values for suture retention, tensile strength, and burst strength are not provided in this summary but were presumably part of the submission.) |
| Ultimate tensile strength | Adequate for the application (similar to predicates) | "Finished devices were tested for mechanical performance... The mechanical performance of the Hybrid Graft is adequate for the application." | |
| Diaphragmatic burst strength | Adequate for the application (similar to predicates) | "Finished devices were tested for mechanical performance... The mechanical performance of the Hybrid Graft is adequate for the application." | |
| Biocompatibility | Genotoxicity | Meets ISO 10993 standards | "The Hybrid Graft met the requirements of the ISO 10993 standards and is substantially equivalent to its predicates." (Specific test results would be in the full submission, referred to here by NAMSA™ assessment) |
| Direct contact in vitro hemolysis | Meets ISO 10993 standards | "The Hybrid Graft met the requirements of the ISO 10993 standards and is substantially equivalent to its predicates." | |
| Cytotoxicity | Meets ISO 10993 standards | "The Hybrid Graft met the requirements of the ISO 10993 standards and is substantially equivalent to its predicates." | |
| Muscle implantation | Meets ISO 10993 standards | "The Hybrid Graft met the requirements of the ISO 10993 standards and is substantially equivalent to its predicates." | |
| Acute intracutaneous reactivity | Meets ISO 10993 standards | "The Hybrid Graft met the requirements of the ISO 10993 standards and is substantially equivalent to its predicates." | |
| ISO sensitization | Meets ISO 10993 standards | "The Hybrid Graft met the requirements of the ISO 10993 standards and is substantially equivalent to its predicates." | |
| Acute systemic toxicity | Meets ISO 10993 standards | "The Hybrid Graft met the requirements of the ISO 10993 standards and is substantially equivalent to its predicates." | |
| Pyrogenicity | Meets ISO 10993 standards | "The Hybrid Graft met the requirements of the ISO 10993 standards and is substantially equivalent to its predicates." | |
| LAL endotoxins | Meets ISO 10993 standards | "The Hybrid Graft met the requirements of the ISO 10993 standards and is substantially equivalent to its predicates." | |
| Subchronic toxicity | Meets ISO 10993 standards | "The Hybrid Graft met the requirements of the ISO 10993 standards and is substantially equivalent to its predicates." |
Note on Acceptance Criteria: For a 510(k) submission, the "acceptance criteria" are intrinsically linked to demonstrating substantial equivalence. The device must perform comparably to predicate devices in mechanical tests and meet established biocompatibility safety standards (ISO 10993). Specific numerical thresholds for mechanical properties are not explicitly stated in this summary but are implied by the statement "adequate for the application" and "substantially equivalent."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the exact number of devices or material samples used for the bench and biocompatibility testing. It only states "Finished devices were tested" and "The SIS material comprising the Hybrid Graft was tested."
- Data Provenance: Not specified, but generally, such bench and biocompatibility testing would be conducted in a controlled laboratory environment, often by the manufacturer or a contract research organization (like NAMSA, mentioned for biocompatibility). The nature of these tests (mechanical and in vitro/in vivo biocompatibility) is prospective for the specific purpose of this submission. Country of origin for data is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable to this type of device submission. The "ground truth" here is established by standardized testing protocols (e.g., ISO 10993 for biocompatibility) and engineering principles for mechanical testing, not by expert interpretation of medical images or clinical outcomes. The "experts" would be testing technicians and engineers qualified in these specific laboratory methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or studies requiring consensus on subjective interpretations (e.g., image reading). The tests performed are objective laboratory measurements.
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 is not applicable. The Hybrid Graft is a physical surgical mesh, not an AI or imaging device that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is a physical implant, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this submission consists of:
- Performance Standards: Established mechanical properties required for surgical meshes (implicitly benchmarked against predicate devices).
- Biocompatibility Standards: Established international standards (ISO 10993) for assessing biological responses to medical devices.
- Predicate Device Performance: The characteristics and performance of the legally marketed predicate devices (SIS Hernia Repair Device, PROCEED™ Ventral Patch, ULTRAPRO® Mesh) serve as a de facto "ground truth" for demonstrating substantial equivalence.
8. The sample size for the training set
This is not applicable. There is no "training set" as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
This is not applicable as there is no training set.
§ 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.