(268 days)
The SIS Hernia Graft is intended for implantation to reinforce soft tissues where weakness exists. Indications for use include repair of a hernia or body wall defect. The graft is supplied sterile and intended for one time only use.
The SIS Hernia Graft is composed of multiple layers of a bioabsorbable, extracellular collagen membrane matrix (Small Intestinal Submucosa, SIS) that are held together with a biodegradable suture to improve the device handling characteristics at time of implant. The SIS Hernia Graft is identical in its base material to its predicate SIS Hernia Repair Device (K974540/K062697), also manufactured by Cook Biotech Incorporated. The SIS Hernia Graft is substantially equivalent to its predicate in its technology in that it has the ability to be incorporated into the body. The device is substantially equivalent to its predicate in its intended use for reinforcement and repair of hernias or a body wall defect. The device is packaged in a dried state and supplied sterile in a sealed double pouch system.
The provided document describes the 510(k) premarket notification for the "SIS Hernia Graft." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed device performance metrics in the way one might find for a novel diagnostic or AI-driven device.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert consensus, and reader studies are not applicable or not provided in this type of regulatory submission.
However, I can extract the relevant information and structure it as much as possible according to your request categories, noting where information is not available from the provided text.
Acceptance Criteria and Device Performance (Based on Substantial Equivalence)
The acceptance criteria for this 510(k) submission are fundamentally based on demonstrating substantial equivalence to a previously legally marketed device (the predicate device). This means the device must meet similar performance standards and safety profiles as the predicate. The "performance" is demonstrated through various tests and comparisons rather than numerical thresholds for a specific diagnostic accuracy.
Table 1: Acceptance Criteria (Demonstration of Substantial Equivalence) and Reported Device Performance
| Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Device must meet biocompatibility requirements of ISO 10993-1 standard. | Demonstrated through various tests on sterilized SIS devices (genotoxicity, hemolysis, cytotoxicity, muscle implantation, acute intracutaneous reactivity, skin irritation, ISO sensitization, acute systemic toxicity, pyrogenicity, LAL endotoxins, subchronic systemic toxicity). Results provided evidence that the SIS Hernia Graft meets biocompatibility requirements. |
| Mechanical Strength | Device must provide adequate mechanical strength for its intended application. | Tested for Suture retention strength, Burst strength, Ultimate tensile strength, Tear strength, Stiffness. Results provided evidence that the SIS Hernia Graft provided adequate mechanical strength for its application. |
| Animal Testing (Safety & Biocompatibility) | Device should be well-tolerated, show minimal tissue response, and satisfactory remodeling characteristics. | Study 1 (Pig Hernia Model, 27 days): Device was well tolerated with minimal localized tissue response. |
| Study 2 (Pig Hernia Model, 1 & 6 months): Satisfactory remodeling characteristics with minimal inflammation (used as a control article). | ||
| Study 3 (Mouse, Angiogenesis): Sutured SIS performed as well as sutureless control SIS with robust vascular penetration. Results show the device is safe and biocompatible in its application. | ||
| Material Composition | Identical to predicate device. | Porcine small intestinal submucosa (porcine), primarily Types I, III, IV, and VI collagen (constituents of the extracellular matrix). (Identical to predicates K974540 and K062697). |
| Intended Use | Identical to predicate device. | Intended for implantation to reinforce soft tissues where weakness exists, including repair of a hernia or body wall defect. (Identical to predicates K974540 and K062697). |
| Dimensions | Comparable to predicate device. | New Device: 5 x 8 cm to 30 x 30 cm. |
| Predicate K974540: 5 x 8 cm to 20 x 30 cm. | ||
| Predicate K062697: 1 x 3 to 20 x 30 cm. (Variations noted but deemed substantially equivalent). | ||
| Thickness | Comparable to predicate device. | 0.1 - 1.5 mm. (Identical to predicates K974540 and K062697). |
| Layers | Identical to predicate device. | 8 layers. (Identical to predicates K974540 and K062697). |
| Drying Method | Acceptable for the material, maintaining similar incorporation and resorption characteristics. | New Device: Lyophilized. |
| Predicates: Vacuum pressed. (Difference noted, but the SIS material is the same and exhibits similar characteristics when implanted). | ||
| Stitching | Addition of biodegradable suture to improve handling, without affecting the SIS material or its characteristics post-resorption. | New Device: Yes (resorbable suture). |
| Predicates: No. (Addition for handling, suture is resorbed without effect on SIS material). |
Additional Information on Studies (Not Directly Applicable/Provided for 510(k))
This 510(k) submission is for a medical device (surgical graft), not a diagnostic algorithm or AI system. Therefore, many of the requested items related to AI/diagnostic study design are not relevant to this type of submission.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Biocompatibility Tests: Performed on sterilized SIS devices (base material). No specific "test set" size is given beyond "SIS devices."
- Mechanical Testing: Performed on "SIS Hernia Graft material." No specific "test set" size or data provenance is detailed.
- Animal Testing:
- Pig hernia model: Two separate studies mentioned. No specific number of animals provided for each study.
- Mouse study: One study mentioned. No specific number of animals provided.
- Data Provenance: Not specified, but likely proprietary internal testing given the nature of the device and testing. All tests are prospective.
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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):
- Not applicable. Ground truth for biocompatibility and mechanical tests is determined by standardized laboratory methods and observations (e.g., cell viability, tensile strength, histopathology readings). For animal studies, expert pathologists would have interpreted the findings, but their number and qualifications are not specified in this summary.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept pertains to consensus among human readers for diagnostic interpretation, which is not part of this device's submission.
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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 or diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical surgical graft, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Biocompatibility: In vitro and in vivo test results against ISO 10993-1 standards (e.g., cell viability, systemic toxicity markers, inflammation scores).
- Mechanical Testing: Objective measurements from testing equipment (e.g., force required for tear, ultimate tensile strength).
- Animal Testing: Gross and histopathological findings from implanted tissue, angiogenesis assessments. Considered direct evidence of tissue response and material integration.
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The sample size for the training set:
- Not applicable. There is no "training set" in the context of this physical medical device. This term is primarily relevant for machine learning or AI algorithm development.
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How the ground truth for the training set was established:
- 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.