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The Biodesign® Diaphragmatic Hernia Graft is intended for implantation to reinforce soft tissues where weakness exists including the repair of diaphragmatic/hiatal hernias.

The graft is supplied sterile and is intended for one time use only.

The Biodesign® Diaphragmatic Hernia Graft, the subject device, has the same indications for use and is physically identical to the predicate device (K133011) with the same name. The only difference between the subject device and the predicate device is the rehydration fluid options described in the devices' instructions for use (IFU).

Both the subject and predicate devices are part of a family of implant devices manufactured from porcine small intestine that have been processed to remove the tunica mucosa from the inner intestinal surface and the serosa and tunica muscularis from the outer intestinal surface. After further disinfection to ensure the material is virally inactive, the resulting layer is a three dimensional, acellular, collagen-rich extracellular matrix (ECM) that is termed small intestinal submucosa (SIS). Both the subject and predicate devices are multilayered SIS sheets configured in two shapes: rectangular shape (7 x 10 cm) and the U-cut shape (7 x 10 cm with U-shaped notch). Both devices are perforated and have polyglycolic acid (PGA) suture stitched across the device and around the perimeter. The purpose of the suture stitching is to prevent delamination due to device handling during implantation. Both devices are provided in a double Tyvek® pouch and are ethylene oxide (EO) sterilized.

Prior to implantation, the Biodesign® Diaphragmatic Hernia Graft, the subject device, can be rehydrated with sterile saline or autologous body fluids (e.g., blood, bone marrow aspirate, or blood concentrates such as platelet concentrate).

Upon implantation, the Biodesign® Diaphragmatic Hernia Graft (both subject and predicate device) will provide mechanical reinforcement of soft tissue in the repair of diaphragmatic/hiatal hernias. Over time, the device will incorporate (remodel) into the body such that no graft material is left behind.

The provided document is a 510(k) summary for a medical device called the Biodesign® Diaphragmatic Hernia Graft. It describes the device, its intended use, and why it is considered substantially equivalent to a predicate device.

However, the document does not contain information about a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device, which is what your detailed questions are tailored to. The device in focus (a surgical mesh) is a physical implant, not a software or AI-driven diagnostic or therapeutic tool.

Therefore, I cannot answer questions 1 through 9 directly from the provided text, as they pertain to the evaluation of an AI/ML system's performance and validation.

The document's "Performance Data" section discusses non-clinical testing (mechanical properties, tensile strength, suture retention strength, hydration time, and simulated use/handling properties) to show that a new rehydration fluid option does not significantly change the device's properties compared to the predicate device. This is a very different type of "performance data" than what would be generated for an AI/ML medical device.

In summary, the provided text does not contain the information required to answer your specific questions.

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The Diaphragmatic Hernia Graft is intended for implantation to reinforce soft tissues where weakness exists, including the repair of diaphragmatic/hiatal hernias. The graft is supplied sterile and intended for one time use.

The Diaphragmatic 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 the time of implant. The Diaphragmatic Hernia Graft is identical in its base material to its predicates SIS Hernia Repair Device (K974540/K062697) and Surgisis Staple Line Reinforcement (K022044), also manufactured by Cook Biotech Incorporated, and similar to its predicate Permacol™ Surgical Implant (K120605), manufactured by Covidien.

The Diaphragmatic Hernia Graft is substantially equivalent to its SIS predicates in that its technology is able to be incorporated into the body. The device is also substantially equivalent to its predicates in its intended use for reinforcement and repair of diaphragmatic/hiatal hernias. The device is packaged in a dried state and supplied sterile in a sealed double pouch system.

This document describes a 510(k) premarket notification for the "Diaphragmatic Hernia Graft" manufactured by Cook Biotech Incorporated. The submission aims to demonstrate substantial equivalence to previously marketed predicate devices.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Diaphragmatic Hernia Graft are primarily demonstrated through substantial equivalence to predicate devices in terms of intended use, materials, and technological characteristics. The performance is assessed across several categories:

• Direct contact in vitro hemolysis
• Cytotoxicity
• Muscle implantation
• Acute intracutaneous reactivity
• Skin irritation
• ISO Sensitization
• Acute systemic toxicity
• Pyrogenicity
• LAL endotoxins
• Subchronic systemic toxicity | "The results of these tests provided evidence that the Diaphragmatic Hernia Graft meets biocompatibility requirements of the ISO standard." (ISO 10993-1 compliant) |
  | Mechanical Strength | - Suture retention strength
• Burst strength
• Tensile strength
• Stiffness | "The results of the mechanical testing provide evidence that the Diaphragmatic Hernia Graft possesses adequate mechanical strength for its application." |
  | Safety and Biocompatibility (Animal Studies) | Animal studies for diaphragmatic/hiatal hernia repair using SIS material. | "These animal studies provide evidence that the Diaphragmatic Hernia Graft is biocompatible and safe in its application." |
  | Clinical Performance (Human Studies) | Assessment of Surgisis (same base material) in several clinical studies. Further clinical evidence for rectangular flat sheet and U-shape configurations. | "The clinical outcomes of these studies show that the SIS material, which comprises the Diaphragmatic Hernia Graft, is safe and biocompatible."
  "Further clinical evidence was submitted showing that the rectangular flat sheet and U-shape configurations of the Diaphragmatic Hernia Graft performed adequately in patients." |
  | Substantial Equivalence | Comparison to predicate devices (SIS Hernia Repair Device, Surgisis Staple Line Reinforcement, Permacol Surgical Implant) in terms of intended use, material, dimensions, and thickness. | The document concludes: "The biocompatibility, mechanical, pre-clinical and clinical tests performed on the Diaphragmatic Hernia Graft show that the device is substantially equivalent to its predicates." |

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the numerical sample sizes for the "test set" in the traditional sense of a randomized controlled trial comparing the new device against a control. Instead, it relies on:

• Biocompatibility Testing: Performed on "sterilized SIS devices," which are "identical in base material to the Diaphragmatic Hernia Graft." The specific number of samples for each test is not detailed.
• Mechanical Testing: Performed on "The Diaphragmatic Hernia Graft material." The specific number of samples for each test is not detailed.
• Animal Testing: The SIS material has been "tested in animal studies for diaphragmatic/hiatal hernia repair." No specific sample size (number of animals) or data provenance (country, retrospective/prospective) is provided.
• Clinical Testing: Refers to "several different clinical studies" for Surgisis (same base material) and "further clinical evidence" for the specific configurations of the Diaphragmatic Hernia Graft. No specific sample sizes, patient demographics, or data provenance (country, retrospective/prospective) are provided for these studies.

This submission focuses on demonstrating substantial equivalence by referring to existing data on the constituent material (SIS) and limited, non-comparative clinical data specific to the device's configurations, rather than a single, large-scale comparative test set for the new device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information (number and qualifications of experts for ground truth establishment) is not applicable or provided in this 510(k) submission. Medical device submissions for materials like surgical mesh typically rely on objective measurements (e.g., mechanical strength, biocompatibility assays) and clinical outcomes (e.g., healing, adverse events) rather than expert consensus on subjective interpretations like image analysis.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1 or 3+1) are typically used in studies involving subjective interpretations (e.g., radiology reads). This is not relevant to the types of tests (biocompatibility, mechanical, animal studies, general clinical outcomes) described for the Diaphragmatic Hernia Graft.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned or appears relevant to this type of medical device (surgical mesh). This study design is typically used for diagnostic or screening devices where human readers interpret medical images.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study

Not applicable. The Diaphragmatic Hernia Graft is a physical surgical mesh, not an algorithm or AI system. Therefore, an algorithm-only standalone performance study was not conducted or mentioned.

7. Type of Ground Truth Used

The "ground truth" for the performance of the Diaphragmatic Hernia Graft is established through a combination of:

• Objective Test Results: Biocompatibility test results (e.g., specific assay outcomes), mechanical strength measurements (e.g., numerical values for suture retention, burst strength).
• Histopathological & Biological Observations: Observations from animal studies and clinical studies regarding tissue integration, inflammatory response, and healing, though specific details are not provided.
• Clinical Outcomes Data: Safe and biocompatible performance, as evidenced in clinical studies, likely including absence of severe adverse events, successful repair, and tissue reinforcement. This is referenced as "clinical outcomes."

8. Sample Size for the Training Set

Not applicable. As this is a physical medical device and not an AI/ML algorithm, there is no "training set" in the context of machine learning. The data supporting its safety and efficacy comes from prior biocompatibility, mechanical, animal, and clinical studies of the material (SIS) and the device configurations.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" as understood in AI/ML. The "ground truth" for the underlying scientific understanding of SIS material and the performance of surgical meshes is established through standard scientific and regulatory practices, including:

• Peer-reviewed scientific literature: Supporting the properties and biological interaction of SIS.
• Industry standards: Such as ISO 10993 for biocompatibility.
• Pre-clinical research: Animal models for hernia repair.
• Prior clinical experience: With predicate devices and the SIS material, often documented in clinical registries or studies.

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