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The Biodesign Onlay Dural Graft is intended for use as a dura substitute for the repair of dura mater. The device is provided sterile and intended for one-time use.

The Biodesign Onlay Dural Graft is composed of a bioabsorbable, extracellular collagen matrix (Small Intestinal Submucosa, SIS). The SIS material that comprises the Biodesign Onlay Dural Graft is identical in composition and technology to that of its predicate Durasis Dural Substitute (K031850), also manufactured by Cook Biotech Incorporated and similar to its other predicate, DuraGen II Dural Regeneration Matrix (K043427) manufactured by Integra LifeSciences. The Biodesign Onlay Dural Graft is implanted as a dura substitute providing a scaffold which becomes infiltrated by the patient's cells and is remodeled into native tissue. The device is packaged in a lyophilized (dried) state and supplied sterile in a sealed double pouch system. The Biodesign Onlay Dural Graft can be placed without sutures during skull base dural repair.

Here's an analysis of the provided text regarding the Biodesign® Onlay Dural Graft, focusing on the acceptance criteria and supporting studies as requested:

Acceptance Criteria and Device Performance

The submission primarily focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel safety and effectiveness criteria through a standalone clinical trial with pre-defined acceptance criteria. The acceptance criteria are implicitly tied to performing "similarly" to predicated devices and meeting established ISO standards for biocompatibility.

• Suture retention strength
• Ultimate tensile strength
• Burst strength test | "The tests provided evidence that the Biodesign Onlay Dural Graft performed similarly to its predicate devices." (No specific numerical values or comparative data are provided in the summary, only the qualitative statement of similarity.) |
  | Biocompatibility Testing | Meets ISO 10993-1 standard for:
• Genotoxicity
• Direct contact in vitro hemolysis
• Cytotoxicity
• Muscle implantation
• Acute intracutaneous reactivity
• ISO Sensitization
• Acute systemic toxicity
• Pyrogenicity
• LAL endotoxins
• Subchronic systemic toxicity | "The results of these tests provided evidence that the Biodesign Onlay Dural Graft meets biocompatibility requirements of the ISO standard." (No specific numerical results are provided, only the qualitative statement of meeting the standard.) |
  | Animal Study (Performance) | Adequate performance as an onlay implant with no adverse health effects (e.g., physiological, histological, functional). | "An animal study using finished devices in a rat model where the device was implanted using an onlay technique showed that the device performed adequately with no physiological, histological or functional evidence of adverse health effects were observed." (Qualitative statement of adequate performance.) |
  | Clinical Equivalence (Implicit) | Similar intended use, materials, and technological characteristics to predicate devices. | The Table of Substantial Equivalence (page 2) explicitly compares the device to Durasis Dural Substitute (K031850) and DuraGen II Dural Regeneration Matrix (K043427) across various parameters (Indications for Use, Material, Dimensions, Thickness), highlighting the similarities. The overall conclusion states: "The Biodesign® Onlay Dural Graft is substantially equivalent to its predicate devices in terms of physical characteristics and safety and effectiveness." |

Study Details

1. Sample sizes used for the test set and the data provenance:

   • Bench Testing: The document does not specify the sample size for each mechanical test (suture retention, ultimate tensile strength, burst strength).
   • Biocompatibility Testing: The document does not specify the sample size for each biocompatibility test.
   • Animal Study: The document indicates a "rat model" but does not specify the number of rats used.
   • Clinical Studies (mentioned but not detailed): The text mentions "clinical studies using the device in cranial base dural repair" in the context of demonstrating equivalence, but no details of these studies (sample size, design, provenance) are provided in this summary. It's possible these refer to previously cleared clinical data for the predicate Durasis Dural Substitute, as it is from the same manufacturer and uses identical composition.

   Data Provenance:

   • Bench testing and biocompatibility testing were likely conducted in a lab setting by Cook Biotech Incorporated.
   • The animal study was conducted using a rat model, likely at a research institution or contract research organization.
   • The "clinical studies" mentioned are not detailed, so their provenance is unknown from this document.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This section is not applicable as the studies described (bench, biocompatibility, animal) do not involve human expert interpretation for ground truth establishment in the way, for example, a diagnostic imaging study would. The acceptance criteria are based on objective measurements (mechanical properties, biological responses) or established ISO standard adherence.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • This is not applicable. The studies described are not of a nature that would require human adjudication of results to establish ground truth or compare interpretations.

4. 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. This submission is for a physical medical device (dural graft), not an AI/imaging diagnostic device. Therefore, MRMC studies and AI assistance are not relevant.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • This is not applicable. This is not an algorithmic or AI device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Bench Testing: Ground truth is established by standardized mechanical testing protocols and measurement instruments.
   • Biocompatibility Testing: Ground truth is established by adherence to ISO 10993-1 standard methods and predetermined acceptable ranges for various biological responses (e.g., cytotoxicity, hemolysis).
   • Animal Study: Ground truth is established by physiological observation, histological examination, and functional assessment by trained animal researchers/veterinarians, evaluating for "adverse health effects."

7. The sample size for the training set:

   • This is not applicable. This device is a physical implant, not an AI model or a diagnostic software, so there is no concept of a "training set" in the context of AI/machine learning. The device itself is "trained" through its manufacturing process and design, informed by historical data and scientific principles, but not in the algorithmic sense.

8. How the ground truth for the training set was established:

   • This is not applicable for the reasons stated above.

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