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LifeCell Dural Substitute Matrix is indicated as a dural substitute for the repair of dura mater.

The LifeCell Dural Substitute Matrix, like the predicate devices made from a biological material, is made from donated human cadaver skin. The donated allograft human dermis is processed to remove cells and freeze-dried to remove moisture while preserving the general structure of the dermal matrix. The LifeCell Dural Substitute Matrix is terminally sterilized using e-beam irradiation and packaged in a double-pouch configuration. The freeze-dried matrix is rehydrated prior to implantation. After implantation, the graft is revascularized and repopulated with cells. The LifeCell Dural Substitute Matrix is packaged in a double-pouch configuration - an inner (Tyvek) peel-pouch and an outer foil pouch.

The provided text describes a 510(k) premarket notification for the "LifeCell Dural Substitute Matrix." This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel safety and effectiveness through extensive, de novo clinical trials with predefined acceptance criteria.

Therefore, the concept of specific "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the traditional sense of a new clinical trial with statistical endpoints is not explicitly detailed in this document. The submission focuses on showing that the new device is as safe and effective as existing, legally marketed predicate devices.

However, based on the provided information, we can infer how performance was assessed for equivalence:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) based on substantial equivalence, there are no specific numerical acceptance criteria like sensitivity/specificity thresholds. Instead, the acceptance is based on demonstrating that the device performs similarly to the predicate devices in terms of its intended function and safety.

Study Information (Inferring from "Performance Data"):

The document mentions "Performance Data" which includes "mechanical," "preclinical animal testing," and "clinical data." This suggests a combination of studies were conducted, but specific details about each study are limited.

2. Sample size used for the test set and the data provenance:

• Mechanical and Preclinical Animal Testing: The specific sample sizes are not provided in this summary.
• Clinical Data: The specific sample size for the clinical data is not provided.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The term "clinical data has shown" suggests some form of observational or compiled data, but details are not given.

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

This information is not provided in the 510(k) summary. For devices of this nature, "ground truth" often refers to histological analysis or clinical outcomes adjudicated by physicians, but no specifics are mentioned here.

4. Adjudication method for the test set:

This information is not provided.

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:

• No. An MRMC comparative effectiveness study is not applicable to this device. This device is a dural substitute (a physical implant), not an AI-powered diagnostic tool that assists human readers.

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

• No. This question is not applicable to this device, as it is a physical implant, not an algorithm.

7. The type of ground truth used:

Based on the nature of the device (dural substitute), the "ground truth" would likely involve:

• Histology/Pathology: For preclinical animal studies (e.g., tissue integration, inflammatory response, dural regeneration, presence/absence of cells).
• Clinical Outcomes Data: For human application (e.g., absence of CSF leak, infection, adverse reactions, successful dural repair as observed surgically or symptomatically).
• Mechanical Testing Results: For physical properties.
• The exact methods for establishing "ground truth" are not detailed in the summary.

8. The sample size for the training set:

• Not applicable/Not provided. This device is a biologic implant, not an AI algorithm that requires a training set. The "clinical data" and "preclinical animal testing" are likely related to validation/performance assessment rather than training a model.

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

• Not applicable/Not provided. As above, there is no "training set" for this type of device.

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