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DuraMatrix™ Collagen Dura Substitute Membrane is indicated for use as a dural substitute for the repair of dura mater.

The Collagen Dura Substitute Membrane is a white, nonfriable, conformable, resorbable, membrane matrix engineered from highly purified type I collagen derived from bovine Achilles tendon. The device has a thickness similar to that of native dura. It is flexible and conforms to the contours of the defect site. The unique conformability properties of the membrane combined with its mechanical strength allow the membrane matrix to be applied as an onlay membrane or sutured in place. The Collagen Dura Substitute Membrane is supplied sterile, non-pyrogenic, in various sizes, and for single use only.

This 510(k) summary describes a medical device, the DuraMatrix™ Collagen Dura Substitute Membrane, which is not an AI or software device. Therefore, many of the requested categories in the prompt, such as "multi reader multi case (MRMC) comparative effectiveness study," "standalone (i.e. algorithm only without human-in-the loop performance)," "sample size for the training set," and "how the ground truth for the training set was established" are not applicable.

Here's an analysis of the provided text based on the other relevant categories for this type of device:

Acceptance Criteria and Device Performance Study for DuraMatrix™ Collagen Dura Substitute Membrane

1. Table of Acceptance Criteria and Reported Device Performance

The provided text for K040888 focuses on demonstrating substantial equivalence to predicate devices rather than specific quantitative performance metrics against pre-defined acceptance criteria for a novel AI or software device. The acceptance is based on the device meeting design requirements for an effective dura substitute and passing various safety and biocompatibility tests.

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

The summary mentions a "large-scale animal study and clinical study" but does not provide specific sample sizes for either.
The data provenance (country of origin, retrospective/prospective) is not specified.

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

Not applicable for this type of device. The "ground truth" for a dura substitute is assessed through its physiological performance and safety in animal models and clinical use.

4. Adjudication Method for the Test Set

Not applicable for this type of device.

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

Not applicable, as this is a medical implant, not an AI or software device.

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

Not applicable, as this is a medical implant, not an AI or software device.

7. The Type of Ground Truth Used

For the safety and effectiveness of a dura substitute, the "ground truth" would be established through:

• Biocompatibility testing: In vitro and in vivo tests (e.g., cytotoxicity, sensitization, irritation, genotoxicity, implantation studies) according to ISO 10993-1 and FDA G95-1 guidelines. The "ground truth" for these tests are the established biological responses that indicate safety.
• Animal study outcomes: Histological analysis of tissue response, assessment of dural repair integrity, absence of adverse events like CSF leakage or infection.
• Clinical study outcomes: Patient outcomes related to dural repair, absence of complications, healing, and functionality.

8. The Sample Size for the Training Set

Not applicable, as this is a medical implant, not an AI or software device that uses a training set in the computational sense. The "training" in this context would refer to the extensive R&D, material characterization, and iterative design work that precedes formal testing.

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

Not applicable, as this is a medical implant, not an AI or software device.

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DuraGen Plus™ Dural Graft Matrix is indicated as a dura substitute for the repair of dura mater.

DuraGen Plus™ Dural Graft Matrix, is an absorbable implant for repair of dural defects. DuraGen Plus™ is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. DuraGen Plus™ is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes.

The provided text, a 510(k) summary for DuraGen Plus™ Dural Graft Matrix, does not contain the detailed information required to fill out the requested table and answer all questions regarding acceptance criteria and a study proving device performance in the context of an AI/human reader study.

This document describes a medical device, DuraGen Plus™ Dural Graft Matrix, and seeks substantial equivalence to a predicate device. The assessment of this type of device typically involves physical property testing and not clinical trials or AI/human reader studies as would be the case for diagnostic or image-based AI software.

Here's how I can answer based only on the provided text, highlighting what's missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative or qualitative manner that would be filled in a table, nor does it provide specific performance metrics from a study related to those criteria. It broadly states the device is "safe and effective under the proposed conditions of use."

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

Not applicable. The clearance is based on physical property testing, not a test set of data from patients or images.

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

Not applicable. Ground truth for a test set is not relevant for this type of device clearance.

4. Adjudication method for the test set

Not applicable.

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. This is a medical device (dural graft matrix), not an AI software/diagnostic tool.

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

No. This is a medical device, not an algorithm.

7. The type of ground truth used

Not applicable in the context of clinical outcomes or diagnostic accuracy. The "ground truth" for a dural graft matrix would relate to its physical and biological properties. The document mentions "physical property testing."

8. The sample size for the training set

Not applicable. There is no "training set" for this type of device.

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

Not applicable.

Summary of what the document does communicate about the study:

• Study Type: The clearance is based on "Valid scientific evidence through physical property testing." This implies laboratory or bench-top testing of the material properties of the DuraGen Plus™ Dural Graft Matrix.
• Conclusion of Study: The testing provided "reasonable assurance that DuraGen Plus™ Dural Graft Matrix is safe and effective under the proposed conditions of use, and is, with respect to intended use and technological characteristics, substantially equivalent to the predicate device [DuraGen® Dural Graft Matrix (K982180)]."

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