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DuraGen II Dural Regeneration Matrix is indicated as a dura substitute for the repair of dura mater.

DuraGen II Dural Regeneration Matrix is an absorbable implant for repair of dural defects. DuraGen II Dural Regeneration Matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix with a mechanically strengthened collagen component. DuraGen II Dural Regeneration Matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes. DuraGen II Dural Regeneration Matrix may be applied using either onlay or suturing technique depending on clinical need and surgeon preference.

The provided text describes a 510(k) premarket notification for the DuraGen II Dural Regeneration Matrix. The submission focuses on demonstrating substantial equivalence to a predicate device through physical property testing, rather than clinical performance data with acceptance criteria for a specific device output. Therefore, many of the requested categories regarding clinical study design and AI performance are not applicable or cannot be extracted from this document.

Here's an analysis based on the provided information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics in the format typically seen for diagnostic or AI-driven devices. Instead, it relies on demonstrating substantial equivalence through "physical property testing."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document refers to "physical property testing" but does not detail the nature or scale of these tests, nor the source of any data.

3. 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)

This information is not provided and is not applicable as the submission is based on physical property testing for a dural substitute, not on expert-adjudicated clinical outcomes or diagnostic accuracy.

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

This information is not provided and is not applicable for this type of device submission.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices involving human interpretation, especially with AI assistance, which is not the case for the DuraGen II.

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

This information is not applicable. DuraGen II is a medical implant (dural substitute), not an algorithm or AI device.

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

The "ground truth" for this submission appears to be derived from the physical properties and established safety/effectiveness profiles of the predicate device, as assessed through "physical property testing." There is no mention of expert consensus, pathology, or clinical outcomes data for this specific submission's "ground truth."

8. The sample size for the training set

This information is not applicable as the DuraGen II is not an AI-driven device requiring a training set.

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

This information is not applicable as there is no training set for an AI model.

Summary of Device and Study Type:

The DuraGen II Dural Regeneration Matrix is a Class II medical device, essentially an absorbable implant for dural repair. The 510(k) submission primarily focuses on demonstrating substantial equivalence to an existing predicate device (DuraGen Plus™ Dural Regeneration Matrix). The evidence for this substantial equivalence is stated as "valid scientific evidence through physical property testing." This type of submission relies on showing that the new device has similar technological characteristics and intended use as a legally marketed device, and therefore can be presumed to be as safe and effective without the need for extensive new clinical trials with patient-specific outcome measures or comparative effectiveness studies against experts.

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