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The Collagen Dura Substitute Membrane are white, nonfriable, conformable, resorbable, membrane matrices engineered from highly purified type I collagen derived from bovine Achilles tendon. The devices have thicknesses similar to that of native dura. They are flexible and conform to the contours of the defect site. The Collagen Dura Substitute Membranes are supplied sterile, non-pyrogenic, in various sizes, and for single use only.

AI/ML Overview

The provided document describes a 510(k) premarket notification for a medical device, the DuraMatrix™ Collagen Dura Substitute Membranes. This submission process focuses on establishing substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a detailed clinical study with reported performance metrics.

Therefore, many of the requested details about acceptance criteria, specific study designs, sample sizes for test and training sets, and expert involvement are not explicitly stated in this type of regulatory document.

However, based on the information provided, here's an attempt to answer the questions:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide a table of acceptance criteria with corresponding device performance metrics in the way one would see for a diagnostic device or a device with quantifiable outputs. Instead, it states that the device was evaluated for safety and effectiveness by demonstrating substantial equivalence to a predicate device.

Acceptance Criteria Category	Reported Device Performance (Summary from Document)
Safety	"Collagen Dura Substitute Membrane equivalent has been evaluated by a number of tests to assess its safety/biocompatibility. The device passed all applicable FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing for the biological evaluation of medical devices." This implies the acceptance criteria were compliance with these established biocompatibility standards. The reported performance is that the device "passed all applicable" tests.
Effectiveness	"The results of a large-scale animal study and clinical study of the equivalent product support the effectiveness of using a membrane material as a dura substitute in the repair of dura mater. The characteristics of the modified Collagen Dura Substitute Membranes meet the design requirements for an effective dura substitute." This implies the acceptance criteria for effectiveness were demonstrated through the "equivalent product" (likely the predicate device) and that the modified device's characteristics "meet the design requirements." Specific performance metrics are not given.
Equivalence	"The results of the in vitro product characterization studies show that the device modifications of the Collagen Dura Substitute Membrane are safe and substantially equivalent to the original device." The acceptance criterion is demonstrated substantial equivalence, with performance being that it was found substantially equivalent.

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

Sample Size: Not specified for the animal or clinical studies mentioned. The clinical study was for an "equivalent product," suggesting it was not directly performed on the current device being cleared.
Data Provenance: The document does not specify the country of origin. The data is retrospective in the sense that the clinical and animal studies were performed on an "equivalent product" (predicate) and the current device's characteristics were compared. The "in vitro product characterization studies" are likely specific to the new device.

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

This information is not provided in the document. The document refers to "evaluations" and "studies" but doesn't detail the involvement of specific experts in establishing ground truth, as would be common for AI/diagnostic device validation.

4. Adjudication Method for the Test Set

Not applicable/Not specified. This type of regulatory submission doesn't typically detail adjudication methods as it's not assessing diagnostic accuracy requiring expert consensus.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size

No. This is a physical medical device, not an AI or imaging diagnostic device where MRMC studies are typically performed.

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

This is not an algorithm or software device, so "standalone performance" in that context is not applicable. The device itself (the membrane) has standalone performance as a dura substitute, which was evaluated for safety and effectiveness as described above.

7. The Type of Ground Truth Used

For safety: Likely biological endpoints (e.g., inflammation, biocompatibility markers) from in vivo animal studies and in vitro tests, compared against established standards (FDA Blue Book G95-1, ISO 10993-1). "Ground truth" here is compliance with these standards.
For effectiveness: Based on the statement "support the effectiveness of using a membrane material as a dura substitute in the repair of dura mater," the ground truth for effectiveness would likely be successful dural repair in the animal and clinical studies (e.g., absence of CSF leakage, successful integration, neurological outcomes). This was established for the "equivalent product."
For equivalence: In vitro product characterization studies (e.g., physical integrity, pore structure, conformability) comparing the new device to the predicate. The ground truth is the measured characteristics of the predicate and whether the new device's characteristics fall within acceptable ranges.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that utilizes training sets.

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

Not applicable, as there is no training set for this type of device.

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