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DuraMatrix™ Collagen Dura Substitute Membranes are indicated as dural substitutes for the repair of dura mater.

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.

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.

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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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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