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510(k) Data Aggregation
(240 days)
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.
| Category | Acceptance Criteria (Implied/General) | Reported Device Performance |
|---|---|---|
| Safety | Compliance with FDA Blue Book Memorandum G95-1 and ISO 10993-1 for biological evaluation of medical devices. | "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 meeting the acceptance criteria for each test within these guidelines. Specific numerical thresholds or results are not provided in this summary. |
| Effectiveness (Dura Substitute) | Must meet design requirements for an effective dura substitute. | "The results of a large-scale animal study and clinical study support the effectiveness of using a membrane material as a dura substitute in the repair of dura mater. The characteristics of the Collagen Dura Substitute Membrane meet the design requirements for an effective dura substitute." Specific details of these study results are not provided in this summary. |
| Technological Characteristics (Comparison) | Similar to predicate devices (Dura-Guard® Dural Repair Patch, DuraGen® Dural Graft Matrix) in key characteristics. | "Collagen Dura Substitute Membrane and its predicates have similar technological characteristics. In particular, the Collagen Dura Substitute Membrane and its predicates are similar with respect to intended use, material, form, sizes, thickness, physical integrity, porosity and conformability." This indicates the device met the criteria of being sufficiently similar to the legally marketed predicates. |
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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