(169 days)
DuraGen Plus® Dural Regeneration Matrix - Spinal Matrix is indicated as a dura substitute for the repair of dura mater. Integra™ SpinalMend™ Dural Regeneration Matrix is indicated as a dura substitute for the repair of dura mater.
DuraGen Plus® Dural Regeneration Matrix - Spinal Matrix and Integra™ SpinalMend™ Dural Regeneration Matrix are absorbable implants for the repair of dural defects. They are easy to handle, soft, white, pliable, nonfriable, porous collagen matrices. DuraGen Plus® Spinal Matrix and Integrating SpinalMend™ are supplied sterile, non-pyrogenic, for single-use. The package contains two (2) 1 inch (2.5 cm) by 3 inch (7.5 cm) DuraGen Plus® devices in double peel packages.
The provided 510(k) summary is for a medical device called "DuraGen Plus® Dural Regeneration Matrix - Spinal Matrix and Integra™ SpinalMend™ Dural Regeneration Matrix," which are Dural Graft Matrices intended as dura substitutes for the repair of dura mater.
This document does not describe a study to prove performance against acceptance criteria in the typical sense of a clinical trial or algorithm performance evaluation. Instead, it argues for substantial equivalence to an existing predicate device (DuraGen Plus® Dural Regeneration Matrix, K032693). The core of the submission is that the new devices are identical to the predicate device except for modifications relating to the packaging configuration.
Therefore, most of the requested information (sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth types for test/training sets) is not applicable or not provided because the submission methodology relies on substantial equivalence rather than de novo performance testing.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Formal, quantifiable acceptance criteria with a corresponding performance table are not presented in this document. The "performance" assessment is based on the devices being identical to a predicate device, with specific testing related to the packaging modifications.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Device | The devices are "substantially equivalent in function and intended use to the currently marketed DuraGen Plus® Dural Regeneration Matrix (K032693)." |
| Safety and Effectiveness under Proposed Conditions of Use | "Valid scientific evidence through physical property testing and upon review of published clinical evidence provide reasonable assurance that the DuraGen Plus® Dural Regeneration Matrix -Spinal Matrix and Integra™ SpinalMend™ Dural Regeneration Matrix are safe and effective under the proposed conditions of use." |
| Technological Characteristics Equivalence to Predicate Device | The devices are "substantially equivalent ... to the predicate device" in terms of "technological characteristics." The only difference noted is the packaging configuration. |
| Packaging Validation | Testing included "packaging validation." |
| Shipping Validation | Testing included "shipping validation." |
| Design Validation | Testing included "design validation." |
2. Sample size used for the test set and the data provenance:
- Not Applicable. This submission is based on substantial equivalence to a predicate device, not on new clinical performance data from a test set. The changes relate to packaging, which would involve engineering/material testing, not a clinical "test set" in the context of diagnostic accuracy or clinical outcomes for a patient population.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. As there is no clinical test set in the traditional sense, there is no mention of experts establishing ground truth for such a set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No clinical test set or adjudication process is described.
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. This device is a dural graft matrix, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a dural graft matrix, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the packaging, shipping, and design validation tests mentioned, the "ground truth" would likely be engineering specifications, material properties, sterility standards, and potentially regulatory guidelines for packaging integrity and device preservation during transit. No specific details are provided on what these "ground truths" were or how they were established, only that the testing was performed.
8. The sample size for the training set:
- Not Applicable. This submission does not involve an algorithm with a training set.
9. How the ground truth for the training set was established:
- Not Applicable. This submission does not involve an algorithm with a training set.
§ 882.5910 Dura substitute.
(a)
Identification. A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain).(b)
Classification. Class II (performance standards).