(60 days)
The DURAFORM Dural Graft Implant is intended for use in procedures where the repair or substitution of the patient's dura mater is needed.
The DURAFORM Dural Graft Implant is a single use, sterile collagen implant manufactured from processed bovine tendons. The Duraform Dural Graft Implant is designed to be a sutureless, onlay graft, but tensionless sutures can be used if preferred by the surgeon.
This document describes the performance testing for the DURAFORM Dural Graft Implant, specifically to support an extended shelf life from 12 months to 30 months. The testing focuses on device stability and packaging stability.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Category | Test | Test Method Summary | Acceptance Criteria (Implied from Results) | Reported Device Performance |
|---|---|---|---|---|
| Device | Compressibility (Time-Zero & 30-Month) | Quantifies the ability of a device to be compressed by comparing the compressed thickness to the original thickness after 120 seconds of compression. | Passed (device behaves as expected for its intended use) | Both time-zero and 30-month real-time tests passed the acceptance criterion, demonstrating substantial equivalence to the predicate device and no new safety/effectiveness issues. |
| Device | Resilience (Time-Zero & 30-Month) | Quantifies the capability of a device returning to its original state by comparing the recovered thickness after compression (30 minutes recovery after 120 seconds compression) to the original thickness. | Passed (device returns to original state as expected) | Both time-zero and 30-month real-time tests passed the acceptance criterion, demonstrating substantial equivalence to the predicate device and no new safety/effectiveness issues. |
| Device | Imbibition (Time-Zero & 30-Month) | Measures how much fluid a material absorbs. Determined by the ratio of dry weight to wet weight after 10 seconds of irrigation, representing clinical use. | Passed (device absorbs fluid appropriately for clinical use) | Both time-zero and 30-month real-time tests passed the acceptance criterion, demonstrating substantial equivalence to the predicate device and no new safety/effectiveness issues. |
| Device | Apparent Density (Time-Zero & 30-Month) | Measures the density of the dural substitute material using the dry weight of the device. | Passed (density remains within acceptable limits) | Both time-zero and 30-month real-time tests passed the acceptance criterion, demonstrating substantial equivalence to the predicate device and no new safety/effectiveness issues. |
| Device | Visual Inspection (Time-Zero & 30-Month) | Samples are inspected to be white in color with no visible stains. | Passed (device remains white with no stains) | Both time-zero and 30-month real-time tests passed the acceptance criterion, demonstrating substantial equivalence to the predicate device and no new safety/effectiveness issues. |
| Device | Tensile Strength (Time-Zero & 30-Month) | Performed according to FDA guidance for dura substitutes. Samples are wetted, placed in an Instron instrument, re-wetted, and then pulled to capture peak load at failure. | Time-zero passed, 30-month results deemed acceptable (device maintains sufficient strength over time) | Time-zero testing passed the acceptance criteria; 30-month testing results were deemed acceptable, demonstrating substantial equivalence to the predicate device and no new safety/effectiveness issues. |
| Packaging | Visual Inspection (120-Month & 132-Month) | Performed for any damage to the packaging. | Passed (no damage to packaging) | Both 120-month and 132-month tests passed the acceptance criterion, indicating packaging integrity will be maintained for the proposed 30-month shelf life. |
| Packaging | Seal Integrity (Dye Penetration) (120-Month & 132-Month) | Tested in accordance with ASTM F1929-12 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration. | Passed (no dye penetration, indicating seal integrity) | Both 120-month and 132-month tests passed the acceptance criterion, indicating packaging integrity will be maintained for the proposed 30-month shelf life. |
| Packaging | Seal Strength (120-Month & 132-Month) | Tested in accordance with ASTM F88/F88M-09 Standard Test Method for Seal Strength of Flexible Barrier Materials. | Passed (seal strength maintained within acceptable limits) | Both 120-month and 132-month tests passed the acceptance criterion, indicating packaging integrity will be maintained for the proposed 30-month shelf life. |
2. Sample Sizes Used for the Test Set and Data Provenance:
The document does not explicitly state the exact sample sizes for each test. However, it indicates that "All testing was performed on final sterile devices unless otherwise specified" for device stability tests. For packaging stability, tests were performed at "120 months and 132 months of real-time aging."
- Sample Size: Not explicitly stated as numerical values for each specific test. Implied to be sufficient for demonstrating statistical significance for shelf-life extension.
- Data Provenance: The data is generated from laboratory testing of the device and its packaging. There is no mention of country of origin of the data, but it's generated by Codman & Shurtleff, Inc., based in Raynham, MA, USA. The testing is retrospective in the sense that it's performed on samples aged for specific durations to simulate shelf life (real-time aging).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Experts:
Not applicable. This is a performance study for physical and material properties, not an AI or diagnostic study requiring expert ground truth for interpretation. The "ground truth" for these tests are the established physical and material property standards and specifications of the device.
4. Adjudication Method for the Test Set:
Not applicable. This is not a study requiring adjudication of expert opinions. The results are objective measurements from laboratory tests against predetermined criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This study is focused on the physical and material performance of a medical implant and its packaging over time to justify a shelf-life extension, not on the interpretative accuracy of human readers with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This product is a physical medical implant, not an algorithm or AI-driven device.
7. The Type of Ground Truth Used:
The ground truth used for these performance tests is based on:
- Established physical and chemical properties of the device: The inherent properties the Dural Graft Implant is expected to maintain for its function.
- Regulatory guidance: The tensile strength testing, for example, is performed "per FDA's guidance on physical and mechanical properties testing for dura substitutes."
- Industry standards: For packaging, ASTM F1929-12 and ASTM F88/F88M-09 are cited.
- Predicate device characteristics: The new device (DURAFORM) is explicitly compared to the predicate device (CODMAN Dural Graft Implant) to ensure "substantial equivalence" and that it "does not raise new issues in safety and effectiveness." The predicate device's established performance serves as a comparative benchmark.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/machine learning study requiring a training set.
9. How the Ground Truth for the Training Set was Established:
Not applicable. There is no training set for this type of performance study.
§ 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).