(90 days)
The Cerafix® Dura Substitute is indicated as a dura substitute for the repair of dura mater. This device is indicated for defects of 1.9 in² (12.5cm²) or less in area. For example, 1.2 in x 1.6 in (3 cm x 4 cm) would be an acceptable defect size.
Cerafix® Dura Substitute is a resorbable implant for repair of dural defects and is to be used with tensionless sutures. Cerafix® Dura Substitute is a soft, white, pliable, nonfriable, porous polymer matrix. Cerafix® Dura Substitute is available in a variety of sizes and is supplied sterile and nonpyrogenic in a single-use nested pouch configuration, which is enclosed within a protective chipboard envelope.
The provided text describes the Cerafix® Dura Substitute, a medical device intended for the repair of dura mater, and its journey through FDA 510(k) clearance. The document details the device's characteristics, indications for use, and the non-clinical testing performed to establish its substantial equivalence to predicate devices.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for many of the mechanical and biological tests were framed as "Equivalent to Predicate or Reference Device" or "Meets Final Device Specification." For some, specific thresholds were mentioned.
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Testing | ||
| Thickness | Equivalent to Predicate or Reference Device | PASS |
| Mass per Area | Equivalent to Predicate or Reference Device | PASS |
| Tensile Strength | Equivalent to Predicate or Reference Device | PASS |
| Suture Pull-Out Strength | Equivalent to Predicate or Reference Device | PASS |
| Burst Strength | Equivalent to Predicate or Reference Device; and burst strength greater than anticipated intracranial pressures | PASS (burst strength greater than anticipated intracranial pressures) |
| Shrink Temperature | Show stability at applicable temperatures | PASS (showed stability) |
| Fiber Diameter | Meets Final Device Specification | PASS (meets specification) |
| Pore Size | Meets Final Device Specification | PASS (meets specification) |
| Biocompatibility Testing | ||
| ISO Cytotoxicity MEM Elution | Non-cytotoxic | Cell culture exhibited no reactivity; non-cytotoxic. |
| Guinea Pig Maximization - Sensitization | Non-irritating, no sensitization response | Did not elicit a sensitization response; non-irritant. |
| Intracutaneous Irritation Reactivity | Non-irritating | Non-irritating. |
| Hemolysis Assay | Non-hemolytic | Found to be non-hemolytic. |
| Genotoxicity (Mouse Lymphoma Assay) | Non-genotoxic | Equivalent to negative control; non-genotoxic. |
| Genotoxicity (Mouse Micronucleus Assay) | Non-mutagenic | Considered non-mutagenic. |
| Genotoxicity (Bacterial Mutagenicity) | Non-mutagenic | Considered non-mutagenic. |
| Pyrogenicity (Rabbit Pyrogen Test) | Non-pyrogenic | Exhibited a negative response; non-pyrogenic. |
| Acute Systemic Toxicity | Non-toxic | Considered non-toxic. |
| Endotoxin Testing | Less than 2.15 EU/device | Less than 2.15 EU/device; non-pyrogenic. |
| Subchronic Toxicity (90-day animal study) | Non-toxic | Showed the device to be non-toxic. |
| Chronic Toxicity (180-day animal study) | Non-toxic | Showed the device to be non-toxic. |
| Side-by-Side Animal Study | Equivalent safety and performance to predicate device | Showed equivalent safety and performance. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for each mechanical test (e.g., number of samples tested for tensile strength or burst strength). It mentions "side-by-side bench testing versus the predicate or commercially available reference device" for mechanical tests, and for biocompatibility, it refers to standard ISO/ASTM tests using animals (e.g., guinea pigs, rabbits, mice) and cell cultures. The data provenance is pre-clinical testing, likely conducted in a laboratory setting. There is no mention of country of origin for the data or whether it was retrospective or prospective in the context of human data, as this is a pre-market clearance based on non-clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for this device's clearance is based on established scientific principles and comparison to legally marketed predicate devices through defined acceptance criteria in mechanical and biocompatibility testing, not on expert consensus of clinical data.
4. Adjudication method for the test set
Not applicable. This device clearance relies on objective laboratory and animal testing, not human-based adjudication of clinical outcomes or images.
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 document pertains to the pre-market clearance of a physical medical implant (dura substitute), not an AI-powered diagnostic or assistive technology. Therefore, no MRMC study or AI-related effectiveness is discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an algorithm or AI device.
7. The type of ground truth used
The "ground truth" for this regulatory submission is a combination of:
- Predicate Device Equivalence: The primary ground truth is established by demonstrating that the Cerafix® Dura Substitute's technological characteristics, performance, and safety are substantially equivalent to a legally marketed predicate device (Ethisorb™ Dura Patch) and a reference device (DuraGen Plus™ Dural Regeneration Matrix).
- Established Scientific Standards: Compliance with ISO and ASTM standards for biocompatibility and mechanical properties (e.g., non-cytotoxic, non-pyrogenic, appropriate burst strength).
- Animal Study Outcomes: Equivalence in safety and performance based on side-by-side animal implantation studies compared to the predicate device.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of this device's pre-market clearance, as it's not a machine learning model.
9. How the ground truth for the training set was established
Not applicable, as there is no 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).