(181 days)
SyntheCel® Dura Onlay is intended for use as a dura replacement for the repair of dura mater in adults.
SyntheCel® Dura Onlay is composed of biosynthesized cellulose and water with a unique construction of non-woven, interconnected cellulose fibers. SyntheCel® Dura Onlay functions as a mechanical layer which protects and repairs the dural defect while preventing further CSF leakage. SyntheCel® Dura Onlay is immunologically inert and has demonstrated minimal foreign body response. It is non-resorbable.
The provided document is a 510(k) summary for the SyntheCel® Dura Onlay device. It primarily focuses on establishing substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a standalone study proving those criteria.
Therefore, many of the requested items cannot be definitively extracted from this document, as the submission relies on previous studies for the predicate device to establish safety and effectiveness.
Here's what can be gathered:
1. A table of acceptance criteria and the reported device performance
The document does not list specific numeric acceptance criteria for performance such as sensitivity, specificity, or AUC, as it's not a performance study of a diagnostic AI device. Instead, the acceptance criteria are based on demonstrating substantial equivalence to a predicate device in terms of technological characteristics and safety/effectiveness data.
| Acceptance Criteria Category | Reported Device Performance (SyntheCel® Dura Onlay) |
|---|---|
| Material | Biosynthesized cellulose |
| Dimensions | 1in x 1in (2.5cm x 2.5cm), 1in x 3in (2.5cm x 7.5cm), 2in x 2in (5.0cm x 5.0cm), 3in x 3in (7.5cm x 7.5cm), 4in x 5in (10.0cm x 12.0cm) |
| Function | Conforms to contours of brain. Functions as a mechanical layer which protects and repairs the dural defect while preventing further CSF leakage. Immunologically inert and has demonstrated minimal foreign body response. |
| Resorbability | Non-resorbable |
| Sterilization | Sterilized by irradiation |
| Biocompatibility | Demonstrated to be non-irritating, non-sensitizing, non-mutagenic, non-cytotoxic, non-hemolytic, and non-pyrogenic (based on prior testing for predicate). |
| Pyrogenicity |
§ 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).