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510(k) Data Aggregation
(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 | < 0.06 EU/ml (Endotoxin Units / ml) using Limulus Amebocyte Lysate (LAL) test (based on prior testing for predicate). |
| Mechanical Strength | Tensile strength and burst strength demonstrated to be substantially equivalent to predicate devices (based on prior testing for predicate). |
| Indications for Use | Intended for use as a dura replacement for the repair of dura mater in adults. |
| Clinical Performance | No new clinical data collected. Relies on data from predicate K113071, which evaluated SyntheCel® Dura Replacement Devices (including SyntheCel® Dura Repair and SyntheCel® Dura Onlay) for safety and effectiveness compared to a Control, demonstrating substantial equivalence to other legally marketed dura replacement products. |
2. Sample size used for the test set and the data provenance
No new test set was used for this specific 510(k) submission. The document states: "No new clinical performance data were collected in support of this submission." and "No new non-clinical performance data were collected in support of this submission."
The previous clinical data referenced was for the predicate device (K113071), but details about its sample size, country of origin, or retrospective/prospective nature are not provided in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no new clinical or performance test set was developed for this submission. The ground truth for the predicate device's studies is not detailed here.
4. Adjudication method for the test set
Not applicable, as no new test set was used for this submission.
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 dura substitute, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical implant device, not an algorithm.
7. The type of ground truth used
For the predicate device's studies, the ground truth would typically be based on clinical outcomes relevant to dura repair (e.g., successful dural closure, lack of CSF leakage, absence of adverse reactions, foreign body response, inflammation) observed in patients. Mechanical testing used measurable physical properties (tensile strength, burst strength). Biocompatibility relied on established in-vitro and in-vivo tests aligned with ISO 10993 standards.
8. The sample size for the training set
Not applicable. This is a medical implant, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is a medical implant, not an AI algorithm.
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