(241 days)
Elemental Granulate is a periodontal wound dressing intended to protect injured periodontal tissue as surgical sites.
Elemental Granulate is a thermoplastic and non-resorbable medical device, which under in vitro conditions is found to be bacteriostatic. Material consistency is plastic-like and highly moldable after heating. Hardening starts 30 to 60 seconds after taking it away from the heat source. Hardens into a rigid material after approximately 90 seconds. Individual granules may slightly differ in size. For use only by a dental professional in the recommended indications.
I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study proving the device meets them. The document is a 510(k) summary for a medical device called "Elemental Granulate," which focuses on establishing substantial equivalence to a predicate device (COE PAK).
While it mentions non-clinical testing performed (biocompatibility, antibacterial activity, dental material evaluation, usability engineering risk assessment), it does not provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for a test set, data provenance, ground truth establishment, or expert qualifications for any specific study proving acceptance criteria.
- Details on adjudication methods.
- Information about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
- Specific ground truth types or sample sizes for training sets (as no AI/algorithm performance is detailed).
The document explicitly states: "Clinical testing, although available, was not needed in support of this 510(k) application." This reinforces that detailed clinical performance studies, which would typically include acceptance criteria and their verification, are not present in this submission summary.
Therefore, I cannot fulfill your request based on the provided text.
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