(160 days)
VICRYL periodontal mesh is intended for use as a barrier to provide temporary support during the early stages of the healing process following periodontal surgery.
VICRYL periodontal mesh is a bioabsorbable implantable material intended to aid in the healing of periodontal defects.
VICRYL periodontal mesh is prepared from a synthetic, bioabsorbable copolymer of glycolide and lactide. The woven mesh is prepared from undyed strands identical to the strands used in VICRYL (polyglactin 910) synthetic, bioabsorbable suture.
VICRYL periodontal mesh is provided sterile, available in various sizes and shapes each with synthetic, bioabsorbable VICRYL ligatures affixed to the barrier.
This document is a 510(k) premarket notification for the Vicryl Periodontal Mesh. It details the device's summary of safety and effectiveness, including intended use, technological characteristics, and performance data. However, it does not contain the specific information required to complete the table and answer the questions about acceptance criteria and a study proving those criteria.
The document states that "Preclinical laboratory and clinical evaluations were conducted to ensure that the device functioned as intended. Sufficient data has been gathered from preclinical and clinical testing to assess the safety and effectiveness of the new device." but it does not provide details of these studies, nor specific acceptance criteria or performance metrics.
Therefore, I cannot provide the requested information from the given text.
To complete the request, I would need a section of a document that specifically outlines:
- Detailed acceptance criteria (e.g., specific quantitative thresholds for performance metrics).
- A summary or full report of a study (clinical or analytical) that presents performance data against those criteria.
- Information on sample sizes, ground truth establishment, expert qualifications, and adjudication methods for such a study.
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.