(184 days)
The Inion GTR™ Biodegradable Membrane System is indicated for the surgical treatment of periodontal defects to aid in the regeneration and integration of tissue components in guided tissue regeneration procedures (e.g. class II furcation defects, intrabony defects and recession type defects), for pre-implant and peri-implant surgery and for covering bone defects and empty sockets.
The Inion GTR™ Biodegradable Membrane System, intended to be used as a barrier membrane in GTR (guided tissue regeneration ) and GBR (guided bone regeneration). consists of membrancs and separately available tacks made of degradable co-polymers composed of L-lactic, D-lactic, glycolic acid and trimethylene carbonate. The membrane provides a barrier that is stable over 8-12 weeks in vivo. Bioresorption takes place within one to two years. NMP (N-methyl-2-pyrrolidone) plasticizer temporarily softens the membrane and is used to facilitate the handling and shaping of the membrane. Plasticizer is added into the membrane just before the operation. The membranes are fastened in position by using separately available Inion GTR™ tacks or commercially available resorbable sutures. The Inion GTR™ Biodegradable System tack looses its strength over 12-26 weeks in vitro with complete strength loss and resorption within two to four years.
This document is a 510(k) summary for the Inion GTR™ Biodegradable Membrane System. It describes the device's intended use, composition, and claims substantial equivalence to predicate devices. However, this document does not contain information about specific acceptance criteria, a study proving device performance against those criteria, or any statistical analysis of device performance.
Therefore, I cannot provide the requested information. The document focuses on establishing substantial equivalence to previously marketed devices rather than presenting a detailed performance study with acceptance criteria.
Specifically, the document lacks:
- A table of acceptance criteria.
- Reported device performance metrics (e.g., sensitivity, specificity, accuracy, or other relevant clinical or technical metrics for a biodegradable membrane).
- Details about a study design (test set sample size, data provenance).
- Information on ground truth establishment (number/qualifications of experts, adjudication method).
- Any mention of MRMC comparative effectiveness studies or standalone algorithm performance.
- Details about the ground truth used (pathology, outcomes data, etc.).
- Sample size or methods for establishing ground truth for a training set (which would be relevant for an AI/algorithm-based device, but this appears to be a physical medical device).
The statement "Extensively testing demonstrates that the device is substantially equivalent to the predicate ones" is a general claim and does not provide the specific data requested.
§ 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.