(248 days)
Striate+TM is indicated for use in:
- augmentation around implants placed in immediate extraction sockets
- augmentation around implants placed in delayed extraction sockets
- filling of bone defects after root resection or removal of retained teeth
- guided bone regeneration in dehiscence defects; and
- guided tissue regeneration procedures in intrabony periodontal defects
Striate+TM is an implantable biocompatible, sterile, resorbable collagen barrier membrane intended for use in dental guided bone and guided tissue regeneration procedures. Striate+1M has a bilayer structure (rough and smooth sides). The rough side, placed facing the bone defect, is composed of a loose distribution of collagen bundles allowing ingrowth of bone forming cells. The smooth side, facing the soft tissue, is composed of densely packed collagen bundles forming a barrier to soft tissue ingrowth into the defect. Striate+TM is supplied dry and can be easily trimmed to the required size. The collagen material becomes soft and pliable when hydrated allowing conformation to the repair site. Striate+TM has sufficient mechanical strength to be sutured in place, if required, and is gradually resorbed into the surrounding tissue. Striate+TM is sterilized with gamma radiation. Striate+TM is provided in the following sizes: 15 mm x 20 mm, 20 mm x 30 mm x 40 mm, 40 mm x 50 mm.
The provided document, a 510(k) summary for Orthocell Ltd's Striate+TM, describes a bone grafting material/implantable collagen membrane, not an AI-powered medical device. Therefore, the information required to answer your query about acceptance criteria and a study proving device performance (especially for AI or software-based medical devices) is not present in the document.
The document discusses the substantial equivalence of Striate+TM to a predicate device (Geistlich Bio-Gide®) primarily based on:
- Intended Use and Indications for Use: Similar applications in guided bone and tissue regeneration.
- Technological Characteristics: Both are bilayer, suturable, absorbent, retrain tensile strength when wet, cell-occlusive, and resorbable Type I porcine collagen membranes.
- Performance Data (Bench Testing and Animal Study):
- Bench Testing: Evaluated characteristics such as tensile strength, suture pull-out strength, absorbency/wettability, thickness, and composition (amino acid analysis, protein, etc.).
- Biocompatibility: In vitro tests according to ISO 10993-1 (cytotoxicity, irritation, sensitization, local/systemic toxicity, genotoxicity, pyrogenicity).
- Animal Study: A pre-clinical study comparing Striate+TM and the predicate device in a large animal intra-oral model to assess cell-occlusiveness, resorbability, biocompatibility, bone formation, inflammatory response, and membrane degradation rate.
There is no mention of:
- Acceptance criteria in the context of AI/algorithm performance (e.g., sensitivity, specificity, AUC). The document's acceptance criteria are related to the physical, chemical, and biological properties of the material and its in-vivo performance in an animal model.
- Sample size for a test set or data provenance for an algorithm.
- Number/qualifications of experts for ground truth establishment.
- Adjudication methods.
- MRMC comparative effectiveness studies (human readers with/without AI).
- Standalone (algorithm only) performance.
- Types of ground truth for AI (e.g., expert consensus, pathology).
- Training set size or ground truth establishment for a training set.
The document's purpose is to demonstrate substantial equivalence of a physical medical device (a collagen membrane) to a legally marketed predicate, not to validate an AI algorithm.
§ 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.