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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:

1. 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.
2. Sample size for a test set or data provenance for an algorithm.
3. Number/qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. MRMC comparative effectiveness studies (human readers with/without AI).
6. Standalone (algorithm only) performance.
7. Types of ground truth for AI (e.g., expert consensus, pathology).
8. 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.

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