(69 days)
Bio-Scaffold Bioscaff Alvelac Scaffold is a bioabsorbable implantable matrix intended for use as a space-making barrier in the treatment of periodontal defects and maxillofacial guided tissue regeneration procedures, including preservation and conservation of alveolar bone height and volume, ridge and extraction site augmentation, sinus lifts, and treatment of associated cystic defects. It is also intended for use as a grafting material containment matrix.
The Bioscaff™ Alvelac™ is a synthetic polymer scaffold synthesized from Poly (lactic-coglycolic) acid (PLGA) and poly vinyl acetate (PVA). The scaffold is designed with macro channels and micropores for cell adhesion, as well as to provide the necessary space for bone and tissues to grow.
I am sorry, but based on the provided document, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance. The document does not explicitly state acceptance criteria or quantify device performance in metrics like accuracy, sensitivity, or specificity.
- Sample size for the test set and data provenance. No specific test set or information about its sample size or origin is provided.
- Number of experts and their qualifications for ground truth establishment. The document does not mention any expert involvement in establishing ground truth.
- Adjudication method for the test set. There is no information about any adjudication process.
- MRMC comparative effectiveness study details. The document does not describe any multi-reader multi-case study.
- Standalone algorithm performance. This device is a physical scaffold, not an algorithm, so standalone performance in the context of AI is not applicable.
- Type of ground truth used. No ground truth definition is provided for performance evaluation.
- Sample size for the training set. There is no mention of a training set as this is a physical device, not an AI model.
- How ground truth for the training set was established. Similarly, this is not applicable for a physical medical device.
What the document does provide regarding performance and validation is:
- Performance Data (under "Performance Data" section): "The mechanical properties of the Bioscaff™ Alvelac™ have been determined to be suitable for the intended use. Animal studies have confirmed biocompatibility, resorption rate, and good bone formation."
- Conclusion (under "Conclusions" section): "Based on the information contained within this submission, it is concluded that the Bioscaff™ Alvelac™ is substantially equivalent to the predicate devices already in interstate commerce within the USA."
This document is a 510(k) summary for a physical medical device (a resorbable scaffold for dental bone grafting), not an AI/ML powered device. The regulatory pathway for such a device focuses on demonstrating substantial equivalence to predicate devices rather than meeting specific performance metrics typically associated with AI. The "performance data" refers to the physical and biological properties of the scaffold, not diagnostic accuracy or similar AI-related metrics.
§ 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.