(215 days)
PerioGlas Plus - Settable Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. PerioGlas Plus is indicated to be packed into bony voids or gaps to fill and/or augment dental intraosseous, oral and maxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone, including: periodontal/infrabony defects; alveolar ridge augmentation (sinusotomy, osteotomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); craniofacial augmentation; sinus lifts; cystic defects. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
PerioGlas Plus is a synthetic resorbable osteoconductive bone graft substitute composed of a calcium phospho-silicate material and a calcium sulfate binder. The device is intended for dental intraosseous, oral, and maxillofacial bony defects. The inorganic calcium and phosphorous components are thermally incorporated in a sodium silicate network (PerioGlas) designed specifically for its absorbability and osteoconductive nature. The calcium sulfate component binds the PerioGlas particles together at the time of implantation and is absorbed from the graft site over the first several weeks following implantation. On absorption of the calcium sulfate, the PerioGlas particles remain in the graft site and are progressively aborbed and replaced by host bone during the healing process.
The provided document is a 510(k) Premarket Notification for the PerioGlas® Plus - Settable Bone Graft Substitute. It does not include information about acceptance criteria or a study proving the device meets those criteria in the context of diagnostic performance (as would be typical for an AI/CADe device).
Instead, this document describes a medical device, its intended use, technological characteristics, and claims substantial equivalence to predicate devices based on its composition and mechanism of action for bone regeneration. The "studies" mentioned are in vitro dissolution data and summaries of prior in vivo performance data for its components, which are used to support the substantial equivalence claim, not to measure against specific performance metrics for a diagnostic device.
Therefore, I cannot populate the table or answer the subsequent questions as they pertain to a type of data (acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, etc.) that is not present in this regulatory submission for a bone graft substitute.
The document does not contain the information required to answer your questions regarding acceptance criteria and performance studies for a diagnostic device.
§ 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.