(75 days)
These products are intended to be packed into bony voids or gaps to fill and/or augment dental intraosseous, oral and cranio-/maxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone, including
- . Periodontal defects;
- . Alveolar ridge augmentation;
- Extraction sockets (ridge preservation, implant preparation/ placement); .
- . Maxillary sinus floor elevation;
- Craniofacial augmentation; .
- Root resection, apicoectomy and cystectomy; .
- Tumor resection. .
One or more of the product formulations, depending upon specific anatomical location and physician and/or dentist preference, can be placed in the dental intraosseous defect site.
Regenafil®, Altiva DBM Paste, BioSet™, RTI Allograft Paste, and Osteofil® contain human demineralized freeze-dried bone allograft (DFDBA, also known as demineralized bone matrix, DBM) in an inert porcine gelatin carrier. Regenaform®, Altiva DBM with cortical cancellous chips, BioSet™ IC, RTI Allograft Paste IC, and Osteofil® ICM contain human DFDBA and human cortical-cancellous bone chips in an inert porcine gelatin carrier.
This document K080418 is a 510(k) premarket notification for bone grafting materials. The acceptance criteria and performance data are primarily focused on demonstrating substantial equivalence to predicate devices rather than directly presenting a study with specific quantitative acceptance criteria for device performance in a clinical trial.
Here's a breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not present specific quantitative acceptance criteria in a typical "performance metrics" table format as one might expect for a diagnostic or AI device. Instead, the acceptance criteria are implicitly met by demonstrating "substantial equivalence" to predicate devices. The "performance" reported is the finding of this equivalence based on technological characteristics and results from animal and clinical studies.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence in Design, Function, and Intended Use | The proposed devices (Regenafil®, Regenaform®, Altiva DBM Paste, Altiva DBM with cortical cancellous chips, BioSet™, BioSet™ IC, RTI Allograft Paste, RTI Allograft Paste IC, Osteofil®, Osteofil® ICM) are stated to be substantially equivalent to GRAFTON PLUS® DBM Paste, GRAFTON® DBM, Accell Connexus, and DBX® Demineralized Bone Matrix in design, function, and intended use. |
| Substantial Equivalence in Design, Function, Materials and Processing | The proposed devices are stated to be substantially equivalent to RTI Allograft Paste and RTI Allograft Paste IC in design, function, materials, and processing. |
| Same Technological Characteristics (Design, Material, Chemical Composition) | The devices containing DBM in a gelatin carrier (Regenafil®, Altiva DBM Paste, BioSet™, RTI Allograft Paste, Osteofil®) have the same technological characteristics (design, material, chemical composition) as the predicate RTI Allograft Paste. |
| The devices containing DBM and cortical-cancellous bone chips in a gelatin carrier (Regenaform®, Altiva DBM with cortical cancellous chips, BioSet™ IC, RTI Allograft Paste IC, Osteofil® ICM) have the same technological characteristics (design, material, chemical composition) as the predicate RTI Allograft Paste IC. | |
| Safety and Effectiveness for Dental Bone Void Filling Applications | "Results from animal and clinical studies demonstrate that these products are safe and effective for use in dental bone void filling applications." (Note: A footnote clarifies that findings from animal models are not necessarily predictive of human clinical results). |
| Osteoinductivity | Finished product from each lot is evaluated for osteoinductivity using the modified athymic nude rat assay. (No specific pass/fail rate or quantitative result is provided in this summary, but the method is stated). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "animal and clinical studies" but does not provide details on the sample size for these studies, nor does it specify the data provenance (e.g., country of origin, retrospective/prospective nature). The focus is on the conclusion of safety and effectiveness rather than the specifics of the underlying studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The studies mentioned (animal and clinical studies) would typically involve experts to assess outcomes, but the submission does not detail their involvement or qualifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as the document doesn't detail the methodology of the "clinical studies" or how ground truth was established.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. The device is bone grafting material, not an AI or imaging device that would involve human "readers" or AI assistance. Therefore, an MRMC study and effect size in human improvement with AI are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For osteoinductivity, the ground truth is established through a "modified athymic nude rat assay."
For the general claims of safety and effectiveness, the document refers to "animal and clinical studies." These would likely involve outcomes data such as bone formation, integration, healing, and potentially histological/pathological assessment, but the specifics are not detailed.
8. The sample size for the training set
This is not applicable. The device is bone grafting material. There is no "training set" in the context of an AI/machine learning model. The relevant "training" relates to the development of the bone graft material, which is a manufacturing and biological process, not an algorithmic one.
9. How the ground truth for the training set was established
This is not applicable for the same reasons as #8.
§ 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.