(535 days)
InRoad® Dental Synthetic Bone Graft is intended for the filling and reconstruction of multi-walled bone defects such as:
- Defects after removal of bone cysts
- Augmentation of the atrophied alveolar ridge
- Sinus lift and sinus floor elevation (subantral augmenation)
- Filling of alveolar defects following tooth extraction for alveolar ridge preservation
- Filling of extraction defects to create an implant bed
- Filling of two- or multi- walled infra-bony pockets. and bi- and trifurcation defects
- Support function for a membrane in controlled tissue regeneration (CTR)
- Defects after surgical removal of retained teeth or corrective osteotomies
- Other multi-walled bone defects of the alveolar processes
InRoad® Dental Synthetic Bone Graft (SBG) is a synthetic, semi-dense porous bioceramic for bone regeneration. It is comprised of 90 ± 5% hydroxyapatite (HA) and 10 ± 5% ß-Tricalcium Phosphate (B-TCP). The granules are provided sterile (gamma irradiated) in a capped vial packaged in a sealed tray with lid. InRoad® Dental SBG granules are designed to resemble trabecular bone structure. The granule structure consists of interconnected primary open pores, a secondary channel-like structure, and tertiary small holes on the surface resulting in a biocompatible, osteoconductive biomaterial. The multi-porous structure of InRoad® Dental SBG makes it possible for the bone cells to migrate into the matrices and for new bone to grow. InRoad® Dental Synthetic Bone Graft is available in granule form in sizes of 0.3 - 1.0 mm (Small) and 0.8 - 1.8 mm (Large).
The provided text describes a 510(k) premarket notification for the "InRoad® Dental Synthetic Bone Graft" device (K202675). This document focuses on demonstrating substantial equivalence to a predicate device, rather than defining and proving acceptance criteria in the context of device performance metrics often associated with AI/software devices.
Because this is a bone graft material, the "acceptance criteria" and "study" are related to its biological safety and performance in vivo against a predicate device, not statistical performance metrics of algorithms. Therefore, many of the requested fields (such as sample size for test/training sets, experts, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable to this type of device submission.
Here's an interpretation based on the available information:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" with numerical targets for performance metrics like sensitivity, specificity, or accuracy, as would be expected for an AI/software device. Instead, acceptance for this medical device (a bone graft) is based on demonstrating biocompatibility and equivalent in-vivo performance to a legally marketed predicate device.
The reported performance criteria and findings are summarized as follows:
| Acceptance Criterion (Implicit) | Reported Device Performance (InRoad® Dental SBG) |
|---|---|
| Biocompatibility | - Cytotoxicity: Passed |
- Sensitization: Passed
- Irritation: Passed
- Acute systemic toxicity: Passed
- Material mediated pyrogenicity: Passed
- Subacute / subchronic toxicity: Passed
- Genotoxicity (mouse lymphoma assay): Passed
- Genotoxicity (bacterial reverse mutation study): Passed
- Implantation: Passed
- Chronic toxicity: Passed
- Carcinogenicity: Passed |
| Equivalent In-Vivo Performance (New Bone Growth & Residual Graft) | - Demonstrated equivalent performance for endpoints assessed, including morphometric analysis of new bone growth and residual synthetic bone graft, in a one-wall periodontal defect model in dogs when compared to the predicate device (Osbone® Dental synthetic bone graft material) at 12 weeks. |
| Sterility Assurance | - Achieved a sterility assurance level (SAL) of 1x10^6 through VDmax23 gamma sterilization validation (ISO 11137-2). |
| Packaging Integrity & Shelf-life | - Packaging integrity testing (ASTM F1140 and ASTM D3078) showed that shipping, sterilization, and accelerated aging (equivalent to 1-year real-time aging) did not compromise package strength or seal characteristics. Product performance verification showed material composition and granule size were not significantly changed. Allows for a 1-year shelf-life. |
2. Sample size used for the test set and the data provenance
- Animal Testing: The "sample size" for the in-vivo performance study is "dogs" with a "one-wall periodontal defect model." The exact number of dogs is not specified in this summary.
- Data Provenance: The animal study was conducted with a "US marketed membrane" and compared against a "US marketed predicate device." This suggests the study was conducted within a context relevant to the US market, likely in the US, but the specific country of origin is not explicitly stated. The study is prospective in nature as it involves treatment and observation over time (4, 8, and 12 weeks).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. For a bone graft material, "ground truth" is typically established through observable biological responses and measurements (e.g., histopathology, micro-CT analysis) by qualified personnel (veterinarians, histopathologists, statisticians). The document does not specify the number or qualifications of experts in this context, nor is it a requirement for this type of device submission to detail expert consensus on "ground truth" in the way it would be for an AI diagnostic device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods like "2+1" or "3+1" are relevant for human interpretation tasks, especially in AI diagnostic studies. For an animal study evaluating bone growth and graft resorption, the assessments (e.g., radiographic, micro-CT, histopathological, histomorphometry) are objective measurements and interpretations performed by a team, rather than a consensus-based adjudication process for subjective human readings.
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
- No. This is a bone graft material, not an AI/software device. Therefore, no MRMC study involving human readers with or without AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a physical medical device (bone graft), not an algorithm. Therefore, no standalone algorithm performance study was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the animal study was established through a combination of objective and interpretative methods:
- Animal health observation
- Radiographic assessment
- Micro-CT evaluation with statistical analysis
- Histopathological evaluation
- Histomorphometry
8. The sample size for the training set
- Not Applicable. This is a physical medical device (bone graft), not an AI/software device that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, there is no ground truth for a training set to be established.
§ 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.