(115 days)
OsOpia is a bone grafting material indicated for use in the specific treatment of extraction sockets and maxillary sinus augmentation procedures.
OsOpia is a synthetic, > 90% TCP (Tri-Calcium Phosphate - Ca3(PO4)2) and
The provided text describes the regulatory clearance for the OsOpia Synthetic Bone Void Filler. It does not, however, describe the acceptance criteria of a device (e.g., an AI/ML algorithm or diagnostic tool) in the typical sense of performance metrics like sensitivity, specificity, or F1-score. Instead, it details the criteria and studies used to demonstrate substantial equivalence for a medical device (a bone grafting material) to existing legally marketed predicate devices, as required for a 510(k) submission to the FDA.
Therefore, many of the requested items (sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable in the context of this traditional medical device submission, which is not for an AI/ML device.
However, I can extract the relevant information from the provided document regarding how the device (OsOpia Synthetic Bone Void Filler) met the criteria for substantial equivalence.
Here's a breakdown based on the document:
1. Table of "Acceptance Criteria" (for Substantial Equivalence) and Reported Device Performance
| Criterion Type | Description of Criterion (as implied by FDA 510(k) process for this device type) | Reported Device Performance (OsOpia) |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1 and FDA Guidance for biological evaluation of medical devices (including cytotoxicity, irritation/sensitization, systemic toxicity, genotoxicity, implantation, and hemocompatibility, as applicable). | Assessed using ISO 10993-5 (cytotoxicity), ISO 10993-6 (local effects after implantation), ISO 10993-9 (degradation of materials), ISO 10993-10 (irritation and skin sensitization), and ISO 10993-11 (systemic toxicity). Found to be biocompatible per ISO 10993-1. |
| Sterilization Validation | Sterility Assurance Level (SAL) of 10^-6 for devices sterilized by gamma irradiation. | Validated in accordance with ISO 11137-1 and ISO 11137-2 to a sterility assurance level of 10^-6. |
| Shelf Life | Demonstration of product and packaging stability over the claimed shelf life, commonly through accelerated and real-time aging studies. Parameters like physical integrity, and product characteristics (e.g., chemical composition, functional properties) should be maintained. | Assigned based on accelerated and real-time aging studies of both packaging and product. Packaging tested with burst (ASTM F1140), peel (ASTM F88), and gross leak (ASTM F2096) tests. Product stability assessed by monitoring color, XRD, SEM, and porosity. |
| Bioburden/Pyrogenicity | Adherence to specifications for microbial load (bioburden) and absence of pyrogenic substances (bacterial endotoxin). | Verification batches met specifications for bioburden and pyrogenicity. Bacterial endotoxin testing (LAL method, USP) showed the device meets FDA established endotoxin limits. |
| Material Characterization | Demonstration of equivalent chemical composition, physical properties, and performance characteristics to predicate/reference devices through standardized testing. This typically includes identification of components, structural analysis, and functional assessments relevant to the device's intended use. | Performed in accordance with ASTM F1088. Included: X-ray diffraction (XRD) and Fourier transform infrared spectroscopy (FTIR) for chemical composition; inductively coupled plasma/mass spectroscopy (ICP/MS) for trace elemental analysis; dissolution for in vitro calcium release rate; and mercury intrusion porosimetry for porosity. Analytical characterization demonstrated equivalent chemical composition, physical properties, and performance to predicate/reference devices. |
| Animal Study Performance | Demonstration of suitable performance as a bone grafting material in a relevant animal model for the intended use, showing bone formation and integration. | Evaluated in a sheep model for intraoral maxillary sinus floor augmentation surgery. Results demonstrated suitable performance as a bone grafting material for maxillary sinus augmentation. |
| Clinical Performance | For bone grafting materials, this often involves demonstrating suitable clinical outcomes such as new bone formation, implant survival rates in procedures where the graft is used, and absence of serious adverse events, to show safety and effectiveness comparable to marketed devices, especially for the stated indications (extraction sockets, maxillary sinus augmentation). | Six clinical studies (all prospective, one randomized, others single-arm) involving 90 patients were used. No serious adverse events reported. Two studies (at 5-6 months post-implantation) showed equal or greater new bone formation than control via bone histology. Four studies evaluated implant placement survival, reporting a survival rate of ≥96%. Demonstrated performance for socket extraction and maxillary sinus augmentation. |
| Indications for Use | The intended use and indications for use should be substantially equivalent to a predicate device, or any differences should not raise new questions of safety or effectiveness. The range of use (e.g., granule size) should be within or narrower than that of the predicate. | Proposed indications (extraction sockets and maxillary sinus augmentation) are narrower than the primary predicate (which includes root resection, apicoectomy, cystectomy, and periodontal defects in addition to sockets and sinus augmentation), raising no new questions of safety/effectiveness. Granule size range (250-1000 µm) is within the predicate's range (200-2000 µm) and narrower, thus raising no new safety/effectiveness issues. |
| Composition | The device's composition (e.g., ratio of β-TCP to HA) should be substantially equivalent to or reasonably compared with predicates or reference devices, without raising new safety/effectiveness concerns. | OsOpia: β-TCP >90%, HA 90%, HA |
§ 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.