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OsOpia is a synthetic, > 90% TCP (Tri-Calcium Phosphate - Ca3(PO4)2) and < 10% Hydroxyapatite (Ca10(PO4)6 (OH)2) resorbable micro-structured bone grafting material for the repair of bony defects. OsOpia induces and guides the three-dimensional regeneration of bone in the defect site into which it is implanted. Rigid fixation techniques are recommended as needed to assure stabilization of the defect in all planes (e.g. bioresorbable barrier membranes). When placed next to viable host bone, new bone will be deposited on the surface of the implant resorbs and is replaced by bone during the natural process of bone remodelling.

OsOpia is gamma sterilized, comes in several sizes in granular form, and is double sterile packaged for single use only.

AI/ML Overview

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<85>) 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 <10%. Primary predicate (OsSatura): β-TCP 20%, HA 80%. A reference device (CuriOs™) has the same β-TCP >90%, HA <10% ratio as OsOpia. This difference in ratio from the primary predicate is addressed by comparison to a reference device with similar composition.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Clinical Studies (Test Set):
- Sample Size: 90 patients overall, across six clinical studies.
- Data Provenance: Not explicitly stated from which country/countries the patients originated, but the studies were prospective. One study was randomized, and the others were single-arm.

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)

Not Applicable. For this bone grafting material, the "ground truth" in clinical studies would typically be assessed by the treating surgeons, periodontists, or oral and maxillofacial surgeons, and confirmed through histological analysis (for bone formation) or clinical follow-up (for implant survival). The document does not specify the number or qualifications of experts for these assessments, but rather the results of those assessments.

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 typically used for discordance resolution in image interpretation or diagnostic evaluations, which is not relevant for the assessment of a bone grafting material.

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

Not Applicable. This is a medical device (bone grafting material), not an AI/ML diagnostic or image analysis tool. MRMC studies are not relevant here.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a bone grafting material, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Clinical Ground Truth:
- Bone Histology: Used in two studies (at 5-6 months post-implantation) to assess new bone formation. This is a form of pathology/histological analysis.
- Implant Survival: Used in four studies, representing outcomes data.
- Adverse Events: Monitoring for adverse events is also a form of outcomes data/safety assessment.
Pre-clinical/Bench Ground Truth:
- Biocompatibility: Based on compliance with ISO standards.
- Sterility: Based on compliance with ISO standards and SAL testing.
- Material Properties: Based on analytical techniques like XRD, FTIR, ICP/MS, and mercury intrusion porosimetry, compared against known characteristics of similar materials (predicates).
- Animal Model Performance: Assessment of bone regeneration in a sheep model.

8. The sample size for the training set

Not Applicable. This is a traditional medical device, not an AI/ML algorithm that requires a training set. The "data" here supports substantial equivalence rather than training a model.

9. How the ground truth for the training set was established

Not Applicable. See point 8.

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