(293 days)
OsteoScaf™ bone grafting material is indicated for filling and/or augmenting intraoral/maxillofacial osseous defects, such as intrabony periodontal osseous defects, furcation defects, augmentation of bony defects of the alveolar ridge, filling of tooth extraction sites, and sinus elevation grafting.
OsteoScaf™ is a synthetic osteoconductive and bioresorbable bone grafting material composed of 3-phase biodegradable polymer and calcium phosphate composite, intended to fill and/or augment intraoral/maxillofacial osseous defects. It functions in the same manner as the predicate devices. The product is available as a particulate, cylinder, or block and is provided in sterile packaging in various dosage volumes.
Here's an analysis of the acceptance criteria and study details for the OsteoScaf™ device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes the device's characteristics and performance relative to predicate devices, rather than explicit numerical acceptance criteria. The criteria are framed around demonstrating equivalence or superiority to predicate devices in various properties.
| Acceptance Criteria Category | Reported Device Performance (OsteoScaf™) |
|---|---|
| Chemical Composition | 3-phase composite of 22% (wt) PLGA, 66% Calcium phosphates, and 12% hydroxyapatite. (Implicitly, this composition is acceptable and comparable to predicates). |
| Impurity | Testing demonstrates compliance with ASTM 1185 requirements. (Acceptance: Meets ASTM 1185). |
| Pore Structure | Highly interconnected macroporous structure of larger than 80% porosity and 0.25~1.2 mm pore size similar to human cancellous bone. (Acceptance: Similar to human cancellous bone and predicates). |
| Mechanical Strength | Provides adequate handling properties and strength to ensure dimensional integrity when handled by the surgeon and delivered to bony application sites. (Acceptance: Adequate handling and dimensional integrity, comparable to predicates). |
| Degradation | All three phases of the composite can be resorbed over time through hydrolytic and/or cell-mediated degradation. (Acceptance: Resorbable over time, comparable to predicates). |
| Osteoconductivity | In vivo studies demonstrate that when OsteoScaf™ is placed in direct contact with viable bone, new bone forms in apposition to its surfaces and within its interstices. (Acceptance: Osteoconductive and comparable to predicates). |
| Bioresorption & Bone Formation (Animal Studies) | 1) More new bone formed with OsteoScaf™ compared to coagulum control in a rat calvaria defect model after 4 weeks. |
- Gave rise to more new bone formation and faster resorption of the material than the predicate in a rat model.
- Biomechanical testing in a rat model demonstrates that OsteoScaf™ facilitates replacement with native bone. (Acceptance: Comparable to or better than predicate devices in promoting new bone formation and appropriate resorption rate). |
| Material Equivalence | The device is substantially equivalent to predicate devices in terms of material composition, geometry, and technological characteristics. (Overall Acceptance: Demonstrates substantial equivalence to predicates in key characteristics). |
| Safety and Effectiveness | The material is at least as safe and effective as predicate devices. (Overall Acceptance: At least as safe and effective as predicates). |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated as a number of individual animals. The studies are described as using "a rat calvaria model" and "a rat model." This suggests multiple rats were involved, but the exact count is not provided.
- Data Provenance: Retrospective, as the study has already been conducted and the results are being reported in the 510(k) summary. The country of origin is not specified, but given the applicant's address in San Antonio, Texas, USA, it is likely the studies were conducted domestically or by contractors overseen by the US applicant.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This device is a bone grafting material, and its performance is evaluated through biological and mechanical studies (animal models, physical/chemical tests), not through expert interpretation of images or clinical assessments requiring adjudicated ground truth. The "ground truth" for the animal studies would be objective measurements of new bone formation, material resorption, and biomechanical strength.
4. Adjudication Method for the Test Set:
Not applicable for this type of device and study. Adjudication methods like "2+1" or "3+1" are typically used in clinical imaging studies where expert consensus is needed to establish a diagnostic ground truth. The animal studies involve objective measurements, not subjective expert interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:
No. An MRMC study is not relevant for this type of medical device (bone graft material). MRMC studies evaluate the performance of diagnostic devices or AI algorithms when interpreted by multiple human readers, often with and without AI assistance. This device is a therapeutic/reconstructive material, not a diagnostic tool.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a material for grafting, not a software algorithm.
7. The Type of Ground Truth Used:
For the animal studies, the ground truth was based on:
- Histological and Morphological Analysis: Measurement of new bone formation and material resorption (e.g., "more new bone formed," "faster resorption").
- Biomechanical Testing: Objective measurement of the mechanical properties of the reconstructed bone ("facilitates replacement with native bone").
For the bench tests, the ground truth was based on:
- Analytical Chemistry and Material Science Techniques: Measuring chemical composition, impurity levels, pore structure, and mechanical strength against established standards (e.g., "compliance with ASTM 1185 requirements").
8. The Sample Size for the Training Set:
Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The studies described are performance validation tests.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this 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.