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Bond Apatite™ is a synthetic osteoconductive, bioresorbable bone grafting material composed of hydroxyapatite and biphasic calcium sulfate in granulated powder form. intended to fill. augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.

Bond Apatite is composed of hydroxyapatite and biphasic calcium sulfate in granulated powder form. The hydroxyapatite component is sintered hydroxyapatite granules that conform to ISO 13779-1 Implants for surgery - Hydroxyapatite - Part 1: Ceramic Hydroxyapatite and ISO 13779-3 Implants for surgery – Hydroxyapatite – Part 3: Chemical analysis and characterization of crystallinity and phase purity. The calcium sulfate material is Bond Bone™, a mixture of surgical grade calcium sulfate dihydrate and calcium sulfate hemihydrate, and cleared under K083858. The calcium suffate component conforms to the chemical requirements of ASTM F2224 Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants. Bone Apatite is provided sterile, in a single unit size of 1 cc in a disposable applicator that is used for mixing the dry powder with sterile saline and for delivery to the treatment site.

The provided text is a 510(k) summary for the Bond Apatite™ device. It thoroughly describes the device, its intended use, its composition, and its substantial equivalence to predicate devices. However, the document does not contain specific information about acceptance criteria, a specific study proving the device meets those criteria, sample sizes for test or training sets, expert qualifications, or details of a multi-reader multi-case study.

The text focuses on demonstrating substantial equivalence to predicate devices based on:

• Intended Use: "Bond Apatite™ is a synthetic osteoconductive, bioresorbable bone grafting material composed of hydroxyapatite and biphasic calcium sulfate in granulated powder form. intended to fill. augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region." This is deemed substantially similar to existing predicate devices.
• Materials: Composed of hydroxyapatite and biphasic calcium sulfate, conforming to ISO and ASTM standards. The calcium sulfate component is explicitly stated to be the predicate device, Bond Bone™ (K083858).
• Design and Functional Characteristics: Dry powder mixed with saline, provided sterile in a single-unit mixing/delivery applicator, similar to predicate devices.
• Performance Characteristics: Data submitted included "material characterization by Fourier transform infrared spectroscopy, x-ray diffraction, and inductively coupled plasma optical emission spectrometry; physical characterization by gravimetric methods, mechanical sieve separation, scanning electron microscopy; performance characteristics including setting time and reaction temperature measurements, compressive mechanical properties, pH. dissolution. device handling under simulated usage conditions, and clinical performance testing."

The document concludes that "Any differences in the technological characteristics between the subject and predicate devices do not raise new issues of safety or efficacy," and "The data included in this submission demonstrates substantial equivalence to the predicate devices listed above."

Therefore, based solely on the provided text, it is not possible to fill out the requested table and answer many of the specific questions. The submission isn't about demonstrating performance against independent acceptance criteria in a controlled study with a defined test set; it's about showing that the device is substantially equivalent to already-marketed devices based on material, design, and general performance characteristics.

Here's how I would answer based on the given information, with clear indications of what is not provided:

1. A table of acceptance criteria and the reported device performance

• Same intended use.
• Same operating principle.
• Same basic design.
• Same or very similar materials (hydroxyapatite and biphasic calcium sulfate, with calcium sulfate being a predicate device).
• Similar packaging and sterilization.
• Conformity of components to ISO 13779-1, ISO 13779-3, and ASTM F2224 standards.
• Material and physical characterization (FTIR, XRD, ICP-OES, gravimetric, sieve separation, SEM).
• Performance characteristics (setting time, reaction temperature, compressive mechanical properties, pH, dissolution, device handling under simulated usage conditions, clinical performance testing [details not provided]). |

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

• Sample Size for Test Set: Not specified. The document mentions "clinical performance testing" but does not detail the size or nature of this testing.
• Data Provenance: Not specified.

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)

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: Not specified.

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

• MRMC Study: No, this is not an AI/software device that would typically involve a multi-reader multi-case study to assess improvement with AI assistance. It is a bone grafting material.

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

• Standalone Performance: Not applicable for this device type. It is a physical bone grafting material, not an algorithm.

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

• Type of Ground Truth: The concept of "ground truth" as typically applied to diagnostic algorithms (e.g., pathology for disease detection) is not directly applicable here. The "truth" for this submission revolves around the material's properties, in vitro performance, and "clinical performance testing" for safety and efficacy, which would likely involve histological or clinical outcome measures compared to predicate devices or established benchmarks, but these details are not provided.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is not a device based on a machine learning algorithm requiring a "training set."

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

• Ground Truth for Training Set: Not applicable.

Ask a specific question about this device

Bond Bone™ is indicated for use in the following ways: by itself in bone regenerative techniques, mixed with other suitable bone filling agents to prevent particle migration in an osseous defect, and to provide a resorbable barrier over other bone graft material.

Bond Bone™ is a synthetic ostcoconductive, bioresorbable bone grafting material composed of biphasic calcium sulfate in granulated powder form, intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. When mixed with saline, Bond Bone forms a paste and hardens via a cementitious reaction. The product is provided sterile and for single patient use.

The provided text is a 510(k) summary for the Augma Biomaterials, Ltd. Bond Bone™ device. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria.

The 510(k) summary focuses on demonstrating substantial equivalence to legally marketed predicate devices, which is the primary requirement for 510(k) clearance. It does not typically include detailed performance studies with acceptance criteria in the way described in your request (e.g., performance metrics, sample sizes for test/training, expert adjudication, MRMC studies, or standalone algorithm performance). These types of studies are more common for devices that rely heavily on AI/ML or new and complex technologies requiring extensive performance validation against a defined ground truth.

Therefore, I cannot populate the table or answer the specific questions you've posed based on the provided text. The document indicates that the device is a "synthetic osteoconductive, bioresorbable bone grafting material composed of biphasic calcium sulfate in granulated powder form" and its "equivalence to marketed product" was demonstrated for FDA's purposes. This means its performance was likely evaluated through comparison to already approved similar bone grafting materials, not through the kind of structured performance study that would generate the data you're asking for.

Ask a specific question about this device