Search Results

NanoGen 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 materials.

NanoGen is a mixture of particles composed of densely packed grains of nanocrystalline calcium sulfate and medical grade calcium sulfate hemihydrate powder. The particles range from 400 - 850 microns in size. The particles of nanocrystalline calcium sulfate are purely synthetic and are manufactured from medical grade calcium sulfate hemihydrate through a proprietary process. Because of its unique structure, NanoGen undergoes controlled, slower degradation as compared to traditional calcium sulfate.

NanoGen is designed to set-up in vivo and may be used either alone or mixed with DFDBA (demineralized freeze-dried bone allograft) or autogenous bone in bone in bone regenerative procedures. It is mixed with small amounts of normal saline to produce a putty-like paste and is then applied to the bone defects. Set NanoGen dissolves with time. The calcium present in NanoGen is believed to contribute to the mineralization of newly regenerated bone.

This response will address the request based on the provided text, but it's important to note that the document (a 510(k) summary) does not contain the specific types of studies (e.g., MRMC, standalone algorithm performance, detailed ground truth establishment for a diagnostic device) typically associated with establishing acceptance criteria for diagnostic or AI-driven medical devices.

The provided document describes a bone filling augmentation material (NanoGen), not a diagnostic device or an AI-powered system that requires performance metrics like sensitivity, specificity, or AUC against a ground truth established by experts. Instead, the "acceptance criteria" for this type of device are primarily related to substantial equivalence to existing predicate devices, focusing on material composition, intended use, physical properties (resorption time), and adherence to recognized standards. The "study" mentioned is primarily a summary of testing related to chemical composition and biocompatibility, along with a literature review.

Therefore, the answers will reflect the nature of the provided document for a bone graft material, rather than a diagnostic AI device.

Description of Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria (for NanoGen - Bone Filling Augmentation Material)

The acceptance criteria for NanoGen are implicitly defined by its demonstration of substantial equivalence to predicate devices (SurgiPlaster K011403 and BoneGen-TR K060285) based on intended use, material composition, physical properties, and adherence to recognized standards. The "study" that proves the device meets these criteria is a combination of chemical testing, literature review, and comparison with predicate devices.

1. Table of Acceptance Criteria and the Reported Device Performance

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

The document does not describe a "test set" in the context of a diagnostic or AI device for which performance metrics (e.g., sensitivity, specificity) are calculated. Instead, the "testing" focused on material characteristics:

• Chemical Composition Testing: The chemical composition of the Calcium Sulfate Hemihydrate used to make NanoGen was tested by an independent laboratory. No specific sample size for this chemical test is provided, but it would typically involve a representative sample of the raw material. The provenance is implied to be from the independent laboratory conducting the test.
• In vitro Dissolution Studies: These studies confirmed NanoGen's degradation time. No specific sample size or provenance is detailed, but these are typically laboratory-controlled experiments.
• In vivo studies: The document states that "This finding [12-week degradation] has been confirmed by in vivo studies." No details on sample size, animal model, or human subjects are provided within this summary.
• Literature Review: Extensive literature articles documenting the use of calcium sulfate particles were provided to support biocompatibility and safety. This is a review of existing, published data rather than new prospective or retrospective data generated for this specific submission.

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)

This information is not applicable to the type of device (bone filling augmentation material) and the nature of the provided 510(k) summary. There was no "ground truth" to be established by clinical experts in the context of diagnostic accuracy. The assessment focuses on material properties, safety, and equivalence.

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

This information is not applicable. There was no "test set" requiring adjudication by multiple experts in the context of diagnostic agreement.

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

This information is not applicable. This device is a bone filling augmentation material, not an AI-assisted diagnostic tool for human readers.

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

This information is not applicable. This device is a physical biomaterial, not an algorithm or AI system.

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

The "ground truth" for this device relates to its material properties and biological interactions, assessed through:

• Chemical analysis: Conformance to recognized standards for calcium sulfate.
• In vitro and in vivo degradation: Observational data on resorption time.
• Biocompatibility: Established through literature review and material testing.

This is fundamentally different from a ground truth for a diagnostic device (e.g., pathology report for a cancer diagnosis).

8. The sample size for the training set

This information is not applicable. This device is a physical biomaterial and does not involve a "training set" in the context of machine learning.

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

This information is not applicable for the reasons stated in point 8.

Ask a specific question about this device