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Bi-Ostetic Bioactive Glass Foam is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created or result from traumatic injury to the bone, and are not intrinsic to the stability of the bony structure. The graft resorbs and is replaced by the growth of new bone during the healing process. Bi-Ostetic Bioactive Glass Foam must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine.

The device is a bone void filler consisting of a collagen matrix mineralized with hydroxyapatite (HA) - tri-calcium phosphate (TCP) granules and 45S5 bioactive glass granules. The bovine fibrillar collagen component is biocompatible. The 45S5 glass particles are bioactive. The device is available in the form of granules, strips and putty. The composition of the granules is 60 wt% HA and 40 wt% TCP. The amount of 45S5 granules in the graft is 20 wt%. When used in the extremities, the granules and strips can be hydrated with sterile water and blood (nominally 1:1). When used in the posterolateral spine, the graft material must be hydrated with bone marrow aspirate (1:1 ratio), then mixed with autograft bone (1:1 ratio). The defect site should be filled as completely as possible. The device provides a scaffold around which new bone can grow. A series of surface reactions on the particles results in the formation of a calcium phosphate layer that is substantially equivalent in composition and structure to the hydroxyapatite found in bone mineral. This apatite layer on the 4555 granules and the hydroxyapatite- tri-calcium phosphate granules provide an osteoconductive scaffold onto which the patient's new bone will grow. During healing, the graft particulate is absorbed and remodeled into new bone.

Here's an analysis of the provided text regarding the acceptance criteria and study for the device, organized according to your requested information. It's important to note that the document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than a detailed report of a de novo clinical trial with explicit acceptance criteria. Therefore, some of your requested points may not be fully addressed by this type of document.

Device Name: Bi-Ostetic Bioactive Glass Foam

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) summary for substantial equivalence, formal, quantitative acceptance criteria are not explicitly stated in the document in the typical statistical sense (e.g., "sensitivity must be > X%, specificity > Y%"). Instead, the 'acceptance criterion' is generally demonstrating that the new device is as safe and as effective as the predicate devices, and performs as well as or better than them. The performance data presented serves to support this claim of substantial equivalence.

2. Sample size used for the test set and the data provenance

• Sample Size: The document only mentions "animal models" for in vivo performance testing. It specifies "postero-lateral spine fusion and femoral cancellous defect animal models." The exact number of animals or defects tested is not provided.
• Data Provenance: The study described is an animal study (in vivo). The country of origin is not specified, but the manufacturer is based in Berkeley, California, USA. The study is presented as evidence for a regulatory submission, implying it was conducted to demonstrate substantial equivalence prospectively for that purpose.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. For animal studies, specific expert involvement for "ground truth" (e.g., blinded histological review) is often part of the methodology, but the details are absent here.

4. Adjudication method for the test set

This information is not provided.

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

No, this type of study was not done. The device is a bone void filler, not an AI-powered diagnostic or assistive tool for human readers.

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

This question is not applicable as the device is a medical implant, not an algorithm.

7. The type of ground truth used

For the in vivo animal studies which assessed "radiographic, morphometric and histologic performance," the ground truth implicitly would have been derived from:

• Radiographic imaging: Interpretation of images.
• Morphometric analysis: Quantitative measurements of bone growth/resorption from histology or imaging.
• Histology: Microscopic examination of tissue sections, often by a veterinary pathologist or histologist.

8. The sample size for the training set

This question is not applicable as the device is a medical implant and not an AI algorithm requiring a training set.

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

This question is not applicable as the device is a medical implant and not an AI algorithm.

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