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BioSphere Flex is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. BioSphere Flex is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects created from traumatic injury to the bone. BioSphere Flex must be hydrated with autogenous bone marrow prior to implantation. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

BioSphere Flex is a sterile, single-use resorbable bone void filler that is composed of porous bioactive glass granules suspended in a carrier. BioSphere Flex utilizes 45S5 bioactive glass, which has been shown to be osteoconductive and bioactive. The carrier is composed of a porous scaffold of collagen and sodium hyaluronate. BioSphere Flex has the ability to absorb fluid such as bone marrow aspirate and becomes flexible following hydration. Following implantation into the target site, BioSphere Flex supports bone formation through the porosity of the implant and on the surface of the bioactive glass granules. As the materials resorb, the device is eventually replaced by host bone. BioSphere Flex is provided in a variety of forms.

This document describes the BioSphere Flex, a resorbable bone void filler. The information provided is based on a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study design with specific acceptance criteria and performance against those criteria in a tabular format as you requested.

Therefore, many of the specific questions you asked about acceptance criteria and study details cannot be directly answered from the provided text. The document primarily discusses the types of tests performed and the conclusions drawn regarding substantial equivalence.

Here's an attempt to extract and infer information relevant to your questions, along with explicit statements where information is not available:

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

No explicit table of acceptance criteria or specific quantitative performance metrics are provided in the regulatory summary. The summary focuses on demonstrating equivalence to predicate devices rather than meeting predefined numerical acceptance criteria against a specific benchmark.

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

• Test Set Sample Size: For the in vivo critical-sized sheep femoral defect study, the exact sample size (number of sheep) is not specified.
• Data Provenance: The in vivo animal study was conducted in a critical-sized sheep femoral defect, which can be inferred as a preclinical study. The origin country is not specified but is typically within the country of manufacture or a collaborating research institution. It is a prospective study in the sense that the animal model was specifically used to test the device.

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. Ground truth in this context would likely be established through histological analysis and radiographic interpretation by veterinary pathologists/radiologists, but the number and qualifications are not detailed.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or implied. This type of study is more common for diagnostic imaging devices involving interpretation by multiple human readers. The BioSphere Flex is a therapeutic bone void filler.

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

This question is not applicable as the BioSphere Flex is a physical medical device, not an algorithm or AI software, and does not have a "standalone" or "human-in-the-loop" performance in the context of AI. Its performance is inherent in its material properties and biological interaction.

7. The type of ground truth used

For the in vivo animal study, the ground truth was established through:

• Histology: Microscopic examination of tissue.
• Histomorphometry: Quantitative analysis of tissue structure, likely measuring new bone formation, remaining biomaterial, etc.
• Radiographic Analysis: X-ray and micro-CT imaging.

8. The sample size for the training set

This question is not applicable as this is a physical medical device and does not involve AI or machine learning algorithms that require a "training set."

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

This question is not applicable for the same reason as above.

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