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A-GRIX Resorbable Bone Void Filler is indicated to fill bony void or gaps of the skeletal system (i.e., the extremities, spine and pelvis) that are not intrinsic to the stability of the bone structure. These defects may be surgically created osseous defects created from traumatic injury to the bone void filler resorbs and is replaced with new bone during the healing process. A-GRIX Resorbable Bone Void Filler may be used at an infected site. When used in the spine, the device is limited to posterolateral fusion procedures only.

The A-GRIX Resorbable Bone Void Filler contains 1 bottle of solid phase and 1 bottle of mixing solution. The solid phase is composed of high purity medical grade calcium sulfate hemihydrate fine powder and different size calcium sulfate granules. Because of the special treated granules, the dissolving of A-GRIX Resorbable Bone Void Filler would be longer than other products and closer to the new bone formation. Besides, the different granule size could make it be easy to be filled into the bony defect. When mixed according to the directions, A-GRIX forms the biodegradable, biocompatible and radiopaque paste or putty, and can then be digitally applied directly or by injection into the defect site. A-GRIX Resorbable Bone Void Filler is osteoconductive which acts as a scaffold and facilitate new bone growth. After implanted, it will be resorbed in approximately 90 days and replaced by new bone during the healing process. This product is supplied sterile for single patient use.

The provided text describes a 510(k) submission for the A-GRIX Resorbable Bone Void Filler, focusing on its substantial equivalence to a predicate device rather than a comprehensive study demonstrating its performance against specific acceptance criteria. Therefore, much of the requested information regarding acceptance criteria and performance studies is not explicitly detailed in the provided document.

Here's an analysis based on the available information:

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

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

The document does not detail specific sample sizes for a clinical test set. The performance is primarily based on conformance to material and biological standards, along with a claim of substantial equivalence to a predicate device. Data provenance is not specified beyond adherence to international and ASTM standards. The study appears to be "bench testing" and compliance with standards, not a clinical trial with a defined test set.

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

Not applicable. The submission focuses on substantial equivalence based on material properties and established standards, not on expert-adjudicated performance in a clinical setting.

4. Adjudication method for the test set

Not applicable. No clinical test set requiring adjudication by experts is described.

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

Not applicable. This device is a bone void filler, not an AI-assisted diagnostic or imaging tool.

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

Not applicable. This device is a physical medical implant, not an algorithm.

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

The "ground truth" for this device's performance is established by:

• Compliance with recognized standards: ISO 10993 (biocompatibility), ASTM F2224-03 (material composition), and ANSI/AAMI/ISO 11137 (sterilization).
• Bench testing: Demonstrating that physical and chemical properties are comparable to the predicate device.
• Predicate device's established safety and effectiveness: The A-GRIX device is deemed "substantially equivalent" to an already marketed device (Osteo-G bone void filler, K031319), which implies that its performance is expected to be similar to that device, whose safety and effectiveness would have been previously established.

8. The sample size for the training set

Not applicable. This device is a physical medical implant, not a machine learning model requiring a training set.

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

Not applicable.

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