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3i® 's Calcium Sulfate Bone Cement is used over a filled defect providing a stable barrier to graft material migration and is also indicated for use as a binder of bone graft particles. For use in dental applications only.

318 Calcium Sulfate Cement is packaged in two syringes. One svringe contains the powder component while the other syringe contains the liguid component. The powder component is calcium sulfate dihydrate (CaSO4 · 2H2O). The liquid component is a solution comprised of potassium citrate monohydrate (KaC6HsOr " H2O), sodium phosphate dibasic (NazHPO4 7H2O), and distilled water (H2O). The svringe with the liguid component comes with a female-female Luer coupler for connecting the two syringes together for mixing. When mixed, the powder and liquid combine to form a homogenous paste. The paste hardens approximately 5-10 minutes after the start of mixing.

This document is a 510(k) premarket notification for a medical device called "3i® Calcium Sulfate Bone Cement." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics like an AI/ML device would require.

Therefore, many of the requested sections regarding acceptance criteria, study design, and performance metrics for an AI/ML device are not applicable to this document.

Here's an analysis based on the provided text, highlighting what information is available and what is not:

1. Table of acceptance criteria and the reported device performance

• Not Applicable. This document does not describe acceptance criteria in the sense of performance metrics for an AI/ML model (e.g., sensitivity, specificity, AUC). Instead, it focuses on demonstrating "substantial equivalence" of the new device to a predicate device based on technological characteristics and intended use. The "performance" discussed is related to biodegradability, resorption time, and biocompatibility in animal studies, not statistical measures of diagnostic accuracy.

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

• Not Applicable. No human clinical test set was used. "Animal studies" are mentioned for biodegradability and biocompatibility, but specific sample sizes or species are not detailed. The document states "Clinical Testing: Not performed on this device."

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

• Not Applicable. No clinical test set or human ground truth establishment process is described.

4. Adjudication method for the test set

• Not Applicable. No clinical test set or adjudication process 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 is not an AI/ML device, and no MRMC study was performed.

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

• Not Applicable. This is not an AI/ML device.

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

• Not Applicable. For the non-clinical testing performed:
  • Biodegradability and resorption: Likely assessed through animal dissection, imaging, and histological analysis over time.
  • Biocompatibility: Assessed through "biocompatibility testing and animal studies," which typically involves in vitro cell assays (cytotoxicity, genotoxicity, sensitization) and in vivo implantation studies with histological examination, blood chemistry, etc. The "ground truth" here would be the results of these biological and analytical tests.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device and therefore no training set was used.

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

• Not Applicable. This is not an AI/ML device and therefore no training set or its ground truth establishment is relevant.

Summary of Relevant Information from the Document:

• Summary of Non-Clinical Testing:
  • The device is biodegradable and in animal studies was found to resorb in approximately four to eight weeks, depending on defect size.
  • Biocompatibility testing and animal studies demonstrate the safety of the material; it was found to be non-toxic, non-mutagenic, non-hemolytic, and nonpyrogenic.
• Clinical Testing: Not performed on this device.
• Substantial Equivalence: The device is deemed substantially equivalent to the predicate device CAPSET® Calcium Sulfate Bone Graft Plaster based on having the "same technological characteristics."
• Intended Use: Used over a filled defect providing a stable barrier to graft material migration and also indicated for use as a binder of bone graft particles. For use in dental applications only.

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