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G3 40 Radiopaque Bone Cement is intended for use in arthroplasty procedures of the hip, knee, ankle, shoulder and other joints for the fixation of polymer or metallic prosthetic implants to living bone.

G3 40 Radiopaque Bone Cement is a polymethylmethacrylate (PMMA) bone cement that provides two separate, premeasured sterilized components which, when mixed, form a radiopaque rapidly setting bone cement. The packaging configuration (powder pouches, amber glass ampoule) for the subject device is identical to the predicate device.

The provided text describes the 510(k) summary for the G3 40 Radiopaque Bone Cement, which is a polymethylmethacrylate (PMMA) bone cement. It details the substantial equivalence to predicate devices rather than providing a study proving the device meets specific performance acceptance criteria for an AI/ML device.

Therefore, many of the requested categories (such as sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth used, sample size for training set, and how training set ground truth was established) are not applicable as this document pertains to a traditional medical device (bone cement) and not an AI/ML powered device.

However, I can extract the information relevant to the performance of the bone cement for the applicable categories.

1. A 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)

• Not Applicable. This is a physical medical device (bone cement), and the testing described is primarily in-vitro and mechanical characterization, not a clinical study with patients or data requiring test sets in the context of AI/ML.

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)

• Not Applicable. Ground truth for an AI/ML algorithm is not relevant for this traditional medical device.

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

• Not Applicable. Adjudication methods are not relevant for the performance testing of this physical medical device.

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, so an MRMC study is not relevant.

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

• Not Applicable. This is a physical bone cement, not an algorithm.

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

• Physical Properties/Standardized Tests: The "ground truth" for this device's performance is established by adherence to recognized international and ASTM standards (e.g., ISO 10993 for biocompatibility, ISO/ASTM standards for mechanical properties like compressive strength, bending modulus, cyclic fatigue, tensile properties, creep, fracture toughness, and shrinkage). The results of these tests define its performance against established benchmarks for PMMA bone cements.

8. The sample size for the training set

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

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

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

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