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G1 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.

G1 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 G1 40 Radiopaque Bone Cement, a medical device intended for use in arthroplasty procedures. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. Therefore,
No information is available regarding acceptance criteria and a study proving a device meets those criteria in the context of device performance metrics like sensitivity, specificity, or accuracy.

Instead, the document details performance testing conducted to show that the G1 40 Radiopaque Bone Cement has comparable characteristics and performs similarly to its predicate devices. This type of testing is common for demonstrating substantial equivalence for Class II devices.

Here's a breakdown of the available information regarding the performance comparison, addressing the relevant parts of your request:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide specific quantitative "acceptance criteria" for clinical performance (e.g., a certain percentage of successful fixation). Instead, the "acceptance criteria" are implied by compliance with established international and ASTM standards for bone cement properties. The "reported device performance" is framed as "comparable" to predicate devices and "in compliance" with these standards.

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

• Test Set Sample Size: Not explicitly stated as a number of samples or patients. The testing involved material samples for mechanical and material characterization, and biological samples for biocompatibility. The standards listed (e.g., ASTM F451-08, ISO 5833:2002) would dictate appropriate sample sizes for each specific test, but these are not enumerated in the document.
• Data Provenance: Not specified. Given the nature of material and biological testing, it would be laboratory-generated data, likely from the manufacturer or a contracted testing facility. No information on country of origin or whether it's retrospective/prospective is provided, as these terms are more relevant to clinical studies.

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

• Not Applicable. This document describes laboratory and material testing, not human-read clinical data where expert ground truth would be established. The "ground truth" for these tests is based on objective measurements against established international and industry standards.

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

• Not Applicable. See point 3.

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 cement, not an AI-powered diagnostic or assistive technology.

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

• Not Applicable. This is not an algorithm or AI device. The "standalone" performance refers to the device's material properties and biological effects, which were indeed tested directly.

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

• The "ground truth" for these material and biological performance tests is objective physical and chemical measurement against established international and industry standards. For example, compressive strength is objectively measured and compared to the acceptable range defined in ASTM F451. Biocompatibility is assessed through standardized in-vitro and in-vivo tests according to ISO 10993.

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning device that requires a training set.

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

• Not Applicable. See point 8.

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