Search Results

VersaBond® Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee, and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary because of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, nonunion of fractures of the femur, osteoporosis, secondary severe joint destruction following trauma or other conditions, and revision of previous arthroplasty procedures.

VersaBond Bone Cement consists of two separate components: polymer powder and monomer liguid. The two components are packaged together and are pre-measured, sterilized components which, when mixed, form a radiopaque, rapidly setting bone cement.

The provided text is a 510(k) summary for VersaBond® Bone Cement and a letter from the FDA. It does not describe an "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in the context of performance metrics for a medical device that would involve a test set, ground truth, or expert review.

Instead, this document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K001160). The "acceptance criteria" here is implicitly that the device is substantially equivalent to the predicate in terms of its characteristics and intended use.

Here's how to address the request based on the provided information, although it will be limited due to the nature of the document:

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 document does not describe a performance study involving a test set as would be relevant for devices that require proof of diagnostic accuracy, clinical effectiveness through new data, or similar metrics. The review is based on a comparison to a predicate device.

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. No ground truth for a test set was established as part of this submission, as it relies on substantial equivalence to a predicate, not new performance data.

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

• Not Applicable. There was no test set or adjudication process described in this document.

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 document is for bone cement, not an AI-assisted diagnostic device. Therefore, no MRMC study, human readers, or AI assistance is relevant.

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

• Not Applicable. This device is a bone cement, not an algorithm or software. Therefore, no standalone performance study in that context was performed.

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

• Implicit Ground Truth: The "ground truth" in this context is the safety and effectiveness of the predicate device (K001160), which would have been established through its own regulatory clearance process, and which this device claims substantial equivalence to. No new ground truth, in the sense of clinical validation data for this specific device, is explicitly presented in this summary.

8. The sample size for the training set

• Not Applicable. This document does not describe a machine learning algorithm or a training set.

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

• Not Applicable. This document does not describe a machine learning algorithm or a training set.

Ask a specific question about this device