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VersaBond® AB Bone Cement with Gentamicin is indicated for the fixation of prostheses to living bone for use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.

VersaBond® AB Bone Cement consists of two separate components: polymer powder and moratists, who The two components are packaged together and are pre-measured, sterlitzed components which, when nixed, form a radiopaque, rapidly setting bone cement.

The provided text is a 510(k) summary for the VersaBond® AB Bone Cement, a Polymethylmethacrylate (PMMA) bone cement loaded with an antibiotic (Gentamicin). This document primarily focuses on demonstrating substantial equivalence to predicate devices and does not contain information about specific acceptance criteria, study designs, sample sizes for test or training sets, expert qualifications, or adjudication methods in the context of device performance metrics like sensitivity, specificity, or image analysis.

The document states that "VersaBond® AB Bone Cement is substantially equivalent to plain VersaBond® Bone Cement, Palacos R, and Simplex." The "Performance Characteristics" section merely says that "denomination and testing has indicated that VersaBond® AB Bone Cement is substantially equivalent to plain VersaBond® Bone Cement, Palacos R, and Simplex."

Based on the provided text, the following information cannot be extracted:

• A table of acceptance criteria and the reported device performance: This document doesn't provide specific quantitative acceptance criteria or detailed performance metrics. It relies on a qualitative statement of "substantial equivalence."
• Sample sizes used for the test set and the data provenance: No information on test sets or data provenance is provided.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no specific test set requiring expert ground truth is described for performance evaluation.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted or reported in this summary.
• Standalone (algorithm-only) performance: Not applicable as this is a physical medical device (bone cement), not an AI algorithm.
• Type of ground truth used: Not applicable as it's not an AI/diagnostic device. The "ground truth" for a bone cement would involve material properties and clinical outcomes, which are not detailed in this summary.
• Sample size for the training set: Not applicable as it's not an AI/machine learning device.
• How the ground truth for the training set was established: Not applicable.

Summary of what can be gleaned from the document regarding "acceptance criteria" and "study":

The "acceptance criteria" for this 510(k) submission revolve around demonstrating substantial equivalence to legally marketed predicate devices. The "study" mentioned is a general "denomination and testing" to establish this substantial equivalence.

Key points from the document regarding substantial equivalence:

• Predicate Devices:
  • VersaBond® Bone Cement, K001160 and K033509 (without antibiotic) by Smith & Nephew, Inc.
  • K012193 (for use of gentamicin antibiotic) by Smith & Nephew, Inc. (likely a prior 510(k) for the antibiotic component)
  • Surgical Simplex P®, PMA N17004 (without antibiotic) by Howmedica Osteonics, Inc.
  • Palacos® G Bone Cement w/Gentamicin, K030086 by Biomet, Inc. (identified as using the "identical, but common antibiotic")
  • Palacos® R Bone Cement, PMA P810020 by EM Industries, Inc.
• Basis for Substantial Equivalence:
  • Technological Characteristics: VersaBond® AB Bone Cement is "to VersaBond Bone Cement (i.e. non-antibiotic)." Similarities include the base bone cement formulation, with the addition of an antibiotic. It shares "similar indications for use and technological characteristics."
  • Antibiotic: The antibiotic used (Gentamicin) is identical to that in Palacos® G Bone Cement with Gentamicin (K030086), which is a predicate device.
  • Performance: "denomination and testing has indicated that VersaBond® AB Bone Cement is substantially equivalent to plain VersaBond® Bone Cement, Palacos R, and Simplex."

In conclusion, this 510(k) summary focuses on regulatory substantial equivalence based on material composition and intended use, rather than presenting a detailed clinical or performance study with quantitative acceptance criteria typically associated with diagnostic or AI-driven devices.

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