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BonOs R is intended for use in arthroplastic procedures of the hip, knee and other joints for the fixation of polymer or metallic prosthetic implants to living bone.

BonOs R is a fast-setting acrylic resin for use in bone surgery. The bone cement is made of two separate sterile components. When both cement components are mixed together, they become a self hardening, radlopaque bone cement which fixes the implant and transfers stressesevenly to the bone.

Bone cements in general are self-polymerizing two-component systems comprising a powder and a liquid which polymerize at room temperature immediately after they are mixed together.

The major powder component is polymethyl methacrylate / acrylate. Furthermore a radio-opacifier and benzoyl peroxide as an initiator is Included.

The liquid mainly consists of methyl methacrylate. It is furthermore comprised of an activator and a stabilizer to prevent premature polymerization.

When the powder and liquid components are mixed together, the activator, DmpT, contained in the liquid activates the initiator in the powder component. This reaction starts the polymerization of the MMA, which is bonded with the polymer powder during ongoing polymerization. A description of polymerization technology is depictured in section 10- Executive summary, annex 10 - A.

As a result, a viscous paste is obtained which can be introduced into bone using a suitable application system. Heat is generated during setting as a result of the progressive polymerization and exothermlc reaction respectively. After curing, the bone cement is able to fix the implant. The setting or curing time is greatly influenced by the temperature of the components and environment, which Is common for all acrylic bone cements.

The provided text describes the 510(k) summary for the BonOs R PMMA bone cement, but it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other specific study design elements requested in your prompt.

The document primarily focuses on demonstrating "substantial equivalence" of BonOs R to a predicate device, Palacos R. This type of submission relies on showing that the new device has the same intended use, materials, and operational principles as a legally marketed device, and that any differences do not raise new questions of safety or effectiveness.

Therefore, I cannot fulfill your request for the detailed study information based on the provided text. The document only states:

1. Table of Acceptance Criteria and Reported Device Performance: This information is not present. The document only compares the constituent materials of BonOs R and Palacos R, and states: "BonOs R bone cement is as safe and effective for the declared indications as the predicate device, Palacos R." This is a conclusion of equivalence, not a report of specific performance metrics against acceptance criteria.

2. Sample size used for the test set and the data provenance: Not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.

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-assisted diagnostic tool.

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 AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned. The "ground truth" for a bone cement would typically be established through in vitro mechanical testing and preclinical/clinical studies, but details of such studies are not in this 510(k) summary.

8. The sample size for the training set: Not mentioned. (Again, this isn't an AI device with a "training set").

9. How the ground truth for the training set was established: Not applicable.

What the document does provide regarding equivalence:

The document states that BonOs R is substantially equivalent to Palacos R (K030902) in regard to:

• Intended use: Both are for "arthroplastic procedures of the hip, knee and other joints for the fixation of polymer or metallic prosthetic implants to living bone."
• Materials: The major components (polymer powder, initiator, radiopacifier, liquid monomer, activator) are listed as being the same for both devices, with Palacos R additionally containing "Chlorophyll Copper Complex."
• Operational principles: Both are "self-polymerizing two-component systems comprising a powder and a liquid which polymerize at room temperature immediately after they are mixed together."

The document mentions that "Intellate ably materified by physical, chemical and mechanical comparative tests to Palacos R" were performed, but it does not detail the results, acceptance criteria, or methodology of these tests.

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BonOs R Genta is intended for use in arthroplastic procedures of the hip, knee and other joints for the fixation of polymer or metallic prosthetic implants to living bone when reconstruction is necessary because of revision of previous arthroplasty procedures due to joint infection. The cement is intended for use to affix a new prosthesis in the second stage of a two-stage revision after the initial infection has been cleared.

BonOs R Genta is a fast-setting acrylic resin with the addition of gentamicin sulfate for use in bone surgery. The bone cement is made of two separate sterile components. When both cement components are mixed together, they become a self hardening, radiopaque bone cement which fixes the implant and transfers stresses evenly to the bone.

The provided text describes the BonOs R Genta bone cement and claims substantial equivalence to the predicate device Palacos R+G. However, it does not include information about acceptance criteria or a study proving the device meets those criteria, as typically found in a clinical trial report.

Instead, the document is a 510(k) summary for a medical device, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a new efficacy study with defined acceptance criteria. The equivalence here is based on material composition, mechanical safety, and performance characteristics compared to an existing device, not on clinical performance against a specific set of outcomes with acceptance thresholds.

Therefore, the requested information cannot be fully extracted from the provided text. I will explain what information is present and what is missing.

Missing Information:

• 1. A table of acceptance criteria and the reported device performance: This is not present as it's not a clinical performance study.
• 2. Sample size used for the test set and the data provenance: No test set in the context of clinical performance is described. The "test set" for equivalence was likely material testing and characterization.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as it's not a diagnostic or prediction study.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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, as this is a bone cement, not an AI diagnostic device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of clinical ground truth for a diagnostic device. The "ground truth" here is the established properties of the predicate device.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

What the document does state regarding "study" and "criteria":

The document claims substantial equivalence based on:

• Scientific concepts, significant physical and performance characteristics: The device is described as a self-polymerizing two-component system, similar to other bone cements.
• Summary of technological characteristics: A direct comparison table is provided between BonOs R Genta and the predicate device Palacos R+G.
  • Shared characteristics: Common name (PMMA Bone Cement), Responsible manufacturer (aap Biomaterials vs. Heraeus Kulzer), Product Code (LOD, MBB), Classification (Class II), Regulation no. (21 CFR 888.3027), Materials (Polymer, Initiator, Radiopacifier, Antibiotic, Monomer, Activator).
  • Specific material comparison:
    • Powder: Both use Poly(methyl acrylate, methyl methacrylate) polymer, Di-benzoyl peroxide initiator, Zirconium dioxide radiopacifier, and Gentamicin antibiotic.
    • Liquid: Both use Methylmethacrylate (stabilized with hydroquinone) monomer and N,N-dimethyl-p-toluidine activator.
    • Note: Palacos R+G is mentioned to contain "Chlorophyll Copper Complex," which is not listed for BonOs R Genta, but the overall conclusion is still substantial equivalence.
• Equivalence verification: "Equivalence was verified by physical, chemical and mechanical comparative tests to Palacos R+G." This implies laboratory-based testing of properties rather than a clinical trial. The specific results of these tests are not provided in this summary.

Conclusion:

This document is a regulatory submission demonstrating substantial equivalence for a bone cement based on material composition and physical/mechanical properties compared to a predicate device. It does not contain information about clinical performance against specific acceptance criteria, nor does it describe a clinical study with human subjects, expert adjudication, or AI performance metrics.

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