(157 days)
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.
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device 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.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”