(151 days)
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.
§ 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.”