(89 days)
Hi-Fatigue G Bone Cement 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. The cement is intended for use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.
Hi-Fatique G Bone Cement is a PMMA, radiopaque bone cement, containing gentamicin, designed for the fixation of prothesis to the living bone. Hi-Fatigue G Bone Cement is a traditional bone cement product. The bone cement is made of two separate sterile components. When both components are mixed together, they become a selfhardening, radiopaque bone cement which fixes the implant. The liquid is contained in a vial and the powder in a pouch; these components are packed in blister with Tyvek lid or an aluminium pouch. The devices are sold disposable, single-use and sterile.
The provided text describes the 510(k) submission for Hi-Fatigue G Bone Cement and focuses on the non-clinical performance data to establish substantial equivalence to predicate devices, rather than a study involving AI or human readers. Therefore, I cannot provide information on acceptance criteria and a study proving the device meets them in the context of AI performance, MRMC studies, or human reader improvement with AI.
However, I can extract the acceptance criteria and study information related to the device's physical, chemical, and mechanical properties based on the "FDA Class II Special Controls Guidance Document: Polymethylacrylate (PMMA) Bone Cement; Guidance for Industry and FDA" dated July 17, 2002.
Acceptance Criteria and Reported Device Performance
The document states that "The performance data fulfill the pre-defined acceptance criteria and demonstrate that the new devices Hi-Fatigue G Bone Cement is substantially equivalent to the predicate device Palacos® R+G... and meet the requirements of the Special Controls Guidance document."
The text lists categories of performance testing but does not provide specific numerical acceptance criteria or the exact reported device performance values for each. It broadly states that the device meets the criteria.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mixing and Application characteristics (e.g. dough time, setting time, viscosity, intrusion) | Fulfilled pre-defined acceptance criteria, demonstrated substantial equivalence. |
| Chemical Composition (e.g. trace elements, residual low MW molecules, leachables) | Fulfilled pre-defined acceptance criteria, demonstrated substantial equivalence. |
| Molecular weight and Polymer structure (e.g. molecular weight, glass transition temperature) | Fulfilled pre-defined acceptance criteria, demonstrated substantial equivalence. |
| Physical Properties (e.g. porosity, shrinkage) | Fulfilled pre-defined acceptance criteria, demonstrated substantial equivalence. |
| Stability of Components (e.g. change in monomer viscosity due to artificial aging) | Fulfilled pre-defined acceptance criteria, demonstrated substantial equivalence. |
| Thermal Properties (e.g. maximum polymerization temperature) | Fulfilled pre-defined acceptance criteria, demonstrated substantial equivalence. |
| Mechanical properties (e.g. cyclic fatique properties, bending properties, compressive properties, tensile properties, fracture toughness) | Fulfilled pre-defined acceptance criteria, demonstrated substantial equivalence. |
| Bacterial Endotoxins (limits of 20 endotoxin units (EU)/device) | Test results meet the endotoxin limits of 20 endotoxin units (EU)/device as defined in USP and as recommended by the FDA guidance. |
Details Regarding the Study
- Sample size used for the test set and the data provenance: Not specified. The document refers to "performance data" and "non-clinical performance testing" without detailing sample sizes for each test. The data provenance is not explicitly stated.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" here refers to established engineering and material science standards (e.g., precise measurements of mechanical properties, chemical composition analysis) rather than expert interpretation of medical images or patient data.
- Adjudication method for the test set: Not applicable. The tests are objective measurements against defined standards.
- 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 pertains to a bone cement device, not an AI-powered diagnostic or assistive tool for human readers.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm or AI device.
- The type of ground truth used: The ground truth is based on established engineering standards for material properties, chemical composition, and performance characteristics of bone cement, as outlined in the "FDA Class II Special Controls Guidance Document: Polymethylacrylate (PMMA) Bone Cement; Guidance for Industry and FDA" and relevant USP/Ph. Eur. standards for endotoxins.
- The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided text describes the non-clinical testing of a bone cement device against established material science and medical device standards, not against AI performance metrics or human perception studies.
§ 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.”