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Bone Cement - Normal Viscosity is indicated for fixation of prostheses to live bone in musculoskeletal orthopedic surgical interventions in cases of rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe secondary destruction of the joints after trauma or other conditions and in the review of previous arthroplasty procedures.

The Bone Cement - Normal Viscosity is a self-curing, radiopaque, polymethyl methacrylatebased cements used for securing a metal or polymeric prothesis to living bone in arthroplasty procedures. The bone cement has no intrinsic adhesive properties but rely instead on close mechanical interlock between the irregular bone surface and the prosthesis.

The provided text is a 510(k) summary for a medical device called "Bone Cement - Normal Viscosity." It describes its indications for use, device description, equivalence to a marketed predicate device, and performance data. However, the document does not describe a study involving an AI/Machine Learning device or a study involving human-in-the-loop performance, expert ground truth adjudication, or statistical performance metrics like sensitivity/specificity or ROC curves typically associated with AI device performance and acceptance criteria.

Instead, this document pertains to a traditional medical device (bone cement) and focuses on demonstrating substantial equivalence to a predicate device through physical, chemical, and mechanical properties, as well as sterilization, shelf-life, and biocompatibility testing according to established FDA guidance for PMMA bone cement.

Therefore, I cannot fulfill the request to describe acceptance criteria, a study proving AI device performance, sample sizes for test/training sets, expert ground truth establishment, or MRMC studies, as this information is not present in the provided text.

The document explicitly states: "No clinical data were included in this submission." This further confirms that the type of study outlined in the request (which heavily implies clinical or reader studies for AI performance) was not part of this 510(k) submission.

Summary of why the request cannot be fully answered based on the provided text:

• Device Type: The device is bone cement, not an AI/ML diagnostic or assistive device.
• Study Type: The studies performed are non-clinical, testing physical, chemical, and mechanical properties, sterilization, shelf-life, and biocompatibility. They are not AI performance studies.
• Lack of AI-related metrics: There are no mentions of sensitivity, specificity, AUC, human reader improvement with AI assistance, or any other metrics relevant to AI device performance.
• No Human-in-the-loop or standalone AI performance: The concepts of human readers, expert adjudication, or AI algorithms acting in standalone mode are not applicable to the studies described for bone cement.
• No Training/Test Set Data for AI: There is no mention of training sets, test sets, or ground truth for an AI model because no AI model is being evaluated.

Therefore, for the sake of completeness, I can only state what is described regarding performance criteria for this specific device, which differs significantly from the AI/ML framework requested.

What is described for "Bone Cement - Normal Viscosity" performance testing (non-AI related):

The performance data to establish substantial equivalence were conducted in accordance with the "FDA Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement; Guidance for Industry and FDA" dated July 17, 2002.

Acceptance Criteria and Reported Device Performance (as gathered from the "PERFORMANCE DATA" section):

• Chemical Composition
• Molecular weight
• Physical Properties
• Stability of Components
• Thermal Properties
• Mechanical properties | "The performance data demonstrate that the new device Bone Cement - Normal Viscosity substantially equivalent to the predicate device application K053003." (This implies the results met the established criteria for substantial equivalence to the predicate as per the guidance document.) |
  | Sterilization and Shelf Life | - Validation of ethylene oxide method
• Validation of membrane filter sterilization | "The sterilization process, including the ethylene oxide method and the membrane filter sterilization has been validated and the sterility of the subject device has been verified according to ISO 11135 and ISO 13408-1/2." |
  | Endotoxins | - Assessment on the presence of endotoxins | "The assessment on the presence of endotoxins was carried out in accordance with USP 43 - NF 38, 2020 Bacterial Endotoxins Test." (Implies compliance with the standard.) |
  | Biocompatibility | - Biological evaluation | "The biological evaluation of subject device was performed in accordance with ISO 10993-1 in accordance with the 'Biological evaluation of medical devices - Part 1: evaluation and testing within a risk management process', issued September 20202018.'" (Implies compliance with the standard.) |

Regarding the AI/ML specific questions:

1. Sample size for test set and data provenance: Not applicable. This is not an AI/ML device study.
2. Number of experts and qualifications for ground truth: Not applicable. Ground truth for AI is not established.
3. Adjudication method: Not applicable.
4. MRMC comparative effectiveness study: Not applicable.
5. Standalone performance (algorithm only): Not applicable.
6. Type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" here is the adherence to material and manufacturing standards for bone cement, not diagnostic accuracy.
7. Sample size for the training set: Not applicable. No AI model is being trained.
8. How the ground truth for the training set was established: Not applicable.

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