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Cobalt™ HV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary because of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, nonunion of fractures of the neck of the femur, sickle cell anemia osteoporosis, secondary severe joint destruction following trauma or other conditions (also for fixation of unstable fractures in metastatic malignancies), and revision of previous arthroplasty procedures.

Cobalt™ Bone Cement provides two separate, pre-measured sterilized components which when mixed form radiopaque rapidly setting bone cement.

The provided text describes the 510(k) premarket notification for Cobalt™ HV Bone Cement. This submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of diagnostic device performance. Therefore, many of the requested categories regarding acceptance criteria derivation and study design for diagnostic devices are not applicable.

Here's an analysis based on the provided text, addressing the relevant points and indicating where information is not present for this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices like bone cement, acceptance criteria are typically based on in-vitro mechanical, chemical, physical, and handling properties. The "performance" isn't a diagnostic accuracy metric but rather meeting specified ranges for these properties.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify the exact sample sizes (e.g., number of test batches, number of samples per test) used for the in-vitro testing. It refers generally to "extensive in-vitro testing."
• Data Provenance: The data is from "in-vitro testing" conducted by the manufacturer, Biomet Manufacturing Corp. It is not patient or clinical data, so terms like "country of origin" or "retrospective/prospective" in the clinical sense are not applicable.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• This question is not applicable. For material performance testing, "ground truth" is established by validated laboratory testing methods rather than expert consensus on clinical cases. The tests themselves provide the "ground truth" data for the material properties.

4. Adjudication Method for the Test Set

• This question is not applicable. Adjudication typically refers to resolving disagreements among human reviewers (e.g., radiologists) in diagnostic studies. For in-vitro material testing, results are quantitative and subject to standard laboratory quality control.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No MRMC study was performed or is mentioned. This type of study is relevant for diagnostic imaging devices where human readers interpret results. The Cobalt™ HV Bone Cement is a bone cement, not an imaging device. The document explicitly states: "No clinical testing was performed."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• This question is not applicable. "Standalone performance" refers to the performance of a diagnostic algorithm without human intervention. This device is a medical material, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance relies on standardized in-vitro test methods for material properties (mechanical, chemical, physical, handling). These tests are designed to objectively measure properties relevant to the function and safety of bone cement, often following international standards or specific guidance documents (e.g., Class II Special Controls Guidance: Polymethylmethacrylate (PMMA) Bone Cement: Guidance for Industry & FDA-July 17, 2002, mentioned in the document).

8. The Sample Size for the Training Set

• This question is not applicable. The device is a physical product (bone cement), not an AI algorithm that requires a "training set." The materials and manufacturing processes are developed through research and engineering, not machine learning.

9. How the Ground Truth for the Training Set Was Established

• This question is not applicable for the same reasons as #8.

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