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INTENDED USE: CEMEX bone cement is intended to be used for the fixation of plastic and metal joint prostheses to host bone.
INDICATIONS FOR USE: CEMEX bone cement is indicated for the fixation of prostheses to bone in orthopaedic musculoskeletal procedures for osteoarthritis, rheumatoid arthritis, osteonecrosis, ankylosing spondylitis, tramatic arthritis, congenital deformities, avascular necrosis, post-traumatic degenerative problems of the joint, sickle cell anemia, osteoporosis, collagen disease and for the revision of previous arthroplasty procedures.

The chemical constituents in CEMEX RX, ISOPLASTIC, and XL bone cements are identical to those in the predicate CEMEX SYSTEM cement (#K000943). The liquid component contains methylmethacrylate, N-N dimethyl p-toluidine, and hydroquinone. The dry powder component contains polymethylmethacrylate, barium sulphate and benzoyl peroxide. Like the predicate CEMEX SYSTEM Bone Cement (#K000943), the ratio between the powder and liquid components of the proposed cements is 3:1. The proportion of each ingredient in the ISOPLASTIC and RX models varies slightly from the predicate model. The XL bone cement formulation is identical to that of CEMEX SYSTEM (#K000943). The differences result in a range of viscosities to accommodate various application techniques.

The provided text describes a 510(k) premarket notification for the Exactech, Inc. Tecres Cemex® System Bone Cement. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a de novo study with reported performance metrics.

Therefore, the input document does not contain the information requested regarding acceptance criteria, reported device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or detailed ground truth establishment methods for a new device study.

The document mainly identifies the device, its intended use, indications for use, contraindications, and lists predicate devices to which it claims substantial equivalence based on chemical composition and manufacturing similarities. The FDA letter confirms the substantial equivalence determination.

Here's how the requested information relates to the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on demonstrating that the new Cemex cements are chemically and functionally similar to existing, legally marketed bone cements (predicates) and the previously cleared Cemex System. It doesn't report new performance data against specific acceptance criteria for this 510(k). For a medical device like bone cement, "performance" would typically involve mechanical properties (tensile strength, compressive strength, fatigue life), biocompatibility, and setting characteristics, but these specific metrics and their acceptance criteria are not detailed as part of this submission summary.

2. Sample sized used for the test set and the data provenance: Not applicable for this type of submission as no new test set data is presented for performance evaluation against acceptance criteria. The basis for substantial equivalence is primarily the similarity in chemical composition and intended use to existing devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new ground truth establishment for a test set is discussed.

4. Adjudication method: Not applicable. No new test set data or expert judgments are presented that would require an adjudication method.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This type of study is typically for diagnostic imaging devices where human interpretation is involved. Bone cement is a therapeutic/fixation device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No. This applies to AI/ML software. The Cemex system is a bone cement.

7. The type of ground truth used: Not applicable in the context of a new performance study. The "ground truth" for a 510(k) submission like this is effectively the established safety and efficacy of the predicate devices.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

In summary, the provided document describes a 510(k) submission for bone cement based on substantial equivalence, not a study evaluating a device against specific performance acceptance criteria.

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