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Montage-XT Settable Bone Putty is indicated for use on the sternum in cardiothoracic surgery following sternotomy to control bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade, as well as to fill bony voids or gaps in the sternum. When hardened in situ, Montage-XT may be used on the sternum to augment hardware to help support bone during the cardiothoracic surgical procedure.

MONTAGE-XT Settable Bone Putty is a sterile, biocompatible, resorbable material for use in the control of bleeding from bone surfaces in cardiothoracic surgery following sternotomy and filling bony voids or gaps in the sternum. The MONTAGE-XT device comprises two separate components of putty-like consistency containing granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, a polyalcohol and a mixture of a lactide-diester and polyesterbased polymers. When mixed together, the components of the MONTAGE-XT device form a cohesive putty-like material that adheres to the bone surface and remains in place following application. The resulting hardened material is primarily calcium phosphate. MONTAGE-XT components must be mixed immediately prior to use. The device serves multiple clinical functions simultaneously that are integral to recovery after cardiac surgery.

This FDA 510(k) summary is for a medical device (Montage-XT Settable Bone Putty), not an AI/ML powered device, therefore the information requested about acceptance criteria and studies (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable.

The document discusses the device's indications for use and states that it is substantially equivalent to legally marketed predicate devices based on materials, manufacturing process, sterilization, and packaging. It notes that "All the pre-clinical, and clinical testing conducted to support the previous 510(k) clearances are applicable to the subject device." However, the details of those previous studies, including specific acceptance criteria and detailed performance results, are not provided within this summary document.

Therefore, for this specific input, the following information cannot be extracted:

1. A table of acceptance criteria and the reported device performance: Not present. The document asserts substantial equivalence without providing specific performance data against criteria.
2. Sample size used for the test set and the data provenance: Not present for any specific study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no diagnostic study described.
4. Adjudication method: Not applicable.
5. Multi reader multi case (MRMC) comparative effectiveness study: Not applicable, as it's a bone putty, not an AI/ML diagnostic.
6. Standalone performance: Not applicable in the context of AI/ML algorithms.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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