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MONTAGE-QS Settable, Resorbable Hemostatic Bone Putty is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade.

MONTAGE-QS Settable. Resorbable Hemostatic Bone Putty is a sterile. biocompatible, resorbable material of putty-like consistency for use in the control of bleeding from bone surfaces. The single use MONTAGE-QS device contains two separate components of putty-like consistency comprised of granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, polyalcohols and a mixture of a lactide-diester and polyester-based polymers. When mixed together, the components of the MONTAGE-QS device form a resorbable putty-like material that can be applied directly to bleeding bone. The resulting material is primarily comprised of calcium phosphate. MONTAGE-QS must be mixed immediately prior to use.

When applied to surgically cut or traumatically broken bone. MONTAGE-QS Settable, Resorbable Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade).

This document (K191140) is a 510(k) Premarket Notification for a medical device called "MONTAGE-QS Settable, Resorbable Hemostatic Bone Putty." It focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving that the device meets specific performance acceptance criteria via a clinical study with a detailed test set, ground truth, and expert evaluation as would be the case for a diagnostic AI/ML device.

Therefore, the information requested for acceptance criteria and a study proving the device meets those criteria (especially points 1 through 9 pertaining to diagnostic performance, expert review, MRMC studies, etc.) cannot be fully extracted or accurately described from the provided text.

Here's a breakdown of what can be extracted and why other points cannot be addressed:

1. A table of acceptance criteria and the reported device performance:

This document does not present acceptance criteria for diagnostic performance outcomes (e.g., sensitivity, specificity, accuracy) or statistical thresholds for improved human reader performance with AI. Instead, it focuses on performance testing to demonstrate substantial equivalence to a predicate device in terms of physical properties, biocompatibility, and functionality.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Sample Sizes: Not explicitly stated for specific tests. The document refers to "bench studies," "biocompatibility studies," and "animal studies" without specifying the number of samples or animals used in each.
• Data Provenance: Not specified. These are engineering and preclinical tests, not clinical data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable. The "ground truth" for this device's evaluation is based on objective physical/chemical measurements (bench testing), biological reactions (biocompatibility), and observed in-vivo effects in animal models, not on human expert radiologist or clinician interpretations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable, as this testing does not involve human interpretation or adjudication of diagnostic findings.

5. 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 device is a bone hemostatic putty, not an AI/ML diagnostic tool meant to assist human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this device's performance is established through:

• Standardized physical and chemical property measurements (e.g., stiffness, dissolution rates).
• Validated biocompatibility assays (ISO 10993 series).
• Direct observation of hemostatic efficacy and resorption in animal models.

8. The sample size for the training set:

Not applicable. This device does not involve machine learning or a "training set."

9. How the ground truth for the training set was established:

Not applicable. This device does not involve machine learning or a "training set."

Summary of Device and Evidence Presented:

The MONTAGE-QS Settable, Resorbable Hemostatic Bone Putty is a sterile, biocompatible, resorbable material intended to control bleeding from cut or damaged bone by acting as a mechanical barrier. The 510(k) submission successfully demonstrated substantial equivalence to a predicate device (MONTAGE Settable, Resorbable Hemostatic Bone Putty K152005) through:

• Bench Testing: Verifying handling properties (stiffness, spreadability, stickiness), temperature sensitivity, electrocautery compatibility, dissolution, and swelling.
• Biocompatibility Testing: According to ISO 10993 recommendations (cytotoxicity, irritation, sensitization, acute systemic toxicity, genotoxicity, implantation, systemic toxicity, hemolysis, endotoxicity, pyrogenicity).
• Animal Testing: Demonstrating intraoperative in vivo hemostasis, resistance to irrigation, local tissue response, and characterizing resorption time.
• Technological Characteristics Comparison: Showing the device is "nearly identical" in configuration, formulation (with one exception for faster setting time), materials (primarily calcium phosphate), and principle of action (mechanical tamponade) to the predicate.

The FDA clearance (K191140) implies that based on these non-clinical tests, the device is considered as safe and effective as the legally marketed predicate device for its stated Indications for Use.

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