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MONTAGE-XT 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-XT 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-XT device contains two separate components of putty-like consistency comprised of granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, a polyalcohol and a mixture of a lactide-diester and polyester-based polymers. When mixed together, the components of the MONTAGE-XT device form a resorbable putty-like material that can be applied directly to bleeding bone. The resulting hardening material is primarily comprised of calcium phosphate. MONTAGE-XT must be mixed immediately prior to use.

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

The FDA document describes the MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty, which is a medical device for controlling bone bleeding. The submission seeks to prove the substantial equivalence of the new device (MONTAGE-XT) to a previously cleared predicate device (MONTAGE) by Orthocon, Inc. The primary difference highlighted is an extended working time for MONTAGE-XT.

Here's an analysis of the provided text in relation to the requested information:

Acceptance Criteria and Study for MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty

The acceptance criteria for this device are based on demonstrating substantial equivalence to a predicate device (MONTAGE Settable, Resorbable Hemostatic Bone Putty, K141502 and K152005). The studies conducted primarily revolve around characterizing the new device's properties and comparing them to the predicate, especially regarding the extended working time. This is not a study proving clinical effectiveness through outcome measures in an AI/software context, but rather a characterization and comparison study for a physical medical device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not provide specific sample sizes for the performance tests.

• Bench Testing: Performed on the device to characterize properties like stiffness, spreadability, stickiness, working time, etc. No specific count of samples is given.
• Biocompatibility Testing: Conducted on a "representative device." No specific sample size (e.g., number of animals for toxicity tests) is provided within this summary.
• Animal Testing: Included "animal studies" to demonstrate intraoperative in vivo hemostasis and resistance to irrigation. The specific number or details of animals used are not provided.

The provenance of this data is from the manufacturer, Orthocon, Inc., as part of their 510(k) submission to the FDA. The studies appear to be prospective as they were conducted specifically for this submission to characterize the new device. The country of origin for the data generation is not explicitly stated, but it's generated by a US-based company for FDA submission, implying US-based or internationally accepted GLP/ISO standards were followed.

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

This submission is for a physical medical device, not an AI/Software as a Medical Device (SaMD). Therefore, the concept of "ground truth" established by experts (like radiologists for imaging data) is not directly applicable in the same way. The "ground truth" here is established by validated laboratory methods and animal models to measure physical properties, biocompatibility, and hemostatic efficacy.

The relevant "experts" would be the scientists, engineers, and veterinarians conducting the bench and animal studies, following established protocols (e.g., ISO, GLP). Their qualifications are implied by their ability to conduct such studies according to regulatory standards, but specific numbers or qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

Not applicable as this is not an expert-driven AI/SaMD ground truth establishment process. Performance is objectively measured through defined test methods.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not a study involving human readers and AI assistance for diagnostic or interpretative tasks. It's a characterization of a physical medical device.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

Not applicable. This is not an AI/SaMD. The device is a physical bone putty. Its performance is inherent to its physical and chemical properties and how it interacts with the biological environment.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance evaluation comes from:

• Bench Test Results: Quantifiable measurements of physical properties (e.g., working time, stiffness, spreadability).
• Biocompatibility Study Results: Standardized tests (e.g., ISO 10993) assessing biological responses.
• Animal Study Results: Direct observation and measurement of hemostatic efficacy and resistance to irrigation in a live biological model.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning model, so there is no "training set."

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

As there is no training set, this question is not applicable.

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