(60 days)
Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade.
Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste is a sterile, biocompatible, resorbable material for use in the control of bleeding from bone surfaces. The single use device contains two separate components of paste-like consistency comprised of granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, polyalcohols, a mixture of a lactide-diester and polyester-based polymers and barium sulfate. When mixed together, the components of the device form a resorbable paste-like material that can be applied directly to bleeding bone by means of a single-use applicator (delivery device). The resulting hardening paste is primarily comprised of calcium phosphate. Montage Flowable XRO is mixed immediately prior to use.
When applied to surgically cut or traumatically broken bone. Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste achieves local control of bleeding by acting as a mechanical barrier (tamponade).
The provided text is a 510(k) summary for a medical device called "Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste." This document aims to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.
However, the 510(k) summary does not contain information about acceptance criteria or a study that rigorously proves the device meets specific acceptance criteria in the manner you've outlined for AI/diagnostic devices.
This type of document for a conventional medical device (like a hemostatic bone paste) primarily focuses on demonstrating substantial equivalence to a predicate device through comparisons of:
- Intended Use: The new device has the same intended use as the predicate.
- Technological Characteristics: The new device has similar technological characteristics to the predicate. Any differences do not raise new questions of safety or effectiveness.
- Performance Data: This typically involves bench testing, biocompatibility, and sometimes animal studies to show that the device performs as intended and is safe.
Therefore, for your specific request regarding acceptance criteria and a study proving performance, I must state that the provided text does not contain the requested information in the format or detail typically associated with AI/diagnostic device performance studies.
Here's why and what the document does provide:
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Table of Acceptance Criteria and Reported Device Performance: This is not present for specific diagnostic metrics (e.g., sensitivity, specificity, AUC). The document lists comparisons of technological characteristics between the subject device and a predicate. The "performance" section describes general types of testing (bench, biocompatibility, animal) but no quantitative results against predefined acceptance criteria for diagnostic accuracy.
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Sample Size Used for the Test Set and Data Provenance: No test set is described in terms of human subjects or data for diagnostic evaluation. The document mentions "animal testing," but not in the context of a diagnostic test set.
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Number of Experts Used to Establish Ground Truth and Qualifications: Not applicable as there's no diagnostic test set with ground truth established by experts.
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Adjudication Method: Not applicable.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study is for evaluating human performance with and without AI assistance for diagnostic tasks.
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Standalone (Algorithm Only) Performance: Not applicable. This device is a physical paste, not an algorithm.
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Type of Ground Truth Used: Not applicable. No diagnostic ground truth mentioned.
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Sample Size for the Training Set: Not applicable. This device is not an AI algorithm that requires a training set.
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How the Ground Truth for the Training Set was Established: Not applicable.
What the document does describe as "Performance Testing" includes:
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Bench Testing:
- Evaluations: Relative stiffness, spreadability, stickiness, temperature sensitivity, electrocautery compatibility, dissolution, and swelling.
- Purpose: To verify handling properties, characterize performance over a range of temperatures, and evaluate dissolution properties.
- Results: Stated as demonstrating substantial equivalence to predicate devices, but no quantitative acceptance criteria or specific results are provided.
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Biocompatibility Testing:
- Evaluations: Irritation, sensitization, acute systemic toxicity, genotoxicity, implantation, systemic toxicity, hemolysis, endotoxicity, and pyrogenicity.
- Standards: Conducted in accordance with ISO 10993 and GLP requirements.
- Results: Stated as demonstrating substantial equivalence.
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Animal Testing:
- Purpose: To demonstrate intraoperative in vivo hemostasis and resistance to irrigation.
- Results: Stated as demonstrating substantial equivalence.
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Sterility:
- Validation: Gamma sterilization process validated to provide a SAL (Sterility Assurance Level) of 10^-6.
- Lot Release: Each lot tested for bacterial endotoxin.
In summary, the provided FDA 510(k) letter and summary are for a physical medical device (hemostatic bone paste) and demonstrate substantial equivalence based on similar intended use, technological characteristics, and general performance testing (bench, biocompatibility, animal studies). It does not contain the detailed diagnostic performance metrics, acceptance criteria, or study designs typically requested for AI/diagnostic devices.
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