(20 days)
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. The material may be used during surgical procedures and in treating traumatic injuries. Montage-XT is also indicated for use in the control of bleeding from bone surfaces in cardiothoracic surgery following sternotomy.
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).
This FDA 510(k) summary is for a medical device called MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty. The submission is to add a new indication for use: "in the control of bleeding from bone surfaces in cardiothoracic surgery following sternotomy." The new device is compared to a previously cleared predicate device, Orthocon, Inc. MONTAGE Settable, Resorbable Hemostatic Bone Putty (K213418).
Here's the breakdown of the acceptance criteria and supporting studies as described in the document:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state "acceptance criteria" in a quantitative format for the new sternotomy indication. Instead, it relies on demonstrating substantial equivalence to the predicate device, Montage, and leveraging clinical data from the Montage device. The core argument is that the devices are nearly identical, with the only clinically meaningful difference being an extended working time for Montage-XT.
The comparison table provided focuses on similarities and differences between the subject device (Montage-XT) and the predicate device (Montage). The "performance" for the new indication is implied by the clinical efficacy shown for the predicate device in a sternotomy setting.
| Device Characteristic/Requirement | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Montage-XT Performance |
|---|---|---|
| Intended Use (New Indication) | Control of bleeding from bone surfaces in cardiothoracic surgery following sternotomy (as demonstrated by predicate) | Montage-XT is being cleared for this indication based on substantial equivalence and clinical data from Montage. |
| Formulation | Sterile mixture of granular calcium phosphate, calcium stearate, vitamin E acetate, triglyceride, polyalcohol, lactide-diester, polyester-based polymers. Forms a settable (hardening) material when mixed. Primarily (~70% by weight) comprised of calcium phosphate. | Identical to predicate. |
| Application Method | Manually applied and spread onto bleeding bone tissue. | Identical to predicate. |
| Resorbability | Resorbable in >30 days. | Identical to predicate. |
| Degradation Mechanism | Non-calcium salt and non-polymeric components degrade via dissolution; polymer degrades via hydrolysis; calcium salts degrade via chemical dissolution and/or cellular removal. | Identical to predicate. |
| Sterilization | Sterile by gamma irradiation. | Identical to predicate. |
| Packaging | Two putties provided separately within a single outer foil pouch with a desiccant. | Identical to predicate. |
| Mixing for Homogeneity | 45 seconds. | Identical to predicate. |
| Working Time | Acceptable working time for surgical procedures. (Predicate: 2 min, Montage-XT: 4 min) | 4 minutes (This is the only clinically meaningful difference from the predicate, allowing for a longer application window). |
| Exothermic Reaction during Cure | No appreciable exothermic reaction. | Identical to predicate. |
| Biocompatibility | Meets ISO 10993 recommendations. | Studies conducted: irritation, sensitization, acute systemic toxicity, genotoxicity, implantation, systemic toxicity, hemolysis, endotoxicity, pyrogenicity. (Reported as compliant with GLP requirements). |
| Bench Testing (Handling) | Comparable to predicate. | Relative stiffness, spreadability, stickiness, temperature sensitivity, electrocautery compatibility, working time. (All demonstrated substantial equivalence to predicate, except working time variation which is acceptable). |
| Animal Testing (Performance) | Demonstrates intraoperative in vivo hemostasis and resistance to irrigation. | Studies conducted to demonstrate these aspects. (Assumed successful based on substantial equivalence claim). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document states that "A human clinical evaluation was conducted that supports the use of Montage during sternotomy procedures." However, it does not specify the sample size of this clinical evaluation.
- Data Provenance: The document implies the clinical data is from a prospective study ("A human clinical evaluation was conducted"). The country of origin is not explicitly stated. It refers to "clinical data obtained from a sternotomy study" relevant to the Montage device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided in the document. The description of the clinical evaluation does not detail the methodology for establishing ground truth or the involvement of experts beyond the general statement of a "human clinical evaluation."
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done in the context of human readers improving with AI vs. without AI assistance. This device is a hemostatic bone putty, not an AI-powered diagnostic or assistive tool. The clinical evaluation described would likely be a direct clinical trial evaluating the putty's efficacy, not a reader study.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
- Not applicable. This device is a physical medical product (bone putty), not a software algorithm. Therefore, "standalone" performance in the context of an algorithm is irrelevant. Its performance is directly tied to its physical application and biological interaction.
7. Type of Ground Truth Used
- For the clinical study on the predicate device (Montage) used to support the new indication for Montage-XT, the ground truth would have been based on clinical observation of hemostasis (cessation of bleeding) during sternotomy procedures. This would fall under outcomes data (i.e., successful control of bleeding).
8. Sample Size for the Training Set
- Not applicable. This product is a physical medical device. It does not employ machine learning algorithms that require a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable for the same reason as point 8.
N/A