(87 days)
MONTAGE 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 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 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 device form a cohesive putty-like material that adheres to the bleeding bone surface and remains in place upon application. The resulting hardened, resorbable material is primarily calcium phosphate. MONTAGE must be mixed immediately prior to use.
When applied to surgically cut or traumatically damaged bone, MONTAGE Settable, Resorbable Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade).
The medical device in question is the MONTAGE™ Settable, Resorbable Hemostatic Bone Putty.
This device is a bone hemostat intended for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade.
1. A table of acceptance criteria and the reported device performance
The provided document describes the MONTAGE device as substantially equivalent to a predicate device, Orthocon HBP4 Hardening, Resorbable Hemostatic Bone Putty (K141502). The acceptance criteria are therefore implicitly aligned with demonstrating this substantial equivalence. The document does not list specific numerical acceptance criteria with corresponding performance values for the MONTAGE device itself, but rather states that it is "exactly the same device" as the predicate, with the only difference being the packaging configuration. Therefore, the performance criteria and results are based on the predicate device.
| Acceptance Criteria Category | Predicate Device Performance / Evidence for MONTAGE |
|---|---|
| Intended Use | MONTAGE has the same indicated intended use as the predicate: "control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade." |
| Technological Characteristics | The document states MONTAGE is "exactly the same device" with the same materials (granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, a polyalcohol and a mixture of a lactide-diester and polyester-based polymers), radiopacity, resorbability, resorption time (>30 days), method of application, intended use (bone hemostasis), degradation process (dissolution, hydrolysis, cellular removal), mechanism of action (mechanical tamponade), sterility (gamma irradiation), and form of device (two-part settable putty). |
| Bench Testing | Testing performed on the predicate HBP4™ demonstrated acceptable handling properties (relative stiffness, spreadability, stickiness), temperature sensitivity, electrocautery compatibility, dissolution, and swelling. Since MONTAGE has the identical formulation, these results are considered relevant for MONTAGE. |
| Biocompatibility | Testing performed on the predicate HBP4™ met ISO 10993 recommendations for irritation, sensitization, acute systemic toxicity, implantation, subacute systemic toxicity, chronic systemic toxicity, hemolysis, endotoxicity, and pyrogenicity. Since MONTAGE has the identical formulation and sterilization method (gamma irradiation), these results are considered relevant for MONTAGE. |
| Animal Functionality Testing | Animal studies performed on the predicate HBP4™ demonstrated intraoperative in vivo hemostasis, resistance to irrigation, and characterized resorption time. Since MONTAGE has the identical formulation, these results are considered relevant for MONTAGE. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes for the bench, biocompatibility, or animal studies conducted on the predicate device.
- Bench Testing: No specific sample sizes mentioned.
- Biocompatibility Testing: No specific sample sizes mentioned. Conducted in accordance with GLP requirements.
- Animal Testing: No specific sample sizes mentioned.
The data provenance is not specified regarding the country of origin. The studies appear to be prospective in nature, as they were conducted to evaluate the predicate device's safety and performance for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The studies mentioned (bench, biocompatibility, animal) typically involve laboratory testing and observation rather than expert ground truth establishment for a diagnostic output.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and therefore not provided in the document. The studies described are not clinical trials requiring adjudication of outcomes by multiple experts.
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
This information is not applicable and therefore not provided. The device is a bone hemostat, not an AI-powered diagnostic tool, so MRMC studies and AI assistance metrics are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and therefore not provided. The device is a physical medical product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically applied to diagnostic algorithms is not directly applicable here. Instead, the studies focused on:
- Bench Testing: Engineering measurements and physical property characterization.
- Biocompatibility: Standardized biological assays and histological evaluations.
- Animal Testing: In vivo observations of hemostasis, resistance to irrigation, and histological assessment of resorption.
8. The sample size for the training set
This information is not applicable and therefore not provided. The device is a physical product, not an algorithm that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable and therefore not provided. As stated above, the device does not involve a training set for an algorithm.
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