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Orthocon Montage-XT Settable, Resorbable Bone Putty is indicated to fill bony voids or gaps in the skeletal system (i.e., extremities and pelvis). These defects may be surgically created, or osseous defects created as the result of traumatic injury to the bone. Montage-XT is indicated only for filling bony voids or gaps that are not intrinsic to the integrity of the bony structure.

When hardened in situ, Montage-XT may be used to augment provisional hardware (e.g., k-wires, plates and screws) and to help support bone fragments during the surgical procedure. The hardened putty acts only as a temporary support medium and is not intended to provide structural support during the healing process.

Montage-XT can be drilled and tapped, and hardware can be placed through it at any time during the setting process.

Montage-XT Settable, Resorbable Bone Putty is a sterile, biocompatible, resorbable material for use in filling bony voids or gaps in skeletal bones of the extremities. The single use Montage-XT device contains two separate components of putty-like consistency containing granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, a polyalcohol and a mixture of a lactide-diester and polyesterbased polymers. When mixed together, the components of Montage-XT form a cohesive putty-like material that adheres to the bone surface and remains in place following application. The resulting hardened material is primarily calcium phosphate. Montage-XT can be drilled and tapped, and hardware can be placed through it at any time during the setting process.

Montage-XT differs from Montage by allowing for an extended working time of up to 4 minutes.

The provided FDA 510(k) summary does not describe an AI/ML device. Instead, it concerns a medical device called "Montage-XT Settable, Resorbable Bone Putty." Therefore, the requested information pertaining to acceptance criteria and studies demonstrating AI device performance (such as sample sizes for test and training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance) is not applicable to this document.

The document discusses the substantial equivalence of Montage-XT to a predicate device (Montage Settable, Resorbable Bone Putty) based on non-AI performance testing. Here's a breakdown of the relevant information provided:

Acceptance Criteria and Reported Device Performance (Non-AI Device)

Given that this is not an AI device, there are no specific "acceptance criteria" in terms of algorithm performance metrics (e.g., sensitivity, specificity, AUC). Instead, the performance is evaluated through bench testing, biocompatibility testing, and animal testing to demonstrate substantial equivalence to a predicate device.

Table of Performance Comparisons for Substantial Equivalence:

Study Information (for Non-AI Device)

1. Sample size used for the test set and the data provenance:

   • Bench Testing: No specific numerical sample sizes are given for each bench test (pH, dissolution/solubility, reaction temperature, relative stiffness, spreadability, stickiness, temperature sensitivity, electrocautery compatibility, working time). These are typically "n=" numbers for in-vitro experiments.
   • Biocompatibility Testing: Not specified in terms of sample size, but indicates a battery of tests (irritation, sensitization, acute systemic toxicity, genotoxicity, implantation, systemic toxicity, hemolysis, endotoxicity, pyrogenicity) conducted in accordance with GLP requirements.
   • Animal Testing: A "rabbit critical sized femoral defect model" was used. The number of animals in the Montage-XT group and Montage predicate group is not specified, but the results (20.4% vs 20.8% new bone formation) suggest multiple animals per group. The study was prospective in nature, comparing Montage-XT to Montage and an empty control. The country of origin for the animals and study is not explicitly stated.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not an AI device, so there's no ground truth established by experts in the context of diagnostic interpretation. Ground truth for animal studies would be based on histological analysis by veterinary pathologists.

3. Adjudication method for the test set: Not applicable for an AI context. For the animal study, the "ground truth" (new bone formation, material remaining) would be determined by quantitative histological or imaging analysis, likely reviewed by experienced individuals, but not an adjudication process in the sense of expert consensus on image interpretation.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, a multi-reader multi-case study is not applicable for this type of medical device (bone putty).

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI algorithm.

6. The type of ground truth used:

   • Bench Testing: Physical, chemical, and mechanical measurements and observations.
   • Biocompatibility Testing: Biological responses in animal models or in-vitro systems according to ISO 10993.
   • Animal Testing: Histological analysis and potentially imaging (e.g., radiography, micro-CT) to quantify new bone formation and material resorption in vivo.

7. The sample size for the training set: Not applicable. There is no training set for a physical medical device.

8. How the ground truth for the training set was established: Not applicable.

Summary of the Device's Approval Justification:

The device (Montage-XT) received 510(k) clearance because it was determined to be substantially equivalent to a legally marketed predicate device (Montage). The primary justification is that Montage-XT is "nearly identical" to Montage in its composition, intended use, technological characteristics, and performance, with the only clinically meaningful difference being an extended working time from 2 to 4 minutes. This extended working time, along with the new bone formation and resorption characteristics, was demonstrated as equivalent to the predicate device in an animal study. The submission also adds "bone void filler" as an indication for Montage-XT, consistent with the predicate device.

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