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510(k) Data Aggregation
(289 days)
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:
| Characteristic | Acceptance Criteria (Implied by Predicate Device) | Reported Device Performance (Montage-XT) |
|---|---|---|
| Indications for Use | To fill bony voids or gaps in the skeletal system (extremities and pelvis); surgically created or traumatic osseous defects. Not for defects intrinsic to bony structure integrity. Can augment provisional hardware and support bone fragments during surgery (temporary support). Can be drilled and tapped; hardware placed through it at any time during setting. | Identical to predicate device (Montage). This submission adds "bone void filler device" indication to Montage-XT, aligning it with Montage. |
| Formulation | Sterile, biocompatible, resorbable material (granular calcium phosphate, calcium stearate, vitamin E acetate, triglyceride, polyalcohol, lactide-diester and polyester-based polymers). Two separate components. | Nearly identical. The document states that the devices have "nearly identical formulations" and Montage-XT contains the same components as Montage described in the device description. |
| Application Method | Manually applied and spread onto bone defects. Putty-like material at application. | Identical. Manually applied and spread onto bone defects. Putty-like material at application. |
| Setting Mechanism | Two-part putty/putty device that forms a "settable" (hardening) material when mixed at the time of surgery. Primarily comprised of calcium phosphate similar to native bone. | Identical. Same setting mechanism and primary composition. |
| Resorption Time | Implanted device is resorbable in greater than 30 days primarily due to presence of calcium phosphate. | Identical. Resorbable in greater than 30 days. Animal study data showed approximately 70% implant material remaining at 12 weeks for both Montage-XT and Montage. |
| Degradation | 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 degradation mechanisms. |
| Sterilization | Sterile by gamma irradiation. | Identical. Sterilized by the same validated gamma irradiation process. |
| Packaging | Two putties separately within a single outer foil pouch, with a desiccant. | Identical. Same packaging. |
| Mixing for Homogeneity | 45 seconds. | Identical. 45 seconds. |
| Working Time | 2 minutes (for Montage). | 4 minutes (for Montage-XT). This is identified as the only clinically meaningful difference. |
| Exothermic Reaction | Cures with no appreciable exothermic reaction. | Identical. Cures with no appreciable exothermic reaction. |
| Drillability/Tappability | Can be drilled and tapped; hardware can be placed through it at any time during setting process. | Identical. Can be drilled and tapped; hardware can be placed through it at any time during setting process. |
| New Bone Formation | Adequate new bone formation to demonstrate efficacy as a bone void filler (implied by predicate clearance). | 20.4% new bone formation in Montage-XT group at 12 weeks, compared to 20.8% in Montage predicate group, and |
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(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.
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