Search Results

Orthocon MONTAGE Settable. Resorbable Bone Putty is indicated to fill bony voids or gaps in the skeletal system (i.e., extremities and pelvis). These osseous defects may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), are surgically created or the result of traumatic injury to the bone. MONTAGE 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 may be used to augment provisional hardware (e.g., kwires, 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 can be drilled and tapped, and hardware can be placed through it at any time during the setting process.

Orthocon Montage-QS Settable, Resorbable Bone Putty is indicated to fill bony voids or gaps in the skeletal system (i.e., extremities and pelvis). These osseous defects may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), are surgically created or the result of traumatic injury to the bone. Montage-QS 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-QS 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-QS can be drilled and tapped, and hardware can be placed through it at any time during the setting process.

Orthocon MONTAGE Flowable Settable, Resorbable Bone Paste is indicated to fill bony voids or gaps in the skeletal system (i.e., extremities and pelvis). These osseous defects may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), are surgically created or the result of traumatic injury to the bone. Montage Flowable 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 Flowable may be used to augment provisional hardware (e.g., kwires, plates and screws) and to help support bone fragments during the surgical procedure. The hardened paste acts only as a temporary support medium and is not intended to provide structural support during the healing process.

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

Orthocon Montage-XT Settable. Resorbable Hemostatic Bone Putty is indicated to fill bony voids or gaps in the skeletal system (i.e., extremities and pelvis). These osseous defects may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), are surgically created or 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.

The devices are sterile, biocompatible, resorbable material for use in filling bony voids or gaps in skeletal bones of the extremities. Each device comprises two separate components of putty-like consistency containing granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, polyalcohol(s) and a mixture of a lactide-diester and polyester-based polymers. When mixed together, the components of each device form a cohesive material that adheres to the bone surface and remains in place following application. The resulting hardened is primarily calcium phosphate. The components must be mixed immediately prior to use. MONTAGE can be drilled and tapped, and hardware can be placed through it at any time during the setting process.

This document is a 510(k) summary, which is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device. Unfortunately, it does not contain the detailed acceptance criteria and study results you would find in a clinical study report or a more comprehensive premarket submission (like a PMA).

This document focuses on demonstrating substantial equivalence to existing predicate devices, particularly for an expanded indication for use. It highlights the addition of "benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old)" to the current Indications for Use statement for four Orthocon MONTAGE products.

Therefore, I cannot provide the specific details about acceptance criteria or a study that proves the device meets those criteria, as requested in your prompt. The information related to sample size, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and ground truth for training sets is simply not present in this type of FDA clearance letter and 510(k) summary.

The document explicitly states: "Any difference between the subject device and the predicate and reference devices have been addressed through risk assessment, and no new verification testing was required to mitigate the potential risks. All the pre-clinical, and clinical testing conducted to support the previous 510(k) clearances are applicable to the subject device." This indicates that the current submission relies on previously conducted studies for the original clearances of these products, and no new studies were performed specifically for this expanded indication to generate new performance data against specific acceptance criteria.

Ask a specific question about this device

Orthocon Montage Flowable Settable Bone Paste is a self-setting calcium phosphate cement indicated for use in the repair of neurosurgical burr holes, contiguous cranial defects with a surface area no larger than 25cm2. Montage Flowable Settable, Resorbable Bone Paste should be used only in skeletally mature individuals.

Montage Flowable Settable, Resorbable Bone Paste is a sterile, biocompatible, resorbable material for use in repair of cranial defects. The Montage Flowable device comprises two separate components of putty consistency containing granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, polyalcohols and a mixture of a lactide-diester and polyester-based polymers. When mixed together, the components of the Montage Flowable device form a cohesive putty-like material that adheres to the bone surface and remains in place following application. The resulting hardened, resorbable material is primarily calcium phosphate. Montage Flowable components must be mixed immediately prior to use.

The provided document is a 510(k) summary for the Orthocon Montage Flowable Settable, Resorbable Bone Paste. This document is a premarket notification for a medical device and is not a study proving the device meets acceptance criteria for an AI/ML-based medical device.

The document discusses:

• The device's name, regulation, and product code.
• Its intended use (repair of neurosurgical burr holes, cranial defects).
• Comparisons of technological characteristics with a predicate device (Stryker HydroSet Injectable Cement).
• Biocompatibility and performance testing (bench testing and in-vivo animal testing).
• A clear statement that no clinical studies have been conducted in support of this 510(k).

Therefore, the requested information about acceptance criteria and a study proving device performance for an AI/ML-based medical device cannot be extracted from this document, as it pertains to a different type of medical device (a bone paste) and the regulatory submission is not based on AI/ML performance.

To answer your prompt, I would need a document describing the regulatory submission for an AI/ML-based medical device, which would typically include detailed information on clinical performance studies, ground truth establishment, expert adjudication, and sample sizes for training and test sets.

Ask a specific question about this device

Orthocon MONTAGE Flowable Settable, Resorbable Bone Paste 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 Flowable 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 Flowable 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 paste acts only as a temporary support medium and is not intended to provide structural support during the healing process.

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

Montage Flowable Settable. Resorbable Bone Paste is a sterile. biocompatible, resorbable material for use in filling bony voids or gaps in skeletal bones of the extremities. The Montage Flowable device comprises two separate components of paste-like consistency containing granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, polyalcohols and a mixture of a lactide-diester and polyester-based polymers. When mixed together in the applicator tip, the components of the Montage Flowable device form a cohesive paste-like material that adheres to the bone surface and remains in place following application. The resulting hardened, resorbable material is primarily calcium phosphate and is slowly resorbed and replaced with bone during the remodeling process. Montage Flowable can be drilled and tapped, and hardware can be placed through it at any time during the setting process.

The provided document is a 510(k) Summary for a medical device (Montage Flowable Settable, Resorbable Bone Paste) and does not describe acceptance criteria for a study proving the device meets those criteria in the context of an AI/ML or diagnostic device. The document primarily focuses on establishing substantial equivalence to a predicate device based on material composition, intended use, and performance in an animal model.

Therefore, many of the specific questions regarding acceptance criteria for a test set, sample sizes for test and training sets, expert qualifications, ground truth establishment, MRMC studies, and standalone algorithm performance cannot be answered from the provided text.

However, I can extract information related to the device performance testing that was done:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present "acceptance criteria" in a table format for performance, but it provides performance data from an animal study and states tests conducted.

Note: "Clinical performance has not been evaluated." |
| Device Resorption (at 12 weeks in rabbit model) | Not explicitly stated as an acceptance criterion value, but the goal is to demonstrate resorbability as intended for a resorbable bone paste. | Approximately 75% of implant material remained in both the Montage Flowable group and the HydroSet group at 12 weeks. |
| Drillability/Temporary Support | Device can be drilled when hardened without fragmenting or being displaced. Provides temporary support to a complex repair until permanent hardware fixation is accomplished. (Implicit acceptance: no fragmentation/displacement, successful temporary support). | "Testing was conducted to verify that the device may be drilled when hardened without fragmenting or being displaced. This allows use in conjunction with provisional hardware. In addition, an in vitro study was conducted to demonstrate that once placed as indicated, the device provides temporary support to a complex repair until permanent hardware fixation is accomplished." (Results stated as successful verification/demonstration). |
| Material Settability/Hardening Time | Consistent with predicate (material settable within 10 minutes of application). | Material is settable within 10 minutes of application. |
| Absence of Appreciable Exothermic Reaction during Curing | No appreciable exothermic reaction. | Device cures with no appreciable exothermic reaction. |
| Biocompatibility | Meet recommendations of ISO 10993 (Cytotoxicity, irritation, sensitization, systemic toxicity, genotoxicity, local tissue toxicity, hemolysis, endotoxicity, pyrogenicity). | "Testing was conducted to evaluate the device's biocompatibility in accordance with the recommendations of ISO 10993." (Implied successful completion and meeting standards). |
| Sterility | SAL of 10^-6; each lot tested for bacterial endotoxin. | "The gamma sterilization process has been validated to provide a SAL of 10-6. Each lot of finished devices is tested for bacterial endotoxin for lot release." |

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size (Animal Study): The document mentions a "rabbit critical sized femoral defect model," implying an animal group size, but the specific number is not provided. It refers to "Montage Flowable group," "HydroSet predicate group," and "empty defect negative control group."
• Data Provenance: Not specified (e.g., country of origin). The study described is an animal study, not human clinical data, and appears to be prospective in its design (creating defects and implanting materials to observe outcomes).

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 is not applicable as the study described is an animal study, not an AI/ML or diagnostic study requiring human expert ground truth for imaging interpretation. Ground truth for the animal study (new bone formation, device resorption) was established through objective measurements via micro-CT and histopathology/histomorphometry.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a human reader study or AI/ML study requiring adjudication.

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

Not applicable. This document describes the performance of a physical medical device (bone paste), not an AI/ML algorithm or diagnostic system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This document describes the performance of a physical medical device (bone paste), not an AI/ML algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the animal study:

• Micro-CT for quantitative assessment.
• Histopathology/Histomorphometry for quantitative assessment of new bone formation and device resorption.

8. The sample size for the training set

Not applicable. There is no training set mentioned or used as this is not an AI/ML device.

9. How the ground truth for the training set was established

Not applicable. There is no training set mentioned or used as this is not an AI/ML device.

Ask a specific question about this device