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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.

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Orthocon MONTAGE-OS Settable Bone Putty 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-QS Settable, Resorbable Bone Putty should be used only in skeletally mature individuals.

MONTAGE-QS Settable, Resorbable Bone Putty is a sterile, biocompatible, resorbable material for use in repair of cranial defects. The MONTAGE-QS 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 polyesterbased polymers. When mixed together, the components of the MONTAGE-QS device form a putty-like material. The resulting hardened, resorbable material is primarily calcium phosphate. MONTAGE-QS components must be mixed immediately prior to use.

The provided text describes a medical device, MONTAGE-QS Settable, Resorbable Bone Putty, and its substantial equivalence to a predicate device. However, it does not explicitly detail acceptance criteria and a study proving the device meets those criteria in the context of typical AI/software device evaluation.

Based on the provided information, here's an attempt to answer your request, focusing on the information that is present and noting where information is absent for an AI device.

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

The document does not explicitly state "acceptance criteria" in the way one would for an AI model's performance metrics (e.g., AUC, sensitivity, specificity thresholds). Instead, the performance evaluation is based on demonstrating equivalence to a predicate device through various tests. The "performance" for MONTAGE-QS is a qualitative assessment of its material properties and biological response compared to the predicate.

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

• Test Set Sample Size:
  • Efficacy Evaluation (Cranioplasty): The study was conducted in a "rabbit cranial critical-sized defect model." The specific number of rabbits or defects studied is not provided.
  • Bench Testing: The sample sizes for each bench test are not specified.
  • In-Vivo Testing: Similar to the efficacy evaluation, it refers to an "animal model" without giving specific numbers.
• Data Provenance: The document states "rabbit cranial critical-sized defect model" and "in-vivo animal testing," indicating the data is from preclinical animal studies. The country of origin and whether it was retrospective or prospective data are not specified.

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)

• The "ground truth" for this device's evaluation (e.g., whether bone defects were filled, or histopathological assessments) would have been established by experts in veterinary pathology or relevant scientific fields. However, the document does not state the number of experts or their qualifications. The assessments are described as "histology-based assessments" and "histopathologic evaluation."

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

• The document does not describe any adjudication method for establishing ground truth or evaluating the test results.

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 is a submission for a bone putty, not an AI or software device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

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

• This is a submission for a bone putty, not an AI or software device. Therefore, a standalone algorithm performance study is not applicable and was not performed.

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

• For the efficacy and in-vivo testing, the ground truth was based on histopathologic evaluation in an animal model. For bench testing, it was based on measurable physical and chemical properties against predetermined specifications.

8. The sample size for the training set

• This is a submission for a physical medical device (bone putty), not an AI or software device. Therefore, the concept of a "training set" in the context of machine learning is not applicable. The device's performance is demonstrated through testing against specifications and comparison to a predicate, not by training an algorithm.

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

• As a training set is not applicable for this type of device, the method for establishing its "ground truth" is not applicable.

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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 defects may be surgically created, or osseous defects created as 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 process.

Montage-QS 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 Montage-QS device comprises two separate components of putty-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, the components of the Montage-QS 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 and is slowly resorbed and replaced with bone during the remodeling process. Montage-QS can be drilled and tapped, and hardware can be placed through it at any time during the setting process.

The provided text is an FDA 510(k) summary for a medical device called Montage-QS Settable, Resorbable Bone Putty. It describes the device, its indications for use, and a comparison to predicate devices, but it does not contain acceptance criteria or a detailed study of the device proving it meets specific acceptance criteria in the format requested.

The document primarily focuses on establishing substantial equivalence to previously cleared devices. It mentions some performance data from an animal study and in-vitro testing but not in the context of acceptance criteria. The requested information regarding sample sizes for training/test sets, expert qualifications, adjudication methods, MRMC studies, or specific ground truth methodologies for a device approval study is not present. This type of detailed study design and results would typically be found in a separate, more comprehensive study report, not a 510(k) summary for a device like a bone void filler which primarily relies on substantial equivalence.

Therefore, I cannot fulfill your request for the tables and study details based on the provided input. The document describes a comparison study in rabbits that assessed new bone formation and implant material remaining, but this is presented as efficacy evaluation and not in the context of a formal acceptance criteria study typically seen for AI/software devices.

Here's what can be extracted and what is missing based on the provided text:

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

• Cannot be provided. The document does not specify quantified acceptance criteria (e.g., "new bone formation must be > X%") for regulatory approval in the way an AI/software device might. It simply presents the results of an animal study comparing the new device to a predicate.

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: Not explicitly stated as a "test set" sample size. The animal study involved a "Montage-QS group," a "HydroSet predicate group," and an "empty defect negative control group." The number of animals in each group is not provided.
• Data Provenance: An animal study (rabbit critical sized femoral defect model). Country of origin is not specified. It is a prospective study as it involved implanting devices and observing 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)

• Not applicable. This is a hardware device (bone putty), not an AI/software device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" here is biological outcomes (new bone formation, material resorption) assessed via micro-CT and histopathology/histomorphometry. The qualifications of the personnel performing these assessments are not mentioned.

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

• Not applicable. This concept pertains to human review of AI outputs, which is not relevant for this device.

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

• No. This is not an AI device.

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

• Not applicable. This is not an AI device.

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

• The "ground truth" for the animal study (efficacy evaluation) was based on micro-CT and histopathology/histomorphometry assessments to quantify device resorption and new bone formation.

8. The sample size for the training set

• Not applicable / Not mentioned. This is not an AI device that would have a training set.

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

• Not applicable. This is not an AI device.

Summary of available "performance" data (not acceptance criteria):

Other relevant performance data mentioned (without specific quantifiable results or acceptance criteria):

• Testing was conducted to verify that the device may be drilled when hardened without fragmenting or being displaced.
• 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.
• Biocompatibility testing was conducted in accordance with ISO 10993 recommendations (cytotoxicity, irritation, sensitization, systemic toxicity, local tissue toxicity, hemolysis, endotoxicity, pyrogenicity). All conducted to GLP requirements.
• Sterility: Gamma sterilization validated to provide SAL of 10^-9. Each lot tested for bacterial endotoxin for lot release.

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