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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.

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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 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.

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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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