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Orthocon Montage Flowable Settable, Resorbable Bone Paste is a self-setting cement indicated for fixation of bone flaps following craniotomy. 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 fixation of bone flaps following craniotomy. 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. MONTAGE Flowable components must be mixed immediately prior to use.

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Orthocon Permatage Flowable, Settable Bone Paste is a self-setting cement indicated for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects. Permatage Flowable, Settable Bone Paste should be used only in skeletally mature individuals.

Permatage Flowable, Settable Bone Paste is a sterile, biocompatible, nonabsorbable material of Paste-like consistency for use in repair of cranial defects. The single use Permatage device contains two separate components of paste-like consistency comprised of granular calcium phosphate, paraffin oil, vitamin E acetate, a triglyceride, and a mixture of nonabsorbable, polyether-based polymers. When mixed together, the components of the Permatage device form a nonabsorbable cohesive, paste-like material that adheres to the bone surface and remains in place following application. The resulting hardening material is primarily calcium phosphate and nonabsorbable polymer materials. Permatage components must be mixed immediately prior to use.

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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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Montage-XT Settable Bone Putty is indicated for use on the sternum in cardiothoracic surgery following sternotomy to control bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade, as well as to fill bony voids or gaps in the sternum. When hardened in situ, Montage-XT may be used on the sternum to augment hardware to help support bone during the cardiothoracic surgical procedure.

MONTAGE-XT Settable Bone Putty is a sterile, biocompatible, resorbable material for use in the control of bleeding from bone surfaces in cardiothoracic surgery following sternotomy and filling bony voids or gaps in the sternum. The MONTAGE-XT device comprises 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 the MONTAGE-XT device 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 components must be mixed immediately prior to use. The device serves multiple clinical functions simultaneously that are integral to recovery after cardiac surgery.

This FDA 510(k) summary is for a medical device (Montage-XT Settable Bone Putty), not an AI/ML powered device, therefore the information requested about acceptance criteria and studies (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable.

The document discusses the device's indications for use and states that it is substantially equivalent to legally marketed predicate devices based on materials, manufacturing process, sterilization, and packaging. It notes that "All the pre-clinical, and clinical testing conducted to support the previous 510(k) clearances are applicable to the subject device." However, the details of those previous studies, including specific acceptance criteria and detailed performance results, are not provided within this summary document.

Therefore, for this specific input, the following information cannot be extracted:

1. A table of acceptance criteria and the reported device performance: Not present. The document asserts substantial equivalence without providing specific performance data against criteria.
2. Sample size used for the test set and the data provenance: Not present for any specific study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no diagnostic study described.
4. Adjudication method: Not applicable.
5. Multi reader multi case (MRMC) comparative effectiveness study: Not applicable, as it's a bone putty, not an AI/ML diagnostic.
6. Standalone performance: Not applicable in the context of AI/ML algorithms.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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Orthocon Permatage Settable Bone Putty is a self-setting cement indicated for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects. Permatage Settable Bone Putty should be used only in skeletally mature individuals.

Permatage Settable Bone Putty is a sterile, biocompatible, nonabsorbable material of putty-like consistency for use in repair of cranial defects. The single use Permatage device contains two separate components of putty-like consistency comprised of granular calcium phosphate, paraffin oil, vitamin E acetate, a triglyceride, and a mixture of nonabsorbable, polyether-based polymers. When mixed together, the components of the Permatage device form a nonabsorbable cohesive, putty-like material that adheres to the bone surface and remains in place following application. The resulting hardening material is primarily calcium phosphate and nonabsorbable polymer materials. Permatage components must be mixed immediately prior to use.

The provided text is a 510(k) summary for the Orthocon Permatage Settable Bone Putty, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through a traditional clinical study with performance metrics like sensitivity or specificity.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert involvement, and ground truth establishment for an AI/algorithm-based device is not applicable to this document. The document describes a traditional medical device (bone putty) and its regulatory clearance process, which relies on biocompatibility testing, bench testing, and in-vivo animal testing to demonstrate substantial equivalence to an existing device, not an AI or software algorithm.

Here's a breakdown of why each section of your request cannot be fulfilled from the provided text:

1. Table of acceptance criteria and reported device performance: Not present. The "Performance Data" section lists various tests (e.g., Visual Inspection, Paste Stiffness, Package Leak Test) and states that they "met specification" or "passed," but it does not provide specific numerical acceptance criteria or quantitative performance results.
2. Sample sized used for the test set and the data provenance: Not present for a "test set" in the context of an algorithm. The in-vivo animal testing mentions demonstrating substantial equivalence in "an animal model," but does not specify the sample size of animals or their provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is not relevant here. The in-vivo animal testing involved "histopathologic evaluation," which would have been performed by experts, but their number and qualifications are not specified.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: Not applicable, as this is not an AI-assisted device.
6. Standalone performance (algorithm only without human-in-the-loop): Not applicable, as this is not an AI/algorithm device.
7. Type of ground truth used: For the in-vivo animal testing, "histopathologic evaluation" served as a form of ground truth for assessing the bone defect repair.
8. Sample size for the training set: Not applicable, as there is no training set for an AI algorithm.
9. How the ground truth for the training set was established: Not applicable.

Summary based on available information:

The document describes the regulatory clearance of a bone putty device (Permatage Settable Bone Putty) based on its substantial equivalence to another marketed device (Stryker HydroSet Injectable Cement). The evaluation involved:

• Biocompatibility Testing: Conducted in accordance with ISO 10993, including tests for cytotoxicity, irritation, sensitization, systemic toxicity, genotoxicity, local tissue toxicity, hemolysis, pyrogenicity, and neurotoxicity. All tests were conducted on the final, finished, gamma-irradiation sterilized device and in accordance with GLP requirements.
• Bench Testing:
  • Visual Inspection: Evaluated paste color using a reference scale. Conclusion: Paste color met specification.
  • Paste Stiffness: Evaluated paste stiffness using a reference scale. Conclusion: Paste stiffness met specification.
  • Package Leak Test: Bubble emission leak test. Conclusion: All test articles passed.
  • Temperature Sensitivity: Acceptable maximum temperature increase observed. Conclusion: Acceptable maximum temperature increase observed.
  • Water Uptake, Swelling, and Dissolution: Measured volume and mass changes over time. Conclusion: Acceptable water uptake, swelling, and dissolution.
• In-Vivo Testing:
  • Study Design: Used to demonstrate substantial equivalence in the repair of a critical-sized cranial bone defect in an animal model compared to the comparator device.
  • Ground Truth: Substantial equivalence was assessed based on histopathologic evaluation.
  • Sample Size/Provenance: Not specified beyond "an animal model."
• Clinical Testing: No clinical studies were conducted in support of this 510(k).

The document concludes that the device is substantially equivalent to the predicate device, and the conducted tests passed stated requirements and recognized standards.

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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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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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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.

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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