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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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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.

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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MONTAGE 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 is also indicated for use in the control of bleeding from bone surfaces in cardiothoracic surgery following sternotomy.

MONTAGE Settable. Resorbable Hemostatic Bone Putty is a sterile, biocompatible, resorbable material for use in the control of bleeding from bone surfaces. The MONTAGE 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 polyester-based polymers. When mixed together, the components of the MONTAGE device form a cohesive putty-like material that adheres to the bleeding bone surface and remains in place following application. The resulting hardened, resorbable material is primarily calcium phosphate. MONTAGE components must be mixed immediately prior to use. When applied to surgically cut or traumatically broken bone, MONTAGE Settable, Resorbable Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade).

The provided text describes the Montagne Settable, Resorbable Hemostatic Bone Putty. The document is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive de novo performance data.

Here's an analysis of the provided information concerning acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table with specific, quantitative acceptance criteria for the device's hemostatic performance (e.g., time to hemostasis, success rate within a defined timeframe). Instead, it states more general performance outcomes.

2. Sample Size Used for the Test Set and Data Provenance:

The document mentions "A human clinical evaluation was conducted that supports the use of Montage during sternotomy procedures." However, it does not specify the sample size for this clinical evaluation, nor does it explicitly state the data provenance (e.g., country of origin, retrospective or prospective nature of the study).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

The document does not provide any information about the number or qualifications of experts used to establish ground truth for the test set of the clinical evaluation.

4. Adjudication Method for the Test Set:

The document does not describe an adjudication method for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not mention or describe a MRMC comparative effectiveness study, nor does it discuss human improvement with or without AI assistance. This is expected as the device is a medical device (putty), not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

The document does not describe a standalone performance study in the context of an algorithm. This is not applicable to a physical medical device like bone putty.

7. Type of Ground Truth Used:

For the "human clinical evaluation" mentioned, the ground truth would implicitly be clinical outcomes (e.g., successful hemostasis, absence of re-bleeding, safety events) as observed and documented by the operating surgeons and medical staff. However, the document does not explicitly state the specific ground truth used. For other performance tests (biocompatibility, sterility, etc.), the ground truth would be established through standardized testing protocols and laboratory measurements as per ISO 10993 and other relevant standards.

8. Sample Size for the Training Set:

The document does not specify a training set sample size. As a physical medical device (bone putty) undergoing a 510(k) submission, the concept of a "training set" in the context of machine learning algorithms is not directly applicable. Performance is typically established through a combination of bench testing, animal studies (if applicable), and clinical evaluation.

9. How the Ground Truth for the Training Set Was Established:

Since there is no "training set" in the context of an algorithm, this question is not applicable. The performance characteristics for the device were likely established through the aforementioned laboratory tests and clinical evaluation, with ground truth based on observed biological or physical responses to the device.

In summary, the provided document is a 510(k) summary focused on substantial equivalence for a medical device. It briefly mentions performance testing and a clinical evaluation but lacks specific details typically found in summaries for AI/ML-powered devices, such as sample sizes, expert qualifications, or detailed performance metrics. The main purpose of this 510(k) was to add a new indication for use (sternotomy procedures) based on demonstrated equivalence to the previously cleared version of the same device and a predicate 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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Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade.

Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste is a sterile, biocompatible, resorbable material for use in the control of bleeding from bone surfaces. The single use device contains two separate components of paste-like consistency comprised of granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, polyalcohols, a mixture of a lactide-diester and polyester-based polymers and barium sulfate. When mixed together, the components of the device form a resorbable paste-like material that can be applied directly to bleeding bone by means of a single-use applicator (delivery device). The resulting hardening paste is primarily comprised of calcium phosphate. Montage Flowable XRO is mixed immediately prior to use.

When applied to surgically cut or traumatically broken bone. Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste achieves local control of bleeding by acting as a mechanical barrier (tamponade).

The provided text is a 510(k) summary for a medical device called "Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste." This document aims to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.

However, the 510(k) summary does not contain information about acceptance criteria or a study that rigorously proves the device meets specific acceptance criteria in the manner you've outlined for AI/diagnostic devices.

This type of document for a conventional medical device (like a hemostatic bone paste) primarily focuses on demonstrating substantial equivalence to a predicate device through comparisons of:

• Intended Use: The new device has the same intended use as the predicate.
• Technological Characteristics: The new device has similar technological characteristics to the predicate. Any differences do not raise new questions of safety or effectiveness.
• Performance Data: This typically involves bench testing, biocompatibility, and sometimes animal studies to show that the device performs as intended and is safe.

Therefore, for your specific request regarding acceptance criteria and a study proving performance, I must state that the provided text does not contain the requested information in the format or detail typically associated with AI/diagnostic device performance studies.

Here's why and what the document does provide:

1. Table of Acceptance Criteria and Reported Device Performance: This is not present for specific diagnostic metrics (e.g., sensitivity, specificity, AUC). The document lists comparisons of technological characteristics between the subject device and a predicate. The "performance" section describes general types of testing (bench, biocompatibility, animal) but no quantitative results against predefined acceptance criteria for diagnostic accuracy.

2. Sample Size Used for the Test Set and Data Provenance: No test set is described in terms of human subjects or data for diagnostic evaluation. The document mentions "animal testing," but not in the context of a diagnostic test set.

3. Number of Experts Used to Establish Ground Truth and Qualifications: Not applicable as there's no diagnostic test set with ground truth established by experts.

4. Adjudication Method: Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study is for evaluating human performance with and without AI assistance for diagnostic tasks.

6. Standalone (Algorithm Only) Performance: Not applicable. This device is a physical paste, not an algorithm.

7. Type of Ground Truth Used: Not applicable. No diagnostic ground truth mentioned.

8. Sample Size for the Training Set: Not applicable. This device is not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established: Not applicable.

What the document does describe as "Performance Testing" includes:

• Bench Testing:

  • Evaluations: Relative stiffness, spreadability, stickiness, temperature sensitivity, electrocautery compatibility, dissolution, and swelling.
  • Purpose: To verify handling properties, characterize performance over a range of temperatures, and evaluate dissolution properties.
  • Results: Stated as demonstrating substantial equivalence to predicate devices, but no quantitative acceptance criteria or specific results are provided.

• Biocompatibility Testing:

  • Evaluations: Irritation, sensitization, acute systemic toxicity, genotoxicity, implantation, systemic toxicity, hemolysis, endotoxicity, and pyrogenicity.
  • Standards: Conducted in accordance with ISO 10993 and GLP requirements.
  • Results: Stated as demonstrating substantial equivalence.

• Animal Testing:

  • Purpose: To demonstrate intraoperative in vivo hemostasis and resistance to irrigation.
  • Results: Stated as demonstrating substantial equivalence.

• Sterility:

  • Validation: Gamma sterilization process validated to provide a SAL (Sterility Assurance Level) of 10^-6.
  • Lot Release: Each lot tested for bacterial endotoxin.

In summary, the provided FDA 510(k) letter and summary are for a physical medical device (hemostatic bone paste) and demonstrate substantial equivalence based on similar intended use, technological characteristics, and general performance testing (bench, biocompatibility, animal studies). It does not contain the detailed diagnostic performance metrics, acceptance criteria, or study designs typically requested for AI/diagnostic devices.

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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 defects may be surgically created, or osseous defects created as 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., 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 can be drilled and tapped, and hardware can be placed through it at any time during the setting process.

MONTAGE 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 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 polyester-based polymers. When mixed together, the components of the MONTAGE 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 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.

The provided text describes a 510(k) premarket notification for a medical device called MONTAGE Settable, Resorbable Bone Putty. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical trials with defined acceptance criteria for device performance. Therefore, many of the requested points, particularly those related to clinical study design, expert involvement, and ground truth establishment, are not applicable or cannot be extracted from this document.

However, I can extract information related to the animal study and performance testing that was conducted.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission focused on substantial equivalence rather than explicit performance acceptance criteria for a new clinical indication, formal acceptance criteria in the traditional sense are not explicitly stated for all performance aspects. The studies aim to demonstrate that MONTAGE performs similarly to or better than the predicate device.

2. Sample size used for the test set and the data provenance

• Animal Study: The sample size for the rabbit critical sized femoral defect model is not explicitly stated as a number of animals, but refers to "MONTAGE group," "HydroSet predicate group," and "empty defect negative control group." No specific numbers are given per group.
• Data Provenance: The animal study was conducted in a laboratory setting, likely in the country of the manufacturer or a contract research organization. The document does not specify the country. It is a prospective animal study. Other performance data are from in vitro studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Animal Study: The histopathology/histomorphometry assessments would typically be performed by veterinary pathologists or experts in bone histology. The document does not specify the number or qualifications of these experts.
• Other Performance Tests: These were likely evaluated against engineering specifications or known material properties, not by human experts establishing ground truth in the clinical sense.

4. Adjudication method for the test set

• Animal Study: Not specified. Histopathology and micro-CT assessments would likely involve independent evaluation, but no formal adjudication process like "2+1" or "3+1" is mentioned.
• Other Performance Tests: Not applicable, as these are technical performance assessments rather than interpretations 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

• No, an MRMC comparative effectiveness study was not done. The device is a bone void filler, not an AI or imaging diagnostic device.

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

• Not applicable. This is a physical medical device (bone putty), not an algorithm.

7. The type of ground truth used

• Animal Study: The "ground truth" for the animal study was based on quantitative measurements from micro-CT and qualitative/quantitative assessments from histopathology/histomorphometry to determine new bone formation and implant resorption.
• Other Performance Tests: The "ground truth" for drillability and temporary support was established through engineering performance tests comparing the device's physical behavior against predetermined functional expectations.
• Biocompatibility: The "ground truth" was established by adherence to ISO 10993 standards and their associated endpoints.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not a machine learning algorithm requiring a "training set." The development of the material involved formulation and testing, but not in the context of a "training set" for AI.

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

• Not applicable for the reasons stated above.

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