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MCP Bone Putty is a bone graft substitute intended for use in bony voids or gaps of the skeletal system not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or result from traumatic injury to the bone. MCP Bone Putty is indicated to be combined with autologous bone marrow aspirate and packed into osseous defects of the extremities, pelvis and posterolateral spine. When used in the posterolateral spine, MCP Bone Putty is to be used as an autograft extender. The device resorbs and is replaced by host bone during the healing process.

MCP Bone Putty is a bone graft substitute comprising biphasic mineral granules suspended in a porous type I collagen matrix, provided terminally sterile and for single patient use. The device is to be combined with autologous bone marrow aspirate to facilitate packing into bony defects and upon implantation, provides an osteoconductive scaffold that resorbs and guides host bone regeneration during the healing process.

The provided text describes the 510(k) premarket notification for "MCP Bone Putty," a bone graft substitute. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study to prove meeting those criteria in the way a clinical trial for a novel drug or a standalone AI diagnostic device might.

However, I can extract the relevant information from the performance testing section to construct an answer regarding acceptance criteria and the studies conducted. It's important to note that the "acceptance criteria" here are implied by the focus on demonstrating "equivalence" to existing devices in terms of safety and performance, rather than explicit numerical thresholds the device must surpass on its own.

Here's the breakdown based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Femoral Defect Animal Study:
  • Test Set Sample Size: 14 defect sites implanted with MCP Bone Putty (total of 19 rabbits for both test and predicate groups).
  • Data Provenance: Prospective animal study conducted in a rabbit model.
• Posterolateral Spine Fusion Animal Study:
  • Test Set Sample Size: The number of MCP Bone Putty test subjects is not explicitly separated from the total per test group, but the study included 25 rabbits, with 8 evaluated at 4 weeks and 12 at 12 weeks across the MCP Bone Putty, Mastergraft Putty, and autograft control groups.
  • Data Provenance: Prospective animal study conducted in a rabbit model.

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

This information is not provided in the document. The "ground truth" in these animal studies would be established through scientific assessments (macroscopic, radiographic, microCT, histological, biomechanical) by researchers and veterinarians, but their specific number and qualifications are not detailed.

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

This information is not provided in the document. While assessments were made, the specific adjudication method for interpreting images/histology is not described.

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 document describes animal studies for a physical bone graft substitute. It does not involve a multi-reader multi-case (MRMC) comparative effectiveness study for human readers or AI assistance.

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

No. This document describes animal studies for a physical bone graft substitute. It does not involve algorithm-only performance testing.

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

For the animal studies, the "ground truth" was established through:

• Pathology/Histology: Histological assessments of the implant site/fusion site.
• Imaging Data: Radiographic and microCT assessments.
• Macroscopic Assessment: Visual inspection.
• Biomechanical Assessment: For the spine fusion study, biomechanical assessments were performed to evaluate fusion strength.
• Safety Outcomes: Observation for device-related adverse reactions.

8. The sample size for the training set

This information is not applicable as this is not an AI/algorithm-based device requiring a training set in that context. The "training" for this device would be its development and iterative testing.

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

This information is not applicable as this is not an AI/algorithm-based device.

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MCS Bone Graft is a bone void filler device intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. MCS Bone Graft is indicated to be packed gently into bony voids or gaps of the skeletal system (i.e., extremities and pelvis) and is used mixed with bone marrow aspirate. Once implanted, the device resorbs and is replaced with host bone during the healing process.

Device Identification and Materials of Use:
MCS Bone Graft is a resorbable bone void filler device comprised of biphasic mineral granulate suspended in a porous type I collagen matrix.
Device Characteristics:
The implant is designed to be hydrated with bone marrow aspirate prior to implantation to facilitate handling and placement in bony defects. The device is supplied freeze dried in strip form, and packaged in a sterile barrier foil pouch. The device is provided sterile, for single use, in a variety of sizes.
Body Contact:
The device is a permanent resorbable implant in bone tissue
Mechanism of Action:
The device's composition allows for resorption and remodeling over time. It is an osteoconductive scaffold for new bone regeneration.

The provided document is a 510(k) summary for the MCS Bone Graft device, which is a resorbable bone void filler. This type of device is classified as a medical device and its clearance process differs significantly from software or AI-powered devices, which typically involve extensive clinical studies and performance metrics against ground truth.

Therefore, the requested information elements (acceptance criteria, specific study types like MRMC, sample sizes for test/training sets, expert ground truth establishment, etc.) do not directly apply to this document as it describes a non-AI bone graft. The clearance for this device is based on showing substantial equivalence to existing predicate devices, not on a formal evaluation of diagnostic performance against a "ground truth" as you would find for an AI-powered diagnostic tool.

However, I can extract the information that is relevant to the device's validation and substantial equivalence claims as presented in the document:

Device: MCS Bone Graft

Device Type: Resorbable calcium salt bone void filler device

Here's a summary of the validation detailed in the document, framed as closely as possible to your request, but acknowledging the difference in device type:

1. Table of Acceptance Criteria and Reported Device Performance

For the MCS Bone Graft, "acceptance criteria" revolve around demonstrating safety and effectiveness compared to predicate devices, primarily through material characterization, biocompatibility, and animal performance, rather than diagnostic accuracy metrics.

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

• Animal Performance Study:
  • Sample Size: Though not explicitly stated as a number, the study utilized a "femoral cancellous defect rabbit model." The exact number of animals is not provided in this summary.
  • Data Provenance: This was an animal study (rabbit model), not human clinical data. The document does not specify the location of the animal study, but it would presumably be a controlled laboratory setting. It is inherently a prospective study in the sense that the animal model was designed and experiments carried out to validate the device's performance.

3. Number of Experts and Qualifications for Ground Truth

• This device clearance relies on technical standards, biocompatibility testing, and animal efficacy studies, not on human expert review for "ground truth" as would be applied to a diagnostic AI tool. Therefore, information on experts establishing ground truth in this context is not applicable. The assessment is made by regulatory bodies (FDA) based on submitted test results.

4. Adjudication Method for the Test Set

• Not applicable for this type of device and study. The "test set" was an animal model, and the outcome measures (e.g., graft resorption, new bone formation) were likely assessed by veterinary pathologists or researchers, but no "adjudication method" in the sense of multiple human readers resolving disagreements is mentioned or relevant here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC study was not conducted. This type of study is relevant for evaluating the impact of AI on human reader performance for diagnostic tasks, which is not the function of a bone graft device.

6. If a Standalone (Algorithm Only without Human-in-the-Loop Performance) was done

• Not applicable. The device is a physical bone graft, not a software algorithm. Its "performance" is evaluated functionally within a biological system (an animal model).

7. The Type of Ground Truth Used

• For the animal performance study, the "ground truth" would be established through histological analysis or imaging of the animal's bone healing process, directly assessing graft resorption and new bone formation. This is a form of direct biological/pathological outcome assessment in an animal model.
• For other testing (biocompatibility, material characterization, sterility), the "ground truth" is adherence to established international and national standards (ISO, ASTM).

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/machine learning device, so there is no "training set."

9. How the Ground Truth for the Training Set was Established

• Not applicable for the same reason as point 8.

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Bioactive Bone Graft Putty is a bone void filler device intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Bioactive Bone Graft Putty is indicated to be packed gently into bony voids or gaps of the skeletal system (i.e., extremities, pelvis and posterolateral spine fusion procedures). Bioactive Bone Graft Putty can also be used with autograft as a bone graft extender in the posterolateral spine. The device provides a bone void filler that is resorbed and replaced with host bone during the healing process.

Bioactive Bone Graft Putty is a synthetic bone void filler comprised of a mixture of calcium phosphate granules and bioactive glass granules suspended in a resorbable polymer carrier that facilitates handling and delivery of the granule components. The device is supplied as putty, pre-loaded in a syringe applicator and packaged in a sterile barrier foil pouch. The device is provided sterile, for single use, in a variety of sizes.

Here's a breakdown of the acceptance criteria and study information for the Bioactive Bone Graft Putty, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text describes a submission for a medical device (Bioactive Bone Graft Putty) seeking 510(k) clearance, which means demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for a novel device. Therefore, the "acceptance criteria" are implicitly the requirements for demonstrating substantial equivalence. The reported "device performance" refers to the results of the studies used to support this equivalence.

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

• Sample Size: The text states "Animal performance testing was performed in femoral cancellous defect and posterolateral spine fusion (PLF) rabbit models." It does not specify the exact number of rabbits used in these models.
• Data Provenance: The animal studies were performed in "rabbit models." This indicates a pre-clinical, prospective study design, typically conducted in a controlled laboratory environment. The country of origin is not explicitly stated.

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

This information is not provided in the text. The animal studies would typically involve veterinary pathologists or researchers to assess outcomes (e.g., new bone formation, graft resorption), but the number and qualifications of such experts are not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the text. Given the nature of animal studies assessing histological or radiographic outcomes, there might have been independent assessment by experts, but the adjudication method (e.g., 2+1, 3+1) is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not reported. This type of study typically involves human readers interpreting medical images or data, which is not applicable to the animal performance testing described.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

N/A. This device is a bone graft putty, not an algorithm or an AI-powered diagnostic tool. The concept of "standalone performance" for an algorithm is not relevant here.

7. The Type of Ground Truth Used

For the animal performance testing, the ground truth was established through direct observation and histopathological assessment of the animal models. This would include:

• Histopathology: Examining tissue samples under a microscope to evaluate new bone formation, graft resorption, and inflammatory reactions.
• Radiographic imaging (implied): While not explicitly stated for confirming the "outcome" in the way pathology would, it's common in bone healing studies to use imaging to track progress. However, the direct measure for bone formation and resorption would largely rely on pathology.

8. The Sample Size for the Training Set

This is not applicable for this device. The Bioactive Bone Graft Putty is a physical medical device, not an AI model requiring a training set. The "testing" mentioned refers to traditional pre-clinical and bench testing.

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

This is not applicable as there is no AI model or "training set" for this device.

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Interface Bone Void Filler is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structures. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Interface Bone Void Filler is indicated to be gently packed into bony voids or gaps of the skeletal system (extremities and pelvis), or in the posterolateral spine when mixed with autograft. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

Interface Bone Void Filler is a synthetic bioactive bone graft for use in the repair of osseous defects. It is supplied as irregular synthetic granules of bioactive glass, sized from 200 microns to 420 microns. The elemental composition of Interface Bone Void Filler granules is Si, Ca. Na, and P. Interface Bone Void Filler conforms to ASTM specification F1538 for 45S5 bioactive glass.

Here's a breakdown of the requested information based on the provided text, focusing on the study and acceptance criteria for the Interface Bone Void Filler:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a comparative equivalency study rather than a study with pre-defined acceptance criteria against specific performance metrics for the subject device alone. The goal was to demonstrate equivalence to a predicate device. Therefore, the "acceptance criteria" here implicitly refers to the demonstration of equivalence.

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

• Sample Size for Physical/Chemical Testing: Not explicitly stated as a numerical sample size. The document mentions "detailed side-by-side material characterization was performed" and lists analytical methods. This implies sufficient samples were tested for each method to ensure accurate characterization.
• Sample Size for Animal Model: Not explicitly stated numerically. The text refers to "a posterolateral spine fusion animal model." More details (e.g., number of animals, number of implants per animal) would typically be in the full study report, but are absent in this summary.
• Data Provenance: Not explicitly stated (e.g., country of origin for the animal study, if it was retrospective or prospective). The animal model description suggests it was a prospective animal study conducted to compare the devices.

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 given document extract. The summary mentions "radiographic, morphometric and histologic performance" in an animal model, which implies assessment by trained individuals (e.g., veterinary radiologists, pathologists), but their number or qualifications are not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the given document extract. For the animal study's assessment of radiographic, morphometric, and histologic performance, no adjudication method (e.g., 2+1, 3+1) is described.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The study described is a comparison of two medical devices (bone void fillers) against each other, and it does not involve human readers interpreting images with or without AI assistance. This type of study is typically done for diagnostic imaging devices.

6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) Was Done

This question is not applicable as the device is a bone void filler, not an AI algorithm. Therefore, an "algorithm only, without human-in-the-loop performance" study was not performed.

7. The Type of Ground Truth Used

For the animal model study, the "ground truth" was established by radiographic, morphometric, and histologic analyses. This implies:

• Radiographic: Interpretation of X-rays or other imaging by experts.
• Morphometric: Quantitative measurements of bone formation or other relevant structures from images or histological sections.
• Histologic: Examination of tissue samples under a microscope by pathologists to assess bone ingrowth, material resorption, inflammation, etc.

8. The Sample Size for the Training Set

This question is not applicable. The device is a bone void filler, not an AI algorithm, so there is no concept of a "training set" in the context of machine learning.

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

This question is not applicable as there is no training set for an AI algorithm.

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Interface Bone Void Filler is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structures. Interface Bone Void Filler is indicated to be gently packed into bony voids or gaps of the skeletal system (the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

Interface Bone Void Filler is a synthetic bioactive bone graft for use in the repair of osseous defects. It is supplied as irregular synthetic granules of bioactive glass, sized from 200 microns to 420 microns. When implanted in living tissue, the material undergoes a time dependent surface modification. The surface reaction results in the formation of a calcium phosphate layer, which is equivalent in composition and structure to the hydroxyapatite found in bone mineral. The biological apatite layer of the granules provides an osteoconductive scaffold for the generation of new osseous tissue. New bone infiltrates around the granules allowing the repair of the defect as the granules are absorbed. The elemental composition of Interface Bone Void Filler granules is Si, Ca, Na, and P. Interface Bone Void Filler conforms to ASTM specification F1538 for 45S5 bioactive glass.

The provided text describes the Interface Bone Void Filler and its 510(k) summary, but it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the context of an AI/ML medical device.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (NovaBone Resorbable Bone Graft Substitute) through:

• Material Characterization: Comparing chemical composition, physical properties, and performance characteristics (e.g., dissolution rates).
• Animal Model Study: Comparing radiographic, morphometric, and histologic performance of the subject device to the predicate device in an animal model.

Therefore, I cannot provide the requested table or detailed study information for acceptance criteria related to AI/ML device performance.

However, I can extract information related to the equivalence study as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for a physical medical device (bone void filler) and not an AI/ML device, the concept of "acceptance criteria" in the context of sensitivity, specificity, or similar metrics for an algorithm's performance is not applicable to the provided text. The "performance" assessment here is about demonstrating equivalence to a predicate device.

The following points (2-9) are not applicable to the provided document as it describes a physical bone void filler, not an AI/ML medical device. Therefore, the information regarding sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance cannot be extracted from this text.

I can only state that:

2. Sample size, data provenance: The document mentions an "animal model" for the performance comparison but does not specify the number of animals used or their origin. It is a prospective study in the sense that the sponsor conducted it to demonstrate equivalence.
3. Number of experts and qualifications: Not applicable. Ground truth was established through scientific analysis (chemical, physical, animal model results).
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This is for AI performance with human readers.
6. Standalone (algorithm only) performance: Not applicable. This is for AI performance.
7. Type of ground truth: For the material characterization, it's based on analytical measurements (e.g., SEM/EDXA, ICP/OES, FT-IR, XRD, laser diffraction, calcium-specific electrode). For the animal study, it's based on radiographic, morphometric, and histologic assessments.
8. Sample size for training set: Not applicable (no AI/ML algorithm involved).
9. How ground truth for training set was established: Not applicable (no AI/ML algorithm involved).

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