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MCS Bone Graft 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. MCS Bone Graft is indicated to be hydrated with autologous bone marrow aspirate and packed into osseous defects of the extremities, pelvis and posterolateral spine. When used in the posterolateral spine, MCS Bone Graft is to be used as an autograft extender. Following implantation, the graft resorbs and is replaced by host bone during the healing process.

MCS Bone Graft is a bone graft substitute comprising biphasic mineral granules suspended in a porous, bovine type I collagen matrix. The biphasic granules are 60% hydroxyapatite (HA) and 40% beta tri-calcium phosphate (betaTCP). The device is provided in a strip form and is supplied terminally sterile for single patent use. The device is designed to be combined with autologous bone marrow aspirate prior to facilitate packing into bony defects and is used with autologous bone in the posterolateral spine. The device provides an osteoconductive scaffold that resorbs and guides host bone regeneration during the healing process.

The provided document is a 510(k) summary for the MCS Bone Graft device. It describes the device, its intended use, and provides a summary of performance testing and substantial equivalence. However, it does not contain specific acceptance criteria, a detailed study description with sample sizes, or information on human reader studies (MRMC or standalone), which are typically associated with artificial intelligence/machine learning devices. The MCS Bone Graft is a medical device, specifically a bone graft substitute, and its evaluation focuses on biocompatibility, material properties, and in-vivo animal studies, not AI performance.

Therefore, the requested information cannot be fully extracted from the provided text in the context of an AI/ML device. I will answer based on the information that is present about the MCS Bone Graft as a physical medical device.

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

The document does not specify quantitative acceptance criteria in a table format, nor does it present device performance in terms of metrics like sensitivity, specificity, or accuracy that are typical for AI/ML devices. Instead, it refers to compliance with standards and successful outcomes in animal studies.

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

• Sample Size: The document mentions a "critical-size rabbit femoral defect study" and a "rabbit posterolateral spine fusion study." It does not specify the exact number of animals used in these studies.
• Data Provenance: The studies are animal studies (rabbits), specifically in vivo performance testing. There is no information on the country of origin of the data or whether it was retrospective or prospective, though animal studies are typically prospective by nature.

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 information is not applicable to this device submission. The MCS Bone Graft is a physical medical device, not an AI/ML diagnostic tool. Ground truth was established through scientific methods such as radiographic, microCT, biomechanical, and histological endpoints in animal models, not by human expert assessment of AI output.

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

This information is not applicable. The device is a bone graft substitute, and its performance evaluation does not involve human adjudication of diagnostic outputs.

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. This type of study is relevant for AI/ML diagnostic devices where human readers interpret medical images with or without AI assistance. The MCS Bone Graft is a therapeutic bone graft substitute.

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

No, a standalone performance study (algorithm only) was not done. This is not relevant for a physical bone graft device.

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

For the animal in vivo performance testing, the ground truth was established using:

• Radiographic endpoints
• MicroCT (micro-computed tomography) endpoints
• Biomechanical endpoints
• Histological endpoints (examination of tissue microstructure)

8. The sample size for the training set

This information is not applicable. The MCS Bone Graft is a physical medical device, not an AI/ML algorithm that requires a training set.

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

This information is not applicable, as there is no training set for this type of medical 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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