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MASTERGRAFT® Resorbable Ceramic Granules is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Additionally, MASTERGRAFT® Resorbable Ceramic Granules can be used with autograft as a bone graft extender. MASTERGRAFT® Resorbable Ceramic Granules is to be gently packed into bony voids or gaps of the skeletal system (e.g., the posterolateral spine, pelvis, ilium and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. MASTERGRAFT® Resorbable Ceramic Granules provides a bone void filler that resorbs and is replaced with bone during the healing process.

MASTERGRAFT® Resorbable Ceramic Granules is made of medical grade combination of hydroxyapatite and b-tricalcium phosphate. MASTERGRAFT® is provided in a 60 percent hydroxyapatite and 40 percent b-tricalcium phosphate formulation. Alternatively, MASTERGRAFT® may be provided in a 15 percent hydroxyapatite and 85 percent b-tricalcium phosphate formulation. The product is supplied sterile for single patient use. MASTERGRAFT® Resorbable Ceramic Granules is an osteoconductive porous implant.

The provided text describes a 510(k) submission for the Medtronic Sofamor Danek MASTERGRAFT® Resorbable Ceramic Granules, seeking to expand its indications for use and size range. However, the document does not contain information about:

• Acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy).
• Any new study conducted to "prove the device meets the acceptance criteria" for the expanded indications.
• Sample sizes for test or training sets.
• Data provenance, number or qualifications of experts, adjudication methods, or ground truth establishment.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.

Instead, the submission relies on demonstrating substantial equivalence to previously cleared predicate devices.

Here's a breakdown based on the provided text, highlighting the missing information:

Acceptance Criteria and Reported Device Performance

The document does not explicitly define acceptance criteria as measurable performance metrics for the device itself in a study context. The "acceptance criteria" for the 510(k) approval process is typically demonstrating substantial equivalence to a legally marketed predicate device for the proposed indications.

Study Details (Information Not Provided in the Document)

1. Sample size used for the test set and the data provenance: Not provided. The submission relies on substantial equivalence to predicate devices, not a new clinical test set.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no new clinical study with a test set requiring expert ground truth is described.
3. Adjudication method for the test set: Not applicable.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is not an AI/imaging device, and no such study is described.
   • Effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device (bone void filler), not an algorithm.
6. The type of ground truth used: Not applicable for this 510(k) summary. For bone void fillers, "ground truth" would typically relate to histological evidence of bone formation, clinical outcomes, or radiological assessment over time, none of which are described in the context of a new study in this document.
7. The sample size for the training set: Not applicable, as this is not an AI/machine learning device that uses training sets.
8. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) summary focused on demonstrating substantial equivalence to predicate devices for device approval and expanded indications, rather than reporting on a new performance study with explicit acceptance criteria and corresponding results for the device itself.

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MASTERGRAFT® Resorbable Ceramic Granules may be used alone or in combination with autograft to provide a bone void filler that is resorbed/remodeled and is replaced by host bone during the healing process. MASTERGRAFT® Resorbable Ceramic Granules is packed into bony voids or gaps to fill and/or augment dental oral/maxillofacial bony tissue. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Procedures include;

• Filling of periodontal defects
• Filling of dental extraction sockets
• Filling of cystic defects
• Sinus lifts
• Alveolar ridge augmentation
• Oral/maxillofacial augmentation or reconstruction. .
  MASTERGRAFT® Resorbable Ceramic Granules may be used with or without internal fixation, and may be mixed with autograft as a bone graft extender.

MASTERGRAFT® Resorbable Ceramic Granules is made of medical grade combination of hydroxyapatite and b-tricalcium phosphate. MASTERGRAFT® is provided in a 60 percent hydroxyapatite and 40 percent b-tricalcium phosphate formulation. Alternatively, MASTERGRAFT® may be provided in a 15 percent hydroxyapatite and 85 percent b-tricalcium phosphate formulation. The product is supplied sterile for single patient use. MASTERGRAFT® Resorbable Ceramic Granules is an osteoconductive porous implant.

This 510(k) premarket notification for Medtronic Sofamor Danek MASTERGRAFT® Resorbable Ceramic Granules primarily focuses on expanding the indications for use to the oral and maxillofacial region, based on substantial equivalence to previously cleared devices. Therefore, the traditional "acceptance criteria" and detailed "study that proves the device meets the acceptance criteria" in terms of performance metrics like sensitivity, specificity, accuracy, and confidence intervals, which are common in AI/Diagnostic device submissions, are not applicable here.

Instead, the "acceptance criteria" for this type of submission revolve around demonstrating substantial equivalence to predicate devices for the new indications. The "study" proving this involves a comparison of the device's characteristics (material composition, intended use, technological characteristics) to the predicate devices.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, for this 510(k) application, the acceptance criteria are not performance metrics but rather a demonstration of substantial equivalence.

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

The provided document does not describe a "test set" in the context of clinical performance or algorithm evaluation. This submission is for substantial equivalence based on material composition and intended use expansion, not for demonstrating clinical efficacy through a new trial with a distinct test set.

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. There was no clinical "test set" requiring expert ground truth establishment for this 510(k) submission.

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

Not applicable. There was no clinical "test set" requiring adjudication for this 510(k) submission.

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 is not an AI/diagnostic device, and no MRMC study was conducted or referenced in this summary.

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

Not applicable. This is a medical device (bone graft material), not an algorithm or AI system.

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

Not applicable in the conventional sense of a clinical study for a diagnostic or AI device. The "ground truth" for this submission is embedded in the regulatory precedent set by the predicate devices (K020986 and K051885) and their established safety and effectiveness. The "truth" being established is that the new device is substantially equivalent to these already-approved devices.

8. The sample size for the training set

Not applicable. There was no "training set" as this is not an AI/machine learning device.

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

Not applicable. There was no "training set."

Summary of the Study for Substantial Equivalence:

The "study" for this 510(k) submission is a comparison to predicate devices (MASTERGRAFT® Resorbable Ceramic Granules K020986 and MBCP™ K051885). The manufacturer provided documentation demonstrating that the subject device shares the same material composition (hydroxyapatite and b-tricalcium phosphate) and similar technological characteristics, and that its expanded oral and maxillofacial indications are substantially equivalent to the existing indications of the predicate devices. The FDA reviewed this documentation and concurred with the substantial equivalence claim, allowing the device to be marketed for the specified expanded indications. This process does not involve new clinical trials or performance studies to establish "acceptance criteria" through statistical metrics.

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MasterGraft™ Resorbable Ceramic is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MasterGraff™ Resorbable Ceramic is to be gently packed into bony voids of the skeletal system (e.g., the spine, pelvis, ilium, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. MasterGraft™ provides a bone void filler that resorbs and is replaced with bone during the healing process.

MasterGraft™ Resorbable Ceramic is made of medical grade combination of hydroxyapatite and ß-tricalcium phosphate. MasterGraft™ is provided in a 60 percent hydroxyapatite and 40 percent ß-tricalcium phosphate formulation. Alternatively, MasterGraft™ may be provided in a 15 percent hydroxyapatite and 85 percent ß-tricalcium phosphate formulation. The product is supplied sterile for single patient use. MasterGraft™ is an osteoconductive porous implant.

This document is a 510(k) summary for the Medtronic Sofamor Danek MasterGraft™ Resorbable Ceramic. A 510(k) submission is a premarket notification demonstrating that a device is at least as safe and effective as a legally marketed predicate device. This type of submission generally does not include detailed studies on performance against specific acceptance criteria in the way a clinical trial for a new drug or a novel, high-risk device might.

Based on the provided text, the submission focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing specific performance metrics against pre-defined acceptance criteria through a standalone study. Therefore, most of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC, standalone performance, ground truth details, training set size) is not present in this type of document.

Here's a breakdown of what can be extracted and what is missing:

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

• Missing. This document does not describe specific numerical acceptance criteria (e.g., a certain percentage of bone regeneration, or a specific mechanical strength) or report performance against such criteria. The entire premise of a 510(k) is to demonstrate substantial equivalence, not to prove novel performance metrics.

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

• Missing. No test set or associated sample size is mentioned. The submission is based on demonstrating equivalence, likely through material characterization, predicate device literature review, and potentially some in-vitro or animal testing (though not detailed here).

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)

• Missing. Not applicable for a substantial equivalence submission of this nature. There is no mention of a test set requiring expert-established ground truth.

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

• Missing. Not applicable.

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

• Missing. Not applicable. This device is a bone void filler, not an AI-assisted diagnostic tool.

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

• Missing. Not applicable. This device is a bone void filler, not an algorithm.

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

• Missing. While the device is intended to be replaced by bone during healing, the 510(k) summary does not describe specific studies that established "ground truth" using pathology or outcomes data in the context of a clinical performance study. The ground truth for substantiating equivalence would be data supporting the properties and efficacy of the predicate devices.

8. The sample size for the training set

• Missing. Not applicable. This is not an AI/machine learning device.

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

• Missing. Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as interpreted for a 510(k)):

The "study" described in this document is a demonstration of Substantial Equivalence to legally marketed predicate devices, not a study proving the device meets specific (new) performance acceptance criteria.

• Substantial Equivalence Claim: The documentation "demonstrated the MasterGraft™ Resorbable Ceramic to be substantially equivalent to itself and Interpore Cross International ProOsteon 500R (K990131)."
• Purpose of Submission: The specific purpose of this particular submission was to:
  • Increase the granule size of the MasterGraft™ device.
  • Expand the indications to include the ilium.
• Implied Acceptance Criteria (for substantial equivalence): The implied acceptance criteria are that the modifications (larger granule size, expanded indication to ilium) do not alter the fundamental safety and effectiveness profile of the device such that it is no longer substantially equivalent to its own previous version or the identified predicate device ProOsteon 500R, for its stated indications. This would typically involve demonstrating similar material properties, biocompatibility, and intended function. The FDA's letter confirms that the review found the device to be substantially equivalent for the stated indications for use.

In conclusion, this regulatory document does not contain the level of detail requested concerning specific acceptance criteria and detailed study methodology because it is a 510(k) submission focused on demonstrating substantial equivalence rather than a detailed performance study against novel, quantitative acceptance criteria.

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MasterGraft™ Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MasterGraft™ Bone Void Filler is to be gently packed into bony voids of the skeletal system (e.g., the spine, pelvis, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. MasterGraft™ provides a bone void filler that resorbs and is replaced with bone during the healing process.

MasterGraff™ Bone Void Filler is made of medical grade combination of hydroxyapatite and ßtricalcium phosphate. MasterGraft™ is provided in a 60 percent hydroxyapatite and 40 percent ßtricalcium phosphate formulation. Alternatively, MasterGraft™ may be provided in a 15 percent hydroxyapatite and 85 percent ß-tricalcium phosphate formulation. The product is supplied sterile for single patient use. MasterGraft™ is an osteoconductive porous implant.

This document is a 510(k) summary for the Medtronic Sofamor Danek MasterGraft™ Bone Void Filler. It focuses on establishing substantial equivalence to previously cleared devices rather than presenting a de novo study with specific performance acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and study details for an AI/device performance evaluation is not applicable or present in this document.

Here's an breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Not Applicable. This document does not describe specific performance acceptance criteria or report on performance metrics in the way one would for an AI or novel device study. The core of this 510(k) summary is to demonstrate "substantial equivalence" of the MasterGraft™ Bone Void Filler to existing, legally marketed bone void fillers.

The "performance" described is the product's intended function based on its composition and mechanism of action, which is assumed to be similar to its predicates.

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

Not Applicable. No test set for performance evaluation is described. The document pertains to regulatory clearance based on substantial equivalence, not a clinical performance study with a test set.

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

Not Applicable. No test set or ground truth establishment by experts is described.

4. Adjudication Method for the Test Set

Not Applicable. No test set or adjudication method 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

Not Applicable. This document concerns a physical medical device (bone void filler), not an AI algorithm. Therefore, an MRMC study and AI assistance are not relevant.

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

Not Applicable. This document concerns a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

Not Applicable. No ground truth for performance evaluation is mentioned as this is a substantial equivalence submission. The closest concept might be the established safety and efficacy of the predicate devices.

8. The Sample Size for the Training Set

Not Applicable. No training set is mentioned as this is a physical medical device, not an AI algorithm.

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

Not Applicable. No training set or ground truth establishment is described.

Summary of the Document's Content:

The document is a 510(k) summary for the Medtronic Sofamor Danek MasterGraft™ Bone Void Filler. It outlines:

• Product Description: A medical-grade combination of hydroxyapatite and β-tricalcium phosphate, supplied sterile, in two formulations (60% HA/40% β-TCP or 15% HA/85% β-TCP). It is described as an osteoconductive porous implant.
• Indications for Use: For bony voids or gaps not intrinsic to the stability of the bony structure, to be gently packed into skeletal voids (spine, pelvis, extremities). These defects can be surgically created or from traumatic injury. The product resorbs and is replaced by bone during healing.
• Substantial Equivalence: The primary assertion is that the MasterGraft™ Bone Void Filler is substantially equivalent to other previously cleared bone void fillers. This means the device is considered as safe and effective as a legally marketed predicate device, and thus does not require a de novo premarket approval application. The FDA letter confirms this finding of substantial equivalence (K012506).

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