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Merries K-PHATE is intended to be packed into bony defects of the skeletal system ( extremities, spine, or pelvis) which are not intrinsic to the stability of the bony structure. These defects may be surgically created voids or from traumatic injury to the bone. The device gradually resorbs and is replaced with bone during the healing process. Rigid fixation techniques should be used in conjunction with this device.

Merries K-PHATE bone graft substitute is a microporous and macroporous biphasic calcium phosphate ceramic consisting of 60% hydroxyapatite and 40% ß-tricalcium phosphate. Merries K-PHATE is supplied sterile in various shapes and sizes. The choice of different form or size of the product depends on the type and size of the recipient site. Blocks and wedges are used for large bony defect while granules are used as bone filler for small area.

The provided text describes the 510(k) Premarket Notification Summary for the "Merries K-PHATE Bone graft substitute" (K063157). This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, performance metrics, and study design for a clinical effectiveness study is not explicitly present in the provided text.

Specifically, this submission relies on:

1. Material characteristics: The device is a biphasic calcium phosphate ceramic, similar to predicate devices.
2. Function and intended use: It's designed as a resorbable bone void filler, the same as predicate devices.
3. Biocompatibility testing: To ensure safety.
4. Sterilization dose auditing: To ensure sterility.
5. Chemical requirements: Conformance to ASTM standards for ceramic hydroxyapatite and beta-tricalcium phosphate.

Here's an attempt to answer your questions based on the provided text, recognizing that a full clinical study with acceptance criteria for effectiveness is not detailed:

Acceptance Criteria and Device Performance (Based on provided 510(k) Summary)

Since this is a 510(k) submission for a bone graft substitute, the primary "acceptance criteria" discussed are related to substantial equivalence to legally marketed predicate devices, and the device's safety through biocompatibility and material testing. Performance in terms of clinical outcomes (e.g., rate of bone fusion, strength of new bone) is inferred from the predicate devices rather than directly proven through a new comparative clinical study for this specific device in this submission.

1. Table of Acceptance Criteria and Reported Device Performance

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 summary does not detail a clinical "test set" for performance evaluation in the way a clinical trial would. The "tests" reported are primarily bench/laboratory tests for material properties and biocompatibility.

• Sample Size for Bench/Biocompatibility Tests: Not specified in the summary. These tests typically involve a relevant number of samples for each specific test (e.g., cell cultures for cytotoxicity, animal models for irritation/sensitization/implantation).
• Data Provenance: The manufacturing company is based in Taipei, Taiwan (Merries International Inc.). The specific locations where the individual biocompatibility tests were conducted are not stated, but given the company's location, they were likely performed in a certified lab, potentially in Taiwan or another country as required for international standards. These tests are prospective in nature, conducted specifically for this submission.

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 as there is no human-read clinical test set described in this summary to establish a "ground truth" for diagnostic or prognostic performance. The "ground truth" for the material and biocompatibility tests is based on objective scientific measurements and established standards (e.g., cell viability, tissue response, chemical composition as per ASTM).

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

This is not applicable. No clinical test set with human assessment requiring adjudication 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

This is not applicable. This device is a bone graft substitute, not an AI-powered diagnostic or assistive technology. No MRMC study was conducted or is relevant to this type of device.

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

This is not applicable. This device is a bone graft substitute, not an algorithm.

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

For the tests conducted:

• Material Composition: Ground truth is based on physical and chemical analysis techniques confirming compliance with ASTM standards.
• Biocompatibility: Ground truth is based on biological assays and histological examination in animal models, evaluated against established criteria for cytotoxicity, irritation, sensitization, and tissue compatibility.
• Sterility: Ground truth is based on microbiological testing (sterilization dose auditing).

There is no "expert consensus" or "pathology" in the sense of a clinical diagnostic study. Outcomes data (e.g., long-term bone healing) would typically be part of a full clinical trial, which is not detailed here for this 510(k) submission.

8. The sample size for the training set

This is not applicable. This device is a medical implant, not a machine learning model, and therefore does not have a "training set."

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

This is not applicable as there is no training set for this device.

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The OSS Bone Graft System and the OSS RapidSet Bone Graft System are indicated for filling bony voids of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from disease or traumatic injury to the bone. The device is intended for bone voids or gaps that are not intrinsic to the structural integrity of the bony structure.

OSS Bone Graft System and OSS RapidSet Bone Graft System are packaged as separate, pre-measured powder and liquid components. The two components are to be mixed intraoperatively to produce a homogenous paste that can be applied to bone gaps or defects. The powder component is a mixture of a ceramic calcium phosphate powder and sodium citrate dihydrate. The liquid component is a solution comprised of anhydrous citric acid (C6H8O7) and distilled water (H2O). When mixed, the powder and liquid combine to form a homogenous paste.

The provided text describes the 510(k) summary for the Biomet OSS Bone Graft System and OSS RapidSet Bone Graft System. Based on the document, here's an analysis of the acceptance criteria and study information:

Key Finding: The submission states "Clinical Testing: None provided," meaning no specific human clinical study was conducted to prove the device met acceptance criteria, as it was cleared through the 510(k) substantial equivalence pathway. The clearance relies primarily on non-clinical testing and similarity to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. No clinical test set data was provided or used for evaluation in this 510(k) submission.
• Data Provenance: Not applicable. No clinical data was used. The submission relies on non-clinical testing and comparison to legally marketed predicate devices.

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

• Not applicable. No clinical test set was used, therefore no experts were required to establish ground truth for clinical performance. The assessment was based on FDA reviewers evaluating the non-clinical data and predicate device comparisons.

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. The document explicitly states "Clinical Testing: None provided."

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

• Not applicable. This is a bone graft substitute, not an AI algorithm or diagnostic device.

7. The Type of Ground Truth Used

• Non-Clinical Data: The "ground truth" for the non-clinical testing (elemental analysis, set time, X-ray diffraction, surface pH, exothermic temperature) would be established by standard laboratory methods and specifications for biomaterials.
• Substantial Equivalence: The primary "ground truth" for regulatory acceptance in this case is the established safety and effectiveness of the legally marketed predicate devices to which the OSS Bone Graft System is deemed "substantially equivalent." This means that the predicate devices, having gone through their own clearance processes (which may or may not have involved clinical trials depending on their regulatory pathway), served as the benchmark.

8. The Sample Size for the Training Set

• Not applicable. This is not a machine learning or AI device.

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

• Not applicable. This is not a machine learning or AI device.

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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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