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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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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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ATLANTIK™ is intended for use as a bone void filler for bony voids or gaps of the skeletal system (e.g. extremities and pelvis) 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.

ATLANTIK™ is a bone void filler without initial mechanical properties. Therefore rigid fixation techniques may often be recommended.

ATLANTIK™ is a synthetic and osteoconductive bone void filler. It is a microporous and macroporous biphasic calcium phosphate ceramic consisting of 70% hydroxyapatite (FIA) and 30% beta-tricalcium phosphate (TCP). Its porosity is interconnected and opened with a total volume ratio of 70%.

ATLANTIK™ is available in the form of irregular-shaped vial-packed granules of different sizes and blocks with various shapes and sizes.

ATLANTIK TM is provided sterile for single use.

The provided text describes a 510(k) Summary for the ATLANTIK™ Bone Void Filler but does not contain information about specific acceptance criteria or a study proving that the device meets those criteria in the context of performance metrics like sensitivity, specificity, or reader improvement with AI assistance.

The document focuses on demonstrating substantial equivalence to predicate devices through bench testing for material properties. Therefore, many of the requested categories about AI performance studies, sample sizes for test/training sets, and expert adjudication cannot be extracted from this text.

Here's a breakdown of what can be extracted and what cannot, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Cannot be provided as requested. The document doesn't list specific performance metrics (like sensitivity, specificity, AUC) or corresponding acceptance criteria. Instead, it discusses the substantial equivalence of material properties.

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

Not applicable. This document describes bench testing of material properties, not a clinical study involving a "test set" of patient data for evaluating a diagnostic device's performance.

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

Not applicable. See point 2. Ground truth in this context refers to the material standards and measurements for comparing physical and chemical properties.

4. Adjudication Method for the Test Set

Not applicable. See point 2.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

No. This is not a multi-reader multi-case study for evaluating diagnostic performance. The device is a bone void filler.

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

Not applicable. The device is a physical bone void filler, not an algorithm or AI system.

7. The Type of Ground Truth Used

For the material properties testing, the "ground truth" was established by standard analytical methods for characterizing materials, such as:

• X-ray diffraction (XRD) for phase composition.
• Induced coupled plasma spectrometry (ICP) for chemical composition.
• Mercury intrusion porosimetry, scanning electron microscopy (SEM), and density measurements for porosity.
• Buffered solution testing for dissolution rate and pH.

The comparison was made against predicate devices using these same analytical methods to demonstrate similarity.

8. The Sample Size for the Training Set

Not applicable. This isn't an AI/machine learning device with a "training set."

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

Not applicable. See point 8.

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