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It is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.

• Augmentation or reconstructive treatment of the alveolar ridge.
• Filling of infrabony periodontal defects.
• Filling of defects after root resection, apicoectomy, and cystectomy.
• Filling of extraction sockets to enhance preservation of the alveolar ridge.
• Elevation of the maxillary sinus floor.
• Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR).
• Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).

OSferion D is a white porous material composed of Beta-tricalcium phosphate(ß-TCP). It is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. The ceramic material complied with US standard specification ASTM F 1088-04. The OSferion D product range consists of two product types with porosities of 75% and of three granule sizes (G0:0.150.8mm,G1:0.51.5mm,G2:1.0~3.0mm).

This document is a 510(k) summary for the device OSferion D, a synthetic bone void filler. It describes the device, its indications for use, and compares it to predicate devices to establish substantial equivalence.

Based on the provided text, a conventional study demonstrating quantitative performance metrics against specific acceptance criteria for OSferion D is not present. The document focuses on establishing substantial equivalence to predicate devices, which is a regulatory pathway that does not typically involve a new clinical study with acceptance criteria and a detailed performance report in the same way a PMA or a de novo submission might.

Therefore, I cannot fulfill all parts of your request as the information is not provided in the input document.

Here's an assessment based on the available information:

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

This information is not provided in the document. The 510(k) summary focuses on demonstrating "substantial equivalence" to predicate devices based on indications for use, materials, and design, rather than presenting a study against specific performance acceptance criteria for the new device.

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

Not applicable/Not provided. The document does not describe a clinical performance study with a 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/Not provided. No test set or ground truth establishment process is described.

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

Not applicable/Not provided. No test set or adjudication process 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 device is a bone void filler, not an AI-powered diagnostic device. An MRMC study is not relevant here.

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

Not applicable. This is not an algorithm or AI device.

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

Not applicable/Not provided. No "ground truth" for a performance study is mentioned as no such study is described. The "ground truth" for substantial equivalence is the safety and effectiveness of the predicate devices.

8. The sample size for the training set:

Not applicable/Not provided. No training set is mentioned as this is not an AI/ML device.

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

Not applicable/Not provided. No training set or ground truth establishment is mentioned.

Summary of Device and its Equivalence Claim:

The document for OSferion D states:

• Acceptance Criteria (Implied by 510(k) pathway): Substantial equivalence to predicate devices in "indication for use, and in specifications of the material." The core acceptance criterion for a 510(k) is demonstrating that the new device is as safe and effective as a legally marketed predicate device and does not raise new questions of safety or effectiveness.
• Study Proving Acceptance Criteria: The "study" is the 510(k) premarket notification process itself. The submission compared OSferion D to several predicate devices (Cerasorb® DENTAL, BioResorb® Macro Pore, OSferion, Vitoss® Scaffold Synthetic Cancellous Bone Void Filler) and found it to be substantially equivalent.
• Reported Device Performance: The document doesn't provide quantitative performance data for OSferion D from a specific study. Instead, it asserts its performance is substantially equivalent to the predicate devices, which have established safety and effectiveness.
  • Technological Characteristics Comparison: "OSferion D is substantially equivalent to the predicate devices in indication for use, and in specifications of the material."
  • Conclusion: "When compared to the predicate device, this subject device "OSferion D" does not incorporate any significant changes in intended use, instruction for use, material, or design that could effect the safety or effectiveness of the device."

In essence, the document is a regulatory submission demonstrating equivalence, not a standalone performance study with detailed acceptance criteria and results.

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Comporus™ is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Comporus™ is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with new bone during the healing process.

Comporus™ is an osteoconductive biodegradable scaffold used as bone void filler. It is manufactured from a mixture of poly-D/L-lactide and hydroxyapatite and provided in granule, block and cylinder forms. They may be pressed into the surgical site by hand. Comporus™ was shown to be biocompatible. Used properly, the implant is resorbed and replaced with natural bone during the healing process. Comporus™ is sterile and intended for single use only. It is radiopaque and has the ability to be modified intraoperatively by trimming or thermal transformation to be adjusted to the shape of a defect.

The provided text details a 510(k) summary for a medical device called Comporus™, a resorbable synthetic bone void filler. This submission focuses on establishing substantial equivalence to legally marketed predicate devices, rather than presenting a study demonstrating its performance against specific acceptance criteria in a quantitative manner. Therefore, many of the requested sections (acceptance criteria, device performance, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) are not available in the provided 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

Not Available. The document does not specify quantitative acceptance criteria. Instead, it asserts "similar compressive strength to the predicate devices and cancellous bone" and "similar technological characteristics (i.e., design and material)" as the basis for substantial equivalence. No specific performance metrics or thresholds are presented.

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

Not Available. The document mentions "Preclinical testing was performed" but does not provide details on the sample size (number of subjects, defects, or units tested) or the provenance (e.g., country of origin, retrospective/prospective nature) of this test data.

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

Not Available. The document does not describe the establishment of a "ground truth" for a test set, nor does it refer to experts involved in such a process.

4. Adjudication method for the test set

Not Available. As no detailed test set or ground truth establishment is described, no adjudication method is mentioned.

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. Comporus™ is a bone void filler, not an AI-powered diagnostic or assistive device for human readers. Therefore, an MRMC study or AI-related metrics are irrelevant to this device type.

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

Not Applicable. Comporus™ is a physical medical device (bone void filler), not an algorithm or AI system.

7. The type of ground truth used

Not Available. The document asserts "Preclinical testing was performed" and states that "Used properly, the implant is resorbed and replaced with natural bone during the healing process." This implies histological or imaging-based assessment of bone formation in a preclinical setting, but the specific type of ground truth (e.g., detailed pathology reports, quantitative imaging analysis, long-term outcome data) is not elaborated upon.

8. The sample size for the training set

Not Applicable/Available. The concept of a "training set" is relevant for AI/ML devices. As Comporus™ is a physical medical device, not an AI/ML algorithm, no training set is described.

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

Not Applicable/Available. See response to #8.

Summary of what the document does provide regarding the study:

The 510(k) summary focuses on establishing substantial equivalence to predicate devices rather than presenting a performance study against specific acceptance criteria. Key points related to the "study" are:

• Evidence of Equivalence: The submission asserts that Comporus™ has:
  • The same intended use as predicate devices.
  • The same principles of operation as predicate devices.
  • "Very similar technological characteristics" (design and material) to predicate devices.
  • "Similar compressive strength to the predicate devices and cancellous bone."
  • The minor technological differences do not raise new safety or effectiveness issues.
• Preclinical Testing: "Preclinical testing was performed and demonstrates that the device is substantially equivalent to the predicate." This is a general statement without specific details on the nature, scope, or results of these tests, beyond the assertion of similar compressive strength and the claim that the implant resorbs and is replaced by new bone.
• Biocompatibility: Comporus™ was shown to be biocompatible.

In essence, the study described in this 510(k) summary is a comparative analysis intended to demonstrate that Comporus™ is as safe and effective as existing, legally marketed devices, rather than a de novo study proving its performance against predefined benchmarks.

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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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