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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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