Search Results

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.

Ask a specific question about this device

OSferion is indicated to be gently packed or placed into bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis,) that are not intrinsic to the stability of the bony structure. Following placement in the bony void or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.

OSferion is a white porous material composed of ß-tricalcium phosphate(ß-TCP). It is intended to fill bony voids or gaps caused by trauma or surgery that are not intrinsic to the stability of the bony structure. OSfenon is to be used as a bone replacement material and has properties that allow it to be replaced by autogenous bone after implantation. The OSferion product range consists of two product types with porosities of 75% and 60%. Products are supplied in blocks, cylinders, granules and wedges.

This 510(k) summary (K080065) is for a medical device called "OSferion," which is a bone void filler. This submission does not refer to a study evaluating a device with AI/ML technology. Instead, it is a premarket notification for a traditional medical device, comparing it to predicate devices already on the market. Therefore, many of the requested categories related to AI/ML device studies are not applicable.

Here's the breakdown of the information that can be extracted from the provided text, and where the information is not available due to the nature of the device and submission:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for a conventional medical device (bone void filler) based on substantial equivalence, there are no specific quantitative "acceptance criteria" for an AI model's performance (like sensitivity, specificity, AUC) outlined in this document as there would be for an AI/ML diagnostic or prognostic device. The acceptance is based on demonstrating substantial equivalence to predicate devices, focusing on materials, indications for use, and mechanism of action.

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

This information is not provided in the summary. Since it's not an AI/ML device, there isn't a "test set" in the context of algorithm evaluation. The submission refers to "clinical literatures" to support safety and efficacy, but details about these studies (sample size, data provenance) are not present in this abstract.

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

This is not applicable/not provided. As there is no AI/ML algorithm being evaluated, there is no "test set" requiring ground truth established by experts in this context. The evaluation is based on material properties, intended use, and comparison to legally marketed predicate devices.

4. Adjudication Method for the Test Set

This is not applicable/not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This is not applicable. This submission is for a physical medical device (bone void filler), not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study related to human readers and AI assistance would not have been performed.

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

This is not applicable. There is no algorithm being evaluated in this submission.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established safety and efficacy of the predicate devices (Synthes chronoSTM and Vitoss® Scaffold) based on their regulatory approvals and clinical use. The "truth" for OSferion's acceptability is its substantial equivalence to these devices, which implies similar clinical performance. The submission states that "The clinical literatures provided in this submission supports the safety and efficacy of OSferion," indicating that past clinical data on similar materials/devices form the basis of the "truth."

8. The Sample Size for the Training Set

This is not applicable. There is no AI model, and thus no "training set" in the AI/ML sense.

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

This is not applicable.

Ask a specific question about this device

OSferion is indicated to be gently packed or placed into bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis,) that are not intrinsic to the stability of the bony structure. Following placement in the bony void or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.

OSferion is a white porous material composed of β-tricalcium phosphate. It is intended to fill bony voids or gaps caused by trauma or surgery that are not intrinsic to the stablity of the bony structure. OSferion is used as a bone replacement material and has properties that allow it to be replaced by autogenous bone after implantation. The OSferion range consists of two product types with porosities of 75% and 60%. Osferion (porosity:75%) tends to have less compression strength than Osferion (porosity:60%.) Products are supplied in blocks, cylinders, granules and wedges.

The provided text is a 510(k) summary for a medical device called OSferion, a bone void filler. It describes the device, its intended use, and compares it to predicate devices to demonstrate substantial equivalence.

However, the document does not contain information related to a study that establishes acceptance criteria for performance, device performance metrics, sample sizes for test or training sets, ground truth establishment, expert involvement, or any multi-reader multi-case (MRMC) comparative effectiveness studies.

The document concludes that "When compared to the predicate device, this particular device "OSferion" does not incorporate changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device." This implies that the acceptance criteria are met by demonstrating substantial equivalence to a legally marketed predicate device, rather than through a direct performance study with predefined metrics.

Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided text.

Here's what can be inferred or explicitly stated based on the text for the questions that can be answered:

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

   • Not applicable / Not provided. The document establishes substantial equivalence to predicate devices (chronOS and Vitoss) rather than reporting specific performance metrics against pre-defined acceptance criteria for OSferion itself. The "performance" is considered equivalent if the device shares the same intended use, materials (with some variation in porosity), and operates safely and effectively, as confirmed by regulatory review.

2. Sample sized 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 submission focuses on demonstrating substantial equivalence to predicate devices through a comparison of specifications and clinical literature, not on a new clinical trial with a "test set" in the context of device performance metrics.

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. Ground truth establishment, in this context, is not mentioned as part of the 510(k) submission process described. The "ground truth" for regulatory clearance is the accepted safety and effectiveness of the predicate devices.

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

   • Not applicable / Not provided.

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 / Not provided. This device is a bone void filler, not an AI-assisted diagnostic or imaging device, so 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 / Not provided. This is not an algorithm-based device.

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

   • Not applicable / Not provided in the context of performance testing for this specific device. The "ground truth" for the 510(k) process is the established safety and effectiveness of the legally marketed predicate devices. The submission relied on "clinical literature provided in this submission supports the safety and efficacy of OSferion," which would presumably draw upon outcomes data or clinical observations related to similar materials.

8. The sample size for the training set

   • Not applicable / Not provided. There is no mention of a "training set" as this is not an AI/machine learning device.

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

   • Not applicable / Not provided.

Summary of what the document implies about meeting acceptance criteria:

The acceptance criteria for OSferion, as presented in this 510(k) summary, are met by demonstrating substantial equivalence to existing predicate devices (chronOS and Vitoss). This means the device is deemed safe and effective if it shares the same:

• Intended Use: Filling bony voids or gaps of the skeletal system that are not intrinsic to stability.
• Patient Population: Individuals with bone voids or gaps caused by surgery or trauma.
• Anatomical Location: Extremities, spine, and pelvis.
• Labeling: Similar intended use, contraindications, warnings, precautions, and adverse events.
• Basic Material Composition: β-Tricalcium phosphate.
• Biocompatibility: Established.
• Mechanical Strength Characteristics: Does not impart mechanical strength to the surgical site.
• Sterility: Sterile, single use.

The document highlights that OSferion is "basically identical to the predicate devices in the indication for use, and is similar in specifications except for the porosity of the material." The "clinical literature provided in this submission supports the safety and efficacy of OSferion" as a basis for meeting these criteria.

Ask a specific question about this device