Search Results

Ceracell® Ortho Foam is intended to fill bony voids or gaps of the skeletal system (posterolateral spine). These osseous defects may be surgically created or from traumatic injury to the bone and are not intrinsic to the stability of the bony structure. In the posterolateral spine Ceracell® Ortho Foam is to be mixed with autograft bone. The device resorbs and is replaced with bone during the healing process.

Ceracell® Ortho Foam is a porous composite material consisting of resorbable ß-tricalcium phosphate ceramic granules (85% by weight of the final device) in a porcine collagen scaffold (Type I and Type III, 15% by weight of the final device). Ceracell® Ortho Foam is provided as Ceracell® Ortho Flexible Foam Strip and Ceracell® Ortho Moldable Foam. Ceracell® Ortho Flexible Foam Strip is provided in various sizes from 2.5 cc to 25 cc. Ceracelle Ortho Moldable Foam is provided in various sizes from 1.2 cc to 25 cc.

This FDA 510(k) summary describes the Ceracell® Ortho Foam, a resorbable calcium salt bone void filler device, and its substantial equivalence to predicate devices. The study performed focuses on demonstrating the equivalence of the subject device to a primary predicate device using an animal model.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" for the animal study. Instead, it aims to demonstrate "equivalence" of the subject device's performance to the primary predicate device. The performance is assessed across several parameters.

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

• Sample Size for Test Set: The document mentions "animals implanted with autograft (positive control) also were evaluated," implying multiple animals were used, but the exact number of animals in the study (test set) is not specified.
• Data Provenance: The study was conducted in a rabbit posterolateral spine fusion model. This indicates preclinical in-vivo data, likely associated with the manufacturer's R&D efforts. The country of origin for the data is not explicitly stated.

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

This type of information is not applicable in this context, as the study is a preclinical animal study evaluating biological and physical characteristics, not human diagnostic interpretation. The "ground truth" here is derived from objective measurements and observations in the animal model.

4. Adjudication Method for the Test Set

This is not applicable as the study did not involve human interpretation or adjudication of diagnostic images or clinical outcomes. The evaluation endpoints included "manual palpation, range of motion/flexibility testing, plain and high-resolution radiography, micro-computed tomography (micro-CT) imaging, undecalcified histologic evaluation, and histomorphometric analysis. Decalcified paraffin histology sections also were graded according to AAMI/ANSI/ISO 10993-6 (Annex E)." These are objective measurements and standardized grading methods.

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. The device is a bone void filler, not an AI or imaging diagnostic tool. Therefore, an MRMC study and AI assistance are irrelevant to its evaluation.

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

This is not applicable. The device is a physical medical implant, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used was based on objective biological and physical measurements and observations from a rabbit posterolateral spine fusion model. This included:

• Radiographic evaluations (plain and high-resolution radiography, micro-CT imaging)
• Histologic evaluation (undecalcified histologic evaluation, decalcified paraffin histology sections graded according to AAMI/ANSI/ISO 10993-6 Annex E)
• Histomorphometric analysis
• Manual palpation
• Range of motion/flexibility testing

These methods aim to directly assess the biological response and integration of the implant.

8. The Sample Size for the Training Set

This is not applicable. The subject device is a physical product, not a machine learning algorithm, and therefore does not have a "training set" in the context of AI/ML.

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

This is not applicable for the reasons stated in point 8.

Ask a specific question about this device

Cerasorb Ortho Foam is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Cerasorb Ortho Foam resorbs and is replaced with bone during the healing process.

Cerasorb Ortho Foam is a highly porous composite material for bone augmentation and regeneration applications, consisting of porcine collagen and a resorbable ceramic. Through the use of pure phase ß-tricalcium phosphate with a regular interconnected porous structure, a degradation of the biomaterial is achieved simultaneously to natural bone regeneration. The pure phase B-tricalcium phosphate is made according to ASTM F 1088-04a. The ß-tricalcium phosphate component of Cerasorb Ortho Foam is a mixture of Cerasorb M Ortho and Cerasorb Ortho, which received previous 510(k) clearances (K040216 and K014156, respectively). The device has been tested to meet pyrogen limit specifications. Cerasorb Ortho Foam is available in five different sizes and two versions (mouldable foam and flexible foam strip) and serves to fill bone defects in the entire skeletal system.

Here's an analysis based on the provided document regarding the acceptance criteria and study for the Cerasorb Ortho Foam device:

This document is a 510(k) premarket notification for a medical device called Cerasorb Ortho Foam. The purpose of a 510(k) submission is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device, rather than proving its absolute safety and effectiveness through extensive clinical trials as would be required for a PMA (Premarket Approval). Therefore, the "acceptance criteria" and "study" described here are focused on demonstrating substantial equivalence to a predicate, not necessarily meeting a specific performance metric in a standalone sense.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set (Animal Study): The document states "A comparative study in sheep using the critical size defect model was performed." It does not specify the exact number of sheep used (sample size) or the number of defects created/treated.
• Data Provenance: The study was "in sheep," which indicates animal data. The location of the study (country of origin) is not explicitly stated in this document but implied to be part of the manufacturer's (curasan AG, Germany) activities. It is a prospective animal study designed for comparison.

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

• The document does not mention the number of experts used or their qualifications for establishing ground truth in the animal study. The evaluation focused on "amount and quality of newly formed bone" and "occurrence of fibrosis and inflammation," which would typically involve histological analysis and potentially expert pathology assessment, but specifics are omitted.

4. Adjudication Method for the Test Set:

• The document does not provide details on an adjudication method. It simply states that bone formation, fibrosis, and inflammation were "evaluated." This suggests standard scientific evaluation by the researchers involved in the study, but no formal adjudication process with independent experts is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, an MRMC comparative effectiveness study was not done. This type of study typically involves human readers (e.g., radiologists) evaluating medical images or cases with and without AI assistance to measure improvement in diagnostic performance. The Cerasorb Ortho Foam is a physical bone void filler, not an AI software device.

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

• This question is not applicable. Cerasorb Ortho Foam is a physical medical device (bone void filler), not an algorithm or AI system.

7. The Type of Ground Truth Used:

• For the animal study (test set): The ground truth was established through histological evaluation of the amount and quality of newly formed bone, and the occurrence of fibrosis and inflammation at the surgical site in the sheep. This is a form of direct biological/pathological assessment.

8. The Sample Size for the Training Set:

• This question is not applicable. Cerasorb Ortho Foam is a physical medical device. It does not involve a "training set" in the context of machine learning or AI. The product's development would have involved various material science and biological compatibility tests, but not a dataset for training an algorithm.

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

• This question is not applicable, as there is no "training set" for this type of device.

Ask a specific question about this device

Osseolive® DENTAL is indicated for applications in oral and maxillofacial surgery and dentistry, including filling and/or reconstruction of multi-walled (artificial or degenerative) bone defects, e.g.:

• Defects after the extirpation of bone cysts .
• Augmentation of an atrophied alveolar ridge ●
• Sinus lift or sinus floor elevation (subantral augmentation) ●
• Filing of alveolar defects after tooth extraction for preservation of the alveolar ridge
• Filling of extraction defects to create an implant bed .
• Filling of two- or multi-walled bone pockets as well as the bi- and trifurcation defects .
• . Defects after operative removal of retained teeth or corrective osteotomies

Osseolive® DENTAL is a synthetic absorbable radiopaque silicated calcium-alkali-phosphate ceramic for filling, bridging and reconstructing bone defects and for bone fusion in dental and maxillofacial applications. Osseolive® DENTAL has an open-cellular porosity of about 80% and is available as polygonal granyles of various grain sizes. It is resorbed by the body over a period of months and simultaneously substituted by local autologous bone. As a synthetic, bioactive ceramic material Osseolive® DENTAL has excellent intra- and extra-osseous tissue compatibility and is neither locally nor systemically toxic. Osseolive® DENTAL is a calcium-sodium phosphate with an open sintered structure. Osseolive® DENTAL morsels are highly porous, available in different grain size fractions between 150 and 2000 um. The high porosity allows blood components and body fluids to penetrate the material rapidly and unhindered. The chemical composition is a modification of tricalcium phosphate, where one calcium atom is replaced by one potassium atom and one sodium atom, resulting in increased solubility. Doping this glass ceramic with 4% sodium-magnesium-silicate on interstitial positions ensures the maximum mechanical stability. Osseolive® DENTAL has a resorption time of 3 to 12 months. Osseolive® DENTAL morsels are packaged for sale in glass vials.

The provided text includes a 510(k) summary for Osseolive® DENTAL, which is a dental bone grafting material. The document primarily focuses on establishing substantial equivalence to predicate devices through bench testing of material characteristics.

Here's an analysis of the requested information based only on the provided text:

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

The document does not explicitly state "acceptance criteria" in a quantitative manner for specific performance metrics in the way a clinical study would for efficacy. Instead, it describes a "comparison summary" indicating that the majority of device characteristics are "similar to one or more of the predicate devices." Where differences exist, they "have no significant effect on device safety or effectiveness."

The "reported device performance" is presented as a list of material characteristics that were assessed, rather than specific numerical results against predefined criteria.

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

The document describes a "Bench test summary" performed by a "GLP compliant third party test laboratory." It assesses material characteristics. However, no specific sample sizes for the test set are mentioned. The provenance of the data is that it was conducted by a third-party lab, and the manufacturer is based in Germany. It's a bench test (laboratory testing), not a clinical study on patients, so concepts like retrospective/prospective or country of origin for patient data are not applicable 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)

This is not applicable to the data provided. The study is a series of bench tests on material characteristics, not an assessment requiring expert interpretation of clinical data or images to establish ground truth.

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

This is not applicable to the data provided. As explained above, this was a bench test on material properties, not a clinical assessment requiring adjudication of observer findings.

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

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The submission is for a material (bone graft), not an AI-powered diagnostic device, so this type of study is not relevant to the provided text.

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

This is not applicable as the device is a bone grafting material, not an algorithm.

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

For the bench tests, the "ground truth" would be the established scientific and engineering standards and methods used to measure the material properties (e.g., USP 34 for bulk density, ASTM C 1251 for specific surfaces). These are physical measurements, not clinical diagnoses or expert consensus.

8. The sample size for the training set

This is not applicable. The submission describes a device that is a material product, not an algorithm that requires a training set.

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

This is not applicable for the same reason as point 8.

Ask a specific question about this device

Ceracell® DENTAL is indicated for:

• Augmentation or reconstructive treatment of the alveolar ridge
• Filling of infrabony periodontal defects .
• Filling of defects after root resection, apicoectomy, and cystectomy
• Filing 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 perio-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)

Ceracell® DENTAL is a synthetic absorbable radiopaque bio-ceramic for dental and maxillofacial bone regeneration, using pure phase beta-tricalcium phosphate with an open-cell sintered structure of biocompatible, bioactive organic and osteoconductive material.

Ceracell® DENTAL polygonal 'morsels' have a porosimately 80% and are available in a grain sizes from 150 - 2,000 µm, with the intended use of filling dental and maxillofacial bone defects. This level of porosity allows rapid ingrowth of the bone, and blood components are able to permeate the material, leading to osseous integration and vascularisation.

The material is doped with 4% sodium-magnesium-silicate to provide mechanical stability.

Ceracell® DENTAL morsels are available in a range of morsel sizes and quantities.

The final product is packed in glass vials, fitted with brombuty rubber stoppers, then subjected to a gamma radiation sterilization process before being packed in outer cartons.

Resorption time varies with technique from 4 to 12 months.

The provided FDA 510(k) clearance letters and summary are for a bone grafting material, Ceracell® DENTAL. These documents primarily focus on demonstrating substantial equivalence to a legally marketed predicate device (Cerasorb® Dental) rather than establishing new performance criteria through a detailed clinical study with acceptance criteria.

Therefore, the information required to populate all sections of your request (e.g., acceptance criteria, test set sample size, number of experts for ground truth, MRMC study results, training set details) is largely absent from these specific 510(k) documents. This is typical for a 510(k) submission for this type of device, where performance is often demonstrated through material characterization, biocompatibility testing, and comparison of technological characteristics to a predicate device, rather than extensive clinical efficacy trials with specific performance metrics defined by acceptance criteria in the way one might see for an AI/software device.

However, I can extract the available relevant information and explain what is not provided based on the nature of the submission.

Here is a breakdown of the requested information:

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

Critically, for this type of device, explicit quantitative "acceptance criteria" for clinical performance metrics (like sensitivity, specificity, accuracy, etc., which are common for AI/diagnostic devices) are not provided in these documents. The primary "acceptance criterion" for a 510(k) is often demonstrating substantial equivalence to a predicate, which usually involves comparing technological characteristics and showing that any differences do not raise new questions of safety or effectiveness.

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

• Sample Size: The documents do not detail a specific "test set" in the context of a clinical performance study with human subjects, as would be common for AI/diagnostic devices. The evaluation focuses on material properties, biocompatibility, and comparison to a predicate device. If animal studies or limited human clinical data were part of the submission, their details are not included in this summary.
• Data Provenance: Not applicable in the context of a "test set" for clinical performance as described. The manufacturing location is listed as Frankfurt, Germany.

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

• Not applicable. There is no described "test set" requiring expert-established ground truth for performance evaluation in the way a diagnostic AI device would. The evaluation is based on material science, literature, and predicate device comparison.

4. Adjudication method for the test set

• Not applicable. There is no described "test set" for clinical performance requiring adjudication.

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

• No. This is a bone grafting material, not a diagnostic AI device. An MRMC study is not relevant to its clearance.

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

• Not applicable. This is a physical medical device (bone grafting material), not an algorithm or AI.

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

• The "ground truth" for this device's clearance is primarily based on:
  • Scientific and engineering principles: Demonstrating that the material properties (composition, porosity, mechanical stability, resorption) are suitable for the intended use.
  • Biocompatibility testing: Ensuring the material is safe to be implanted in the human body (though specific test results are not in this summary).
  • Literature review and established clinical use: Reliance on the known safety and effectiveness of similar tricalcium phosphate-based bone grafting materials, particularly the predicate device.
  • Regulatory precedent: A successful 510(k) clearance often relies heavily on demonstrating scientific and technological similarity to a device already cleared by the FDA.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI/machine learning model that would have a "training set."

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

• Not applicable. There is no "training set."

Ask a specific question about this device

Osbone® DENTAL is intended for the filling and reconstruction of multi-walled bone defects, e.g .:

• · Defects after removal of bone cysts
• · Augmentation of the atrophied alveolar ridge
• · Sinus lift and sinus floor elevation (subantral augmentation)
• · Filling of alveolar defects following tooth extraction for alveolar ridge preservation
• · Filling of extraction defects to create an implant bed
• · Filling of two- or multi-walled infrabony pockets, and bi- and trifurcation defects
• · Support function for a membrane in controlled tissue regeneration (CTR)
• · Defects after surgical removal of retained teeth or corrective osteotomies
• · Other multi-walled bone defects of the alveolar processes.

Osbone® DENTAL is an open-cellular, synthetic bioceramic for bone regeneration. It is comprised of a pure phase hydroxyapatite with an open sintering structure resulting in a biocompatible, bioactive and osteoconductive biomaterial. Osbone® DENTAL morsels are open-cellular highly porous morsels, ranging from 150-8000 um for filling bone defects in dental procedures. While Osbone® DENTAL can be manufactured with a granule size of up to 8000 um, curasan will only market granule sizes of 0.25-2.0 mm, which is within the size range of the predicate devices. The high porosity helps to accelerate ingrowth of bone.

Here's an analysis of the provided text regarding the acceptance criteria and study for Osbone® DENTAL:

1. Table of Acceptance Criteria and Reported Device Performance

The submission for Osbone® DENTAL is a 510(k) premarket notification, which establishes substantial equivalence to predicate devices rather than proving a device meets specific, pre-defined quantitative acceptance criteria in a clinical study. Therefore, the "acceptance criteria" here are based on demonstrating that Osbone® DENTAL is as safe and effective as its predicates.

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

• Sample Size for Test Set: Not applicable. This submission is for a 510(k) premarket notification and relies on demonstrating substantial equivalence to existing devices, primarily through non-clinical testing and comparison of technological characteristics. No clinical testing was submitted in support of this 510(K) premarket notification (Section 9).
• Data Provenance: Not applicable for a clinical test set. Non-clinical data (materials characterization, biocompatibility) are derived from in-vitro testing and product specification analyses of Osbone® DENTAL, conducted by curasan AG (Germany).

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

• Not applicable, as no clinical test set requiring expert-established ground truth was used for this submission. The "ground truth" for substantial equivalence is derived from the established safety and effectiveness of the legally marketed predicate devices.

4. Adjudication Method for the Test Set

• Not applicable, as no clinical test set or human reader evaluation was performed.

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

• Not applicable. This device is a synthetic bone void filler and not an AI-powered diagnostic or assistive technology.

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

• Not applicable. This device is a physical medical implant, not an algorithm or software.

7. The Type of Ground Truth Used

• The "ground truth" for this 510(k) submission is the established safety and effectiveness of the identified predicate devices (BIO-OSS, Endobon, OsteoGraf/D). The submission makes its case by demonstrating that Osbone® DENTAL shares the same indications for use, principles of operation, and technological characteristics, and that any minor differences do not impact safety or efficacy. The "truth" is therefore based on regulatory precedent and a detailed comparison against accepted standards and devices.

8. The Sample Size for the Training Set

• Not applicable, as no algorithm or machine learning model was developed or trained for this device.

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

• Not applicable, as no algorithm or machine learning model was developed or trained for this device.

Ask a specific question about this device

Cerasorb® MIX is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structures. It is indicated for filling of bone defects, caused by surgery, trauma or degenerative process. Cerasorb® MIX granules are intended to be gently packed into the bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine, and pelvis). Cerasorb® MIX is not indicated for use in load-bearing applications. It does not possess sufficient mechanical strength, therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization. Following placement in the bony voids or gaps, the Beta-tricalcium phosphate granules are gradually resorbed and replaced with new bone.

The Cerasorb® MIX Device is a mixture of two legally marketed bone void filler devices, the Cerasorb Ortho granules subject of K014156 and Cerasorb M Ortho granules subject of K040216. The bone replacement and bone regeneration material Cerasorb MIX consists of ≥99% pure phase beta-tricalcium phosphate (beta-TCP). The Cerasorb® and Cerasorb® M mixture includes granule sizes of 500-1000 um and 1000-2000 um. The mixing ratio is 1cc to 1cc of Cerasorb® and Cerasorb® M granules.

The material should not be packed in dry form; it should be mixed with autologous blood (blood from the void or venous blood). The implanted material must be in direct contact with the bleeding vital bone.

This 510(k) summary for the Cerasorb® MIX device is for a medical device (bone void filler), not an AI/ML powered device. As such, the typical acceptance criteria and study designs associated with AI/ML device performance (e.g., sensitivity, specificity, AUC, MRMC studies, standalone performance, ground truth establishment with experts) are not applicable.

The document demonstrates substantial equivalence to predicate devices based on:

1. Identical Technological Characteristics: The Cerasorb® MIX is a mixture of two previously cleared bone void fillers (Cerasorb® Ortho and Cerasorb® M Ortho) with identical base material (beta-tricalcium phosphate) and similar granule sizes.
2. Identical Intended Use, Contraindications, Warnings, Precautions, and Adverse Events: The labeling of Cerasorb® MIX is the same as the predicate devices.
3. Established Safety and Biocompatibility: The safety and biocompatibility of calcium phosphates, the core material, have been established through prior clearances and a long history of clinical use.

Therefore, the "acceptance criteria" for this device are met by demonstrating substantial equivalence to its predicate devices, rather than through a performance study with quantitative metrics for AI/ML outputs.

Here's a breakdown of the requested information, adapted for this device type:

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)

• Not applicable. This submission relies on demonstrating substantial equivalence to predicate devices that have already undergone testing and have a history of safe clinical use. There is no new "test set" in the context of an AI/ML performance evaluation for this device. The documentation provided does not detail new clinical studies or a specific test set. The efficacy and safety are inferred from the established performance of the constituent materials.

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. Ground truth establishment by experts is not relevant for this type of medical device submission. The device's characteristics are determined through material science and preclinical testing referenced from previous clearances, not through expert interpretation of data.

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

• Not applicable. Adjudication methods are used in studies involving human interpretation or uncertain outcomes (e.g., diagnostic imaging). This is not relevant for a bone void filler's substantial equivalence pathway.

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. MRMC studies are specific to evaluating diagnostic accuracy or reader performance, typically with AI-assisted tools. This device is a material implant, not a diagnostic or AI system.

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

• Not applicable. This submission is for a physical medical implant, not an algorithm.

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

• Not applicable in the typical AI/ML sense. The "ground truth" for this device's safety and effectiveness is primarily established through:
  • Material Science and Characterization: Chemical composition (beta-TCP purity), physical properties (granule size, porosity), and in vitro/in vivo biocompatibility testing of the constituent materials (calcium phosphates) from previous clearances.
  • Clinical History/Outcomes Data: The "long history of safe clinical use" mentioned for calcium phosphates represents a form of outcomes data globally, but no specific new outcomes study is presented for the Cerasorb® MIX itself.
  • Compliance with Standards: Meeting "applicable requirements of the FDA guidance documents on bone void fillers" based on prior testing of the predicate components.

8. The sample size for the training set

• Not applicable. "Training set" refers to data used to train AI/ML models. This is a physical device, so no training set is involved.

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

• Not applicable. As there is no training set for an AI/ML model, there is no ground truth to be established for it.

Ask a specific question about this device

The REVOIS® Implant System is an implant system recommended for: Surgical placement in the edentulous or partially edentulous jaw bone (upper or lower jaw bone) to create support for prosthetic devices such as single artificial teeth, fixed or removable bridges or dentures. The titanium implant can be applied either in a one-stage surgical procedure with immediate loading when good primary stability is achieved and with appropriate occlusal loading, or in a two-stage surgical procedure (after osseointegration of the implant). Angled abutments on small diameter implants (3.8 mm) of the REVOIS® Implant System are intended for the anterior region of the mouth and not intended for the posterior region of the mouth due to limited strength of the implant.

The REVOIS® Implant System is a self-contained, modular dental implant system for placement into the jaw bone (upper or lower jaw bone) to support prosthetic devices for dental restoration. The system is designed for one-stage or two-stage surgical procedures. The REVOIS® Implant System is composed of a titanium, screw type implant, preassembled with a multifunctional precision abutment and a transfer tool that snaps onto the abutment (Snap-on-tool). The implant is also available with a transfer tool only. A cover screw is contained in the top of the snap-on or transfer tool. The system offers implants in various diameters and lengths (3.8; 4.3; 5.0 mm diameter; 9; 11; 13; 15 mm lengths). The REVOIS® Implant System is provided with a number of corresponding tools and surgical instruments, as well as a variety of prosthetic components. For ease of identification the implants and corresponding tools are color coded according to diameter. The main components of the implant system are made of Grade IV or Grade V Titanium (implant, abutment) or plastic (snap-on tool, transfer tool). The materials comply with the ASTM standards ASTM F067 (implant), ASTM F0136-2a (abutment) and ASTM F2026 (Snap-on tool, Transfer tool). The implant surface is blasted with zirconium and then acid-etched for roughness. The REVOIS® titanium implant (pre-assembled with the multifunctional precision abutment and snap-on-tool or with the transfer tool only) is supplied in double sterile packages (sterile inner plastic vial in a sterile glass vial, which is sealed in a blister) and is for single use only. Tools and other re-usable instruments must be sterilized prior to use.

This document is a 510(k) premarket notification for a medical device (REVOIS® Implant System), not a study report. Therefore, it does not contain the detailed information about acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study results as requested in your prompt.

The 510(k) process is primarily a demonstration of "substantial equivalence" to a predicate device already on the market, rather than a full efficacy study with specific acceptance criteria and performance metrics.

Here's a breakdown of why the requested information isn't present in this document:

• Acceptance Criteria and Reported Device Performance: This document states the device is "substantially equivalent" to predicate devices, implying that its performance is expected to be similar and safe for its intended use, based on comparisons to already cleared devices. It does not provide specific quantitative acceptance criteria or detailed reported performance data (e.g., success rates, failure rates, specific biomechanical measurements with thresholds).
• Study That Proves the Device Meets Acceptance Criteria: No such clinical study is described. The basis for clearance is substantial equivalence (Section 6), which relies on comparing the new device's characteristics (materials, design, intended use, performance aspects) to those of predicate devices.
• Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance: These are all terms related to clinical trials and performance studies. As this is a 510(k) submission focused on substantial equivalence, such detailed study information is not included. The FDA review letter confirms that this is a 510(k) premarket notification, which does not require approval of a premarket approval application (PMA) – PMAs typically involve extensive clinical data.
• Type of Ground Truth: This concept is relevant for diagnostic devices or AI studies where a definitive "correct answer" is needed for evaluation. For an implant system, "ground truth" would relate to successful osseointegration and long-term function in patients, which isn't detailed in a 510(k) submission.
• Sample Size for Training Set & How Ground Truth for Training Set Was Established: These questions are specific to machine learning/AI studies. The REVOIS® Implant System is a physical medical device, not an AI or software device that relies on training data.

In summary, the provided document demonstrates substantial equivalence to predicate devices, but does not present a study with explicit acceptance criteria and device performance metrics, nor does it involve the type of clinical trial data or AI/ML-specific information requested.

Ask a specific question about this device

Cerasorb® M DENTAL is recommended for:

• 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).

Cerasorb® DENTAL is recommended for:

• 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).

Cerasorb® Perio is recommended for:

• Filling and/or reconstruction of non-infected periodontal bone defects in conjunction with other products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR).
• Filling of infrabony periodontal defects
• Filling of single-or multi-wall bone pockets.
• Filling of bifurcations and trifurcations

Cerasorb® DENTAL, Cerasorb® M DENTAL and Cerasorb® Perio are a sterile, synthetic, ceramic matrix in either granular form (Cerasorb DENTAL), polygonal shaped morsels (Cerasorb M DENTAL) or polygonal broken granulate (Cerasorb Perio). This material consists of pure-phase Beta-Tricalcium Phosphate with a phase purity of > 97% and complies with the ASTM F 1088-04. The devices, when applied to a bony defect, create a matrix of large, smoothly interconnected pores providing an osteoconductive scaffold (Cerasorb DENTAL approx. 65 vol% [total porosity], Cerasorb M DENTAL approx. 65 vol% [total porosity] and Cerasorb Perio approx. 25 vol%). The different designs are managed and controlled by a validated manufacturing process which guarantees batch to batch conformity and reproducibility. Due to their synthetic nature the devices are free of any biological contaminants and are neither locally nor systemically toxic. In contact with vital bone the Cerasorb granules, morsels or granulate is resorbed and gradually replaced by new bone. Cerasorb DENTAL, Cerasorb M DENTAL and Cerasorb Perio are provided in double sterile packaging (sterilized by gamma irradiation) and are for single-use only.

The provided document is a 510(k) premarket notification for Cerasorb® Dental, Cerasorb® M Dental, and Cerasorb® Perio, which are bone grafting materials. This type of regulatory submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through clinical studies.

Therefore, many of the requested details regarding acceptance criteria, study design, sample size, ground truth, and expert involvement are not explicitly available in this document. The document mainly discusses the intended use, device description, and comparison to predicate devices to establish substantial equivalence.

Here's what can be inferred or stated based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission, the "acceptance criteria" are primarily based on demonstrating substantial equivalence to predicate devices. Specific quantitative performance metrics with defined acceptance thresholds for the new device are typically not required or presented in this type of submission. The performance is implied to be similar to the predicate devices.

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

• Sample Size: Not explicitly stated as this is a 510(k) submission primarily relying on previous predicate device data and material characterization, not a new clinical trial with a defined "test set" for performance evaluation in the typical sense.
• Data Provenance: The document implies reliance on existing data and regulatory clearances for the listed predicate devices (PMA800035, K992416, K040278, K033815, K970321). The devices are manufactured by curasan AG in Kleinostheim, Germany.

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

• Number of Experts/Qualifications: Not applicable or provided. This type of submission does not involve a "test set" of cases evaluated by external experts to establish ground truth in the way AI/ML performance studies do. The ground truth for substantial equivalence is based on regulatory standards and the established performance of predicate devices.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable or provided, as there is no mention of a "test set" requiring adjudication by multiple readers/experts.

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

• MRMC Study: No. This document concerns a bone grafting material, not an AI/ML-driven diagnostic device that would involve human readers or AI assistance.

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

• Standalone Performance Study: No. This is not an AI/ML device.

7. The Type of Ground Truth Used

• Ground Truth: For a 510(k) of a bone grafting material, the "ground truth" for demonstrating substantial equivalence often relies on:
  • Prior Regulatory Clearances/Approvals: The FDA's previous findings for predicate devices.
  • Material Standards: Compliance with recognized standards like ASTM F 1088-04 for Beta-Tricalcium Phosphate.
  • Pre-clinical data: (Though not detailed here, often part of the submission) such as in-vitro tests and animal studies demonstrating biocompatibility and osteoconductivity/resorbability.
  • Clinical experience: The known performance and safety profile of the class of devices and the specific predicate devices.

The document states, "The effectiveness and safety of the Cerasorb designs compared to the predicate devices" are the basis for substantial equivalence, implying reliance on the established performance of the predicate technologies.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is not an AI/ML device that uses a "training set."

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

• Ground Truth for Training Set: Not applicable. This is not an AI/ML device.

Ask a specific question about this device

Cerasorb® M ORTHO (polygonal broken morsels) is intended for use as a bone void filler in voids or gaps (resulting from surgery, trauma or degenerative processes) in the skeletal system (e.g. extremities, spine, pelvis) that are not intrinsic to the stability of the bony structure. Following placement in the bony void or gap, the ß-TCP ceramic material is gradually resorbed and replaced with bone. The placement of Cerasorb® M ORTHO should not be in dry form, the material should be mixed with autologous blood.

The device modification is a change in the shape resp. size of the bone void filler. The predicate device Cerasorb® ORTHO, a synthetic, porous, resorbable and osteoconductive bone void filler, was developed in granular form (spherical granules) of different diameter (500-1000um, 1000-2000um) to be filled in the bone void(s). The material consists of pure phase Beta-Tricalcium Phosphate of interconnecting porosity. This submission is intended to address a modification in the shape of the bone void filler. The bone void filler is now additionally presented as polygonal shaped morsels of different sizes ranging from 50 8000m. The pure phase Beta-Tricalcium Phosphate material is of interconnecting microporosity and additionally contains defined interconnecting meso-, and macropores (50 - 500 um).

This appears to be a 510(k) premarket notification for a medical device (Cerasorb® M ORTHO). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than performing a separate study to prove the device meets specific acceptance criteria in the way a new, novel AI/software device would. Therefore, most of the requested information about acceptance criteria and a study proving performance isn't applicable in this context.

Here's an explanation based on the provided document:

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

Not applicable in this document. This submission is for a material modification (shape/size) of an existing bone void filler. The "acceptance criteria" here are based on demonstrating substantial equivalence to existing predicate devices, primarily in terms of material composition, intended use, and general performance characteristics. The document doesn't report specific performance metrics or acceptance thresholds for a new study.

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. There is no "test set" in the context of proving new performance claims. The submission focuses on the material's properties (Beta-Tricalcium Phosphate composition, porosity) and intended use, which are compared to predicate devices.

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. There is no test set requiring expert ground truth in this submission.

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

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

Not applicable. This is not an AI/software device.

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

Not applicable. This is not an AI/software device.

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

Not applicable. The "ground truth" in this context is the established safety and efficacy of the predicate devices and the chemical/physical properties of the material itself (Beta-Tricalcium Phosphate with interconnecting porosity, osteoconductive, resorbable). The document states the material conforms to ASTM F 1088-87, reapp. 1992.

8. The sample size for the training set

Not applicable. There is no training set mentioned, as this is not an AI/software device or a de novo submission requiring extensive new clinical data.

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

Not applicable.

Summary of what the document does provide regarding "acceptance":

The "acceptance" in this 510(k) submission is based on the FDA's determination of substantial equivalence to legally marketed predicate devices. Key aspects considered for this determination include:

• Identical Intended Use: The intended use of Cerasorb® M ORTHO (morsels) is explicitly stated and compared to the predicate device, Cerasorb® ORTHO (granular form), and other similar bone void fillers. Both are for use as bone void fillers in voids/gaps in the skeletal system not intrinsic to stability, to be gradually resorbed and replaced by bone.
• Similar Technological Characteristics:
  • Material Composition: Both the modified device and the predicate are stated to consist of "pure phase Beta-Tricalcium Phosphate ceramic material according to ASTM F 1088-87, reapp. 1992." This is the primary claim for material similarity.
  • Porosity: Both are described as having interconnecting porosity, osteoconductive, and resorbable properties. The modified device specifically mentions interconnecting micro-, meso-, and macropores.
  • Functionality: Both are designed to be bone void fillers that are gradually resorbed and replaced by bone.
• Safety and Effectiveness: By demonstrating substantial equivalence to legally marketed predicate devices, the submission implicitly claims similar safety and effectiveness without needing a new, comprehensive clinical trial for this specific modification. The FDA's letter states they "have determined the device is substantially equivalent... to legally marketed predicate devices."

In essence, for this type of submission (line extension/modification of an existing material), the "acceptance criteria" revolve around proving that the minor change (shape/size) does not alter the fundamental safety or effectiveness parameters established by the predicate devices. The study proving this is the 510(k) submission itself, which provides a comparative analysis to the predicate devices.

Ask a specific question about this device

Cerasorb" ORTHO (granular or block forms) is intended for use as a bone void filler in voids or gaps (resulting from surgery, trauma or degenerative processes) in the skeletal system (extremities, spinc, pelvis) that arc not intrinsic to the stability of the bony structure. Following placement in the bony vold or gap, the B-TCP ceramic material is gradually resorbed and replaced with bonc. The placement of Cerasorb ORTHO should not be in dry form, the material should be mixed with autologous blood.

The predicate device Cerasorb™ ORTHO, a synthetic, porous, resorbable and osteoconductive bone void filler, was developed in granular form (spherical granules) of different diameter (500-1000um, 1000-2000um) to be filled in the bone void(s). The material consists of pure phase Beta-Tricalcium Phosphate of interconnecting porosity. This submission is intended to address a modification in the shape of the bone void filler. The bone void filler is now additionally presented as block forms of different geometry (for example wadge, cylinder, cube, parallelepiped) and in different sizes up to 30cc. The basic pure phase Beta-Tricalcium Phosphate material is also of interconnecting microporosity. Straight through macropores of different size (500-2000um) are mechanically introduced by drilling.

This document is a 510(k) summary for a line extension to Cerasorb™ ORTHO, a bone void filler. It describes a modification to the device, changing its form from granular to additional block shapes. The document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

The 510(k) process is primarily a premarket notification to demonstrate that a device is substantially equivalent to a legally marketed predicate device, not necessarily to prove its performance against specific acceptance criteria through a clinical study in the way one might typically describe for a software-as-a-medical-device (SaMD) or diagnostic device.

The provided text focuses on:

• Device Identification: Cerasorb™ ORTHO Bone Void Filler.
• Predicate Devices: Cerasorb™ ORTHO (granular form), ChronOs, Viitoss Scaffold Synthetic.
• Device Modification: Change in size/geometry from granular forms to additional block forms (wadge, cylinder, cube, parallelepiped) up to 30cc, while maintaining the same Beta-Tricalcium Phosphate material with interconnecting porosity and introducing macropores mechanically.
• Intended Use: As a bone void filler in the skeletal system for voids/gaps not intrinsic to bony structure stability, to be gradually resorbed and replaced with bone, and mixed with autologous blood (same intended use as the predicate).
• Technological Comparison: Stating that all design modifications consist of the same pure phase Beta-Tricalcium Phosphate ceramic material (ASTM F 1088-87), porous, osteoconductive, and resorbable.
• FDA Substantial Equivalence Determination: The FDA letter confirms the device is substantially equivalent to the predicate, allowing it to be marketed.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving those criteria are met, as this information is not present in the provided document. The 510(k) process for this type of device (a material-based implant with a geometry change) typically relies on demonstrating material equivalence, manufacturing controls, and potentially biocompatibility, rather than a clinical performance study with defined acceptance criteria and statistical endpoints in the manner described by the prompt's questions.

Ask a specific question about this device