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Augmentation or reconstructive treatment of alveolar ridge Filling of periodontal defects

Filling of defects after root resection, apicoectomy, and cystectomy. Filling of extraction sockets to enhance preservation of the alveolar ridge Elevation of 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)

BIO-OSS COLLAGEN® is a combination of purified cancellous natural bone mineral granules and 10% collagen fibers in a block form and is sterilized by y-irradiation.

The provided text describes a 510(k) summary for the BIO-OSS COLLAGEN® device, focusing on a change in its manufacturing process. Therefore, the study described is not a performance study as typically understood for AI/ML medical devices. Instead, it is a validation study demonstrating that a change in the manufacturing process (specifically, the alkalinization step) does not compromise the device's safety, efficacy, or quality compared to the previously cleared version.

Here's a breakdown based on the information provided, framed to address your questions where possible:

Acceptance Criteria and Reported Device Performance

Study That Proves the Device Meets Acceptance Criteria

The study performed was a revalidation of the manufacturing process for BIO-OSS COLLAGEN® after a modification to the alkalinization step.

1. Sample sizes used for the test set and the data provenance:

   • Test Set: Four lots of product manufactured with the revised alkalinization step were tested.
   • Data Provenance: Not explicitly stated, but it's implied to be internal testing commissioned by the company (Ed. Geistlich Soehne Ag für Chemische Industrie). Given the context of a 510(k) summary, these would be controlled laboratory studies rather than clinical data. It is a prospective validation relative to the manufacturing change, but not a prospective clinical trial.

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

   • Not applicable in this context. The "ground truth" here is objective laboratory measurements for viral inactivation and product specifications, not subjective expert assessment of medical images or patient outcomes.

3. Adjudication method for the test set:

   • Not applicable. The "adjudication" was based on meeting pre-defined laboratory testing limits and product specifications.

4. 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 is relevant for diagnostic devices where human readers interpret data (e.g., images) with and without AI assistance. The BIO-OSS COLLAGEN® device is a bone grafting material, and this submission focuses on a manufacturing process change.

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

   • Not applicable. This is not an AI/ML device, so "standalone algorithm performance" is not relevant.

6. The type of ground truth used:

   • The "ground truth" used for this revalidation study was laboratory test results for viral inactivation efficiency (measurement of viral load reduction) and pre-defined product release specifications (e.g., chemical composition, physical properties, sterility) that the finished product lots had to meet.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device that requires a training set. The "training" here would be the development and optimization of the manufacturing process itself, which is not described in terms of data sets.

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

   • Not applicable, as there is no "training set" in the context of an algorithmic device. The ground truth for manufacturing process development would typically be process engineering principles, material science, and prior experimental data, not a labeled dataset.

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Simultaneous use of GBR-membrane (MUCOGRAFT®) and implants; covering of implants placed in immediate extraction sockets; covering of implants placed in delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; covering of bone defects after root resection; cystectomy, removal of retained teeth; guided bone regeneration in dehiscence defects; guided tissue regeneration procedures in periodontal and recession defects.

MUCOGRAFT® is a pure collagen membrane obtained by a standardized controlled manufacturing process. The membrane is made of collagen type I and type III without further cross-linking or chemical treatment. The collagen is extracted from veterinary certified pigs and is carefully purified to avoid antigenic reactions. MUCOGRAFT® is sterilized in double blisters by gamma irradiation. MUCOGRAFT® has a bilayer structure with one smooth, non-permeable layer and one porous. The "outer," smooth side has a smooth surface which is cell occlusive and prevents cell adhesion and acts as a barrier. It allows tissue adherence favoring wound healing. It is made from the peritoneum of pigs. This side is turned towards the soft tissue. The smooth texture has appropriate elastic properties to accommodate suturing to the host mucosal margins and to protect the graft material from oral trauma during biodegradation and healing. The "inner" porous layer consists of collagen fibers in a loose, porous arrangement to enable cell invasion. This porous layer is made from pig skin. This side is turned toward the bone defect and/or soft tissue to encourage bone-forming cells and tissue growth and to stabilize the blood clot.

The provided text is a 510(k) summary for the MUCOGRAFT® Collagen Matrix, focusing on establishing substantial equivalence to predicate devices rather than presenting a standalone study with specific acceptance criteria and performance data for a new device.

Therefore, many of the requested sections about acceptance criteria, study details, expert consensus, and ground truth establishment cannot be fully answered based on the provided document. The document primarily compares the new MUCOGRAFT® Collagen Matrix to its predicate device (MUCOGRAFT® Resorbable Bilayer Membrane) based on existing characteristics and manufacturing changes, not new performance data.

Here's what can be extracted and what information is missing:

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

The document does not explicitly state acceptance criteria in the context of a performance study for the new MUCOGRAFT® Collagen Matrix beyond maintaining the characteristics of its predicate. Instead, it compares the characteristics of the proposed device to the predicate device.

Note on "Acceptance Criteria": In this context, the "acceptance criteria" are implied by the substantial equivalence argument – the new device must demonstrate similar characteristics to the predicate device to be considered equally safe and effective. The "reported device performance" are the characteristics of the new device that align with or are minor variations of the predicate.

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

Not explicitly provided. The document refers to "all data submitted in the previous notification and clearance of BIO-GIDE® (K042197) and MUCOGRAFT® Resorbable Bilayer Membrane (K061244)." This indicates reliance on previously cleared data, not new, specific performance study data for the new MUCOGRAFT® Collagen Matrix.

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. The document does not describe a study involving expert assessment of a test set to establish ground truth for the new device. The substantial equivalence argument relies on the inherent properties and established safety/efficacy of the predicate devices.

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

Not applicable/Not provided. There is no described test set or adjudication method.

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 document describes a medical device (collagen matrix) for guided tissue and bone regeneration, not an AI-assisted diagnostic or interpretive system. Therefore, an MRMC study or AI-related effectiveness is irrelevant.

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

Not applicable. As above, this is not an AI algorithm.

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

Implied ground truth: The "ground truth" for the substantial equivalence claim is the established safety and efficacy of the predicate devices (MUCOGRAFT® and BIO-GIDE®) based on their previous clearances (K012423, K061244, K960724, K042197, K050446). This would have likely involved a combination of biocompatibility testing, mechanical testing, and potentially animal or clinical outcomes data for those predicate devices, but these details are not provided for the current submission.

8. The sample size for the training set

Not applicable/Not provided. This is not an AI system, so there is no training set in that sense. If "training set" refers to data used to initially establish the predicate devices, that is not detailed here.

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

Not applicable/Not provided. As above, this is not an AI system.

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Simultaneous use of GBR-membrane (MUCOGRAFT) and implants; augmentation around implants placed in immediate extraction sockets; augmentation around implants placed in delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects after root resection, cystectomy, removal of retained teeth; guided bone regeneration in dehiscence defects; and guided tissue regeneration procedures in periodontal defects.

MUCOGRAFT® resorbable bilayer membrane for guided tissue and bone regeneration is physically identical to MUCOGRAFT® resorbable bilayer membrane (K012423), but labeled with an additional indication: guided tissue regeneration in periodontal defects. MUCOGRAFT® is a pure collagen membrane obtained by a standardized controlled manufacturing process. The membrane is made of collagen type I and type III without further cross-linking or chemical treatment. The collagen is extracted from veterinary certified pigs and is carefully purified to avoid antigenic reactions. MUCOGRAFT® is sterilized in double blisters by gamma irradiation. MUCOGRAFT® has a bilayer structure with one smooth, non-permeable layer and one porous. The "outer," smooth side has a smooth surface which is cell occlusive and prevents cell adhesion and acts as a barrier. It allows tissue adherence favoring wound healing. It is made from the peritoneum of pigs. This side is turned towards the soft tissue. The smooth texture has appropriate elastic properties to accommodate suturing to the host mucosal margins and to protect the graft material from oral trauma during biodegradation and healing. The "inner" porous layer consists of collagen fibers in a loose, porous arrangement to enable cell invasion. This porous layer is made from pig skin. This side is turned toward the bone defect and/or soft tissue to encourage bone-forming cells and tissue growth and to stabilize the blood clot.

This is a 510(k) premarket notification for a medical device called MUCOGRAFT®, a resorbable bilayer membrane used for guided tissue and bone regeneration. The submission aims to establish substantial equivalence to previously cleared predicate devices, specifically BIO-GIDE® (K960724; K042197; and K050446) and MUCOGRAFT® (K012423), with an additional indication for "guided tissue regeneration procedures in periodontal defects."

The document states that the new MUCOGRAFT® is physically identical to the previously cleared MUCOGRAFT® (K012423), and the primary basis for substantial equivalence is the existing clearances and the comparison to BIO-GIDE® (K042197) which already includes the new indication sought for guided tissue regeneration in periodontal defects.

Therefore, the submission does not describe a new study to prove the device meets acceptance criteria. Instead, it relies on the substantial equivalence principle, asserting that the device is essentially the same as already cleared devices, particularly the predicate device BIO-GIDE® for the new indication.

Given this, many of the requested details about acceptance criteria and study design are not present in this 510(k) summary. I can, however, extract the comparative information presented in lieu of specific acceptance criteria from a new study.

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) submission does not present a formal table of "acceptance criteria" against newly generated "reported device performance" from a dedicated study for the MUCOGRAFT® device. Instead, it demonstrates substantial equivalence to predicate devices based on product characteristics and intended use. The table provided is a comparison of MUCOGRAFT® to its predicate device, BIO-GIDE®, highlighting their similarities, which serves as the basis for regulatory acceptance.

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

• Not applicable. The submission does not describe a new test set or study conducted for this specific 510(k) submission. It relies on the equivalence to previously cleared devices.

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

• Not applicable. No new study for ground truth establishment is described.

4. Adjudication method for the test set

• Not applicable. No new test set or adjudication method 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 resorbable membrane, not an AI-assisted diagnostic tool.

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

• Not applicable. This device is a resorbable membrane, not an algorithm.

7. The type of ground truth used

• Not applicable (for this submission). For the original clearance of the predicate devices (BIO-GIDE® and initial MUCOGRAFT®), the ground truth for their effectiveness would have been established through pre-clinical testing, animal studies, and potentially clinical trials (outcomes data, histological evidence of regeneration, etc.) as required for their initial 510(k) clearances. This specific submission relies on referencing those prior clearances.

8. The sample size for the training set

• Not applicable. This is not an AI/algorithm-based device, so there is no "training set."

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

• Not applicable. See point 8.

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Simultaneous use of GBR-membrane (BIO-GIDE®) and implants; augmentation around implants placed in immediate extraction sockets; augmentation around implants placed in delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects after root resection, cystectomy, removal of retained teeth; guided bone regeneration in dehiscence defects; and guided tissue regeneration procedures in periodontal defects.

BIO-GIDE® resorbable bilayer membrane for guided tissue and bone regeneration. BIO-GIDE® is a pure collagen membrane obtained by a standardized controlled manufacturing process. The collagen is extracted from veterinary certified pigs and is carefully purified to avoid antigenic reactions. BIO-GIDE® is sterilized in double blisters by gamma irradiation. BIO-GIDE® has a bilayer structure. The porous surface facing the bone - allows the ingrowth of bone forming cells. The dense surface - facing the soft tissue - prevents the ingrowth of fibrous tissue into the bone defect. The membrane is made of collagen type I and type III without further cross-linking or chemical treatment.

The provided text does not contain information about acceptance criteria or a study demonstrating device performance against such criteria. The document is a 510(k) summary for the BIO-GIDE® resorbable bilayer membrane, which focuses on demonstrating substantial equivalence to previously cleared predicate devices (K960724 and K042197).

The key point of this 510(k) summary is the addition of a heating step (70℃ for at least 30 minutes) to the manufacturing process for assurance that organisms causing Transmissible Spongiform Encephalopathies Disease have been destroyed. The document explicitly states: "The revised manufacturing process has been validated and tests have been done that confirm that the additional heating step does not affect the final product and that, as such, there were no changes that would render the product not substantially equivalent to the previously cleared predicate product."

Therefore, the requested information cannot be extracted from this document, as it does not describe a study proving the device meets specific performance acceptance criteria. It focuses on validating a manufacturing process change and demonstrating substantial equivalence.

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BIO-GIDE® is recommended for:

• . Simultaneous use of GBR-membrane (BIO-GIDE®) and implants;
• . Augmentation around implants placed in immediate extraction sockets;
• . Augmentation around implants placed in delayed extraction sockets;
• . Localized ridge augmentation for later implantation;
• . Alveolar ridge reconstruction for prosthetic treatment;
• Filling of bone defects after root resection, cystectomy, removal of retained teeth; ●
• . Guided bone regeneration in dehiscence defects; and
• Guided tissue regeneration procedures in periodontal defects,

BIO-GIDE® resorbable bilayer membrane for guided tissue and bone regeneration is physically identical to BIO-GIDE® (K960724), but labeled with an additional indication; guided tissue regeneration in periodontal defects. BIO-GIDE® is a pure collagen membrane obtained by a standardized controlled manufacturing process. The collagen is extracted from veterinary certified pigs and is carefully purified to avoid antigenic reactions. BIO-GIDE® is sterilized in double blisters by gamma irradiation. BIO-GIDE® has a bilayer structure. The porous surface - facing the bone - allows the ingrowth of bone forming cells. The dense surface - facing the soft tissue - prevents the ingrowth of fibrous tissue into the bone defect. The membrane is made of collagen type I and type III without further cross-linking or chemical treatment.

The provided document is a 510(k) summary for the BIO-GIDE® resorbable bilayer membrane, seeking clearance for an additional indication: guided tissue regeneration in periodontal defects. The submission primarily relies on substantial equivalence to predicate devices and literature review rather than a de novo clinical study with specific acceptance criteria and detailed performance metrics of the device itself.

Therefore, the requested information components related to acceptance criteria, specific device performance, sample size for test sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details are not explicitly available in the provided text related to the BIO-GIDE® device's performance.

The document mainly focuses on comparing the new generation BIO-GIDE® with its predicate devices (previous BIO-GIDE® and BioMend Extend™) for the expanded indication. It cites existing clinical studies from the literature to support the safety and effectiveness of the principle of guided tissue regeneration with collagen membranes, to which the BIO-GIDE® is deemed substantially equivalent.

Here's an attempt to answer based on the available information, noting the missing data:

1. Table of acceptance criteria and the reported device performance

The submission does not define specific quantitative "acceptance criteria" for the BIO-GIDE® device's performance for its new indication in the way one might expect for an AI algorithm or a novel functional device. Instead, the "acceptance" is based on demonstrating substantial equivalence to legally marketed predicate devices for the specified indications. The performance is inferred from the established efficacy of the predicate devices and the cited literature on similar collagen membranes used for guided tissue regeneration.

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

• Sample Size for Test Set: Not applicable in the context of a de novo clinical trial for the BIO-GIDE® device itself. The evidence is derived from a review of previously published clinical studies. Therefore, individual sample sizes would vary across the cited literature, and these studies were not conducted as a test set specifically for this 510(k) submission.
• Data Provenance: The cited studies are peer-reviewed publications. The geographic origin of these studies is not specified in the 510(k) summary but typically would be international. They are clinical studies, hence prospective data collection for their original purposes.

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

Not applicable. The submission relies on scientific literature discussing the clinical outcomes of Guided Tissue Regeneration (GTR) using collagen membranes, not on a ground truth established by experts for a specific test set within this 510(k) submission. Clinical outcomes (e.g., changes in probing depth, attachment levels) assessed by clinicians in the referenced studies would serve as the "ground truth" for those studies.

4. Adjudication method for the test set

Not applicable. This was not a trial involving expert adjudication of device performance in a test set.

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 resorbable membrane for guided tissue/bone regeneration, not an AI or imaging diagnostic device.

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

Not applicable. This is not an algorithm.

7. The type of ground truth used

The "ground truth" is derived from clinical outcomes data reported in the referenced scientific literature regarding the effectiveness of guided tissue regeneration using collagen membranes for periodontal defects. These outcomes typically include measurements like:

• Probing depth reduction
• Clinical attachment level gain
• Bone fill
• Histological evidence of regeneration (in some studies)

8. The sample size for the training set

Not applicable. There is no training set in the context of this device submission. The device is a physical product, not a machine learning model.

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

Not applicable.

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MUCOGRAFT® is indicated for:

• simultaneous use of GBR-membrane (MUCOGRAFT®) and implants; -
• augmentation around implants placed in immediate extraction sockets; -
• augmentation around implants placed in delayed extraction sockets; -
• localized ridge augmentation for later implantation; -
• alveolar ridge reconstruction for prosthetic treatment; -
• filling of bone defects after root resection, cystectomy, removal of retained teeth;
• guided bone regeneration in dehiscence defects.

Not Found

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study design details (like sample size, data provenance, expert qualifications, or adjudication methods), or any mention of AI assistance. The document is a 510(k) premarket notification letter regarding a dental bone grafting material called MUCOGRAFT, indicating its substantial equivalence to a predicate device and specifying its indications for use. It does not include the type of performance study data you are requesting.

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