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• covering of implants placed in immediate or delayed extraction sockets;
• localized gingival augmentation to increase keratinized tissue (KT) around teeth and implants;
• alveolar ridge reconstruction for prosthetic treatment;
• guided tissue regeneration procedures in recession defects for root coverage

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. This side is turned towards the soft tissue. The smooth texture has appropriate elastic properties to accommodate i suturing to the host mucosal margins and to protect the graft material from oral trauma during biode radation 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 boneforming cells and tissue growth and to stabilize the blood clot.

The provided text describes the MUCOGRAFT® Collagen Matrix, a pure collagen membrane for dental grafting procedures. It establishes substantial equivalence to previous versions and other collagen membranes, rather than presenting a study to prove acceptance criteria for a new AI-powered medical device. Therefore, much of the requested information regarding AI device testing is not applicable.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of quantitative metrics for a device's performance that would typically be seen in an AI device study (e.g., sensitivity, specificity, AUC). Instead, it relies on demonstrating substantial equivalence to predicate devices and evidence of safety and efficacy through preclinical and clinical studies for specific indications.

Acceptance Criteria (Implied for Substantial Equivalence):

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

• Preclinical Studies:
  • Wehrhan et al. 2010: Porcine model (sample size not specified).
  • Herford and Boyne 2002: Primate model (sample size not specified).
• Clinical Studies:
  • Multiple clinical studies are mentioned, but specific sample sizes for each are not provided in this document. The studies are cited as "clinical studies have been conducted" and are not detailed within this summary.
• Data Provenance: The document implies an international scope given the sponsor's location (Switzerland) and the cited authors. Some cited studies (e.g., Herford and Boyne, McGuire and Scheyer) are from the US. The studies are assumed to be prospective clinical trials, but this is not explicitly stated for all.

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

N/A. This information is typically relevant for studies using expert-labeled data as ground truth for AI algorithms. For this medical device (a collagen matrix), the "ground truth" is established through clinical and histological outcomes observed by researchers and clinicians in the preclinical and clinical studies, rather than a separate expert review panel for a test set.

4. Adjudication Method for the Test Set

N/A. This is relevant for studies where multiple annotators or reviewers might disagree on ground truth labels, necessitating an adjudication process. This is not applicable to the preclinical and clinical studies evaluating a physical implantable device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

N/A. This concept is specific to evaluating AI's impact on human performance (e.g., radiologists interpreting images with and without AI assistance). The MUCOGRAFT® device is a biomaterial, not an AI diagnostic/interpretive tool, so an MRMC study is not relevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Done

N/A. As MUCOGRAFT® is not an algorithm, this question is not applicable.

7. Type of Ground Truth Used

For the preclinical and clinical studies, the "ground truth" is based on:

• Histological and pathological examination: For outcomes like uneventful healing, normal-appearing tissue, revascularization, and epithelialization (e.g., in animal models).
• Clinical observation and measurement: For outcomes like gingival augmentation (increase in keratinized tissue width/thickness) and root coverage, assessed by clinicians based on established dental criteria.

8. Sample Size for the Training Set

N/A. The concept of a "training set" applies to machine learning algorithms. This document describes a medical device tested through traditional scientific studies (preclinical and clinical), not an AI system.

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

N/A. As there is no training set mentioned for an AI algorithm, this question is not applicable.

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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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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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