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Geistlich Mucograft® and Geistlich Mucograft® Seal are indicated for:

• · 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; and
• · recession defects for root coverage.

Geistlich Mucograft® and Geistlich Mucograft® Seal are surgically implanted, fully resorbable devices intended for oral tissue regeneration. The matrices are made of collagen without further cross-linking. All configurations of the product are sterilized in a double package by gamma irradiation. Geistlich Mucograft® and Geistlich Mucograft® Seal are composed of two structures: one smooth structure and one porous structure. The device allows tissue adherence as a prerequisite for favorable wound healing. The "outer" side (i.e., turned towards the soft tissue) with a smooth surface consists of compact collagen and has a smooth texture with the appropriate elastic properties to accommodate suturing. The "inner" porous structure consists of collagen fibers in a loose, porous arrangement to allow cell invasion for soft tissue ingrowth. This roughened surface is placed next to the host tissue to facilitate tissue integration.

The products are provided as follows:

• Geistlich Mucograft®: 15 x 20 mm, 20 x 30 mm, and 30 x 40 mm ●
• . Geistlich Mucograft® Seal: 8 mm and 12 mm diameter

This document is a 510(k) Premarket Notification from the FDA regarding Geistlich Mucograft® and Geistlich Mucograft® Seal. It concludes that the device is substantially equivalent to legally marketed predicate devices. However, the provided text does not contain acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner typically expected for medical device performance evaluation (e.g., accuracy, sensitivity, specificity, or clinical outcomes with defined thresholds).

Instead, the document focuses on demonstrating substantial equivalence to existing predicate devices based on:

• Identical Indications for Use.
• Similar technological characteristics (material, shape, single-use, sterilization method).
• Leveraging performance data from the applicant's own predicate device (mechanical testing, biocompatibility, sterilization, shelf-life, and clinical performance testing).
• Risk assessment to demonstrate that minor changes (new size configuration and slight manufacturing changes) do not raise new questions of safety or effectiveness.

Therefore, many of your requested details, such as a table of acceptance criteria, device performance, sample sizes for test sets, expert qualifications for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable to this type of FDA submission for substantial equivalence.

Here's an analysis based on the information available in the provided text:

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

The document does not specify quantitative acceptance criteria or reported device performance in terms of clinical metrics (e.g., success rates, healing times) for the subject device. The primary "performance" reported is its substantial equivalence to predicate devices, which implies that it performs similarly to devices already on the market.

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 "performance data... from the applicant's own predicate device" and a "risk assessment" rather than specific new clinical or performance test sets for the current iteration of the device. Therefore, details about test set sample size or data provenance for a new study are not provided.

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 for a specific test set is not described, as the submission focuses on substantial equivalence to predicate devices based on a comparison of characteristics and leveraging existing predicate data.

4. Adjudication method (e.g., 2+1, 3+1, none) 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 collagen matrix (bone grafting material), not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this device.

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

Not applicable. This is not an algorithmic or AI-based device.

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

The document states "clinical performance testing from the applicant's own predicate device was leveraged." This implies that outcomes data from previous clinical studies on the predicate device were considered, rather than a new "ground truth" being established for the current submission.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable. This device does not involve a "training set" or establishing ground truth for machine learning.

Summary regarding acceptance criteria and study data:

The provided text for K210280 (Geistlich Mucograft® and Geistlich Mucograft® Seal) is an FDA 510(k) summary for a "substantial equivalence" determination. It does not describe a new clinical study with specific acceptance criteria and performance metrics for the subject device. Instead, it demonstrates substantial equivalence by:

• Highlighting identical Indications for Use with predicate devices.
• Confirming identical materials, manufacturing, sterilization methods, and packaging to predicate devices (with minor exceptions for size and slight manufacturing process changes).
• Leveraging performance data (mechanical testing, biocompatibility, sterilization, shelf-life, and clinical performance) from the applicant's own predicate device.
• Performing a risk assessment to conclude that minor changes do not raise new questions of safety or effectiveness.

Therefore, the "proof" that the device meets "acceptance criteria" here is the FDA's determination of substantial equivalence, based on the documented comparison to predicate devices and the existing performance data of those predicates. There are no new, specific quantitative acceptance criteria or a dedicated study described for this submission in the way you might find for novel device performance claims.

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Geistlich Bio-Gide® is intended for the following uses:

• 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.

Geistlich Bio-Gide® Shape is indicated for:

• 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.

Geistlich Bio-Gide® Compressed is indicated for:

• 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.
• guided tissue regeneration procedures in periodontal defects.

Geistlich Bio-Gide® Perio is intended for the following uses:

• 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.

Geistlich Bio-Oss Collagen® is intended for the following uses:

• augmentation or reconstructive treatment of the 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 the maxillary sinus floor;
• filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR); and
• filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).

Geistlich Mucograft® and Geistlich Mucograft® Seal are indicated for:

• 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; and
• recession defects for root coverage.

Geistlich Bio-Gide® is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation.

Geistlich Bio-Gide® Shape is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells into the membrane, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. The Geistlich Bio-Gide® Shape membrane has a pre-shaped form with a maximum width and height of 14 mm x 24 mm, respectively.

Geistlich Bio-Gide® Compressed is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells into the membrane, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. The Geistlich Bio-Gide® Compressed membrane is available in two different sizes, 13 x 25 mm and 20 x 30 mm.

Geistlich Bio-Gide® Perio is a pure collagen membrane with a bilayer structure and smoothed dense (cell-occlusive) surface. The modified surface makes the membrane somewhat stiffer in the dry state, and this facilitates cutting the membrane for periodontal applications. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. Preformed sterile templates are provided to simplify the cutting of the respective membrane shape. Four templates (uncoated Tyvek®) are packaged with Geistlich BioGide® Perio to serve as an aid to assist the clinician in trimming the Geistlich Bio-Gide® Perio membrane to fit the defect and are in varying shapes to fit the clinical need (e.g., rectangular, interproximal). The templates are packaged as an accessory product with Geistlich Bio-Gide® Perio.

Geistlich Combi-Kit Collagen is a convenience kit containing one unit of Geistlich Bio-Oss Collagen® and one unit of Geistlich Bio-Gide®. The two devices are packaged in double blisters in one package and then sterilized by gamma irradiation. Geistlich Bio-Oss Collagen® is a combination of purified spongiosa (cancellous) natural bone mineral granules and 10% collagen fibers in a block form (100 mg) and is sterilized by gamma irradiation. Geistlich Bio-Gide® is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. The size of the Geistlich Bio-Gide® bilayer membrane to be provided in the Geistlich Combi-Kit Collagen convenience kit is 16 mm x 22 mm.

Geistlich Perio-System Combi-Pack is a convenience kit containing one unit of Geistlich Bio-Oss Collagen® and one unit of Geistlich Bio-Gide® Perio. Geistlich Bio-Oss Collagen® is a combination of purified spongiosa (cancellous) natural bone mineral granules and 10% collagen fibers in a block form (100 mg) and is sterilized by gamma irradiation. Geistlich Bio-Gide® Perio is a pure collagen membrane with a bilayer structure and smoothed dense (cell-occlusive) surface. The modified surface makes the membrane somewhat stiffer in the dry state, and this facilitates cutting the membrane for periodontal applications. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. The size of the Geistlich Bio-Gide® Perio bilayer membrane to be provided in the Geistlich Perio-System Combi-Pack convenience kit and as individual units is 16 mm x 22 mm. Preformed sterile templates are provided to simplify the cutting of the respective membrane shape. Four templates (uncoated Tyvek®) are packaged with Geistlich Bio-Gide® Perio to serve as an aid to assist the clinician in trimming the Geistlich Bio-Gide® Perio membrane to fit the defect, and are in varying shapes to fit the clinical need (e.g., rectangular, interproximal). The templates are packaged as an accessory product with Geistlich Bio-Gide® Perio.

Geistlich Mucograft® and Geistlich Mucograft® Seal are surgically implanted, fully resorbable devices intended for oral tissue regeneration. The matrices are made of collagen without further cross-linking. All configurations of the product are sterilized in a double package by gamma irradiation. Geistlich Mucograft® and Geistlich Mucograft® Seal are composed of two structures: one smooth structure and one porous structure. The device allows tissue adherence as a prerequisite for favorable wound healing. The "outer" side (i.e., turned towards the soft tissue) with a smooth surface consists of compact collagen and has a smooth texture with the appropriate elastic properties to accommodate suturing. The "inner" porous structure consists of collagen fibers in a loose, porous arrangement to allow cell invasion for soft tissue ingrowth. This roughened surface is placed next to the host tissue to facilitate tissue integration.

Here's an analysis of the acceptance criteria and supporting study details based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For all listed devices (Geistlich Bio-Gide®, Geistlich Bio-Gide® Shape, Geistlich Bio-Gide® Compressed, Geistlich Bio-Gide® Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft® and Geistlich Mucograft® Seal), the acceptance criteria are not explicitly stated as numerical thresholds. Instead, the criterion for acceptance is that the material properties remain unchanged when using an alternate supplier of porcine raw material compared to the predicate devices. The reported device performance is that these properties did remain unchanged.

Specific Performance Studies Conducted:

• Elongation: Verified to be unchanged.
• Suture pull-out test: Verified to be unchanged.
• Swelling: Verified to be unchanged.
• Differential Scanning Calorimetry (DSC): Verified to be unchanged.
• Collagenase digestion (to assess degradation): Verified to be unchanged.
• Scanning Electron Microscopy (SEM) (to assess optical differences): Verified to be unchanged.
• Viral safety evaluation per ICH Q5A(R1) and ISO 22442-3:2007: Verified (leveraged from K171050).
• Biocompatibility, sterilization, shelf-life, and clinical performance: Leveraged from the applicant's own predicate devices, implying these aspects also remained consistent.

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

The document does not explicitly state the numerical sample size for "test sets" in the traditional sense of a clinical trial. Instead, the performance studies were conducted on "representative product" for each device to verify material properties. The provenance of this "representative product" is not specified (e.g., country of origin). The studies appear to be laboratory-based and not involving patient data, so the terms "retrospective" or "prospective" are not applicable.

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

This information is not provided in the document. The studies performed are physical and chemical characterizations of the material, not clinical evaluations requiring expert interpretation of results. The "ground truth" for these tests would be the established scientific methods and parameters for each test.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the physical and chemical tests, it's unlikely a human-based adjudication method (like 2+1 or 3+1) would be used. The results of these tests are typically objectively measured and compared to established specifications or to the predicate device's performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This submission is for a material change (alternate raw material supplier) and not a new diagnostic or therapeutic device requiring human interpretation of results.

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

This question is not applicable. The device is a physical bone grafting material/membrane, not a software algorithm.

7. The Type of Ground Truth Used

The ground truth used for these studies is based on objective physical and chemical material properties and standards. The performance of the modified devices (with the alternate raw material supplier) was compared to the known performance and characteristics of the predicate devices. The determination of "unchanged" would rely on laboratory measurements meeting predefined specifications or falling within an acceptable range relative to the predicate device.

8. The Sample Size for the Training Set

This question is not applicable. This submission is about a physical medical device and a change in its raw material supplier. There is no machine learning model or "training set" involved.

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

This question is not applicable, as there is no training set for an AI/ML model.

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Geistlich Mucograft® and Geistlich Mucograft® Seal are indicated for:

• 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
• Recession defects for root coverage

Geistlich Mucograft® and Geistlich Mucograft® Seal are surgically implanted, fully resorbable devices intended for oral tissue regeneration.

Geistlich Mucograft® and Geistlich Mucograft® Seal are collagen matrices obtained by a standardized controlled manufacturing process. The matrices are made of collagen without further cross-linking. The collagen is extracted from veterinary certified pigs and is carefully purified to avoid antigenic reactions. All configurations of the product are sterilized in a double package by gamma irradiation. Geistlich Mucograft® and Geistlich Mucograft® Seal are composed of two structures: one smooth structure and one porous structure. The device allows tissue adherence as a prerequisite for favorable wound healing. The "outer" side (i.e., turned towards the soft tissue) with a smooth surface consists of compact collagen and has a smooth texture with the appropriate elastic properties to accommodate suturing. The "inner" porous structure consists of collagen fibers in a loose, porous arrangement to allow cell invasion for soft tissue ingrowth. This roughened surface is placed next to the host tissue to facilitate tissue integration.

Available Products:

• Geistlich Mucograft® 15x20 mm .
• Geistlich Mucograft® 20x30 mm .
• Geistlich Mucograft® Seal 8 mm diameter .

The provided text does not contain information about acceptance criteria or a study proving that the GEISTLICH MUCOGRAFT® and GEISTLICH MUCOGRAFT® SEAL device meets specific acceptance criteria in the way described by the request (e.g., performance metrics like sensitivity, specificity, accuracy for an AI/device output).

Instead, this document is a 510(k) summary for a medical device (collagen matrix) indicating substantial equivalence to a predicate device. The "study that proves the device meets the acceptance criteria" in this context refers to the data submitted to demonstrate substantial equivalence to legally marketed predicate devices, not typically a clinical trial with pre-defined performance acceptance criteria for a novel AI or diagnostic device.

The "acceptance criteria" here are largely implicit in the substantial equivalence determination process, which involves demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is achieved by showing it has:

• The same intended use as the predicate.
• The same technological characteristics as the predicate; OR
• Different technological characteristics, but the information submitted demonstrates that the device is as safe and effective as the legally marketed device, and it does not raise different questions of safety and effectiveness.

Here’s a breakdown based on the information provided, recognizing that it doesn't fit the typical format for AI/diagnostic device performance studies:

1. Table of Acceptance Criteria and Reported Device Performance:

• Sterilization validation: Relied upon data previously submitted in support of Mucograft®.
• Packaging materials: Relied upon data previously submitted in support of Mucograft®.
• Materials and Manufacturing: Made of collagen from veterinary certified pigs, purified, sterilized by gamma irradiation. Composed of two structures (smooth and porous) for tissue adherence and cell invasion. The materials, extraction, purification, and sterilization processes are consistent with the predicate. |
  | Effectiveness: Device is as effective as the predicate device (i.e., performs as intended). | - Intended Use: The device shares the same intended uses as the predicate: covering implants, localized gingival augmentation, alveolar ridge reconstruction, and recession defects for root coverage.
• Technological Characteristics: Geistlich Mucograft® is stated to be "the same as the predicate device, Mucograft®." Geistlich Mucograft® Seal is a "new size and shape" but has "the same chemical composition and same materials as the predicate device." It is noted that the differences in size and shape "do not change the intended use of the device."
• Bench-type evaluations: Confirmed that Geistlich Mucograft® Seal is "easily sutured in two extraction socket models." Evaluations by Geistlich and clinicians showed it could be "sutured readily to an extraction socket" and should be sutured "in a dry state." (These are more functional validation points rather than clinical effectiveness metrics).
• Performance testing (Animal and Clinical): Relied upon data previously submitted in support of Mucograft®. |
  | No new or different questions of safety and effectiveness. | - The submission concluded that "there are no new or different questions regarding safety and effectiveness if Geistlich Mucograft® and Geistlich Mucograft® Seal are used according to their intended use." This is the overarching "acceptance criterion" for 510(k) clearance. |

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

• The document primarily refers to "bench-type evaluations" and reliance on "data previously submitted in support of Mucograft®."
• For the bench evaluations of Geistlich Mucograft® Seal: "two extraction socket models" were used. No sample size for clinical or animal data for the new device is explicitly stated; instead, it relies on the predicate device's data.
• Data Provenance: The document does not specify country of origin for the studies underlying the predicate device. The bench evaluations for the new device were conducted by "Geistlich and by clinicians," but geographical location is not mentioned. The studies appear to be retrospective in the sense that existing data from the predicate device was leveraged.

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

• This information is not provided in the document. The "evaluations by Geistlich and by clinicians" for suturing properties do not detail the number or qualifications of these clinicians. In a 510(k) for a device like this, ground truth is typically established by physical testing, animal studies, and clinical results from the predicate device, rather than expert consensus on diagnostic interpretations.

4. Adjudication method for the test set:

• Not applicable/Not mentioned. Given the nature of a collagen matrix and the substantial equivalence pathway, an adjudication method for a "test set" in the context of diagnostic performance (e.g., 2+1, 3+1) is not relevant to this submission.

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 collagen matrix for tissue regeneration, not an AI or diagnostic tool designed to assist human readers.

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

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

7. The type of ground truth used:

• For the overall substantial equivalence determination, the "ground truth" is that the predicate device (Mucograft®) is legally marketed and deemed safe and effective for its indications.
• For the new device's specific evaluations, the ground truth relates to physical properties (e.g., ease of suturing in extraction socket models) and, presumably, the clinical outcomes linked to the predicate device via animal and clinical performance testing. This would be physical testing results, animal study outcomes, and clinical outcomes data from the predicate device.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable.

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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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