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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 Fibro-Gide® is intended for soft tissue augmentation. It is indicated for:

• 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. 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

Geistlich Fibro-Gide® is a fully resorbable, porous, collagen matrix of porcine origin of a spongious consistency. The collagen is extracted from veterinary certified pigs and is carefully purified to avoid antigenic reactions. The collagen scaffold is weakly crosslinked. Geistlich Fibro-Gide® is sterilized in double packaging by Gamma-irradiation.

Geistlich Fibro-Gide® is an implantable device intended for use in soft tissue augmentation procedures. As described in more detail below, the device is indicated specifically for insufficient tissue volume at the alveolar ridge and for soft tissue recession. It has mechanical properties appropriate to withstand the mechanical stresses that occur after wound closure in soft tissue augmentation procedures, i.e., it has good volume stability and it withstands early resorption to allow the formation of new soft tissue and degrades over time. In addition, the matrix is designed with an appropriate thickness to provide sufficient space for the ingrowth of new soft tissue. Due to its good wettability, suturability and biological properties, the device becomes well integrated into the surrounding soft tissue.

The products are provided as follows:

• 15 x 20 x 6 mm
• 20 x 40 x 6 mm
• 15 x 20 x 3 mm
• 20 x 40 x 3 mm

N/A

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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; and
• 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, and
• guided tissue regeneration procedures in periodontal defects.

Geistlich Bio-Gide® Forte 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, and
• 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 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® is provided in the following sizes: 13 x 25 mm, 25 x 25 mm, 30 x 40 mm, 40 x 50 mm.

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® Forte 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® Forte membrane is available in five different sizes, 13 x 25 mm, 25 x 25 mm, 20 x 30 mm, 30 x 40 mm, and 40 x 50 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. Pre-formed 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 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® (sold either as an individual unit or as one of the components of Geistlich Perio-System Combi-Pack) 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 (sold either as an individual unit or as one of the components of Geistlich Perio-System Combi-Pack) 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.

The provided FDA 510(k) clearance letter and associated S510(k) summary documents describe a class II medical device, Geistlich Bio-Gide and its variants, which are resorbable bilayer membranes and bone grafting materials. This submission is for a determination of substantially equivalent to a predicate device.

Crucially, this document is focused on demonstrating substantial equivalence based on material characteristics, manufacturing processes, and performance data for the device itself (a physical membrane and bone grafting material), not on the performance of an AI/ML powered device.

Therefore, most of the requested information regarding acceptance criteria, training/test sets, expert adjudication, MRMC studies, standalone performance, and effect sizes for AI assistance are not applicable to this type of medical device submission. The "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical performance testing conducted to confirm the physical and biochemical properties of the new device are equivalent to the predicate device, especially after changes to supplier and manufacturing processes.

Here's an attempt to extract relevant information and note the inapplicable sections based on your request:

Acceptance Criteria and Device Performance (for a physical medical device)

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

Since this is not an AI/ML device, the acceptance criteria are not typically expressed in terms of accuracy, sensitivity, or specificity. Instead, they are based on physical, chemical, and biological properties demonstrating equivalence to a predicate device. The performance data provided is primarily comparative to the predicate.

The "analysis" column in the provided tables consistently states "The material of construction is identical," "The sizes offered are identical/similar," etc., implying the acceptance criterion is indeed identity or substantial similarity to 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)

• Sample Size for Test Set: Not explicitly stated as a single "test set" in the context of an AI/ML model. The performance data consists of various physical, biochemical, and experimental tests. The number of samples for each specific test (e.g., number of membranes for tensile strength testing) is not provided.
• Data Provenance: Not specified regarding country of origin. The studies are described as "in vitro and in vivo biocompatibility," "sterilization," "shelf-life," "bench," and "clinical performance studies" leveraged from previous predicate device submissions (e.g., K212463, K171643). These are likely a mix of lab-based and potentially historical clinical data. It is not specified if these are prospective or retrospective studies; however, given they are leveraged from previous clearances, they would be historical for this specific submission.

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. This is not an AI/ML diagnostic device requiring expert interpretation or ground truth establishment in that manner. The "ground truth" for a resorbable membrane involves objective physical, chemical, and biological measurements, and comparison to established standards and predicate device characteristics, not expert consensus on image interpretation.

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

• Not Applicable. No human adjudication method is described or relevant for the physical and chemical performance tests conducted on this medical device.

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-assisted device, so MRMC studies are not relevant.

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

• Not Applicable. This is not an AI algorithm. Its "standalone" performance refers to its intrinsic physical and chemical properties.

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

• Not Applicable / Different Context. The "ground truth" for this device's performance is established by:
  • Objective Measurements: Results of standardized physical and biochemical tests (e.g., SEM, porosity, tensile strength, DSC, solubility, degradation, molecular weight, hydration capacity, suture pull-out force).
  • Regulatory Standards: Compliance with ISO and ASTM standards (e.g., ISO 10993-1, ISO 11137 series, ISO 22442-3, ASTM F2450-18, ASTM F2150-19, ASTM F2212-20).
  • Predicate Device Data: Comparison and leveraging of performance data (biocompatibility, sterilization, shelf-life, bench, clinical) from previously cleared predicate devices. The claim is substantial equivalence, meaning it performs as safely and effectively as the legally marketed predicate.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not an AI/ML model, so there is no "training set."

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

• Not Applicable. As there is no training set for an AI/ML model, this question does not apply.

Summary of the Study Proving Device Meets Acceptance Criteria (in this context):

The "study" conducted for the Geistlich Bio-Gide product family in this 510(k) submission primarily consists of a comprehensive battery of non-clinical performance tests combined with the leveraging of existing performance data from previously cleared predicate devices. The purpose of these tests was to demonstrate that modifications (e.g., new slaughterhouse, non-significant manufacturing changes) did not alter the fundamental safety and effectiveness of the device, making it substantially equivalent to its predicates.

The non-clinical tests included:

• Physical and Biochemical Testing: SEM (surface morphology), porosity, tensile strength, DSC (onset temperature), suture pull-out force, solubility, enzymatic degradation, SDS-PAGE (molecular weight distribution), and hydration capacity. For Geistlich Bio-Gide Forte and Compressed, handling properties were also evaluated.
• Other Experimental Testing: Viral safety according to ISO 22442-3:2007.

These tests, performed on the modified devices, aimed to show that their properties were consistent with a product that would continue to perform as intended and as safely and effectively as the predicate devices. The acceptance criteria were implicitly that the new devices exhibit equivalent performance characteristics to the cleared predicate devices, as supported by these various in vitro and experimental studies and referencing past clinical data from the predicates.

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SwissMembrane X 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.

SwissMembrane X Socket 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.

SwissMembrane X and SwissMembrane X Socket are resorbable collagen membranes made of porcine collagen. 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 membranes are made of collagen without further cross-linking and are sterilized by gamma irradiation.

SwissMembrane X is provided in the following variants and sizes:

• SwissMembrane X D-Line
  • 13 x 25 mm (rectangle)
  • 25 x 15/25 mm (trapezoid)
  • 30 x 25/40 mm (trapezoid)
• SwissMembrane X Socket D-Line
  • 14 x 24 mm

The provided FDA 510(k) Clearance Letter for SwissMembrane X and SwissMembrane X Socket indicates that the device has been cleared based on substantial equivalence to a predicate device, Geistlich Bio-Gide® and Geistlich Bio-Gide® Shape (K212463).

This type of clearance (510(k)) generally means that the device does not require new detailed performance data to prove safety and effectiveness if it can demonstrate through comparison that it is as safe and effective as a legally marketed predicate device. Therefore, the document does not describe acceptance criteria for performance, nor does it detail a study proving device performance against specific metrics in the way one might expect for a novel device or a device involving an AI component.

The document explicitly states:

"Non-clinical data was not deemed necessary to support the extension to the product line. As the subject devices fall within the range of size configurations cleared under the predicate device, there is no new worst-case configuration."

"Results from biocompatibility, sterilization, shelf-life, packaging validation, bench and clinical performance studies from the applicant's own predicate device (K212463) were leveraged in support of substantial equivalence."

Because the clearance is based on substantial equivalence to an existing and already cleared device, the typical requirements for a new performance study with specific acceptance criteria, test sets, and ground truth establishment (as is common for AI/ML-driven devices or novel diagnostic tools) are not present or reported in this 510(k) summary.

Therefore, the following information cannot be extracted from this document as no new performance study, in the sense of demonstrating a device's de novo performance against predefined metrics, was conducted or reported for this submission.

Based on the provided document, the following information cannot be extracted for the reasons stated above:

1. A table of acceptance criteria and the reported device performance: Not applicable. Performance data against specific acceptance criteria for a new study is not provided, as substantial equivalence was based on the predicate device's data.

2. Sample sized used for the test set and the data provenance: Not applicable. No new test set for proving performance was described. The submission leveraged existing data from the predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new ground truth establishment process for a performance study is described.

4. Adjudication method for the test set: Not applicable. No new test set requiring adjudication is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. No MRMC study described. The device is a physical bone grafting material/membrane, not one that typically involves human readers assisted by AI.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm is involved.

7. The type of ground truth used: Not applicable. No new performance study requiring independent ground truth is described.

8. The sample size for the training set: Not applicable. This is not an AI/ML device; therefore, no training set is relevant.

9. How the ground truth for the training set was established: Not applicable. No training set is relevant.

Summary of what the document DOES state regarding "performance data":

The "Performance Data" section (Page 7) explicitly states that "Non-clinical data was not deemed necessary to support the extension to the product line." It further clarifies that "Results from biocompatibility, sterilization, shelf-life, packaging validation, bench and clinical performance studies from the applicant's own predicate device (K212463) were leveraged in support of substantial equivalence."

This means the acceptance criteria and performance data for this particular 510(k) submission refer back to the studies and their results that supported the initial clearance of the predicate device (K212463). The current submission argues that since SwissMembrane X and SwissMembrane X Socket are essentially variants (different shapes and sizes within an existing range) of the already cleared predicate device, no new performance studies are required. They are considered "substantially equivalent" based on identical materials, manufacturing, sterilization, and similar use cases, and the safety and efficacy of the underlying technology have already been established by the predicate device's clearance.

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The Soft Tissue Augmentation Resorbable (STAR) Matrix is intended to support localized gingival augmentation to increase keratinized tissue.

STAR Matrix is indicated for:

• Covering of implants placed in immediate or delayed extraction sockets;
• Localized gingival augmentation to increase keratinized tissue (KT) around teeth and implants.

The Soft Tissue Augmentation Resorbable Matrix (STAR Matrix) is a cross – linked, resorbable membrane engineered from highly purified Type I collagen fibers derived from Porcine Achilles Tendon for use in periodontal, oral, and maxillofacial surgery. STAR Matrix is composed of two structures: a smooth outer layer that acts as a barrier membrane and a porous matrix layer to allow cell invasion and tissue ingrowth. The product is oriented so that the porous layer is in contact with the host tissue bone/bone graft or periosteum to facilitate tissue integration. The product is provided sterile, non-pyrogenic, and for single use only. Product is provided in various sizes where it can be easily trimmed for appropriate fit and sutured into place during surgery.

The provided document is a 510(k) summary for a medical device (Soft Tissue Augmentation Resorbable Matrix - STAR Matrix) and focuses on demonstrating substantial equivalence to a predicate device. It does not contain information about acceptance criteria and a study proving the device meets those criteria, as typically found in a clinical study report for software as a medical device (SaMD) or AI/ML-driven devices.

The document primarily covers:

• Description of the device: A resorbable membrane for gingival augmentation.
• Comparison to predicate devices: Highlighting similarities and differences in technical characteristics.
• Performance data: Primarily non-clinical (in vitro, animal, biocompatibility, sterilization, shelf life).
• No clinical studies were required to determine substantial equivalence for this device.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving a device meets those criteria because the document does not describe such a study. The information requested (acceptance criteria table, sample sizes, ground truth establishment, expert adjudication, MRMC studies, standalone performance, training set details) is typically found in documentation for the validation of AI/ML-based medical devices or devices demonstrating clinical efficacy/safety through trials, which is not the nature of this 510(k) submission.

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The Oral Matrix is intended for use in extraction sockets only to contain or prevent migration of graft material. The device is supplied sterile and intended for one time use.

The Oral Matrix consists of layered sheets of bioabsorbable extracellular collagen membrane matrix derived from porcine Small Intestinal Submucosa (SIS). These sheets are freeze-dried, packaged in a Tyvek pouch, and sterilized using ethylene oxide to achieve a SAL of 10-6.

The Oral Matrix is available in eighteen different models, the differences between the models are shown in the table below.

The provided document describes the "Oral Matrix" device and its FDA 510(k) summary, which often includes information on acceptance criteria and supporting studies. However, this specific document focuses on demonstrating substantial equivalence to a predicate device rather than providing explicit acceptance criteria with numerical targets for clinical performance metrics or a detailed standalone study for human-in-the-loop performance. Instead, it relies on non-clinical and animal studies to justify equivalence based on product performance and composition.

Here's an analysis of the provided information concerning acceptance criteria and studies:

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

The document does not explicitly list quantitative acceptance criteria in a table format with specific performance targets for the device's intended clinical use (e.g., success rate of socket preservation, bone regeneration metrics). Instead, it presents various non-clinical and animal study findings which implicitly serve as evidence that the device performs similarly to the predicate device or meets regulatory standards.

Implicit "Acceptance Criteria" through Equivalence and Standards Compliance:

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

• Test Sets:
  • Non-Clinical (Product Performance, Composition, Package Integrity, Shelf Life, Biocompatibility): The document doesn't specify sample sizes for these tests. The data provenance is not explicitly stated as country of origin, but the sponsor is Beijing Biosis Healing Biological Technology Co., Ltd. from China, and the testing was likely conducted in a setting compliant with international standards (ISO, ASTM). These are generally prospective tests conducted specifically for the submission.
  • Virus Inactivation: Not specified, but likely an in-vitro study designed to demonstrate log reduction, which is a prospective test.
  • Animal Study: The sample size for the canine model is not specified. The study was performed in an animal model, which is a prospective study. Data provenance in terms of country is not specified, but usually, animal studies are conducted by or for the submitting company.

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 section is not applicable as the document describes non-clinical and animal studies, not studies involving human expert interpretation for ground truth. Ground truth for these types of tests is established through laboratory methods and histopathological analysis (for the animal study), not expert consensus on human data.

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

This is not applicable as the studies described (non-clinical, animal) do not involve human interpretation or adjudication processes typical of clinical diagnostic studies.

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 MRMC comparative effectiveness study was done or mentioned. The device is a bone grafting material, not an AI-assisted diagnostic tool.

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

Not Applicable. The device is not an algorithm, but a physical bone grafting material. There is no "algorithm only" performance to evaluate. The performance evaluations described are for the physical properties and biological effects of the material itself.

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

• Non-Clinical (Product Performance, Composition, Package Integrity, Shelf Life): Ground truth is established by physical and chemical measurements against established standards (e.g., ASTM, ISO guidelines) and comparative data from the predicate device.
• Virus Inactivation: Ground truth is established by virological assays to determine viral load reduction.
• Biocompatibility: Ground truth is established by in vitro and in vivo biological assays (e.g., cytotoxicity, sensitization, implantation responses) adhering to ISO 10993 series standards.
• Animal Study: Ground truth for socket preservation would be established by histopathological examination of the extracted socket sites, potentially including measurements of bone formation, reduction in ridge resorption, and inflammation, compared to control groups.

8. The sample size for the training set

Not Applicable. The device is a bioabsorbable extracellular collagen membrane matrix, not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of an AI model.

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

Not Applicable. As explained above, there is no training set for this type of device.

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Endoform Dental Membrane is specifically intended for use in extraction sockets and soft tissue grafting. The device contains and prevents migration of guided bone regeneration graft material and prevents loss of alveolar height and ridge following tooth extraction. The device is provided sterile and intended for one-time use.

Endoform Dental Membrane is an ovine derived bioabsorbable extracellular matrix intended for application in dental and periodontal procedures. The device is composed of non-cross linked and non-reconstituted collagen. The device is supplied sterile in a variety of sizes and thicknesses which may be trimmed by a licensed dentist or oral surgeon to meet individual patient needs.

The provided text describes the non-clinical testing performed on the Endoform Dental Membrane to demonstrate its safety and performance. However, it does not include information about acceptance criteria for all the tests, nor does it detail a study that defines "device performance" in terms of clinical or comparative effectiveness against specific criteria in the way you've outlined.

Based on the available text, here's a breakdown of the information that is present, and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document details numerous non-clinical tests. For many, it states that the device "met the pre-defined specification" or "meets the specification," but it often does not explicitly list the numerical acceptance criteria in this summary. The table below compiles the criteria where they are explicitly mentioned.

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

The document describes several non-clinical tests but does not explicitly state the specific numerical sample sizes for each test set. It mentions "All EDM devices" or "all samples" in some contexts.

For the Animal Performance Testing:

• Sample Size (Test Set): Not explicitly stated how many animals were used, but it was an ovine (sheep) defect model study using "selected timepoints (week 4, 8 and 16)".
• Data Provenance: Prospective animal study conducted in an ovine (sheep) defect model. The country of origin is not specified, but the applicant's address is New Zealand.

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

This information is not provided in the document. The non-clinical tests described rely on validated laboratory methods and specifications, which are based on scientific standards rather than expert consensus on a test set in the way clinical diagnostic devices might.

For the animal study, the assessment criteria (resorption, cellular infiltration, inflammatory response, retention of bone grafting material, hard tissue infill) would likely be evaluated by veterinarians or pathologists, but the number and qualifications of these experts are not mentioned.

4. Adjudication Method for the Test Set

This information is not provided as the document focuses on laboratory and animal study results rather than human-read test sets.

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

No. A MRMC comparative effectiveness study was not performed or described. The document explicitly states: "Clinical data was not required to demonstrate substantial equivalence."

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

Not applicable. This device is a bioabsorbable extracellular matrix (Endoform Dental Membrane), not an AI algorithm. Therefore, "standalone algorithm" performance is not relevant.

7. Type of Ground Truth Used

The "ground truth" for the various tests conducted for the Endoform Dental Membrane is based on:

• Validated Test Methods: For biochemical content (collagen, GAG, DNA), physical properties (moisture, DSC, permeability, suture retention, modulus, thickness), residual substances (Tx-100, EDTA, PAA), bioburden, endotoxin, and shelf-life. These are quantitative measurements against predefined specifications.
• Standards Compliance: For biocompatibility (ISO 10993 series), sterilization (ISO 11135), and packaging (ASTM standards).
• Histopathological and Macroscopic Assessment: For the animal performance study, evaluating resorption, cellular infiltration, inflammatory response, and bone graft retention based on examinations at specific time points. This likely involves expert evaluation of tissue samples, but it's not "expert consensus" on a diagnostic task, rather assessment of biological outcomes compared to a reference device.
• "Critically sized" defects: The animal study also demonstrated that untreated controls did not completely regenerate bone, indicating the defects were appropriately sized for evaluating the device's performance.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI algorithm. Therefore, there is no "training set."

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

Not applicable. As above, there is no training set for this type of device.

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THE Cover is recommended for:

• Covering of immediate or delayed extraction socket to enhance preservation of the alveolar ridge.

THE Cover Resorbable Collagen Membrane is a white, pliable membrane consisting of fibrous collagen matrix purified from porcine tendon. THE Cover act as a barrier between the gingival and the new bone that can facilitate proper bone regeneration. As soft tissues tend to grow faster than the bone can regenerate, the membrane can help protect the bone graft particles from this faster growing connective tissue. As collagen membrane will be dissolved, no additional operation is necessary. THE Cover does not have a distinction between face and back.

The provided text describes the regulatory clearance of a medical device called "THE Cover" and details the studies conducted to demonstrate its substantial equivalence to a predicate device. However, it does not contain information related to an AI/Software as a Medical Device (SaMD) or an algorithm.

Therefore, I cannot provide an answer to your request as it pertains to AI/SaMD acceptance criteria and studies demonstrating algorithm performance. The document focuses on the physicochemical, mechanical, biocompatibility, and in vivo performance of a physical bone grafting material (collagen membrane), not an AI algorithm.

If you have a document about an AI/SaMD, please provide it, and I will be happy to answer your questions regarding acceptance criteria and study details.

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InterCollagen® Guide alone or in combination with suitable augmentation materials (like autogenous bone, allogeneic, xenogeneic or alloplastic bone replacement materials) is immediate or delayed guided tissue and bone regeneration.

• · in the context of a treatment of fenestration defects
• · in case of dehiscence defects
• · after apicoectomy and resection of retained teeth
• · in extraction sockets after tooth extractions
• · in case of immediate or delayed augmentation around implants in extraction sockets

InterCollagen® Guide is a resorbable collagen membrane, derived from porcine pericardium. InterCollagen® Guide is intended for periodontal and/or dental surgical procedures as a barrier membrane restricting the entry of rapidly proliferating non-osteogenic cells within the bone defect while allowing the ingrowth of slow-growing bone forming cells. The membrane is a bioresorbable barrier which eventually is remodeled and/or incorporated by the host tissue. InterCollagen® Guide is substantially resorbed within 15 weeks after implantation. It is adaptable and easy to handle. It can be trimmed to the desired size and conforms easily when hydrated. The product is terminally sterilized via gamma irradiation.

This FDA 510(k) summary describes the InterCollagen® Guide, a resorbable collagen membrane. The submission seeks to prove substantial equivalence to a predicate device, the Straumann Jason Membrane, rather than demonstrate strict acceptance criteria and performance against those criteria. Therefore, the response will be structured to extract relevant performance claims and the study details provided, even if they don't explicitly fit a "table of acceptance criteria" format with numerical targets.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission seeking substantial equivalence, explicit numerical "acceptance criteria" with defined thresholds are not typically presented in the same way as a de novo or PMA submission. Instead, the focus is on demonstrating similar performance to a legally marketed predicate device. The following table summarizes the key performance aspects that were evaluated and the results presented, which essentially serve as the "reported device performance" against the implicitly accepted standard of the predicate device's performance.

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

The primary "test set" for performance evaluation was the canine two-wall intrabony defect model.

• Sample Size: Not explicitly stated in terms of the number of animals or defects. The document mentions "End points for pathology, histology, histomorphology and micro-CT were taken after 2, 6, and 13 weeks," implying a longitudinal study.
• Data Provenance: Conducted as an animal study (canine model). The country of origin is not specified in the provided text. The study design was a comparison between the test article (InterCollagen® Guide), a predicate device (Jason membrane), and an empty control. This is a prospective study design for evaluating the device's performance post-implantation.

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

The document does not explicitly state the number or qualifications of experts used to establish ground truth for the animal study. Histology, histomorphology, and pathology evaluations are typically conducted by trained veterinary pathologists or researchers specialized in bone regeneration, but specific details are not provided.

4. Adjudication method for the test set

The document does not specify any adjudication method for establishing ground truth in the animal study. Evaluations of pathology, histology, histomorphology, and micro-CT are usually performed by experts, but whether independent reviews or consensus methods were used is not mentioned.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a resorbable collagen membrane for guided bone and tissue regeneration, not an AI-assisted diagnostic or interpretative tool. Therefore, the concept of "human readers improve with AI" is not applicable here.

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

A standalone performance study of an algorithm was not performed. This is a medical device (collagen membrane), not a software or AI/ML algorithm.

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

For the animal study:

• Pathology: Evaluation of pathological changes in tissues.
• Histology: Microscopic examination of tissue samples.
• Histomorphology: Quantitative analysis of tissue morphology (e.g., bone formation).
• Micro-CT: Three-dimensional imaging for bone volume and structure analysis.

These are considered objective biological and imaging endpoints, typically interpreted by experts, to establish the "ground truth" regarding the device's in-vivo performance and tissue response.

8. The sample size for the training set

This is not applicable. This device is a physical medical implant, not an AI/ML algorithm that requires a "training set."

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

This is not applicable as there is no training set for this type of medical device.

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