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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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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.
• quided bone regeneration in dehiscence defects.

Geistlich Bio-Gide® Compressed is indicated for:

• auqmentation 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® 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 14mm x 24mm, respectively. With the exception of the size and shape, Geistlich Bio-Gide® Shape is the same as its predicate device, Geistlich Bio-Gide® Perio (K112575).

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. With the exception of the size and a minor difference during manufacturing to mark the dense surface of the membrane, which should face the soft tissue, Geistlich Bio-Gide® Compressed is the same as its predicate device, Geistlich Bio-Gide® Perio.

The provided text describes Geistlich Bio-Gide® Shape and Geistlich Bio-Gide® Compressed, which are collagen membranes used as bone grafting materials. The 510(k) submission argues for their substantial equivalence to predicate devices, rather than establishing acceptance criteria for a new device's performance metrics. As such, explicit acceptance criteria with numerical targets and a study designed to prove the device meets those new acceptance criteria (as would be typical for novel devices with distinct performance claims) are not presented in this document.

Instead, the documentation focuses on demonstrating that the new devices are substantially equivalent to existing legally marketed predicate devices by showing they have:

• The same intended use.
• Similar technological characteristics.
• Similar performance and safety profiles.

The "studies" described are primarily to support this claim of substantial equivalence by showing that material properties, biocompatibility, and clinical outcomes are consistent with the predicate and reference devices.

Therefore, for this specific submission:

1. Table of Acceptance Criteria and Reported Device Performance:

Since the submission is for substantial equivalence, formal acceptance criteria in the traditional sense of a new performance threshold are not explicitly stated for Geistlich Bio-Gide® Shape or Geistlich Bio-Gide® Compressed. Instead, the "acceptance criteria" are implied to be "demonstrates substantial equivalence to the predicate device" based on the following characteristics and their performance relative to the predicate:

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

• Geistlich Bio-Gide® Shape & Compressed (for testing against predicate):
  • Test Set Sample Size: Not applicable in the context of a new efficacy study. The "test set" here refers to the actual manufactured devices (Geistlich Bio-Gide® Shape and Compressed) subjected to physical/chemical, sterility, biocompatibility, and usability testing to confirm they meet specifications and are comparable to the predicate. The exact number of units tested for each characteristic is not specified.
  • Data Provenance: The manufacturing and testing data are from Geistlich Pharma AG, Switzerland. This is directly related to the newly submitted devices.
• Clinical Data (from reference devices):
  • An animal study related to Geistlich Bio-Gide® (K960724).
  • A clinical study of 75 patients examining Geistlich Bio-Gide® as a barrier membrane for guided bone regeneration in simultaneous implant placement.
  • Another clinical study involving 15 patients and 16 Geistlich Bio-Gide membranes for defect filling.
  • Several clinical studies on Geistlich Bio-Gide® for guided tissue regeneration procedures in periodontal defects:
    • Recession defects: 20 patients (pairs of defects).
    • Furcation defects: 52 grade II mandibular molar furcation defects; 21 patients with 31 furcation defects.
    • Intrabony defects: 22 paired intrabony defects; 28 patients (each with one intrabony defect); 124 patients (each with at least one intrabony defect); two studies with 4 intrabony defects each.
  • Data Provenance for Clinical Studies: The specific countries of origin for these clinical studies are not provided in the document. They are generally referenced as "clinical testing data from the K960724 and K042197 reference devices," implying these studies were conducted prior to this submission and are being cited to support the equivalence claim. The studies appear to be prospective clinical trials assessing the performance of the reference device.

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

• Not directly applicable. "Ground truth" in this context would typically refer to a definitive diagnosis or outcome for a diagnostic device. For these devices (bone grafting materials), the assessment criteria are objective (e.g., meeting chemical specifications, biocompatibility, histological evaluation in animal models, and clinical outcomes reported in existing literature).
• The clinical studies referenced would have involved clinicians (dentists, periodontists) who assessed the outcomes and established the "truth" for those studies. However, the exact number and qualifications of these experts are not provided in this summary.

4. Adjudication Method for the Test Set:

• Not applicable as this is not a diagnostic device requiring human adjudication in the described testing. Assessment involves laboratory tests, biocompatibility assays, and clinical outcomes from human studies, not consensus of human readers on images or test results.

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

• No, a MRMC comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging devices where human readers interpret medical images with and without AI assistance to measure improvements in diagnostic accuracy or efficiency.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):

• Not applicable. These devices are physical materials (collagen membranes) for bone grafting, not algorithms or software. Their performance is assessed through material properties, biocompatibility, and clinical outcomes, not as a standalone algorithm.

7. Type of Ground Truth Used:

• For material and biocompatibility testing: Laboratory Assay Results, Chemical Specifications, Histological Evaluation (animal study).
• For clinical studies (referenced for Geistlich Bio-Gide® family): Clinical Outcomes (e.g., gain of root coverage, decrease of recess depth, pocket reduction, gain in clinical attachment level (CAL), vertical/horizontal defect fill, radiographic appearance, and histological evaluation in some cases), and Safety Data (adverse events). These are objective clinical measurements and observations.

8. Sample Size for the Training Set:

• Not applicable. These are physical medical devices, not AI/ML algorithms that require training sets. The "training" for these devices would be the extensive research and development and prior clinical experience with similar collagen membranes.

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

• Not applicable, as this is not an AI/ML device that uses a training set.

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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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The Collagen Bone Healing Protective Sheet is intended to maintain the relative position of weak bony tissue such as bone grafts, bone graft substitutes, or bone fragments from comminuted fractures. The Collagen Bone Healing Protective Sheet is also indicated for cement restriction in total joint arthroplasty procedures.

Only when used in conjunction with traditional rigid fixation, the Collagen Bone Healing Protective Sheet is intended to maintain the relative position of weak bony tissue in trauma and reconstructive orthopedic procedures involving:

• Long bones .
• Flat bones t
• Short bones
• Irreqular bones .
• Appendicular skeleton
• Thorax .

When used alone (without traditional rigid fixation), the Collagen Bone Healing Protective Sheet is intended to maintain the relative position of bone graft substitutes in reconstructive orthopedic procedures involving:

• Tumor resections where bone strength has not been compromised .
• . lliac crest harvests

This device is not intended for use in the spine. The device is not intended for load bearing indications unless used in conjunction with traditional rigid fixation.

The Collagen Bone Healing Protective Sheet is a white, nonfriable, conformable, resorbable, membrane matrix engineered from highly purified type I collagen derived from bovine Achilles tendon. The Collagen Bone Healing Protective Sheet can be cut with scissors to the desired shape and size. The Collagen Bone Healing Protective Sheet is fully conformable when hydrated and can conform three dimensionally to most any anatomical orientation. The Collagen Bone Healing Protective Sheet can be rolled into a tube or used as a flat sheet. The Collagen Bone Healing Protective Sheet can be used cither alone or in conjunction with internal bonc fixation devices such as plates and screws, which also can scrve to further stabilize the anatomical region.

The Collagen Bone Healing Protective Sheet is provided in sheets of 20 x 20 mm to 120 x 120 mm and will be provided in other sizes as needed for particular surgical procedures. The thickness of the Collagen Bone Healing Protective Shect ranges from 0.5 mm to 2.0 mm according to the orthopedic region to be treated. The Collagen Bone Healing Protective Sheet consists of micropores

The provided document is a 510(k) Summary for a medical device called the "Collagen Bone Healing Protective Sheet." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study data with acceptance criteria for device performance as would be seen for a novel or high-risk device.

Therefore, many of the requested elements for acceptance criteria and a study proving those criteria are not available or applicable in this document.

Here's an analysis based on the information provided:

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

• Not Applicable / Not Provided. The document does not specify quantitative acceptance criteria for device performance. Instead, it relies on demonstrating substantial equivalence to predicate devices in terms of technical characteristics (material, form, sizes, thickness, physical integrity, mechanical strength, porosity, and in vivo stability) and intended use. Performance is implicitly accepted if these characteristics are comparable and safety/biocompatibility is established.

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

• Not Provided. This document does not describe specific testing with a "test set" in the context of clinical performance evaluation (e.g., diagnostic accuracy, treatment efficacy) as would be relevant for software or more complex devices. The safety assessment mentions biocompatibility testing, but details on sample sizes or data provenance for that are not included in this summary. The "animal and clinical literature reviews" are mentioned, implying a synthesis of existing data rather than a new, dedicated study with a specific test set.

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. Given the nature of a 510(k) for a collagen sheet, there is no "ground truth" establishment in the context of diagnostic interpretation or clinical outcomes by expert consensus as might be seen for an AI diagnostic device. The evaluation is based on technical characteristics and biological response.

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

• Not Applicable / Not Provided. No adjudication method is described as there isn't a "test set" requiring expert review and adjudication in this context.

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 biomaterial (collagen sheet), not an AI-assisted diagnostic or treatment device. Therefore, an MRMC study is not relevant.

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

• Not Applicable. As above, this is a biomaterial, not an algorithm.

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

• The document refers to "animal and clinical literature reviews" providing "compelling support for the use of the Collagen Bone Healing Protective Sheet in containing bone graft material and bony fragments in bone defects." This suggests that the "ground truth" or evidence for clinical utility is derived from existing scientific literature and clinical experience with similar materials. For safety, biocompatibility testing (in accordance with FDA's Blue Book Memorandum G95-1 and ISO 10993-1) served as the primary evidence.

8. The sample size for the training set

• Not Applicable / Not Provided. There is no "training set" in the context of machine learning for this device. The development of the device would rely on material science research, preclinical testing, and potentially existing clinical data from predicate devices or similar materials.

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

• Not Applicable / Not Provided. As there is no "training set" in the ML sense, this question is not applicable. The design and intended use are based on established biomedical principles and comparison to predicate devices, not on a data-driven training process.

Summary of Relevant Information from the Document:

Device Description:
The Collagen Bone Healing Protective Sheet is a white, nonfriable, conformable, resorbable membrane matrix engineered from highly purified type I collagen derived from bovine Achilles tendon. It comes in various sizes (20x20mm to 120x120mm) and thicknesses (0.5mm to 2.0mm), with micro- and optional macropores. It is supplied sterile, non-pyrogenic, and for single use.

Intended Use:
The device is intended to:

• Maintain the relative position of weak bony tissue (bone grafts, bone graft substitutes, or bone fragments from comminuted fractures).
• Cement restriction in total joint arthroplasty procedures.

Specific uses with traditional rigid fixation:

• Trauma and reconstructive orthopedic procedures involving long bones, flat bones, short bones, irregular bones, appendicular skeleton, and thorax.

Specific uses alone (without traditional rigid fixation):

• Maintain the relative position of bone grafts or bone graft substitutes in reconstructive orthopedic procedures involving tumor resections (where bone strength is not compromised) and iliac crest harvests.

Contraindications/Limitations:

• Not intended for use in the spine.
• Not intended for load-bearing indications unless used with traditional rigid fixation.

Basis for Substantial Equivalence (and implied "acceptance"):

• Comparable Technical Characteristics: The Collagen Bone Healing Protective Sheet is stated to be comparable to predicate devices in "key aspects of the device such as material, form, sizes, thickness, physical integrity, mechanical strength, porosity and in vivo stability."
• Identical Intended Use: The indication for use is stated to be "the same as that of its predicate devices."
• Safety/Biocompatibility: Supported by testing performed in accordance with FDA's Blue Book Memorandum G95-1 and ISO 10993-1 Biological Evaluation of Medical Device.
• Literature Support: "The animal and clinical literature reviews provide compelling support for the use of the Collagen Bone Healing Protective Sheet in containing bone graft material and bony fragments in bone defects."

In conclusion, this 510(k) summary demonstrates substantial equivalence to predicate devices rather than providing a detailed study with explicit performance acceptance criteria and outcomes for a novel clinical claim.

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