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THE Graft Collagen is recommended for:

• Filling of extraction sockets to enhance preservation of the alveolar ridge.

THE Graft Collagen, composed of porcine derived bone mineral matrix from cancellous bone and Type I Collagen from porcine tendon. The bone mineral matrix is similar to physical and chemical aspects of the mineralized matrix of human bone. Hydrated collagen components have viscosity that facilitates for blending of the bone mineral matrix. With this characterization, it can be trimmed and/or molded to the various shapes of defects. THE Graft Collagen is sterilized using gamma irradiation and recommended for the patient who needs filling of bone defects and bone augmentation.
THE Graft Collagen is available in various sizes.
Block (Height x Length x Width)
3 x 5 x 7 mm, 5 x 5 x 5 mm, 5 x 5x 10 mm, 7 x 7x 7 mm
THE Graft Collagen contains 85% The Graft Bone Substitute (K173188) granules and 15% porcine collagen in a block form. The Graft Bone Substitute (K173188) is a porous bone mineral matrix available in cancellous granules made of porcine bone. Granules serve as a scaffold for new bone, and collagen holds the granules not to break away from the implanted site and facilitates handling.

Description of the Device

The device, "THE Graft Collagen," is a bone grafting material composed of a porcine-derived bone mineral matrix from cancellous bone and Type I Collagen from porcine tendon. It is designed to be trimmed and molded to fit various defect shapes and comes in block form in different sizes (e.g., 3 x 5 x 7 mm, 5 x 5 x 5 mm, 5 x 5 x 10 mm, 7 x 7 x 7 mm). It contains 85% The Graft Bone Substitute (K173188) granules and 15% porcine collagen. The granules act as a scaffold for new bone, while the collagen helps hold the granules together and facilitates handling. The device is sterilized using gamma irradiation.

Indications for Use

THE Graft Collagen is recommended for:

• Filling of extraction sockets to enhance preservation of the alveolar ridge.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for "THE Graft Collagen" are based on demonstrating substantial equivalence to its predicate devices, K122894 Bio-Oss® Collagen (primary predicate) and K173188 The Graft Bone Substitute (reference predicate), through non-clinical performance testing. The reported device performance aligns with these criteria, confirming substantial equivalence.

Study Details

Due to the nature of this submission being a 510(k) premarket notification for a Class II medical device (Bone Grafting Material) that primarily relies on demonstrating substantial equivalence to predicate devices, the detailed information typically found in clinical trials for AI/software devices (e.g., explicit test set sample sizes, data provenance for clinical images, number/qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, or large-scale training set details) is not applicable or not provided in the document.

The "study" that proves the device meets acceptance criteria consists of:

1. Bench Testing: Performed on the device itself to evaluate physicochemical properties (Ca/P ratio, residue on ignition, heavy metal, pH, compressive strength).
2. Biocompatibility Testing: Conducted in accordance with ISO 10993-1, including various in vitro and in vivo tests.
3. Sterilization Validation: Performed according to ISO 11137.
4. Shelf-Life Study: A real-time aging study in accordance with ISO 11607.
5. Control of Animal Origin Materials Validation: Performed according to ISO 22442-2 and ISO 22442-3.
6. Comparative In-Vivo Study: An animal study comparing the performance of the subject device to the primary predicate device in a beagle mandibular intraoral model.

Here's the breakdown of the specific points requested, based on the provided document:

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

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

   • In-Vivo Study (Beagle Mandibular Intraoral Model): The specific number of animals (beagles) used in the study is not explicitly stated, nor is the country of origin of the study. It is an animal implant study used for performance comparison.
   • Bench, Biocompatibility, Sterilization, Shelf-Life, Animal Origin Control tests: Sample sizes for these tests are not provided in this summary but would be standard for material and safety testing of medical devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this type of device and study. The ground truth in the animal study would be based on scientific and pathological assessments (histology, histomorphometry, Micro-CT) performed by qualified scientific personnel (e.g., veterinarians, pathologists, histotechnicians), but their specific number and qualifications are not detailed in this 510(k) summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for the type of animal study and material testing conducted. Data analysis would involve measurements and interpretations by individual experts or teams, rather than a consensus-based adjudication process for diagnostic labeling.

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 a bone grafting material, not an AI/software device involving human readers or interpretation of diagnostic images.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used:

   • In-Vivo Study: The "ground truth" was established through histology, histomorphometry, and Micro-CT analyses in a beagle mandibular intraoral model, assessing new bone formation, integration, and other tissue responses. This combines pathological assessment with quantitative imaging analysis.
   • Other tests: Ground truth for bench performance, biocompatibility, sterilization, and shelf-life is based on established scientific and regulatory standards (e.g., ISO, USP) and laboratory measurements.

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, as there is no training set for this 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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OpenTex is a temporarily implantable material (non-resorbable) for as a space-making barrier in the treatment of periodontal defects.

OpenTex is a non-resorbable PTFE membrane composed of proprietary 100% polytetrafluoroethylene (PTFE) sheet with inert biological features and predictable barrier effect. OpenTex is designed to function as a physical barrier to avoid gingival cell invasion, thus providing a favorable environment for neovascularization and bone derived cells to repopulate and repair the defect. Since space-making is critical to this procedure, the membrane is sufficiently stiff to prevent spontaneous collapse but supple enough to conform easily to tissue contours. OpenTex is supplied sterile and intended for single use only. It is available in various sizes.

This is a 510(k) summary for a medical device called OpenTex, a non-resorbable PTFE membrane for guided tissue regeneration in periodontal defects. The information provided is for regulatory clearance and does not involve AI or algorithms with human-in-the-loop performance. Therefore, many of the requested fields are not applicable.

Here's an analysis of the provided text based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

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THE Graft Bone Substitute is intended for use as a bone grafting material in dental surgery such as:

• Filling of extraction sockets to enhance preservation of the alveolar ridge
• Elevation of maxillary sinus floor

THE Graft Bone Substitute is a resorbable bone graft material made of porcine cancellous bone consisting of Hydroxyapatite(HA).

THE Graft Bone Substitute is a natural and porous bone mineral matrix available in cancellous granules packaged in vial or syringe. It is produced by removal of all organic components from porcine bone. The composition of THE Graft Bone Substitute meets the requirements of ASTM F1581 Standard Specification for Composition of Anorganic Bone for Surgical Implants. Due to its natural structure of macro and microscopic structures, the anorganic bone mineral of THE Graft Bone Substitute is physically and chemically comparable to the mineralized matrix of human bone. When packed into a bony site, THE Graft Bone Substitute is gradually resorbed and replaced with new bone during the healing process. The formation and ingrowth of new bone at the implantation site of THE Graft Bone Substitute is favored due to its trabecular architecture, interconnecting macro and micro pores and its natural consistency.

THE Graft Bone Substitute is supplied sterile, non-pyrogenic, and for single use only.

THE Graft Bone Substitute is not intended to be marketed or sold with multiple components and/or accessories.

This document (K191737) is a 510(k) summary for a medical device called "The Graft Bone Substitute." It is for a bone grafting material used in dental surgery. The document is primarily focused on demonstrating substantial equivalence to a predicate device, not on presenting a clinical study that proves the device meets specific performance acceptance criteria for a diagnostic AI/ML device.

Therefore, most of the requested information regarding acceptance criteria and a study proving device performance (especially for AI/ML aspects like accuracy, sample sizes, expert ground truth, MRMC studies, etc.) is not applicable and not present in this document.

Here's why and what information can be extracted:

• This is a bone graft material, not a diagnostic AI/ML device. The questions are framed around AI/ML device validation (e.g., "effect size of how much human readers improve with AI vs without AI assistance," "standalone algorithm only without human-in-the-loop performance"). This document is about a physical material used in surgery.
• The focus is on "substantial equivalence" to a predicate device. The main purpose of this 510(k) is to show that the new device (with a changed syringe package material) is as safe and effective as a previously cleared device. This is done through non-clinical testing (physical, mechanical, biocompatibility) rather than clinical performance studies comparing it to a "ground truth" to establish diagnostic accuracy.

However, to address the prompt as best as possible given the provided document's content:

The document describes non-clinical testing criteria and their successful completion, which serve as "acceptance criteria" for establishing substantial equivalence for this type of medical device.

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

Since this isn't a diagnostic AI/ML device, the performance isn't measured in terms of metrics like sensitivity, specificity, or AUC. Instead, the "performance" refers to meeting established standards for bone graft materials and biological safety.

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

• Sample Size: Not applicable in the context of human patients or image datasets for AI/ML. The "sample size" here would refer to the number of batches/units of the physical bone graft material tested in the labs. This information is not detailed in the document, nor is it typically provided in a 510(k) summary for material testing.
• Data Provenance: Not applicable in the geopolitical sense (country of origin of data). These are laboratory tests on manufactured materials. The manufacturer is "Purgo Biologics Inc." located in "Seongnam-si, Gyeonggi-do Republic of Korea." The tests are non-clinical, so "retrospective or prospective" does not apply in the typical clinical study sense.

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

• Not Applicable. No human "experts" are establishing ground truth for diagnostic decisions here, as it's a material. Ground truth is based on established laboratory testing standards (ASTM, ISO, USP) and analytical methods performed by qualified laboratory personnel.

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

• Not Applicable. This is not a human reader study. Laboratory tests follow predefined protocols and pass/fail criteria.

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/ML device that assists human readers.

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

• Not Applicable. This is not an algorithm.

7. The type of ground truth used:

• For Mechanical and Physical Testing: Ground truth is defined by the ASTM F1581 Standard Specification for Composition of Anorganic Bone for Surgical Implants and FDA's Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.
• For Biocompatibility Testing: Ground truth is defined by International Standard ISO 10993-1 and its sub-parts (e.g., ISO 10993-5, 10993-10, 10993-11) and USP standards (Pharmacopeia). These standards specify the methods and acceptable limits for biological responses.

8. The sample size for the training set:

• Not Applicable. This device does not use an AI/ML model that requires a training set.

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

• Not Applicable. No training set is involved.

In summary, this document is a 510(k) summary for a traditional medical device (bone graft material) seeking clearance based on substantial equivalence, not an AI/ML diagnostic device with performance claims needing clinical study validation against human performance or ground truth.

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Biotex Non-Absorbable PTFE Suture is indicated for use in dental soft tissue approximation and/or ligation. The device is not indicated for use in cardiovascular, ophthalmic surgery, microsurgery or peripheral neural tissue. Biotex is provided sterile as a single use device and the duration of use or contact with the body is less than 30 days.

Biotex Non-Absorbable PTFE Suture is comprised of a single-arm, non-absorbable monofilament suture and the stainless-steel surgical needle connected to the suture. It is composed of 100% high-density PTFE provided uncoated, undyed and sterile for one-time use only.

The Biotex Non-Absorbable PTFE Suture was evaluated for substantial equivalence to a predicate device through mechanical, physical, and biocompatibility testing.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The document does not specify the exact sample sizes used for each test. The studies were performed in accordance with FDA's Class II Special Controls Guidance Document for Surgical Sutures and ISO 10993-1. These are likely prospective evaluations conducted in a laboratory setting, with data provenance typically from the device manufacturer's testing facilities.

3. Number of Experts and Qualifications

Not applicable. This is a medical device for approximation and/or ligation of dental soft tissue, not an AI/CADe device. The ground truth for this device is based on standardized physical, mechanical, and biological testing, not expert interpretation of medical images.

4. Adjudication Method

Not applicable. This is a medical device for approximation and/or ligation of dental soft tissue, not an AI/CADe device. The assessment relies on objective measurements against established standards.

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

Not applicable. This is a medical device for approximation and/or ligation of dental soft tissue, not an AI/CADe system.

6. Standalone Performance Study

Yes, standalone (algorithm only) performance was done. The performance of the Biotex Non-Absorbable PTFE Suture was assessed independently against established standards such as the USP monograph for non-absorbable sutures and ISO 10993-1 for biocompatibility.

7. Type of Ground Truth Used

The ground truth used for performance evaluation was based on:

• Established Standards: USP monograph for non-absorbable surgical sutures (for mechanical and physical properties).
• International Standards: ISO 10993-1 "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing Within a Risk Management Process" (for biocompatibility).
• Internal Specifications: Derived from the above standards, for tests like pyrogenicity, EO residuals, and shelf-life.

8. Sample Size for the Training Set

Not applicable. This is a medical device, not an AI/CADe system that requires a "training set." Performance is evaluated against pre-defined, objective criteria.

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

Not applicable, as there is no "training set" for physical medical devices of this nature. The ground truth for the performance evaluation relies on established scientific and regulatory standards.

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THE Graft Bone Substitute is intended for use as a bone grafting material in dental surgery such as:

• Filling of extraction sockets to enhance preservation of the alveolar ridge
• Elevation of maxillary sinus floor

THE Graft Bone Substitute is a resorbable bone graft material made of porcine cancellous bone consisting of Hydroxyapatite(HA). THE Graft Bone Substitute is a natural and porous bone mineral matrix available in cancellous granules packaged in a vial or syringe. It is manufactured by removal of most organic components from porcine bone. The composition of THE Graft Bone Substitute meets the requirements of ASTM F1581 Standard Specification for Composition of Anorqanic Bone for Surgical Implants. Due to its natural structure of macro and microscopic structures, the anorqanic bone mineral of THE Graft Bone Substitute is physically and chemically comparable to the mineralized matrix of human bone. When packed into a bony site, THE Graft Bone Substitute is gradually resorbed and replaced with new bone during the healing process. The formation and ingrowth of new bone at the implantation site of THE Graft Bone Substitute is due to its trabecular architecture, interconnecting macro and micro pores and its natural consistency. THE Graft Bone Substitute is supplied sterile, non-pyrogenic, and for single use only.

The provided document is a 510(k) summary for "THE Graft Bone Substitute". It focuses on demonstrating substantial equivalence to a predicate device rather than providing specific acceptance criteria and detailed study results for standalone performance.

Therefore, much of the requested information, such as sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, specific effect sizes, training set size, and detailed ground truth establishment for the training set, is not available within this document. This document is a summary of regulatory submission, not a scientific publication detailing performance studies.

However, based on the information available, here's what can be extracted:

Acceptance Criteria and Reported Device Performance

The document states, "All of the acceptance criteria were met" for the performance data. While the specific numerical acceptance criteria for each test are not explicitly detailed, the studies conducted and their purpose are mentioned. The general acceptance criterion is compliance with the referenced standards and guidance documents.

Study Details

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

• Not explicitly stated in the provided document. The document mentions "in-vivo dog model" and "Clinical data" were provided but does not specify the number of animals or human subjects, nor their geographical origin.

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

• Not applicable / Not explicitly stated. For mechanical, physical, biocompatibility, and sterilization tests, the "ground truth" is typically defined by adherence to established international standards (e.g., ASTM F1581, ISO 10993, ISO 11137). For the in-vivo and clinical evaluations, the ground truth would be determined by the study's endpoints (e.g., bone formation, material resorption) assessed by qualified personnel, but the number and qualifications of experts involved in this assessment are not provided.

3. Adjudication method for the test set:

• Not applicable / Not explicitly stated. This type of adjudication (e.g., 2+1) is typically relevant for studies involving subjective human interpretation of data (e.g., imaging reads). The performance data cited are primarily objective laboratory and animal/clinical study results.

4. 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 bone substitute material, not an AI-powered diagnostic or assistive technology. Therefore, MRMC studies and AI assistance are not relevant to its evaluation.

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

• Not applicable. This is a medical device (bone substitute), not an algorithm or software. Its "standalone performance" refers to its inherent physical, chemical, and biological properties, which were assessed through the listed performance tests (mechanical, physical, biocompatibility, sterilization, viral inactivation) and in-vivo/clinical evaluations.

6. The type of ground truth used:

• For Mechanical and Physical testing: Compliance with ASTM F1581 Standard Specification.
• For Biocompatibility testing: Compliance with ISO 10993 series of standards.
• For Sterilization: Compliance with ISO 11137-1 and ISO 11137-2.
• For Viral Inactivation: Successful inactivation of viruses, which would be measured against specific validated viral assays.
• For In-vivo dog model and Clinical data: Likely pathology (histological assessment of bone formation and material resorption) and potentially outcomes data (e.g., successful integration, absence of adverse events). The specific endpoints are not detailed.

7. The sample size for the training set:

• Not applicable. There is no "training set" as this is a physical medical device and not a machine learning model.

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

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

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