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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.

AI/ML Overview

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.

Aspect of Performance	Acceptance Criteria	Reported Device Performance
Physicochemical Properties	To be comparable to predicate devices and acceptable for intended use. Specific tests include Ca/P ratio, residue on ignition, heavy metal content, and pH.	Bench testing performed to evaluate Ca/P ratio, residue on ignition, heavy metal, and pH, demonstrating properties consistent with satisfactory performance and substantial equivalence to predicate devices (though specific values aren't provided, the conclusion is drawn).
Compressive Strength	To be appropriate for handling and stability in the intended application (block form).	Bench testing included compressive strength, indicating the device possesses adequate mechanical properties for its intended use, comparable to predicate devices.
Biocompatibility	To meet ISO 10993-1 standards for medical devices in contact with tissue. Specific tests: Cytotoxicity (ISO 10993-5), Irritation (ISO 10093-10), Sensitization (ISO 10993-10), Genotoxicity (ISO 10993-3), Acute toxicity (ISO 10993-11), Subchronic toxicity (ISO 10993-11), Implantation (ISO 10993-6), Pyrogenicity (ISO 10993-11).	Biocompatibility evaluated per ISO 10993-1, covering all listed tests (Cytotoxicity, Irritation, Sensitization, Genotoxicity, Acute toxicity, Subchronic toxicity, Implantation, Pyrogenicity). Results demonstrated the device to be biocompatible, confirming it meets safety standards.
Pyrogenicity	To be non-pyrogenic. Specific tests: Material-mediated pyrogenicity (ISO 10993-11) and endotoxin testing (LAL, USP ).	Material-mediated pyrogenicity testing (ISO 10993-11) and endotoxin testing (LAL, USP ) were performed, demonstrating the device is non-pyrogenic.
Sterilization	To achieve a Sterility Assurance Level (SAL) of 10^-6 for terminally sterilized medical devices.	Sterilization process validation performed according to ISO 11137 demonstrated an SAL of 10^-6, confirming the device is sterile.
Shelf-Life Stability	To demonstrate product stability and packaging integrity over its intended shelf life.	Real-time aging shelf-life study performed in accordance with ISO 11607, demonstrating product stability and packaging integrity.
Control of Animal Origin Materials	To ensure safety regarding animal-derived components. Specific tests: Controls on sourcing, collection, and handling (ISO 22442-2); Viral Inactivation (ISO 22442-3).	Controls on sourcing, collection, and handling performed per ISO 22442-2, and Viral Inactivation performed per ISO 22442-3. These validations ensure the safety of the porcine-derived materials.
In-Vivo Performance	To demonstrate substantial equivalence to the primary predicate device (Bio-Oss® Collagen) in promoting bone regeneration and integration when implanted in bone defects, specifically in a mandibular intraoral model. Assessment through histology, histomorphometry, and Micro-CT analyses at various time points.	An in-vivo study comparing "THE Graft Collagen" to Bio-Oss® Collagen (primary predicate) and a negative control in a beagle mandibular intraoral model. Histology, histomorphometry, and Micro-CT analyses conducted at 4, 8, 12, 16, and 24 weeks. Results demonstrated that the performance of the subject device and the primary predicate device was substantially equivalent.
Indications for Use Alignment	The proposed indication for use (filling of extraction sockets to enhance preservation of the alveolar ridge) should be a subset of or equivalent to the predicate device's indications, proving similar technological characteristics for the specified use.	The indication for use of the subject device is "Filling of extraction sockets to enhance preservation of the alveolar ridge," which is a subset of the primary predicate device's broader indications for bone augmentation and reconstructive treatment. This similarity supports substantial equivalence for the specified indication.
Technological Characteristics	The device's material composition, form, color, size range (in context of trimmability), biocompatibility, sterilization method, sterility level, pyrogenicity, and use (prescription, single-use) should be equivalent to or demonstrate comparable safety and effectiveness to the predicate devices. Differences must be justified as not raising new questions of safety or effectiveness.	The subject device shares essential technological characteristics (e.g., product code, basic function as a scaffold, biocompatibility, gamma irradiation sterilization, SAL 10^-6, non-pyrogenic, prescription use, single use only) with the predicate devices. Differences in size range, specific proportions of bone mineral/collagen, and animal origin of bone mineral were deemed not to affect intended use or raise new safety/effectiveness concerns, due to the device's trimmability, comparable functionality of components, and robust validation of material safety (biocompatibility, viral inactivation).

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:

Bench Testing: Performed on the device itself to evaluate physicochemical properties (Ca/P ratio, residue on ignition, heavy metal, pH, compressive strength).
Biocompatibility Testing: Conducted in accordance with ISO 10993-1, including various in vitro and in vivo tests.
Sterilization Validation: Performed according to ISO 11137.
Shelf-Life Study: A real-time aging study in accordance with ISO 11607.
Control of Animal Origin Materials Validation: Performed according to ISO 22442-2 and ISO 22442-3.
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:

A table of acceptance criteria and the reported device performance: Provided above.
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.
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.
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.
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.
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.
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.
The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.
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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