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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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