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Xenograft Bovine Bone Particulate is intended for use in dental surgery.

The products may be used in surgical procedures such as:

• Augmentation or reconstructive treatment of alveolar ridge
• Filling of periodontal defects
• Filling of defects after root resection, apicocectomy, and cystectomy
• Filling of extraction sockets to enhance preservation of the alveolar ridge
• Elevation of maxillary sinus floor
• Filling of defects in conjunction with products intended for Guided Bone Regeneration (GBR)
• Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)

The Xenograft Bovine Bone Particulate is a porous bone mineral matrix that is used in periodontal, oral, and maxillofacial surgery. It has a trabecular architecture, interconnecting macro and micro pores and consistency which allows formation and ingrowth of new bone. The particulate is available in clinically relevant sizes. The anorganic bone composition meets all requirements found in ASTM 1581-08: Standard Specification for Composition of Anorganic Bone for Surgical Implants. The device is packaged, and electron beam irradiated to meet all requirements and is non-pyrogenic. Using standard dental techniques, the dentist will loosely pack the xenograft particulate granules into the osseous defect using sterile instruments.

This document is a 510(k) premarket notification for a medical device, the "Xenograft Bovine Bone Particulate." It focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study to prove acceptance criteria for a new, novel device. Therefore, much of the requested information (like sample sizes for test/training sets, expert details for ground truth, MRMC studies, standalone performance, etc.) is not directly applicable or available in this type of submission.

However, I can extract the acceptance criteria related to the device's characteristics and the non-clinical performance testing conducted to demonstrate that the device meets its requirements and specifications, thereby supporting its substantial equivalence.

Here's a breakdown of the requested information based on the provided document:

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

The document doesn't explicitly state "acceptance criteria" in a numerical or pass/fail table for novel device performance metrics. Instead, it demonstrates that the subject device's characteristics and performance are "substantially equivalent" to a predicate device and meet recognized industry standards. The "performance" here refers to demonstrating these equivalences and adherence to standards.

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

• Test Set Sample Size: The document mentions an "in-vivo performance" study conducted in a "beagle mandibular intraoral critical size defect model." However, the specific number of beagles or defects used in this model is not specified in the provided text.
• Data Provenance: The in-vivo study appears to be an experimental animal study (beagle model) conducted for the purpose of this submission. The country of origin is not stated but typically these studies are conducted in a controlled lab environment. It is a prospective study for the purpose of demonstrating equivalence, as it was designed and executed to compare the subject device against the predicate.

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

• The ground truth for the in-vivo study was assessed by histomorphometry and histopathology. The document does not specify the number of experts (e.g., pathologists, histomorphometrists) or their qualifications.

4. Adjudication method for the test set

• The document does not specify an adjudication method for the histomorphometry and histopathology assessments. It's likely standard laboratory practice was followed, but no details are given.

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

• This device is a physical medical device (bone graft particulate), not an AI or imaging diagnostic software. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

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

• This question is not applicable as the device is not an algorithm or software.

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

• For the in-vivo performance study, the ground truth was established through histomorphometry and histopathology assessments of new bone formation, residual graft material, and tissue reaction in beagles. This is a form of pathology/histological assessment.

8. The sample size for the training set

• This question is not applicable as the device is not an AI/ML model that requires a training set. The "training" here would refer to the manufacturing and quality control processes to ensure the consistency of the particulate.

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

• This question is not applicable as the device is not an AI/ML model. The "ground truth" for manufacturing would be established through adherence to Good Manufacturing Practices (GMP) and compliance with specified material and sterility standards.

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