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InterGro® Oral is a bone filling material indicated for dental intraosseous and oral/maxillofacial defects including: localized ridge augmentations, extraction sockets, cystic defects, sinus lifts, peri-implant defects, defects associated with root resection or apicoectomy, and periodontal defects.

InterGro® Oral is a resorbable, osteoconductive, and osteoinductive bone graft substitute that resorbs and is replaced with bone during the healing process. Its main component, demineralized cortical bone matrix (DBM), is derived from donor human tissue (allograft bone) and contains various growth factors including osteoinductive proteins. The DBM has been granulated, lyophilized and aseptically processed. In some versions of the product, calcium salt granules shall be incorporated to provide additional osteoconduction and enhanced structural strength. The carrier for InterGro® Oral is a resorbable, biocompatible, semi-viscous lipid. InterGro® Oral is provided ready-to-use in various physical consistencies. It is packaged in various sizes by volume for single patient use.

This document is a 510(k) Premarket Notification for the BIOMET 3i InterGro® Oral device, a bone grafting material. It is a submission to the FDA to demonstrate substantial equivalence to a predicate device. As such, it does not contain a study demonstrating the device meets acceptance criteria for reported performance. Instead, it focuses on demonstrating equivalence to an already legally marketed device based on intended use, materials, select performance properties, and handling.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, and human reader performance is not applicable to this type of regulatory submission.

Here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

This information is not provided in the document. The document states: "Performance standards applicable to DBM base products have not been published by the FDA." Instead of specific performance metrics, the submission focuses on establishing substantial equivalence to a predicate device.

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

Not applicable. This document does not describe a performance study with a test set of data in the context of device performance metrics. It's a regulatory submission for substantial equivalence.

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 document does not describe a performance study involving expert assessment of a test set to establish ground truth.

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

Not applicable. No such test set or adjudication is described in the document.

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 bone grafting material, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study with human readers and AI assistance is not relevant or included.

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

Not applicable. This device is a bone grafting material, not an algorithm.

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

Not applicable. As no performance study with a defined test set and ground truth is described, this information is not available. The "ground truth" for this submission is implicitly the established safety and effectiveness of the predicate device (GRAFTON® DBM).

8. The sample size for the training set:

Not applicable. This document describes a new medical device (a bone grafting material), not a machine learning model that would require a training set.

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

Not applicable. As there is no training set, this information is not relevant.

Summary of what the document does provide regarding "performance":

The document states that BIOMET 3i intends to have Interpore Cross International manufacture and package the device "according to the regulations and standards that are appropriate to the risk that Class II devices reasonably present."

It further mentions the use of voluntary performance standards such as:

• Materials certifications
• In-house Standard Operating Procedures (SOPs)
• FDA Guidance Documents
• AATB Standards (American Association of Tissue Banks)
• ASTM Standards (American Society for Testing and Materials)

The "study" in this context is the 510(k) Premarket Notification process itself, which aims to demonstrate substantial equivalence to a predicate device, GRAFTON® DBM (Gel, Flex, Putty, Matrix, Crunch). The conclusion drawn is: "The safety and effectiveness of InterGro® Oral is adequately supported by the substantial equivalence information, materials data, and testing results provided within this premarket notification. InterGro® Oral was found to be substantially equivalent to the predicate device based on the intended use, base materials, select performance properties, and use of a handling material."

This means that instead of proving the device meets specific numerical acceptance criteria (as one might find for a diagnostic tool's sensitivity/specificity), the "acceptance criterion" for this submission is that it is substantially equivalent to a legally marketed and safe/effective predicate device based on the factors listed above. Specific performance test results (e.g., biocompatibility testing, mechanical properties, osteoinductivity data for DBM) would have been part of the "materials data, and testing results" provided in the full 510(k) submission, even if not explicitly detailed in this summary.

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