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OsSatura™ Dental is a bone filling augmentation material for used for augmentation or reconstructive treatment of alveolar ridge. This includes, filling of defects after root resection, apicoectomy and cystectomy, filling of extraction sockets to enhance preservation of the alveolar ridge, elevation of maxillary sinus floor and treatment of periodontal defects.

OsSatura™ Dental is a synthetic, osteoconductive bone void filler, which consists of a biphasic ceramic (e.g. hydroxyapatite/tri-calcium phosphate) scaffold. The open porous structure of OsSatura™ Dental is similar in structure to human cancellous bone. OsSatura™ Dental is available as irregular shaped chips of size 200μm -2000um.

This document, a 510(k) Summary for IsoTis NV OsSatura™ Dental, relies on establishing substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a study proving those criteria are met for the device itself.

Therefore, many of the requested categories (acceptance criteria table, sample sizes, expert details, adjudication methods, MRMC study, standalone performance, training set details) are not applicable (N/A) in the context of this 510(k) submission.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• N/A. This submission is a 510(k) for substantial equivalence. It refers to "pre-clinical animal data" and "extensive bench and animal testing" but does not specify sample sizes for these tests in a way that aligns with a traditional "test set" for performance evaluation in the context of AI/software. The primary "data provenance" is the long history of safe clinical use of the material class and the predicate devices.

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

• N/A. Ground truth in the context of expert consensus is not relevant to this submission. The "ground truth" for the safety and effectiveness claims is derived from the established safety profile of the material class (calcium phosphates) and the safe use of predicate devices, as well as general biological principles verified in animal models.

4. Adjudication method for the test set:

• N/A. No formal adjudication method is mentioned as this is not a study requiring expert consensus on specific cases.

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:

• N/A. This device is a bone graft material, not an AI or diagnostic imaging device. Therefore, MRMC studies and "human readers" are irrelevant.

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

• N/A. This is a physical medical device (bone graft material), not an algorithm or software. "Standalone performance" in this context refers to the device's inherent material properties and biological performance, which were assessed through bench and animal testing.

7. The type of ground truth used:

• The "ground truth" for this submission is based on:
  • Established Material Standards: Compliance with ASTM F1185-88 and F1088-87 for hydroxyapatite and tricalcium phosphate.
  • Biological/Physiological Response: Demonstrated bone ingrowth, degradation, and resorption through pre-clinical animal data and extensive bench and animal testing.
  • Historical Clinical Data: Over 25 years of safe clinical use for calcium-based ceramic materials (hydroxyapatite and tri-calcium phosphate) and safe use of predicate devices.
  • Regulatory Guidance: Compliance with applicable FDA guidance documents on bone void fillers.

8. The sample size for the training set:

• N/A. This is not an AI/machine learning device. The concept of a "training set" is not applicable.

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

• N/A. As above, this is not an AI/machine learning device.

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