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KAINOS®+ is intended for use as a bone void filler for bony voids or gaps of the skeletal system (extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. KAINOS®+ is a bone filler without initial mechanical properties. Therefore rigid fixation techniques may often be recommended. When packed into a bony site, KAINOS®+ gradually resorbs and is replaced with bone during the healing process.

KAINOS®+ is a synthetic, resorbable calcium phosphate bone void filler with a trabecular structure. It is an osteoconductive material which provides a porous scaffold upon which bone formation can occur. KAINOS+ is available in granule or block-shaped forms.

This document is a 510(k) summary for a medical device called KAINOS®+, a bone void filler. It describes the device, its intended use, materials, and substantial equivalence to previously cleared devices. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a regulatory submission for premarket notification to the FDA, demonstrating substantial equivalence to existing devices rather than presenting a performance study with acceptance criteria.

Therefore, I cannot fulfill your request for the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size
6. If a standalone performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

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