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Mg OSTEOREVIVE™ is intended for bony voids or defects of the extremities, posterolateral spine, and pelvis that are not intrinsic to the stability of the bony structure. These osseous defects may be the result of benign bone cysts and tumors (in adults), may be surgically created osseous defects created by traumatic injury to the bone.

Mg OSTEOREVIVE™ can be used as an adjunct to conventional rigid hardware fixation by supporting the bone fragments during the surgical procedure only in the extremities and pelvis.

Once the material has set, it acts as a temporary support medium and is not intended to provide structural support during the healing process.

Mg OSTEOREVIVE™ is intended to be placed into bony voids either before or after final fixation.

Mg OSTEOREVIVE™ is resorbed and replaced with bone during the healing process.

Mg OSTEOREVIVE™ must be used with morselized autograft bone in the posterolateral spine. When used in intervertebral body fusion procedures Mg OSTEOREVIVE™ must be used with morselized autograft and/or allograft bone with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

Mg OSTEOREVIVE™ is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously.

Mg OSTEOCRETE™ is intended for bony voids or defects of the extremities, posterolateral spine, intervertebral disc space, and pelvis that are not intrinsic to the stability of the bony structure. These osseous defects may be the result of benign bone cysts and tumors (in adults), may be surgically created osseous defects created by traumatic injury to the bone.

Mg OSTEOCRETE™ can be used as an adjunct to conventional rigid hardware fixation by supporting the bone fragments during the surgical procedure only in the extremities and pelvis.

Once the material has set, it acts as a temporary support medium and is not intended to provide structural support during the healing process.

Mg OSTEOCRETE™ is intended to be placed into bony voids either before or after final fixation.

Mg OSTEOCRETE™ is resorbed and replaced with bone during the healing process.

Mg OSTEOCRETE™ must be used with morselized autograft bone in the posterolateral spine.

When used in intervertebral body fusion procedures Mg OSTEOCRETE™ must be used with morselized autograft and or allograft bone with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

Mg OSTEOCRETE™ is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously.

The subject devices are a magnesium-based synthetic bone void filler that is moldable, drillable, resorbable, adhesive, radiopaque, and osteoconductive. The subject devices consist of a powder component (magnesium-based compound) and a mixing solution (buffered saline). Once the components are mixed intra-operatively prior to implantation, an acid-base reaction occurs to form a cohesive paste. Once the product is placed into the bony void, the paste will adhere to the adjacent bone during the curing process. The devices are provided sterile to the end user for single-use only in various sizes from 3 cc to 15 cc.

The provided text is a 510(k) Premarket Notification from the FDA regarding two bone void filler devices, Mg OSTEOREVIVE™ and Mg OSTEOCRETE™. This document primarily outlines the administrative information, device classification, indications for use, and a comparison to predicate devices to demonstrate substantial equivalence. It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device.

The document states: "No clinical data were included in this submission." and focuses on non-clinical testing data leveraged from a previous submission (K234013) to demonstrate substantial equivalence, including chemical composition, physical properties, sterilization, shelf life, and biocompatibility.

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

• A table of acceptance criteria and reported device performance (for AI/ML performance).
• Sample sizes used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method for the test set.
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
• Information on standalone (algorithm-only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• Sample size for the training set.
• How the ground truth for the training set was established.

This document pertains to the clearance of a medical device (bone void fillers) based on demonstrating substantial equivalence to existing predicate devices through non-clinical data, not on the performance evaluation of an AI/ML component.

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