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Mg OSTEOINJECT™ is intended for bony voids or defects of the extremities 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 or osseous defects created by traumatic injury to the bone.
Mg OSTEOINJECT™ 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 OSTEOINJECT™ is intended to be placed into bony voids either before or after final fixation.
Mg OSTEOINJECT™ is resorbed and replaced with bone during the healing process.
Mg OSTEOINJECT™ is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously.

Mg OSTEOREVIVE™ 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 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 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 tysts 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 OSTEOCRETETM 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 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, injectable, drillable, adhesive/cohesive, radiopaque, and osteoconductive. The subject devices comprises 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 happens 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 Medical Device 510(k) Premarket Notification from the FDA. It does not describe acceptance criteria or a study that proves the device meets those criteria. Instead, it is a notification letter and a "510(k) Summary" which highlights the device's intended use, classification, comparison to predicate devices, and performance data summary.

Specifically, the "PERFORMANCE DATA" section states: "No clinical data were included in this submission." This indicates that there was no clinical study performed to demonstrate the device meets acceptance criteria in a human clinical setting. The submission primarily relies on non-clinical testing and leveraging data from previously cleared predicate and reference devices to demonstrate substantial equivalence.

Therefore, I cannot provide the requested information from the given text because the information regarding acceptance criteria and a study to prove the device meets these criteria (especially in a clinical context with human subjects/data) is explicitly stated as not included in this submission.

The document discusses:

• Non-clinical testing data referenced from other K numbers (K212991, K071004) for aspects like chemical composition, physical properties, sterilization, shelf life, biocompatibility, drillability, and use as an adjunct to hardware fixation.
• Bacterial endotoxin testing (LAL test) meeting a specified limit, again demonstrating a non-clinical performance aspect.
• Comparison to predicate devices to establish substantial equivalence.

It does not describe:

• Acceptance criteria for clinical performance (e.g., success rates in healing, pain reduction, etc.).
• A clinical study with human subjects, patient data, ground truth establishment by experts, or MRMC studies.

Without such information in the provided text, I cannot generate the table or answer the specific questions about clinical study design and results.

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Mg OSTEOINJECT™ is intended for bony voids or defects of the extremities 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 by traumatic injury to the bone. Mg OSTEOINJECT™ 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 OSTEOINJECT™ is intended to be placed into bony voids either before or after final fixation. Mg OSTEOINJECT™ is resorbed and replaced with bone during the healing process. Mg OSTEOINJECT™ is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously.

Mg OSTEOINJECT™ is a magnesium-based synthetic bone void filler that is drillable, resorbable, radiopaque, and osteoconductive. The Mg OSTEOINJECT™ Kit contains powder (magnesium-based compound) and a mixing solution (buffered saline). Once the components are mixed intra-operatively prior to implantation, an acid-base reaction happens 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 device is provided sterile to the end user for single-use only in two sizes, 3 cc and 5 cc.

The provided text describes the 510(k) premarket notification for the Mg OSTEOINJECT™ device. This is a medical device submission, and the content primarily focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing performance against specific acceptance criteria through a clinical study or AI model evaluation.

Therefore, the information required to populate the requested table and answer the study-related questions (sample size, expert qualifications, adjudication, MRMC, standalone performance, ground truth, training set details) is not present in the provided document. The document explicitly states:

"No clinical data were included in this submission." (Page 4, under "PERFORMANCE DATA")

The performance data mentioned ("Non-clinical testing data... referenced from K212991") pertain to:

• Chemical composition
• Physical properties
• Sterilization
• Sterile barrier shelf life
• Product shelf life
• Biocompatibility
• Drillability
• LAL testing for bacterial endotoxins

These are all non-clinical tests assessing the physical characteristics, safety, and sterility of the device, and are not related to an AI model's performance on medical images or clinical outcomes.

Based on the provided text, here's what can be stated:

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

Since this is a 510(k) submission for a bone void filler and not an AI/imaging device requiring performance metrics like sensitivity/specificity, there are no "acceptance criteria" in the traditional sense of an AI model's performance on a test set. The acceptance here is based on substantial equivalence to a predicate device.

The document highlights the following characteristics that demonstrate equivalence, acting as de-facto "performance" attributes:

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

• Not applicable. No clinical test set data was included. The performance details are based on non-clinical testing and comparison to a predicate device.

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

• Not applicable. No clinical ground truth was established for this submission.

4. Adjudication method for the test set:

• Not applicable. No clinical test set was evaluated.

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 void filler, not an AI diagnostic/imaging assistance tool.

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

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• Not applicable. No clinical ground truth was established. Performance demonstration relies on non-clinical testing results and substantial equivalence to a predicate device's established safety and effectiveness.

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not an AI/machine learning product.

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

• Not applicable. There is no "training set" for this device.

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