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The intended use for the OSTEOSET® BVF resultant paste is to be injected, digitally packed into open bone void/gap to cure in-situ; or molded into solid pellets that are gently packed into open bone voids/gap that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities, spine, and pelvis). These open bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The paste/pellets provide a bone void filler that resorbs and is replaced with bone during the healing process.

The OSTEOSET® paste cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K-Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.

The OSTEOSET® BVF Kit is provided sterile for single use only.

OSTEOSET® BVF Kits consist of pre-measured surgical grade calcium sulfate, premeasured mixing solution, and the tools necessary to mix the components into a paste. These products are provided sterile for single patient use. When mixed according to directions, the OSTEOSET® BVF Kit produces biodegradable, radiopaque paste/molded pellets that resorb in approximately 30-60 days, when used according to labeling.

After the powder is hydrated using all of the mixing solution supplied in each kit, the resultant paste can be injected, digitally packed into the bone void to cure in-situ; or molded into solid implants that are gently packed into non-load bearing voids or gaps of the skeletal system (i.e., the extremities, spine, and pelvis). These bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The implants provide a bone void filler that resorbs and is replaced with bone during the healing process.

The paste/beads are used to fill bone voids and may be used at an infected site.

Here's a breakdown of the acceptance criteria and study information for the OSTEOSET® BVF Kit, based on the provided text:

Important Note: The provided document is a 510(k) summary for a bone void filler. These types of submissions primarily demonstrate "substantial equivalence" to a predicate device rather than presenting detailed clinical trial data with acceptance criteria for a novel AI/software medical device. Therefore, many of the requested elements (like AI-specific metrics, expert adjudication, MRMC studies, training set details) are not applicable to this type of submission for a physical medical device. I will address the relevant sections and note where information is not available due to the nature of the submission.

Acceptance Criteria and Device Performance Study for OSTEOSET® BVF Kit

This 510(k) submission establishes substantial equivalence of the OSTEOSET® BVF Kit to a previously marketed predicate device, the Wright Plaster of Paris Bone Void Filler. The "acceptance criteria" in this context are primarily related to material composition, intended use, and design features demonstrating functional similarity and safety, rather than performance metrics against a specific threshold typically seen in diagnostic device studies.

1. Table of Acceptance Criteria and Reported Device Performance

• Filling surgically created osseous defects or those from traumatic injury.
• Resorption and replacement with bone during healing.
• Temporary support media to augment provisional hardware (e.g., K-Wires) during surgical procedure (not structural support during healing).
• Use at infected sites (added claim). | Substantially equivalent to the predicate device's intended use, with expanded claims supported by the substantial equivalence information, materials data, and testing results provided within the Premarket Notification. The device provides a bone void filler that resorbs and is replaced with bone. The paste provides an open void/gap filler that can augment provisional hardware. The paste/beads can be used to fill bone voids and at an infected site. |
  | Design Features | - Provided sterile for single use.
• Pre-measured surgical grade calcium sulfate, pre-measured mixing solution, and mixing tools.
• Produces biodegradable, radiopaque paste/molded pellets. | Substantially equivalent to the predicate device.
  Resorbs in approximately 30-60 days when used according to labeling.
  Radiopaque. |
  | Resorption Time (Explicit) | To resorb in a specific timeframe. | Resorbs in approximately 30-60 days. |

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

• Not Applicable (N/A) in the context of an AI/software device. This is a physical medical device. The submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than a test set in the conventional sense for AI performance evaluation. The "data" primarily refers to material specifications, existing regulatory approvals for similar materials, and potentially previous testing on the predicate device.
• The document implies that the safety and effectiveness are supported by "substantial equivalence information, materials data, and testing results provided within this Premarket Notification," but does not explicitly detail a specific "test set" or its provenance for a study designed to meet numerical acceptance criteria for device performance in the AI sense.

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

• N/A. This is a physical medical device submission, not an AI/software device requiring expert-established ground truth for a diagnostic performance test set. The "ground truth" for chemical composition would be established by analytical testing against USP/NF standards, and clinical outcomes for the predicate device would be based on historical data or general medical understanding.

4. Adjudication method for the test set

• N/A. Not relevant for this type of device submission.

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 void filler, not an AI-assisted diagnostic tool.

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

• N/A. This device is a bone void filler, not an algorithm.

7. The type of ground truth used

• The "ground truth" for the claims in this submission is primarily based on:
  • Chemical/Material Standards: Conformance to USP/NF Standards for calcium sulfate and calcium stearate, and sterile NaCl (saline).
  • Predicate Device Performance: Historical performance and regulatory acceptance of the "Wright Plaster of Paris Bone Void Filler" are the primary "ground truth" for establishing substantial equivalence in terms of intended use, safety, and general efficacy.
  • Biocompatibility/Resorption: Implicitly, the understanding of calcium sulfate's biocompatibility and resorption properties in bone defects.

8. The sample size for the training set

• N/A. This is a physical medical device and does not involve AI model training sets.

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

• N/A. Not applicable, as there is no AI training set for this device.

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