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PRO-DENSE® resultant paste is intended for use as a bone graft substitute to be injected or digitally packed into open bone voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities and pelvis) to cure in situ. These open bone voids may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), surgically created osseous defects or osseous defects created from traumatic injury to the bone. The paste provides a bone graft substitute that resorbs and is replaced with bone during the healing process.

The PRO-DENSE® 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.

PRO-DENSE® is provided sterile for single use only.

PRO-DENSE® is indicated as a bone graft substitute to be injected and/or digitally packed into open bone voids/gaps that are not intrinsic to the structural stability of the skeletal system to cure in-situ. It is supplied in separate powder and liquid vials along with the instruments for mixing it into a paste and delivering it to the defect site. The triphasic resorption of PRO-DENSE® results in a scaffold that is osteoconductive allowing tissue infiltration and must eventually be degraded through osteoclastic action as bone remodels within the scaffold. The clinical use of calcium sulfate, calcium phosphate, and composites thereof as a bone void filler has been well established through many peer reviewed publications.

This document describes the PRO-DENSE® Bone Graft Substitute. However, it is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a formal study with acceptance criteria and device performance metrics in the way a clinical trial for a new drug or a novel AI diagnostic device would.

Therefore, many of the requested categories are not applicable or cannot be extracted from this type of regulatory submission. The document relies heavily on demonstrating the technological characteristics of the device are identical to its predicate and uses a literature review to support an expanded indication.

Here's an attempt to answer your questions based on the provided text, with clear indications where information is N/A or not provided:

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

This document does not define specific acceptance criteria (e.g., a required sensitivity or specificity threshold) or report quantitative device performance metrics in the way a study for a diagnostic device would. The "performance" is demonstrated by substantial equivalence to a predicate device and a literature review supporting an expanded indication.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not applicable. No specific test set in the traditional sense was used for a direct performance comparison with acceptance criteria. The "evidence" came from a literature review.
• Data Provenance: Not applicable. The "data" consisted of published literature. The document does not specify the origin (country, etc.) or nature (retrospective/prospective) of the studies included in this literature review.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No ground truth establishment by experts for a test set is described. The literature review served as the basis for the expanded indication.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No adjudication method is mentioned as there was no test set requiring such a process.

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 graft substitute, not an AI-assisted diagnostic tool. Therefore, an MRMC study and effects on human reader performance are irrelevant.

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

Not applicable. This device is a bone graft substitute, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" or evidence supporting the device's efficacy and safety (particularly for the expanded indication) was based on a literature review discussing the clinical use of calcium sulfate, calcium phosphate, and composites thereof as bone void fillers, as well as specific literature establishing the safety and effectiveness of PRO-DENSE® for benign bone cysts/tumors. This implicitly relies on clinical outcomes and expert observations reported in those publications.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device, so there is no training set in that context.

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

Not applicable. No training set, thus no ground truth for it.

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