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DB-Composite Bone Void Filler is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, posterolateral spine, pelvis). These defects may be surgically created osseous defects created from traumatic injury to the bone. DB-Composite is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

DB-Composite Bone Void Filler is a moldable and biocompatible calcium sulfate/calcium phosphate bone void filler. The DB-Composite kit is comprised of two components: A calcium sulfate/calcium phosphate powder mix and a mixing solution in premeasured quantities, which will be mixed together prior to implantation. The 3cc, 5cc, and 10cc DB-Composite Bone Void Filler Kits are provided sterile to SAL 10-6 and are for single use only.

The provided text describes a 510(k) premarket notification for a medical device called DB-Composite Bone Void Filler. This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness or meeting specific performance criteria through new clinical studies. Therefore, the information typically requested in your prompt (e.g., acceptance criteria, detailed study results, AI performance, ground truth establishment) is not present here.

Instead, the submission focuses on comparing the new device's characteristics and performance to those of a predicate device (Skeletal Kinetics Callos ProModel Bone Void Filler). The "performance testing" section outlines a summary of tests performed on the predicate device (K112383) to demonstrate its safety and effectiveness, and the DB-Composite device is deemed substantially equivalent based on having identical materials, manufacturing processes, and indications for use.

Here's an attempt to answer your questions based on the available information, noting where specific details are not provided:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" for the DB-Composite device as part of a new study designed to prove its performance against such criteria. Instead, it relies on demonstrating substantial equivalence to a predicate device whose performance has already been accepted by the FDA. The performance testing outlined was primarily conducted on the predicate device, and the DB-Composite is considered equivalent due to identical characteristics.

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

The document does not provide specific sample sizes for the "test set" or information on data provenance. The performance testing section describes general test methods performed, primarily on the predicate device. It does not refer to a "test set" in the context of clinical or comparative studies on the DB-Composite device.

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)

No clinical "test set" requiring expert ground truth is described for the DB-Composite device within this 510(k) summary. The evaluation relies on substantial equivalence to the predicate device and non-clinical performance testing.

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

No clinical "test set" or adjudication method is described.

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

No MRMC study was performed or is relevant here, as this device is a bone void filler, not an AI-powered diagnostic tool.

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

This refers to AI performance, which is not applicable to this medical device.

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

For the non-clinical performance tests mentioned (e.g., pH profile, FTIR Analysis, Bacterial Endotoxins, etc.), the "ground truth" would be established by the standardized methods and instrument readings defined by the test protocols (e.g., ASTM F1185-03, USP, USP, mineralogic standards). No clinical ground truth (like pathology or outcomes data from new studies) was used for the DB-Composite device, as no new clinical studies were conducted or required.

8. The sample size for the training set

This is not applicable as this is not an AI/machine learning device.

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

Not applicable.

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