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

DB-EZ Bone Void Filler is a pre-mixed moldable and biocompatible putty/paste bone void filler. DB-EZ consists of a mixture of calcium phosphate powder in a bioinert polyethylene glycol (PEG) based polymer that resorbs and is replaced with bone during the healing process.

The provided document is a 510(k) Premarket Notification for the DB-EZ Bone Void Filler. This type of submission establishes substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through novel clinical trials. Therefore, the information typically associated with acceptance criteria and a study proving device performance (like sensitivity, specificity, or AUC) for diagnostic AI/ML devices is not applicable here.

The device is a resorbable calcium salt bone void filler, which is a Class II medical device. The submission establishes substantial equivalence by demonstrating that the DB-EZ Bone Void Filler has the same intended use, technological characteristics, and performance characteristics as the predicate device, Skeletal Kinetics SKaffold NMX (K132211).

Instead of "acceptance criteria" related to diagnostic performance metrics, the document focuses on demonstrating equivalence through various physical, chemical, and biological tests.

Here's a breakdown of the information requested, tailored to the context of this 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, "acceptance criteria" are implied by the predicate device's established performance and the demonstration that the subject device meets or is equivalent to those characteristics. The reported device performance is presented as being identical or substantially equivalent to the predicate.

2. Sample Size Used for the Test Set and Data Provenance

This is a materials science and engineering equivalence study, not a diagnostic performance study with a "test set" in the typical sense of a human-read or AI-analyzed dataset. The "testing" referred to in the document consists of various in-vitro and physical/chemical characterization tests.

• Sample Size: The document does not specify the exact number of samples used for each individual test (e.g., Working Time, Setting Time, FTIR, etc.). It refers to "test samples" without providing specific counts for each parameter.
• Data Provenance: The tests described were performed on the predicate device (K132211) and the results were provided in that earlier submission. For the subject device (DB-EZ Bone Void Filler), the submission states, "The following testing was performed on the predicate device and presented in the K132211 documentation." It further indicates that the subject device is composed of the same material and is manufactured and packaged by the same processes. New specific test results for the subject device are not independently presented for each parameter, but rather a claim of "identical" or "similar" performance based on the shared specifications and manufacturing process. The provenance of the original predicate testing data (K132211) is not detailed in this current submission. Given the nature of these tests, they would be lab-based, likely performed in a controlled environment.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable. The "ground truth" for this type of device is established through scientific and engineering principles, material characterization, and established standards (e.g., ASTM, USP), not through expert consensus on interpreting medical images or clinical outcomes in the same way as an AI diagnostic device. The performance is objectively measured by the tests listed.

4. Adjudication Method for the Test Set

This is not applicable. There is no "adjudication" in the sense of resolving discrepancies among experts for diagnostic interpretation. The tests are designed to yield objective, measurable results against predetermined specifications or comparisons to the predicate.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This is not applicable. An MRMC study is relevant for diagnostic devices that involve human interpretation, often assisted by AI. The DB-EZ Bone Void Filler is a biomaterial device, not a diagnostic AI/ML device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable. This question pertains to AI/ML algorithm performance. The DB-EZ Bone Void Filler is a physical biomaterial.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on:

• Material Science and Engineering Standards: Compliance with established physical, chemical, and mechanical properties (e.g., working time, setting time, solubility, crystal structure, porosity, density, pH, temperature profile) measured through validated test methods (e.g., ASTM F1185-03, USP, USP).
• Biocompatibility Standards: Demonstration of biocompatibility through compliance with relevant standards. The document states, "No new biocompatibility studies were needed... because no changes to the product were made from the identical predicate device."
• Sterility and Shelf-Life Testing: Verification against established sterilization (SAL 10-6) and shelf-life requirements.

8. The Sample Size for the Training Set

This is not applicable. There is no AI/ML algorithm involved, and therefore no "training set" in this context.

9. How the Ground Truth for the Training Set Was Established

This is not applicable, as there is no training set for an AI/ML algorithm.

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