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Callos Bone Void Filler is indicated to the following indications:
1 . To fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis) not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
2. To be used with autograft as a bone graft extender (i.e. extremities, and pelvis only).
Callos resorbs and is replaced by bone during the healing process.

Callos Bone Void Filler is a moldable and biocompatible calcium phosphate bone void filler. The single-use Callos Kit contains the necessary components for mixing of the bone void filler. The Callos sterile kit contains: Calcium Phosphate Powder, Dilute Sodium Silicate Liquid, and a Mixing System (Mixing Bowl, Pestle and Spatula).

The provided text is a 510(k) summary for the Callos® Bone Void Filler. This document describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study that specifically proves the device meets particular numerical performance criteria.

Instead, the summary focuses on demonstrating substantial equivalence to previously approved devices based on:

• Technological characteristics: Callos is composed of a calcium phosphate powder and a sodium silicate solution, which when mixed forms a paste that hardens into hydroxyapatite, similar to the mineral phase of native bone. Its function as a bone graft extender is similar to predicate devices.
• Biocompatibility: In accordance with ISO 10993-1.
• Sterilization validation: Compliant to ANSI/AAMI/ISO 11137-2.2006.
• Physical/mechanical characteristics: Evaluated using setting tests (modified ASTM) and X-ray Diffraction (XRD) phase analysis, and compared with predicate devices.
• Clinical use (for new indication): An "ewe study" (sheep study) demonstrated its use as an orthopedic bone graft extender.

Therefore, most of the specific questions about acceptance criteria, numerical performance, sample sizes, expert ground truth, adjudication, MRMC studies, or standalone algorithm performance cannot be answered from the provided text, as these concepts are typically associated with performance evaluations of diagnostic or AI-based devices, not material equivalence for a bone void filler as presented here.

However, I can extract the specific information that is present regarding the device and its evaluation methods.

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the document does not present quantitative acceptance criteria or device performance in the manner typically seen for diagnostic devices (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices based on material properties, biocompatibility, and functional similarity.

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

• Sample Size: Not specified in the provided summary.
• Data Provenance: The "ewe study" is mentioned, indicating an animal (sheep) model in a prospective study design for the new indication as a bone graft extender. Other tests (biocompatibility, sterilization, physical/mechanical) are cited as having been performed previously for earlier Callos clearances (K030554 and K051123) and are standard laboratory evaluations. The location/country of origin is not specified.

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

Not applicable/provided. This type of detail is not required or typically included in a 510(k) summary for a bone void filler's substantial equivalence determination. The "ewe study" likely involved veterinary surgeons and pathologists, but specific numbers and qualifications are not listed.

4. Adjudication Method for the Test Set

Not applicable/provided. This is not relevant for the type of device and evaluation described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC study was done. This type of study is typically for evaluating the performance of diagnostic imaging devices or CAD systems, not for a bone void filler.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

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

7. The Type of Ground Truth Used

For the "ewe study," the ground truth for evaluating bone graft extension would likely involve histopathology (analysis of tissue samples under a microscope to confirm bone formation, resorption of the material, integration with host bone) and potentially radiographic imaging over time. For the physical/mechanical tests, the "ground truth" is defined by the standardized test methods (e.g., modified ASTM) and the material characteristics of the predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set. The "ewe study" could be considered a "test set" for the expanded indication.

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

Not applicable. No training set is involved.

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