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Norian SRS Bone Void Filler is intended only for bony voids or defects that are not intrinsic to the stability of the bony structure. Norian SRS Bone Void Filler is intended to be placed or injected into bony voids or gaps of the skeletal system (the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

Norian SRS Bone Void Filler is an injectable, moldable, and biocompatible bone void filler. The Reactants Pack contains sterile powder (calcium phosphate) and a syringe that contains sterile solution (dilute sodium phosphate). The Reactants Pack is designed to be placed in a reusable mixer where the 2 components are mixed together to form a smooth, viscous paste that remains injectable for approximately 5 minutes at 18°-23°C / 64°- 73°F. At body temperature (37°C / 98.6°F), Norian SRS Bone Void Filler begins to harden after 2 minutes and sets in approximately 10 minutes. Norian SRS Bone Void Filler is slowly resorbed and replaced by bone over a period of years.

The provided text is a 510(k) summary for the Norian SRS Bone Void Filler. This document describes a medical device and its intended use, but it does not contain information about acceptance criteria, device performance studies, or ground truth establishment for an AI/CADe device.

The document states: "Norian SRS Bone Void Filler is equivalent to the predicate device in terms of material composition, physical properties, and performance characteristics." This implies that the device's performance was compared to a previously approved predicate device, but it does not detail any specific acceptance criteria or a study design like those typically associated with evaluating AI/CADe systems.

Therefore, I cannot fulfill your request for information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment based on the provided text. This information is usually found in performance data sections of 510(k) submissions for AI/CADe devices, which this document is not.

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Norian SRS Bone Void Filler is intended only for bony voids or defects that are not intrinsic to the stability of the bony structure. Norian SRS Bone Void Filler is intended to be placed or injected into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

Norian SRS Bone Void Filler is an injectable, moldable and biocompatible bone void filler. The reactants pack contains sterile powder (calcium phosphate) and solution (dilute sodium phosphate) components. The reactants pack is designed to be placed in a reusable mixer where the two components are mixed together to form a smooth, viscous paste that remains injectable for approximately 5 minutes at 18 - 23°C. Norian SRS Bone Void Filler begins to harden after 2 minutes and sets in approximately 10 minutes at body temperature (37°C). Norian SRS Bone Void Filler is slowly resorbed over a period of years. The 3cc, 5cc, and 10 cc reactants packs are provided sterile and are for single use only.

The provided text describes a 510(k) submission for the Norian SRS Bone Void Filler. This document focuses on demonstrating substantial equivalence to predicate devices based on non-clinical performance data (animal studies), rather than a clinical study evaluating the device's diagnostic performance or human-in-the-loop improvements. Therefore, many of the requested categories related to diagnostic device performance evaluations are not applicable or cannot be answered from this document.

Here's an analysis of the available information:

Acceptance Criteria and Study Details (Based on available information)

Reported Device Performance: Pre-clinical animal data demonstrated that Norian SRS Bone Void Filler supports bone growth into a metaphyseal defect. It was shown to resorb over a period of time, accompanied by bone ingrowth and bone remodeling. This performance was deemed "as safe and effective as the predicate devices." |
| 2. Sample size and data provenance (Test Set) | Not applicable for a diagnostic performance test set. The data provenance is "Pre-clinical animal data." The specific animal sample size is not mentioned. |
| 3. Number of experts and qualifications (Ground Truth - Test Set) | Not applicable for this type of non-clinical, animal-based study. The "ground truth" would be histopathological findings and imaging from the animal models, interpreted by veterinary pathologists or researchers. The number and qualifications of these experts are not detailed in this submission summary. |
| 4. Adjudication method (Test Set) | Not applicable for this type of non-clinical study. |
| 5. MRMC Comparative Effectiveness Study | No. This is not a diagnostic device, and thus, a multi-reader multi-case (MRMC) comparative effectiveness study evaluating human reader improvement with AI assistance is not applicable. |
| 6. Standalone Performance Study | Yes, in a way. The "Non-clinical performance data" section describes the device's performance in animal models in a standalone manner, demonstrating its ability to support bone growth and resorb. This is not "standalone algorithm performance" in the context of an AI/diagnostic device, but rather the device's intrinsic biological performance. |
| 7. Type of Ground Truth | The ground truth for the non-clinical study appears to be based on histopathology and imaging findings from animal models, demonstrating bone ingrowth, remodeling, and material resorption. |
| 8. Sample size for the training set | Not applicable. This is not an AI/machine learning device. The "training set" concept does not apply. |
| 9. How ground truth for training set was established | Not applicable. This is not an AI/machine learning device. |

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