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Dimensional Bioceramics™ (DB) Calcium Sulfate Device (CSD) is a bone graft substitute that is intended for use as a bone void filler for voids and gaps and pelvis that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or created from a traumatic injury to the bone. DB-CSD is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., extremities and pelvis). DB-CSD is a bone graft substitute that resorbs and replaced with bone during the healing process. DB-CSD is biodegradable and biocompatible and may be used in an infected site.

Dimensional Bioceramics (DB) Calcium Sulfate Device (CSD) [DB-CSD] Bone Void Filler Kit is provided sterile for single patient use. The Kit contains medical grade calcium sulfate powder and mixing solution in pre-measured quantities. When mixed together in a sterile mixing bowl, the resultant paste may be injected, digitally implanted, or applied to a mold to produce pellets. DB-CSD resorbs and is replaced with bone during the healing process. DB-CSD is a moldable, biocompatible, biodegradable, and resorbable calcium sulfate material that is to be applied directly to the intended sites. It may be used within an infected site. The critical specifications are chemistry, crystallinity, physical form, porosity, and solubility.

The provided text describes a 510(k) premarket notification for a medical device, the Dimensional Bioceramics Calcium Sulfate Device (DB-CSD), which is a bone void filler. It details the device's characteristics, indications for use, and a summary of testing performed to demonstrate substantial equivalence to a predicate device.

However, the provided text does not describe:

• Acceptance criteria in the context of a statistical study with specific numerical thresholds for performance metrics (e.g., sensitivity, specificity, F1-score).
• Performance metrics for an AI/algorithm-based device.
• Details about a test set, including its sample size, data provenance, ground truth establishment by experts, or adjudication methods.
• Multi-Reader Multi-Case (MRMC) studies or comparative effectiveness studies involving human readers and AI assistance.
• Standalone algorithm performance.
• Training set details (sample size, ground truth establishment).

The "Summary of Testing" section primarily focuses on:

• Laboratory Testing: Comparison of critical specifications (chemistry, crystallinity, physical form, porosity, solubility) of DB-CSD with a predicate device through various analytical techniques (FTIR, XRD, SEM, Mercury Intrusion Porosimetry, ICP-AES). The acceptance criterion here is substantially equivalent to the predicate device.
• Biocompatibility Testing: Demonstrated DB-CSD met the requirements of ISO 10993-1. The acceptance criterion is meeting these ISO standards.
• Pyrogenicity Testing: ISO Materials Mediated Rabbit Pyrogen testing showed DB-CSD is non-pyrogenic. The acceptance criterion is non-pyrogenic.
• Sterilization and Shelf-Life Testing: Validated radiation dose in accordance with ISO 11137-2006 to a Sterility Assurance Level (SAL) 10-6. The acceptance criterion is achieving SAL 10-6.
• Animal Testing: An ovine model study analyzed biocompatibility, implant resorption, bone formation, and surgical handling. The results indicated biocompatibility, complete resorption, and normal bone healing. The acceptance criteria relate to these biological outcomes being comparable to the predicate device.
• Clinical Testing: Explicitly states "N/A: This product type does not require clinical testing."

Therefore, I cannot populate the table or answer the specific questions related to AI/algorithm performance and clinical study design for an AI device because this document pertains to a resorbable calcium salt bone void filler device, which is a physical medical device, not an AI or imaging diagnostic device.

If you have a document describing an AI/algorithm-based medical device study, I would be happy to analyze it according to your criteria.

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