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CERAMENT | BONE VOID FILLER is a ceramic bone graft substitute intended for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure.

CERAMENT | BONE VOID FILLER is indicated to be injected, or placed, into bony voids or gaps in the skeletal system, i.e. extremities, pelvis, and posterolateral spine (only during open surgery in spine). These defects may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 9 years old), or osseous defects created as a result of either surgery or traumatic injury to the bone.

CERAMENT | BONE VOID FILLER resorbs and is replaced by bone during the healing process.

CERAMENT | BONE VOID FILLER can augment hardware and support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process. CERAMENT | BONE VOID FILLER can be drilled and screws can be placed through it.

CERAMENT| BONE VOID FILLER is a fast-setting, injectable and moldable ceramic bone graft substitute intended for filling bone voids/gaps. The material consists of a powder and a liquid component. The major constituents of the powder are hydroxyapatite and calcium sulfate hemihydrate. The liquid component (C-TRU) contains iohexol as a radio-opacification enhancer. Mixing the components with the combined mixing injection (CMI) device, results in a viscous material intended to set ex vivo or in vivo.

By combining hydroxyapatite and calcium sulfate, an optimal balance is achieved between implant resorption rate and bone ingrowth rate. Calcium sulfate acts as a resorbable carrier for hydroxyapatite. Hydroxyapatite has a slow resorption rate, high osteoconductivity, promoting bone ingrowth and gives long term structural support to the newly formed bone.

The ceramic bone graft substitute is placed into the bone defect under direct visualization or under radiographic monitoring during open or percutaneous surgery. The paste may be injected into the defect, molded by hand and digitally placed into the defect, or used to prepare beads that are placed into the defect. The accompanying injection device (ID) and Tip Extenders may be used to facilitate filling the bone defect.

When fully set in vivo, CERAMENT | BONE VOID FILLER is drillable and can be used to augment hardware during the surgical procedure.

This document describes the regulatory submission for CERAMENT BONE VOID FILLER, a medical device, and its acceptance criteria as defined by the FDA. However, it does not describe acceptance criteria for an AI device's performance or a study proving an AI device meets those criteria.

Therefore, I cannot fulfill the request as it pertains to an AI device. The provided text is a 510(k) submission for a bone void filler and does not contain information about AI device performance testing, ground truth establishment, or clinical study methodologies for AI.

The closest relevant information is a statement about the device meeting "pre-determined acceptance criteria identified in the Design Control Activities Summary," but the document does not provide details about those specific acceptance criteria beyond general biocompatibility and mechanical properties for a bone void filler. It also mentions "Performance Testing" was previously provided, but again, the specifics of these tests and their results are not detailed in this submission.

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AS20 resultant paste is intended for use as a bone graft substitute to be injected or digitally packed into open bone voids/ gaps that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities and pelvis) to cure in situ. These open bone voids may be the result of benign bone cysts and tumors (in adults and pediatric patients > 6 years old), surgically created osseous defects or osseous defects created from traumatic injury to the bone. The paste provides a bone graft substitute that resorbs and is replaced with bone during the healing process.

The AS20 paste cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.

AS20 is provided sterile for single use only.

The AS20 Core Decompression Procedure Kit, consisting of a bone void filler and manual surgical instruments, is intended to be used during core decompression procedures. The bone void filler component resorbs and is replaced with bone during the healing process. The bone void filler included in the AS20 Core Decompression Procedure Kit is not intended to be used as a load-bearing device.

AS20 is a bone graft substitute to be injected and/or digitally packed into open bone voids/gaps that are not intrinsic to the structural stability of the skeletal system and cure in-situ. It is supplied in a syringe mix package (dual syringes of powder and liguid vial) for mixing it into a paste and delivering it to the defect site. When the components are mixed according to directions, an injectable paste forms and subsequently hardens via hydration reactions. The benefits of this composite include:

• Calcium Sulfate .
  • Primary osteoconductive filler l
  • Resorbs first primarily through simple dissolution to allow early vascular infiltration ■
  • 트 Excellent clinical history
• Calcium Phosphate ●
  • Osteoclastic resorption 트
  • Secondary porous scaffold that is resorbed after primary filler
  • I TCP granules are resorbed in the third and final phase

The provided document is a 510(k) summary for the AS20 Composite Bone Graft. It details the device, its intended use, and argues for its substantial equivalence to a predicate device.

This document describes a medical device, specifically a bone graft substitute, and its regulatory filing. It does not contain information about an AI/ML-driven device or study results relevant to the acceptance criteria usually associated with such devices (e.g., sensitivity, specificity, AUC).

Therefore, I cannot provide the requested information regarding acceptance criteria and study details as they pertain to an AI/ML device. The document focuses on non-clinical evidence (material properties and mixing systems) to establish substantial equivalence for a bone graft product, not on the performance of a diagnostic or predictive algorithm.

Here's what I can extract from the document regarding the device and its evaluation:

• Device Name: AS20 Composite Bone Graft
• Intended Use: As a bone graft substitute to be injected or digitally packed into open bone voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system (extremities and pelvis) to cure in situ. This includes benign bone cysts and tumors, surgically created osseous defects, or traumatic injury. Also, as a void/gap filler to augment provisional hardware (e.g., K-Wires) for temporary support during surgery.
• Predicate Device: K132656: PRODENSE® Bone Graft Substitute
• Evaluation Method: Substantial Equivalence to a predicate device based on non-clinical evidence.
• Non-Clinical Evidence:
  • Identical Implant Material: The subject device uses the same implant material as the predicate.
  • Performance Testing:
    • Dissolution
    • Porosity
    • Vicat set time
    • Gillmore set time
    • Diametral tensile strength
• Clinical Evidence: N/A (Not applicable for this 510(k) submission, as substantial equivalence was established through non-clinical means).

Since there is no AI/ML component described, the following requested information points are not applicable:

1. A table of acceptance criteria and the reported device performance (for an AI/ML device)
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
6. If a standalone (algorithm only) performance study was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
8. The sample size for the training set
9. How the ground truth for the training set was established

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