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Norian Drillable Inject and Norian Drillable Fast Set Putty are intended for bony voids or defects of the extremities and pelvis that are 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. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. Norian Drillable Inject and Norian Drillable Fast Set Putty can be used as an adjunct to conventional rigid hardware fixation by supporting the bone fragments during the surgical procedure. Once the material has set, it acts as a temporary support medium and is not intended to provide structural support during the healing process. Norian Drillable Inject and Norian Drillable Fast Set Putty are intended to be placed into bony voids either before or after final fixation.

Norian Drillable Inject and Norian Drillable Fast Set Putty are moldable, biocompatible bone void fillers with added reinforcing fibers. Norian Drillable Inject and Norian Drillable Fast Set Putty are intended to be placed into bony voids or defects of the extremities or pelvis either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during or after the setting process. When fully cured. the composition formed closely approximates the mineral phase of bone.

The product is available in two delivery forms. Norian Drillable Inject is an injectable paste that is mixed with an automatic mixer, and Norian Drillable Fast Set Putty is manually mixed with a cup and spatula.

Norian Drillable Inject is provided in a sterile pouch (the "Rotary Pouch"). The Rotary Pouch is constructed of a clear-film outer pouch and a foil laminate inner pouch with an attached delivery syringe. The Rotary Pouch contains sterile powder with fibers and is designed with an injection port for the purpose of adding the mixing solution to the pouch. The mixing solution is contained in the Solution Syringe, which is packaged separately.

The Rotary Pouch is designed to be placed in a reusable mixer (the “Rotary Mixer”) where the two components are mixed together to form a smooth, viscous paste. The paste remains injectable for approximately 5 minutes at 18°-23°C / 64°-73°F. At body temperature (37°C / 98.6°F), Norian Drillable Inject begins to harden after 2 minutes and sets in approximately 10 minutes. Norian Drillable Inject is slowly resorbed over a period of years and replaced with bone during the healing process.

Norian Drillable Fast Set Putty is supplied in two containers. The mixing cup holds sterile powder with fibers and the Solution Syringe holds sterile solution. When the powder and solution are mixed together with the provided cup and spatula, the resultant putty material can be manipulated for two minutes at 18°-23°C / 64°-73°F.

At body temperature (37°C / 98.6°F), Norian Drillable Fast Set Putty begins to harden after 2 minutes and sets in approximately 3 to 6 minutes. Norian Drillable Fast Set Putty is slowly resorbed over a period of years and replaced with bone during the healing process.

The provided text describes the Norian Drillable™ Inject and Norian Drillable™ Fast Set Putty, which are bone void fillers. The document is a 510(k) summary submitted to the FDA for market clearance. While it details the device and its intended use, it does not contain information about acceptance criteria or a specific study proving the device meets acceptance criteria regarding performance metrics such as sensitivity, specificity, accuracy, or any statistical measures.

The document states that "Documentation is provided that demonstrates that Norian Drillable is substantially equivalent to other legally marketed devices." This implies that the device achieved market clearance based on its substantial equivalence to predicate devices (Norian SRS Bone Void Filler and Norian SRS Fast Set Putty, K073303), rather than through a study designed to establish specific performance acceptance criteria for the new device itself.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor can I provide information on sample size, ground truth establishment, expert adjudication, or comparative effectiveness studies, as these types of data are not present in the provided text for this specific device.

The FDA's 510(k) clearance process often relies on demonstrating substantial equivalence to a predicate device, meaning that the new device is as safe and effective as a legally marketed device, even if it has different technological characteristics. This process typically doesn't require a new clinical trial or performance study with defined acceptance criteria for the new device if its equivalence can be successfully demonstrated.

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Norian Drillable Bone Void Filler and Norian Drillable Fast Set Putty™ are intended for bony voids or defects of the extremities and pelvis that are 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. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. Norian Drillable Bone Void Filler and Norian Drillable Fast Set Putty™ can be used as an adjunct to conventional rigid hardware fixation by supporting bone fragments during the surgical procedure. Once the material is set, it acts as a temporary support medium and is not intended to provide structural support during the healing process. Norian Drillable Bone Void Filler and Norian Drillable Fast Set Putty™ are intended to be placed into bony voids either before or after final fixation.

Norian Drillable Bone Void Filler and Norian Drillable Fast Set Putty™ are moldable, biocompatible bone void fillers with added reinforcing fibers. Norian Drillable Bone Void Filler and Norian Drillable Fast Set Putty™ are intended to be placed into bony voids or defects of the extremities or pelvis either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during or after the setting process. When fully cured, the composition formed closely approximates the mineral phase of bone.

The product is available in two delivery forms. Norian Drillable Bone Void Filler is an injectable paste that is mixed with an automatic mixer, and Norian Drillable Fast Set Putty™ is manually mixed with a cup and spatula.

Norian Drillable Bone Void Filler is provided in a sterile pouch (the "Reactants Pack"). The Reactants Pack is constructed of a clear-film outer pouch and a foil laminate inner pouch with an attached delivery syringe. The Reactants Pack contains sterile powder with fibers and is designed with an injection port for the purpose of adding the mixing solution to the pouch. The mixing solution is contained in the Solution Syringe, which is packaged separately.

The Reactants Pack is designed to be placed in a reusable mixer (the "Rotary Mixer") where the two components are mixed together to form a smooth, viscous paste. The paste remains injectable for approximately 5 minutes at 18°-23°C / 64°-73°F. At body temperature (37°C / 98.6°F), Norian Drillable Bone Void Filler begins to harden after 2 minutes and sets in approximately 10 minutes. Norian Drillable Bone Void Filler is slowly resorbed over a period of years and replaced with bone during the healing process.

Norian Drillable Fast Set Putty™ is supplied in two containers. The mixing cup holds sterile powder with fibers and the Solution Syringe holds sterile solution. When the powder and solution are mixed together with the provided cup and spatula, the resultant putty material can be manipulated for two minutes at 18°-23°C / 64°-73°F.

At body temperature (37°C / 98.6°F), Norian Drillable Fast Set Putty begins to harden after 2 minutes and sets in approximately 3 to 6 minutes. Norian Drillable Fast Set Putty™ is slowly resorbed over a period of years and replaced with bone during the healing process.

This document is a 510(k) summary for the Norian Drillable™ Bone Void Filler and Norian Drillable™ Fast Set Putty™. It describes the device, its intended use, and its substantial equivalence to predicate devices, ultimately resulting in FDA clearance. However, it does not contain specific acceptance criteria or a study proving the device meets those criteria, nor does it provide details about sample sizes, expert qualifications, or ground truth establishment typically found in performance studies.

Instead, the document focuses on regulatory clearance based on substantial equivalence, meaning the device is considered as safe and effective as a legally marketed predicate device.

Therefore, I cannot provide the requested information from the provided text as it is not present. The document mainly outlines the regulatory classification, product description, and the FDA's decision regarding its market clearance.

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