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PRO-DENSE LoVisc™ resultant pastel 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 sketal 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 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 PRO-DENSE LoVisc™ 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.

PRO-DENSE LoVisc™ is provided sterile for single use only.

PRO-DENSE LoVisc™ Bone Graft Substitute is a calcium sulfate formulation consisting of a powder component and aqueous mixing solutions. When the two component types are mixed according to directions, an injectable paste is formed. This paste is subsequently injected and/or digitally packed into a bone void where the graft cures and hardens via hydration reactions.

The provided text is a 510(k) summary for the PRO-DENSE LoVisc™ Bone Graft Substitute. It does not describe a study involving an AI device or present acceptance criteria and performance data for such a device. Instead, it focuses on demonstrating substantial equivalence of a medical device (bone graft substitute) to a predicate device based on non-clinical evidence.

Therefore, I cannot extract the requested information regarding an AI device's acceptance criteria, study details, expert involvement, or ground truth establishment from this document.

The document states:

• "SUBSTANTIAL EQUIVALENCE - CLINICAL EVIDENCE: N/A"
• "Ejection testing and LAL testing demonstrated that subject with increased working time, adjusted fill volumes, and updated kit accessories are equivalent to the predicate."

This indicates that the equivalence was established through non-clinical testing, not a clinical study involving human readers or AI performance metrics.

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PRO-STIM™ 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 surgically created 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 PRO-STIM™ 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.

PRO-STIM™ is provided sterile for single use only.

For the PRO-STIM™ Core Decompression Procedure Kit:

The PRO-STIM™ 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 PRO-STIM™ Core Decompression Procedure Kit is not intended to be used as a load-bearing device.

PRO-STIM is indicated as 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 via hydration reactions. The subject implant kits consist of pre-measured surgical grade calcium sulfate and calcium phosphate, demineralized bone matrix, pre-measured mixing solution, and the tools necessary to mix the components into a paste and inject the material into the defect site. When the implant components are mixed according to the instructions, an injectable paste is formed.

The subject includes an updated mixing and delivery system for the implant material as well as new size configurations for the kits. The subject accessories include two sizes of syringe mixers (14 mL and 40 mL); a spindle drive for mechanical assist, a larger delivery syringe, and associated cannulas and adaptors.

There is no information in the provided document about acceptance criteria or a study that proves the device meets the acceptance criteria. The document is a 510(k) clearance letter from the FDA for a medical device called PROSTIM™ Injectable Inductive Graft, indicating that the device is substantially equivalent to legally marketed predicate devices.

The information provided describes the device, its intended use, and non-clinical testing performed to establish substantial equivalence, but it does not detail specific acceptance criteria or the full results of a study designed to demonstrate performance against such criteria.

Specifically, the document states:

• Non-Clinical Evidence: "Dissolution, vicat set time, and diametral tensile strength (DTS) testing showed that the new syringe mixing and delivery systems produced a resultant graft that met all the material specification of the current PRO-STIM graft. Pyrogenicity testing was also performed."
• Clinical Evidence: "N/A" (Not Applicable)
• Conclusion: "The design characteristics of the subject system do not raise any new types of questions of safety or effectiveness. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate devices."

This indicates that some material properties were tested against existing specifications for the "current PRO-STIM graft," but the specific acceptance criteria (e.g., exact values or ranges for dissolution, vicat set time, DTS) and the detailed results of those tests are not provided. The document highlights that the new mixing and delivery system produces a graft that meets the specifications of the current graft, rather than detailing a study against new, explicit acceptance criteria for the entire device.

Therefore, I cannot provide the requested table or answer the specific questions about sample size, data provenance, expert involvement, adjudication, MRMC studies, standalone performance assays, or ground truth establishment based solely on the provided text.

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