Search Results

The ACE SurgicalPlaster Calcium Sulfate Hemihydrate is intended to be used by itself in bone regenerative techniques; mixed with other suitable bone filling agents to prevent particle migration in an osseous defect, and, to provide a resorbable barrier over other bone graft material.

The ACE SurgicalPlaster Calcium Sulfate Hemihydrate is a medical grade calcium sulfate hemihydrate. The ACE SurgicalPlaster Calcium Sulfate Hemihydrate is intended to be used by itself in bone regenerative techniques. The ACE SurgicalPlaster Calcium Sulfate Hemihydrate is designed to set-up in vivo. It is mixed with small amounts of regular saline solution to produce a putty-like paste and it is applied on bone defects in amounts of 0.5 cc to 5.0 cc. The setting of the paste over may be set using a small square of sterile gauze soaked in the fast setting solution. With time, the ACE SurgicalPlaster Calcium Sulfate Hemihydrate dissolves and recedes leaving behind spaces that have been found to stimulate bone in-growth.

The provided text is a 510(k) summary for a medical device (ACE SurgicalPlaster Calcium Sulfate Hemihydrate) seeking substantial equivalence to a predicate device. It specifically states:

"Among the information and data presented in the 510(k) submission to support the substantial equivalency among the Miorination and data presented in the origins damicate device are 1) device are: 1) device of the ACE Surgical Flaster Oalerials, and 4) labeling. In particular, the information demonstrated description, a) indications for asc, of materials, and 1) ias civing ess between the ACE SurgicalPlaster Calcium Sulfate Hemihydrate and the specified predicate device."

This excerpt indicates that the 510(k) submission relies on demonstrating substantial equivalence based on device description, indications for use, materials, and labeling. It does not describe a clinical study or performance data with specific acceptance criteria that the device had to meet through testing.

Therefore, I cannot provide the requested information about acceptance criteria or a study proving the device meets them because the provided text does not contain that level of detail, as it's a summary of a regulatory submission primarily focused on demonstrating substantial equivalence, not reporting on a performance study with quantitative results.

If this were a submission for a new device requiring performance testing, such a study would typically be included. For a 510(k) for substantial equivalence, clinical performance studies are not always required if equivalence can be demonstrated through other means (e.g., comparison of technological characteristics).

Ask a specific question about this device