(49 days)
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).
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.