(198 days)
Stryker® Injectable Cement is a self-setting calcium phosphate cement indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, craniofacial, spine, and pelvis). These defects may be surgically created or osseous defects created from traumatic injury to the bone. The Stryker Injectable Cement is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure.
Stryker® Injectable Cement is a self-setting calcium phosphate cement.
The provided text is a 510(k) summary for a medical device (Stryker® Injectable Cement) and its FDA clearance letter. It does not contain any information about acceptance criteria, device performance, or human studies for the device itself.
The document primarily focuses on:
- Device Identification: Name, common name, regulatory class, product codes.
- Submitter and Manufacturer Information.
- Date of Summary Preparation.
- Intended Use Statement.
- Substantial Equivalence Information: Listing predicate devices (K043334 BoneSource® HAC Rapid Setting Cement, K041842 Norian SRS® Fast Set Putty, and K024336 Wright Medical MIIG II).
- FDA Clearance Letter: Confirming substantial equivalence to predicate devices and allowing the device to be marketed.
Therefore, I cannot fulfill your request for information regarding acceptance criteria, device performance, sample sizes, expert qualifications, study types (MRMC, standalone), or ground truth establishment based on the provided text. This type of detail is typically found in the full 510(k) submission or associated test reports, which are not included here.
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.