(51 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 cured in situ provides an open void/gap filler that can augment provisional hardware (e.g., K-Wires, plates, screws) to help support bone fragments during the surgical procedure. The cured cement acts only as a temporary support media and is not intended to provide structural support during the healing process.
Stryker® Injectable Cement is a self-setting calcium phosphate cement.
The provided documentation is a 510(k) summary for the Stryker® Injectable Cement, a medical device for filling bony voids. However, it does not contain the information required to answer your prompt.
Specifically, the document does not describe acceptance criteria, performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC comparative effectiveness studies. This type of information is typically found in design validation reports or clinical study summaries, which are not part of this 510(k) submission summary.
The 510(k) summary focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than providing detailed performance data from a specific study against predefined acceptance criteria. It mentions the intended use and states that the device is substantially equivalent to other Stryker Injectable Cement products and Walter Lorenz Otomimix.
Therefore, I cannot provide the requested table and details because the source document does not contain this information.
§ 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.