(185 days)
Stryker® Injectable Cement is a self-setting, calcium phosphate cement intended for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects as well as in the augmentation or restoration of bony contour in the craniofacial skeleton.
Stryker® Injectable Cement is a self-setting calcium phosphate cement indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, cramofacial; 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 fragments during and is not intended to provide structural support during the healing process.
Stryker® Injectable Cement is a self-setting, calcium phosphate cement.
This 510(k) premarket notification for the Stryker® Injectable Cement does not contain information about acceptance criteria or a study proving that the device meets those criteria.
The provided document is a 510(k) summary and the FDA's clearance letter for the Stryker® Injectable Cement. It focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and safety and effectiveness.
Here's a breakdown of why the requested information is not present in the provided text:
- Acceptance Criteria and Device Performance Table: This type of information (specific performance metrics, thresholds, and reported results) is typically found in a detailed study report that would be part of the full 510(k) submission, but not in the summary or clearance letter. The summary states that the device is "substantially equivalent" to legally marketed predicate devices, implying that its performance is considered acceptable based on that comparison, but it doesn't quantify or define specific performance criteria.
- Sample size, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size, and ground truth for training set: These items relate to the methodology and results of specific clinical or performance studies. The provided 510(k) summary of safety and effectiveness, while mentioning "Substantial Equivalency Information," does not include details of any primary studies conducted for this particular premarket notification. It references predicate devices (K060061 Stryker® Injectable Cement and K043334 Stryker® HAC Rapid Set Cement) as the basis for substantial equivalence, implying that their existing data or established safety and efficacy profiles are being leveraged.
In summary, the provided text is a regulatory clearance document, not a detailed technical report of a study designed to establish and meet specific acceptance criteria. Such studies would have been part of the broader submission that led to this clearance, but the details are not included in the publicly available summary or the FDA letter.
§ 882.5300 Methyl methacrylate for cranioplasty.
(a)
Identification. Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.(b)
Classification. Class II (performance standards).