(51 days)
Norian CRS Fast Set Putty is intended for filling craniofacial defects in the restoration or augmentation of bony contours of the craniofacial skeleton (including fronto-orbital, malar, and mental areas) such as burr hole voids and other craniofacial defects, with a surface area no larger than 25cm2.
Norian CRS Fast Set Putty is not intended for use in the spine and should not be used in the presence of active or suspected infection.
Norian CRS Fast Set Putty is a moldable, thermally activated, biocompatible bone cement. Norian CRS Fast Set Putty is supplied in two containers: one container holds sterile powder (calcium phosphate) and the second container holds sterile solution (dilute sodium phosphate). When the powder and solution are mixed together with the provided cup and spatula, the resultant putty material is suitable for augmentation and restoration of the craniofacial skeleton. When fully cured, the composition formed closely approximates the mineral phase of bone. Norian CRS Fast Set Putty is gradually remodeled over time. This material is provided sterile and is for single use only.
The provided document, K060443, is a 510(k) summary for the Norian CRS Fast Set Putty, a medical device, and therefore does not contain information about acceptance criteria or a study proving its performance in the manner typically described for AI/ML-driven devices.
This document serves as a regulatory submission demonstrating substantial equivalence to a predicate device, which is a different type of assessment than proving performance against predefined acceptance criteria through clinical or scientific studies involving data analysis, as would be common for AI/ML devices.
Therefore, I cannot provide the requested information for the following reasons:
- No Acceptance Criteria or Performance Metrics: The document does not specify any quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy, F1-score) or reported device performance metrics in the context of an AI/ML system.
- No Study Details: There is no mention of a study involving a test set, training set, ground truth establishment, expert adjudication, or MRMC comparative effectiveness study, as these are not relevant to a 510(k) submission for this type of device.
- Nature of the Device: The Norian CRS Fast Set Putty is a biocompatible bone cement, not an AI/ML-driven device that would typically undergo the kind of performance validation outlined in your request. Its regulatory pathway (510(k)) relies on demonstrating substantial equivalence in material composition, physical properties, and performance characteristics to a legally marketed predicate device, rather than proving diagnostic or prognostic accuracy with data-driven metrics.
The document's purpose is to establish that the Norian CRS Fast Set Putty is substantially equivalent to a predicate device based on its intended use, material, and physical properties. It does not involve "acceptance criteria" and "device performance" in the context of diagnostic or predictive capabilities, which are central to your query.
§ 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).