Search Results

The CushionCast™ Moldable Cushion is to be used by trained medical professionals for stable support and positioning of patients undergoing radiation therapy or other treatment in a clinic or hospital setting.

The CushionCast™ is moldable stabilization cushions for radiation therapy patients. This product targets customers who require stabilization cushions for patients who are undergoing radiation therapy. The CushionCast™ is needed in order to mold to the shape of the patient's head to immobilize any movement during radiation therapy.

The cushion is constructed with a biocompatible and water resistant fabric and internal components, which include low viscosity casting resins that are sealed in pouches and polystyrene beads as filler material. To activate the cushion, the pouches are popped, and the internal components are mixed for 2 minutes. The plug inserted in the vent tube is removed prior to the molding process. The vent tube serves to expel excess air to allow for an accurate mold. The mixture of the Part A and Part B liquid plastics should yield a hardened mold. The fully cured mold provides a dimensionally stable cushion required by radiotherapy systems.

The provided text describes a medical device called the CushionCast™ Moldable Cushion and its 510(k) summary, which includes a claim of substantial equivalence to a predicate device, the Klarity Mold Cushions. However, the document does not contain specific acceptance criteria, reported device performance metrics in a structured table, details of a specific study proving the device meets acceptance criteria, sample sizes for test or training sets, data provenance, expert qualifications for ground truth, adjudication methods, or MRMC comparative effectiveness study results as requested in the prompt.

The document mentions a "design verification study" was conducted to ensure dimensional stability and equivalent performance to the predicate, but it does not provide any specifics about this study, its methodology, or its results.

Based on the information provided, I cannot fulfill your request for a detailed description of acceptance criteria and the study proving the device meets them with the specific points you listed. The 510(k) summary is primarily focused on demonstrating substantial equivalence to a predicate device, rather than providing a detailed performance study with quantifiable acceptance criteria.

Therefore, I must state that the requested information (items 1-9) is not present in the provided text.

The only relevant snippet is:

"A design verification study was conducted to ensure that the dimensional stability of the CushionCast™ meets necessary requirements. The study also indicated that the CushionCast™ performs equivalently to the Klarity Mold Cushions. It is reasonable to conclude that the CushionCast™ and Klarity Mold Cushion are substantially equivalent with respect to use, safety, and effectiveness."

This statement confirms a study was done for "dimensional stability" and "equivalent performance," but it does not provide any of the specifics to answer your numbered prompts.

Ask a specific question about this device