(50 days)
The AccuFix Radiolucent Patient Immobilization System is designed to be used with an Aquaplast RT Thermoplastic (K 935067) mold or mask to immobilize, position and reposition patients undergoing radiation therapy on a linear accelerator treatment table. The AccuFix Immobilization Board attaches or mounts to a treatment table or to a Qfix Radiolucent Replacement Couchtop, which in turn mounts to the treatment table. The patient is then positioned on the immobilization board as deemed appropriate by the treating physician. Warm Aquaplast RT Thermoplastic, in its pliable state, is then molded over the patient where it conforms to the patient's anatomy. As the Aquaplast RT Thermoplastic cools, it becomes rigid, creating a negative mold or mask of the patient's anatomy. This mold or mask can then be used to minimize patient movement, and accurately reposition the patient for subsequent treatment sessions.
The AccuFix Radiolucent Patient Immobilization System is designed to be used with an Aquaplast RT Thermoplastic (K 935067) mold or mask to immobilize, position and reposition patients undergoing radiation therapy on a linear accelerator treatment table. The AccuFix Immobilization Board attaches or mounts to a treatment table or to a Qfix Radiolucent Replacement Couchtop, which in turn mounts to the treatment table. The patient is then positioned on the immobilization board as deemed appropriate by the treating physician. Warm Aquaplast RT Thermoplastic, in its pliable state, is then molded over the patient where it conforms to the patient's anatomy. As the Aquaplast RT Thermoplastic cools, it becomes rigid, creating a negative mold or mask of the patient's anatomy. This mold or mask can then be used to minimize patient movement, and accurately reposition the patient for subsequent treatment sessions.
Based on the provided text, there is no information available regarding acceptance criteria or a study proving that the device meets specific performance criteria. This document is a 510(k) clearance letter from the FDA, which primarily focuses on establishing "substantial equivalence" to a legally marketed predicate device, rather than detailed performance evaluations against specific acceptance criteria.
Therefore, I cannot populate the requested information. The document does not describe:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, or the number/qualifications of experts.
- Adjudication methods.
- Information about MRMC comparative effectiveness studies or standalone algorithm performance.
- The type of ground truth used.
- Sample size for training sets or how ground truth for training was established.
The 510(k) clearance process primarily relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through comparison of technological characteristics and intended use, rather than extensive new clinical trials with detailed performance metrics and acceptance criteria.
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.