(33 days)
All devices apart from Handgrips HNS, set/2 (111730):
Positioning and immobilization of the patient during radiotherapy. This includes positioning and immobilization of the patient during image acquisition to support treatment.
Handgrips HNS, set/2 (111730):
Positioning of the patient during radiotherapy and radio diagnostics, including MR where indicated.
The DSPS-Prominent baseplate, MR is an MR Safe baseplate which supports the positioning and immobilization of the patient within DSPS-Prominent occipital and facial masks. The device features a cantilevered frame on the cranial side which facilitates the use of both facial and occipital head, neck and shoulder masks and head only masks. The device is fixed to the couch strips. A Coil Reference Tool accessory is available.
The DSPS-Prominent baseplate supports the positioning and immobilization of the patient within DSPS-Prominent occipital and facial masks. The device features a cantilevered frame on the cranial side which facilitates the use of both facial and occipital head, neck and shoulder masks and head only masks. The device is fixed to the couch using couch strips. Optional accessory hand grips are available.
The DSPS-Prominent cradles support the positioning and immobilization of the patient within DSPS-Prominent occipital and facial masks. The devices feature a cantilevered frame which facilitates the use of both facial and occipital head, neck and shoulder masks and head only masks. The device is required to be fixed to a baseplate.
The DSPS-Prominent Masks are facial and occipital thermoplastic masks which are used together with a DSPS-Prominent baseplate or cradle to facilitate accurate positioning and immobilization of the head and neck or head, neck and shoulder region of the patient. The Masks which do not support the positioning of the shoulders are termed 'head only' masks. Shoulder Profile and Shim accessories are available.
The provided document does not detail specific acceptance criteria or an associated study with quantitative results for the device's performance against said criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices through comparisons of design, materials, technological characteristics, and indications for use.
The document states:
- "Non-clinical performance testing was completed to ensure that the devices fulfilled the defined requirements."
- "Clinical testing was performed to ensure that the use of the devices supports the achievement of submillimeter positional accuracy."
- "In addition, attenuation measurements were taken, and water equivalence measurements were calculated, for the devices."
- "The testing confirmed that the new devices are as safe and effective as the predicate devices."
However, it lacks the specific numerical acceptance criteria for these tests (e.g., "positional accuracy must be within X mm") and the reported performance values from these tests. It also does not provide details on the study design for the "non-clinical performance testing" or "clinical testing," such as sample size, ground truth establishment, expert qualifications, or adjudication methods.
Therefore, I cannot populate the requested table or answer the specific questions about sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details. This information is not present in the provided text.
§ 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.