(142 days)
DSPS-Prominent™ Masks, DSPS-Prominent™ Baseplate, MR:
Positioning and immobilization of the patient during radiotherapy. This includes positioning and immobilization of the patient during image acquisition to support treatment such as in Magnetic Resonance (MR) and Computed Tomography (CT) Imaging Systems.
CouchStrip:
Positioning of the patient during radiotherapy and radio diagnostics, including MR where indicated.
DSPS-Prominent Masks: The DSPS-Prominent Masks are facial and occipital thermoplastic masks which are used as part of the DSPS-Prominent system to facilitate accurate positioning and immobilization of the head, neck and shoulder region of the patient.
DSPS-Prominent™ Baseplate, MR: 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. The device is fixed to the couch using couch strips.
CouchStrip: CouchStrips are bars which connect the patient positioning device onto the treatment table at indexed positions. The DSPS-Prominent CouchStrip is MR Safe.
This document describes a 510(k) premarket notification for patient positioning devices (DSPS-Prominent™ Masks, DSPS-Prominent™ Baseplate, MR, CouchStrip). This submission is for medical devices, specifically for radiotherapy positioning and immobilization, not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details for AI/ML performance (e.g., sample size, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) is not applicable.
The document focuses on demonstrating substantial equivalence to predicate devices based on design, materials, intended use, and functionality, rather than presenting performance metrics against specific acceptance criteria for an AI algorithm.
The "Testing Performed" section broadly states:
- "Clinical and non-clinical testing was performed."
- "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 enables submillimetre positional accuracy to be achieved."
- "The testing confirmed that the new devices are as safe and effective as the predicate devices."
However, specific acceptance criteria and detailed quantitative results from these tests are not provided in this summary.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the specific questions related to AI/ML study design, as 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.