(242 days)
The FlexBoard™ is indicated to aid in the positioning of patients 18 and older undergoing radiation therapy of the breast and chest region, including photon, and electron treatments. The device is also used to position the patient during image acquisition to support treatment planning including in Computed Tomography (CT) imaging systems.
The EagleBoard™ is indicated to aid in the positioning of patients 18 and older undergoing radiation therapy of the breast and chest region, including photon, and electron treatments. The device is also used to position the patient during image acquisition to support treatment planning including in Computed Tomography (CT) and Magnetic Resonance (MR) imaging systems.
The BreastBoard SX™ is indicated to aid in the positioning of patients 18 and older undergoing radiation therapy of the breast and chest region, including photon, proton, and electron treatments. The device is also used to position the patient during image acquisition to support treatment planning including in Computed Tomography (CT) imaging systems.
The FlexBoard™ base is a lightweight baseplate with a locking system specially designed to host multiple types of breast treatment modules, in order to facilitate the positioning of the patient for breast and chest treatments. Multiple variants of FlexBoard™ breast treatment modules are available. To enable enhanced treatment possibilities, the 122930 EagleBoard™-2 Base device can be used with the 172120 FlexBoard™ BTM-EX breast module as part of the FlexBoard™ setup.
The EagleBoard™ devices consist of baseplates with a tapered design, and accessories, such as hand grips, which can be used together to support the positioning of the patient for breast and chest treatments. The 122930 EagleBoard™-2 Base device can be utilized both as part of a FlexBoard™ setup, or individually on the treatment table. The 122950 EagleBoard™-2 Base, MR and 122850 EagleBoard™ MR devices are intended to be utilized individually on the treatment table.
The BreastBoard SX™ is a lightweight baseplate designed to facilitate the positioning of patients for breast and chest treatments. The BreastBoard SX™ is adjustable and can be secured at various tilt positions. It features an adjustable bottom-stop, arm support possibilities for positioning the patient's arms above their head, place for a head rest, and fixation points for thermoplastic masks.
The provided text is a 510(k) summary for patient positioning devices (FlexBoard, EagleBoard, BreastBoard SX). It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone performance study with a test set, expert ground truth, or MRMC studies.
Therefore, the requested information regarding acceptance criteria, studies proving the device meets them, sample sizes, expert involvement, and ground truth establishment is not present in the provided document.
The document primarily states:
- Performance Data: "Mechanical non-clinical testing and other performance data demonstrated that the devices performed as intended and that the differences in technological characteristics did not raise any new issues of safety or effectiveness." This is a general statement and does not provide specific acceptance criteria or detailed study results.
- Substantial Equivalence: The core argument is that the proposed devices have equivalent designs and intended uses to previously cleared predicate devices.
Without more detailed performance study reports, it's impossible to fill out the requested table or describe the specific study methodologies outlined in your prompt.
Here's why the requested information is missing based on the document:
- Nature of the Submission: This is a 510(k) premarket notification. For Class II devices like these, the primary mechanism for clearance is often demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new, de novo clinical trials to establish efficacy and safety against predefined performance criteria in the way a novel AI or diagnostic device might.
- Device Type: Patient positioning devices are mechanical aids. Their safety and effectiveness are typically demonstrated through engineering analyses (e.g., strength, durability, material compatibility), dimensional comparisons, and ensuring they don't introduce new risks compared to existing devices. They are not diagnostic or AI-driven tools that would require complex performance metrics like sensitivity, specificity, or reader studies.
If this were a diagnostic or AI-enabled device, the provided information would be insufficient for FDA clearance, and the kind of detailed performance data you're asking for would be mandatory. However, for a patient positioning device, the level of evidence presented (mechanical non-clinical testing and comparison to predicates) is considered adequate for a 510(k) pathway.
§ 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.