(129 days)
Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan.
Elekta Unity is intended for use with compatible Treatment Planning and Oncology Information Systems. The Elekta Unity 1.5T MR scanner is a magnetic resonance imaging system that produces cross-sectional images in any orientation of the internal structure of the whole body before, during, and after the radiotherapy treatment.
When interpreted by a trained physician magnetic resonance images acquired before, during, and after the radiotherapy treatment yield information that can be useful in diagnosis and may assist therapy planning, patient positioning and treatment delivery related to radiation oncology.
Elekta Unity is a multifunctional digital linear accelerator designed to assist licensed medical practitioners in the delivery of ionizing radiation to defined volumes (e.g. malignant and benign tumors). Elekta Unity is capable of both intensity modulated radiation therapy (IMRT) and image guided radiation therapy (IGRT).
The Elekta Unity 1.5T MRI scanner is a magnetic resonance imaging sub-system that produces cross-sectional images in any orientation of the internal structure of the whole body before, during, and after the radiotherapy treatment.
When interpreted by a trained physician the images acquired before, during, and after the radiotherapy treatment vield information that can be useful in diagnosis and may assist therapy planning, patient positioning, and treatment delivery related to radiation oncology.
In addition to the motion monitoring with manual interrupt previously cleared with predicate Unity devices, the subject device Elekta Unity has added the following motion management strategies:
- · Anatomic Position Monitoring (APM) with Manual interrupt (also referred to as True Tracking as it 'tracks' in 3D and enables the system to gate using the 3D position of the anatomy's motion)
- · APM with Anatomic Tolerance Check (ATC)
- Adaptive Therapy with optional Baseline Shift (BLS) Recovery.
These modifications are not contained solely within the Elekta Unity Device, as the full clinical benefit is achieved with interoperability of Unity, Monaco RTP, and MOSAIQ OIS.
The provided text is a 510(k) summary for the Elekta Unity MR Linac and describes updates to an existing device rather than a new standalone AI/ML device with a clinical performance study. Therefore, a direct answer to all points regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML algorithm's clinical performance cannot be fully provided from this document.
Specifically, the document states: "No animal or clinical tests were performed to establish substantial equivalence with the predicate device." This indicates that a human-in-the-loop (MRMC) or standalone (algorithm only) clinical performance study as typically understood for AI/ML diagnostic or treatment planning algorithms was not conducted for this 510(k) submission. The clearance is based on substantial equivalence by demonstrating that the new motion management strategies do not change the fundamental scientific technology or raise different questions of safety or effectiveness.
However, I can extract the information relevant to the device's technical specifications and the non-clinical testing performed to establish substantial equivalence.
Here's a breakdown of the available information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present "acceptance criteria" in the traditional sense of a clinical performance study against a ground truth. Instead, it provides a comparison of "Technological Characteristics" between the subject device (Elekta Unity with new features) and its predicate device (Elekta Unity K212114). The "acceptance" here relates to demonstrating that the new features do not negatively impact the established performance and safety characteristics, or that they meet expected performance defined by engineering specifications.
| Technological Characteristic | Acceptance Criteria (Predicate Performance - Implied) | Reported Device Performance (Subject Device) |
|---|---|---|
| Radiation Source / Beam | 7MV Bremsstrahlung X-Rays | ✓ (Same) |
| Method of IMRT | MLC based cone-beam delivery | ✓ (Same) |
| Collimation | Field shaping, Multi Leaf Collimator (MLC) | ✓ (Same) |
| MLC material | Tungsten Alloy | ✓ (Same) |
| Number of leaves | 80 leaf pairs | ✓ (Same) |
| Range of MLC collimated beam size | 0.5cm x 0.5cm to 57.4cm x 22cm | ✓ (Same) |
| Gantry | Ring Gantry, collision with patient not possible | ✓ (Same) |
| Radiation Head Shielding | Lead, Tungsten Alloy, and Steel shielding | ✓ (Same) |
| Source control mechanism | Dual channel dose monitoring system | ✓ (Same) |
| Radiation Transmission through head | 0.2% of the primary beam | ✓ (Same) |
| Isocenter distance | 143.5 cm | ✓ (Same) |
| Isocenter accuracy (Radius) | 0.5 mm | ✓ (Same) |
| Max Dose Rate | Clinical use: 450 cG/min at isocentre | ✓ (Same) |
| Static Dose Accuracy | >95% points passing 3%/3mm (high dose); >95% passing 5mm/5% (low dose); 1% agreement for output factors | ✓ (Same) |
| Motion Management Strategies | Motion monitoring with manual interrupt | ✓ (Same + APM with manual interrupt, APM with ATC, Adaptive Therapy with optional BLS Recovery) |
| End-to-End Gating Latency | Not applicable to previous predicate; new feature | [-200 to +200 ms] (radiation off) and [-200 to +280 ms] (radiation on) for ATC |
| Patient table degrees of freedom | 2 (vertical & longitudinal) | ✓ (Same) |
| Integrated imaging | Magnetic resonance imaging system | ✓ (Same) |
| MR Physical Characteristics (Bore Diameter) | 700 mm | ✓ (Same) |
| MRI Frequency | 64 MHz | ✓ (Same) |
| Field Strength | 1.5T | ✓ (Same) |
| Field of View | Up to 500 mm Sequence dependent | ✓ (Same) |
| Field Homogeneity |
§ 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.