(327 days)
The ViewRay System, with magnetic resonance imaging capabilities, is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
The ViewRay™ System for Radiation Therapy is a single medical device that combines a magnetic resonance imaging system for image guidance, with a cobalt-60 radiation delivery system. The system is designed so that the imaging and radiotherapy fields of view coincide, permitting imaging of the patient at the radiotherapy isocenter before and during treatment. These imaging and radiation delivery systems are designed to operate together as the ViewRay System, for accurate, targeted administration of radiation therapy. The ViewRay System is used with the ViewRay Treatment Planning and Delivery System (TPDS) (K102915, FDA clearance 1/12/11).
The magnetic resonance imaging system (MRIS) of the ViewRay System can be used by the clinician to perform three (3) different functions before and during the treatment of a patient. A trained clinician may choose to perform all, some, or none of the functions. These 3 functions are:
- Treatment planning the images from the ViewRay MRIS can be used to perform pre-treatment and on-table planning.
- Patient positioning Fast pilot or planning volumetric images can be used to position the patient.
- Treatment gating (soft tissue tracking)- If the prescribing clinician employs this feature during therapy, planar MR images (in a single plane or in 3 planes) are taken continuously during therapy delivery, to control the beam based on anatomy motion.
The ViewRay radiation delivery system (RDS) consists of:
- Radioactive cobalt-60 sources
- Source shielding heads and movement mechanism
- Gantry and base
- Multi-leaf collimators
- Radiation therapy control system
- User console
The sealed cobalt-60 sources are housed in source-shielding heads made of tungsten alloy and depleted uranium encased with stainless steel. The heads are mounted on a ring gantry located between the gap in the MRIS magnets. The sources can be positioned for therapy (BEAM ON), standby (BEAM HOLD) and shielding (BEAM OFF) by the source movement mechanism. The beams from the sources are shaped to conform to the target using double focused multi-leaf collimators. The radiation therapy interfaces with the radiation treatment planning, imaging, gating, and dose calculation functions by means of the radiation therapy control system (RTCS). This system is the central point of control and is designed to provide fail-safe operation of the ViewRay System. The RTCS includes the Radiation Therapy Controller (RTC) and the Auxiliary Controller (AUXC). The AUXC provides secondary monitoring of the ViewRay System safety functions in the event of an RTC failure. The ViewRay System records patient information, treatment plans, dose administered during each fraction, the accumulated dose, imaging data, and system performance during treatment.
The provided text is a 510(k) Premarket Notification Summary for the ViewRay™ System for Radiation Therapy. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results with specific performance metrics against acceptance criteria in the way a PMA or de novo submission might.
Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not present in this document.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conformance to design requirements | Passed all verification testing |
| Ensure all identified risks and hazards were mitigated | Passed all verification testing |
| Demonstrate conformance to relevant standards: |
- IEC 60601-1 (2.0 Edition)
- IEC 60601-2-33 (3.0 Edition)
- IEC 60601-2-11 (2.0 Edition) | Conformed with all applicable sections of IEC 60601-1 (2.0 Edition), IEC 60601-2-33 (3.0 Edition) and IEC 60601-2-11 (2.0 Edition) |
| Substantial equivalence to predicate device (Trilogy Mx™ Radiotherapy Delivery System K092871) | System performance was found to be equivalent in function to the predicate device. |
Note: The document describes "Design Verification testing" as the study proving the device meets these criteria.
2. Sample size used for the test set and the data provenance
- Sample size: Not specified. The document states "Design Verification testing was performed," but does not detail the number of patients, phantoms, or test cases used.
- Data provenance: Not specified. As a 510(k) submission primarily focused on engineering and functional testing, clinical data provenance is not typically detailed in this section unless a specific clinical study for performance was required beyond substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not specified.
- Qualifications of experts: Not specified.
- Rationale: This document describes verification testing against design requirements and standards, not a clinical study requiring expert-established ground truth for performance evaluation in the typical sense of diagnostic or prescriptive AI algorithms. The "ground truth" here would be the established engineering specifications and standard requirements.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication method: Not specified.
- Rationale: As above, this type of adjudication is typically for clinical performance evaluation (e.g., grading images) and not for engineering verification testing described here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC study: No, a multi-reader, multi-case comparative effectiveness study was not explicitly mentioned or indicated in the provided text.
- Effect size: Not applicable, as no MRMC study was reported.
- Rationale: The ViewRay system is a medical device combining imaging and radiation delivery for treatment, not an AI-assisted diagnostic tool for human readers in the way an MRMC study would typically evaluate. The text describes the system's capabilities (e.g., continuous imaging for soft tissue tracking) but not as an "AI assistance" to human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance: Yes, the device itself underwent "Design Verification testing" to show conformance to design requirements and standards. This testing evaluates the device's inherent functionality (imaging quality, radiation delivery accuracy, safety features, etc.) as a standalone system. However, it's not an "algorithm-only" standalone performance in the context of an AI device but rather the integrated system's performance. The document focuses on the system's performance against engineering metrics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of ground truth: The "ground truth" for the verification testing described would primarily be:
- Engineering specifications and design requirements: The device was tested to ensure it met its pre-defined design parameters.
- Applicable international standards (IEC 60601 series): The device's performance was compared against the requirements set by these medical device standards.
- Predicate device's established performance: The ViewRay system's function was compared to the Trilogy Mx™ System to demonstrate substantial equivalence, meaning the predicate's performance served as a benchmark for equivalence.
8. The sample size for the training set
- Sample size: Not applicable.
- Rationale: This document does not describe the development of an "AI algorithm" in the sense that would require a distinct training set for machine learning. The ViewRay system is a complex integrated medical device, and its functional verification does not typically involve training a machine learning model.
9. How the ground truth for the training set was established
- Ground truth establishment: Not applicable.
- Rationale: As there is no mention of a training set for an AI algorithm, the concept of establishing ground truth for such a set is not relevant to this document's content.
§ 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.