(183 days)
Clarity® is indicated for use in external beam radiation therapy, to provide 3D ultrasound and hybrid imaging of soft-tissue anatomy to support radiation therapy simulation and planning, and to guide patient positioning prior to the delivery of treatment.
Clarity® may also be used with an Autoscan Probe for transperineal ultrasound (TPUS) imaging, to continuously monitor the motion of the prostate and to accurately guide patient positioning during the delivery of treatment (i.e., intra-fractionally).
Clarity® integrates medical diagnostic ultrasound and a real-time optical measurement system, which determines the 3D position of the ultrasound probes, to acquire and reconstruct 3D images of soft-tissue anatomy for use in external beam radiation therapy. During the course of treatment, non-ionizing 3D ultrasound imaging and optical tracking of couch position with Clarity® offers a noninvasive means for accurate localization of anatomical structures and patient positioning.
Clarity® comprises the following functional components:
- The Clarity® Acquisition Station is configured around an ultrasound console, which may be suspended from an articulated arm or mounted on a cart, with an integrated computer system and high-resolution touch screen. Acquisition stations are placed in the CT-Sim room (Clority® Sim) and the treatment room (Clority® Guide), with a celling-mounted optical measurement system and patient/couch position tracking tools.
- Each acquisition station is equipped with optically-tracked ultrasound probes; one or two hand-held probes for manual scanning and a motorized (Autoscan) probe for automated scanning. The user can select the probe and scanning method that is most appropriate for the given target anatomy and the patient's clinical presentation. The Autoscan probe includes a positioning apparatus that is specifically designed for transperineal imaging. The Autoscan probe remains in place during a CT-Sim scan and during radiation treatment; scanning is controlled from a remote console interface.
- A multimodality phantom is used for image calibration to the room's coordinate system that is defined by the corresponding room lasers, and for daily verification of system integrity for sub-millimeter target localization accuracy within each room.
- One or more dedicated workstation computer systems, connected to the hospital's local area network, are used for multimodality image fusion and review, soft-tissue structure definition, approval of patient positioning references, and review of treatment sessions.
- A dedicated central server computer system (typically combined with a workstation) houses the patient database and provides for interoperability with other imaging and treatment planning/simulation systems using the DICOM 3/RT protocol.
The Clarity® software is designed to step the user through a radiation therapy workflow or "course." Different courses are defined (e.g., "Prostate", "General", "QC") to help classify patients in the database and to present the user with default choices and settings, tailored for the target anatomy (e.g., prostate, bladder, liver, uterus & cervix, breast, head & neck) and daily QC. Such configurations include probe type, scan settings, contouring and assisted segmentation tools, and alert values for target misalignments.
At the time of CT-Simulation, a 3D ultrasound (3DUS) scan is acquired with the patient in the planning position. At the Workstation, the planning CT is imported and fused with the 3DUS, the structure of interest is defined, and a baseline positioning reference is approved. The 3DUS may be exported via DICOM to a third-party virtual simulator or treatment planning system (TPS),
In the treatment room, a 3DUS scan is used to determine target displacement relative to the baseline planning-day position, and to guide patient positioning prior to treatment.
When used with the Autoscan probe, Clarity® allows for continuous imaging of the prostate and surrounding anatomy to enable precise motion management during the delivery of treatment (i.e., intra-fractionally).
To assist with the clinical workflow, Clarity® can be configured to send calculated couch shifts to the operator at the couch control user interface.
A web-based software interface is available with Clarity® for remote review of treatment session data and positioning references.
Given the provided text, the device in question is Clarity®, a patient positioning system for ultrasound, indicated for use in external beam radiation therapy, and specifically for continuous monitoring of prostate motion during treatment with an Autoscan Probe.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets those criteria:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria in a clear, tabulated format. However, it mentions qualitative statements about performance and verification.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Localization accuracy and precisions | Verified with multimodality phantoms. |
| Clinical performance for prostate motion tracking | Demonstrated in a side-by-side comparison with the Calypso® 4D Localization System and qualitative assessment of transperineal 3DUS images from continuous monitoring sessions with actual patients under simulated treatment conditions. |
| Safe and effective performance of critical tasks | Evaluated through observational and performance data from a usability (simulated use) study with representative end-users and monitoring session data. |
| Compliance with design and risk management requirements | Test results demonstrate fulfillment. |
| Substantial equivalence to predicate devices for safety and effectiveness | Determined to be as safe and effective for its Intended Use as legally marketed predicate devices. Differences in technological characteristics do not raise different questions of safety and effectiveness. |
| 4D monitoring capability for prostate motion | Able to identify the soft-tissue target and track its motion over successive 3DUS images. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document mentions "actual patients" for the prostate motion tracking study, but does not specify the number of patients or the sample size.
- Data Provenance:
- Country of Origin: Not specified.
- Retrospective or Prospective: Not explicitly stated, but the description "continuous monitoring sessions with actual patients under simulated treatment conditions" suggests a prospective observational study. The usability study was a "simulated use" study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide information on the number of experts or their qualifications used to establish ground truth for the test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not specify any adjudication method for the test set.
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
The document describes a "side-by-side comparison with the Calypso® 4D Localization System" concerning "clinical performance for prostate motion tracking." This comparison is mentioned as a way to demonstrate the device's performance, but it is not described as an MRMC comparative effectiveness study where human readers improve with AI vs without AI assistance. The Clarity® device itself performs the "automatic image analysis and contouring of soft-tissue structures" to track motion, rather than assisting human readers in a diagnostic or interpretive task where improvement metrics like effect size would be quantified in the manner described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance assessment was done for the algorithm's capability.
The text states: "4D monitoring with Clarity® is based on automatic image analysis and contouring of soft-tissue structures, such as the prostate, in transperineal 3DUS images, which are continuously acquired during treatment. This is an expanded capability over the predicate Clority® OBP System, in that the Clority® software is now able to identify the soft-tissue target and track its motion over successive 3DUS images." This description clearly indicates an algorithm-only function (automatic image analysis and contouring, tracking motion over successive images).
Additionally, "Localization accuracy and precisions have been verified with multimodality phantoms," which would typically be a standalone performance test.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document mentions a "side-by-side comparison with the Calypso® 4D Localization System" for prostate motion tracking. In this context, the Calypso® 4D Localization System (which tracks electromagnetic signals from implanted markers) likely served as the reference or "ground truth" for the prostate motion, against which Clarity's performance was evaluated.
For "localization accuracy and precisions," the ground truth was derived from multimodality phantoms, which have known, precise target locations.
8. The sample size for the training set
The document does not provide any information about the sample size used for a training set. This is not uncommon for 510(k) summaries, which often focus on verification and validation studies rather than detailed development data.
9. How the ground truth for the training set was established
The document does not provide any information on how ground truth was established for a training set, as it does not mention a training set.
§ 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.