(61 days)
The Calypso System is intended for use as an adjunct in treatment planning and radiation therapy, to align and/or monitor the patient's position relative to the isocenter of a radiation therapy system. The Calypso System provides accurate, precise and continuous localization of a treatment isocenter by using two or more Beacon transponders.
The optional Dynamic Edge™ Gating component may signal a radiation therapy system to impose a beam-hold when the treatment target position has moved outside the defined tracking limits and to signal the radiation therapy system to remove the beam-hold upon the target's return to a position inside the defined tracking limits. The Dynamic Edge Gating feature has been shown to be compatible with Varian and Siemens radiation therapy treatment systems with external gating interfaces.
Implanted Beacon® transponders are indicated for use to radiographically and electromagnetically mark soft tissue for future therapeutic procedures.
Permanent Beacon transponders are indicated for implantation in the prostate and the peri-prostatic tissue (i.e., prostatic bed) to align and monitor the treatment isocenter in real time during radiation therapy.
Surface Beacon® transponders are indicated for temporary external placement on the skin. to monitor respiratory motion and other patient motion in real time during radiation therapy.
The Calypso System utilizes non-ionizing electromagnetic and optical technology to provide accurate, objective, and continuous localization of a treatment target for patient alignment and target position monitoring during radiation therapy. Use of the Calypso System for target localization is based on the system's detection of non-ionizing electromagnetic signals from passive markers, called Beacon® transponders. The Beacon transponders are implanted in or near the treatment target or placed externally on the surface of a patient.
Implanted Beacon transponders when used with the Calypso System enable objective measurement of the location of the target in 3 dimensions. The system operator uses this information to align the patient's treatment target to the isocenter of the therapy system prior to treatment. This information can also be used to monitor (track) the position of the treatment target during radiation therapy treatment.
When using Surface Beacon transponders this information can be used to monitor respiratory motion and other patient motion in real time during radiotherapy. When correlated to the patient's treatment target motion the system provides objective measurement of the location of the target in 3 dimensions.
The Dynamic Edge Gating feature enables the Calypso System to connect with radiation therapy systems configured with gating capabilities via an interface to external systems. With this feature added to the Calypso System, a beam hold is signaled to the radiation therapy system when the treatment target position has moved outside the defined tracking limits. The radiation therapy system is signaled to remove the beam-hold upon the target's return to a position inside the defined tracking limits.
The Calypso® System with Dynamic Edge™ Gating is a patient localization system. The application describes its key features and how it differs from already cleared devices.
Here's an analysis of the provided text regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly list quantitative acceptance criteria for the Calypso System's performance (e.g., specific accuracy thresholds in millimeters or latency requirements in milliseconds). Instead, it makes a general statement about performance testing.
| Acceptance Criteria Category | Specific Acceptance Criteria (Not explicitly stated, but implied) | Reported Device Performance |
|---|---|---|
| Target Localization Accuracy | Not explicitly stated (implied: accurate, precise, continuous localization) | "The Calypso System provides accurate, precise and continuous localization of a treatment isocenter..." |
| Gating Functionality (Dynamic Edge Gating) | Not explicitly stated (implied: compatible with radiation therapy systems, signals beam-hold/release appropriately) | "The Dynamic Edge Gating feature has been shown to be compatible with Varian and Siemens radiation therapy treatment systems with external gating interfaces." |
| Safety - Electrical & Mechanical | EN60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) | Device complies with EN60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) |
| Safety - EMC | EN60601-1-2 ed. 2.0 | Device complies with EN60601-1-2 ed. 2.0 |
| Software, Hardware, and System Validation | Performance to satisfy intended use. | "Results of software, hardware and system verification and validations testing demonstrate that the Calypso System satisfies the intended use as described above." |
| Interoperability | Compatibility with Varian and Siemens radiation therapy systems. | "The Dynamic Edge Gating feature has been shown to be compatible with Varian and Siemens radiation therapy treatment systems with external gating interfaces." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for any test set or provide details about the data provenance (e.g., country of origin, retrospective or prospective) for performance testing. It generally refers to "software, hardware and system verification and validations testing."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
The document does not mention the use of experts or a ground truth established by experts for performance testing related to target localization or gating. The performance testing appears to be internal engineering and validation tests rather than clinical studies requiring expert interpretation of ground truth.
4. Adjudication Method for the Test Set
As there is no mention of an expert panel or subjective assessment for performance testing, no adjudication method is described or implied.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. This device is a localization and gating system, not an AI-based diagnostic imaging tool, so such a study would not typically apply.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The entire system, including the Dynamic Edge Gating feature, operates as an automated system to monitor and signal beam-holds based on target position. While a human operator defines the tracking limits, the gating process itself is standalone in its execution (i.e., the algorithm automatically signals the beam-hold/release without constant human intervention during the process). The performance testing would therefore inherently be "standalone" in this context, evaluating the system's ability to accurately track and gate. However, the document does not explicitly use the term "standalone study" in this manner.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the type of ground truth used for its performance testing. Given the nature of the device (a localization and gating system), the "ground truth" for its accuracy and precision would likely be established through:
- Physical phantoms and precise measurement systems: For validating the 3D localization accuracy of the Beacon transponders.
- Simulated motion profiles: For validating the tracking and gating capabilities under controlled conditions.
- Technical specifications and engineering measurements: For assessing compliance with electrical and EMC safety standards.
8. The Sample Size for the Training Set
The document does not mention a training set or its sample size. The Calypso System is described as utilizing non-ionizing electromagnetic and optical technology for localization and monitoring, which implies a deterministic algorithm based on physics principles rather than a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned or implied, this information is not applicable and not provided.
§ 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.