(57 days)
The Calypso® System is intended for use as an adjunct in treatment planning and radiation therapy, to align and 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.
Beacon transponders are indicated for use to radiographically and electromagnetically mark soft tissue for future therapeutic procedures.
Permanent Beacon transponders are indicated for permanent implantation in the prostate and the peri-prostatic tissue (i.e., prostatic bed).
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 either the prostatic tissue (i.e., prostatic bed). When used with the Calypso System, the Beacon transponder signals enable objective measurement of the location of the treatment 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.
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.
This 510(k) summary does not contain the acceptance criteria or a study proving the device meets specific acceptance criteria for the new "Dynamic Edge Gating" feature beyond compatibility. The document explicitly states: "There has been no change to the device performance, software or hardware. Testing performed in support of K102373 demonstrated substantial equivalency and safety and effectiveness." This indicates that the current submission (K112768) is a modification to an already cleared device, and thus, relies on previous clearances for performance validation.
However, based on the information provided, we can infer some details related to the device's functionality and the predicate device's performance, as well as the context of substantial equivalence.
Here's an analysis based on the provided text, highlighting the absence of specific details for the requested categories related to this specific submission:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied from device function/Indications for Use) | Reported Device Performance (from the document) |
|---|---|
| Target Localization Accuracy: Ability to accurately determine the 3D position of Beacon transponders. | "The Calypso System provides accurate, precise and continuous localization of a treatment isocenter by using two or more Beacon® transponders." (Indications for Use) |
| "The Beacon Transponders are implanted in either the prostatic tissue (i.e., prostatic bed). When used with the Calypso System, the Beacon transponder signals enable objective measurement of the location of the treatment target in 3 dimensions." (Device Description) | |
| Gating Functionality: Ability to signal a beam-hold to a radiation therapy system when the target moves outside defined limits and remove the beam-hold when it returns. | "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." (Device Description) |
| "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." (Indications for Use) | |
| Compatibility with Radiation Therapy Systems: Successful integration and communication with external radiation therapy systems with gating interfaces. | "The Dynamic Edge Gating feature has been shown to be compatible with Varian and Siemens radiation therapy treatment systems with external gating interfaces." (Indications for Use) |
| Real-Time Monitoring and Tracking: Continuous display and recording of patient motion. | "Real Time Monitor patient motion" (No change from predicate) |
| "Real Time Tracking Patient motion" (No change from predicate) | |
| "Display and Record motion" (No change from predicate) | |
| Electrical Safety: Compliance with relevant international standards. | "IEC 60601-1; IEC 60601-1-1" (No change from predicate) |
| EMC Safety: Compliance with relevant international standards. | "IEC 60601-1-2" (No change from predicate) |
Note on Acceptance Criteria: The document primarily focuses on the capabilities and compatibility of the new feature and states "No change" in performance for core functionalities. It refers to previous submissions (K102373, K060906, K080726) for substantial equivalency and safety/effectiveness testing. Therefore, specific quantitative acceptance criteria (e.g., "accuracy must be within X mm") for the new feature are not detailed in this particular summary. The "compatibility" statement for Varian and Siemens systems serves as a key performance criterion for the "Dynamic Edge Gating" component.
Study Details (for the new "Dynamic Edge Gating" feature)
Based on the provided 510(k) summary, specific details about a new study for the "Dynamic Edge Gating" feature are largely absent, as the submission relies on previous clearances.
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Sample size used for the test set and the data provenance:
- Not explicitly stated for the "Dynamic Edge Gating" feature. The document states, "The Dynamic Edge Gating feature has been shown to be compatible with Varian and Siemens radiation therapy treatment systems with external gating interfaces." This implies testing was done, but specific sample sizes (e.g., number of tests, duration, patient data if any) are not provided. The provenance of data for this compatibility testing is also not specified.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not stated for this submission. The determination of "compatibility" for the gating feature would likely involve technical verification against specifications of the interfaced systems, rather than expert interpretation of medical images or outcomes.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not stated for this submission. This refers to methods for resolving discrepancies in expert opinion, which is not relevant for the type of technical compatibility testing implied here.
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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:
- No. This device is a patient localization and motion monitoring system, not an AI diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant to its function.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The core device operation, including localization and gating, functions largely automatically once parameters are set. The "Dynamic Edge Gating" component autonomously signals beam holds based on defined tracking limits. The "compatibility" testing would have assessed this automated function. However, the device is explicitly "an adjunct in treatment planning and radiation therapy" and involves operator alignment, so it's not entirely without human involvement in its overall use. The performance of the gating system itself (signaling beam holds) is an automated function.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the "Dynamic Edge Gating" feature's "compatibility" claim: The ground truth would likely be the actual operational state of the interfaced Varian and Siemens radiation therapy systems (i.e., did the beam-hold signal correctly trigger a beam hold, and did the release signal correctly release it, according to the predefined motion thresholds). This is a technical validation against the expected behavior of the interconnected systems. For the underlying localization, the ground truth would be precise physical measurements of transponder positions.
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The sample size for the training set:
- Not applicable. This device is hardware and software for real-time localization and gating based on electromagnetic signals. It does not explicitly mention machine learning or AI models that require a "training set" in the conventional sense (e.g., for image classification or diagnosis). Its functionality is based on known physics and engineering principles.
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How the ground truth for the training set was established:
- Not applicable. (See #7).
Summary of the K112768 Submission's Approach:
This 510(k) submission (K112768) is for an updated version of an existing device (Calypso System) with an added feature, "Dynamic Edge Gating." The document explicitly states that there are "no changes to the device performance, software or hardware" for the core system. The primary focus of this new submission, regarding performance and a "study," is the compatibility of the "Dynamic Edge Gating" feature with specific Varian and Siemens radiation therapy systems. The claim of "substantial equivalency" largely rests on the predicate device's existing performance data and the successful technical integration of the new gating function. Specific, detailed reports of new clinical studies with quantitative acceptance criteria for this particular submission are not provided within the 510(k) summary.
§ 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.