(140 days)
The Calypso System is intended for use as an adjunct in treatment planning and radiation the our poor ijo align and/or 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 which 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 interface with radiation therapy systems configured with gating capabilities via an interface to external systems. With this optional 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 provided text is a 510(K) summary for the Calypso® System Surface Beacon® transponders. It describes the device, its indications for use, and a summary of performance testing. However, it does not contain specific acceptance criteria, detailed study results, sample sizes for test/training sets, or details about expert ground truth establishment for the performance testing.
The summary states: "Results of verification and validation testing demonstrate that the Surface Beacon transponder satisfies the intended use as described above." This is a general statement that implies the device met its performance goals, but the specific metrics, criteria, and detailed study information are not included in this document.
Therefore, I cannot populate the requested table or provide the detailed information about the study design using only the provided text.
Here's a breakdown of what could be extracted if the information were present, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Specific Metric & Threshold) | Reported Device Performance (Value/Outcome) |
|---|---|
| Not provided in the document | Not provided in the document |
Missing Information for 2-9:
- Sample size used for the test set and the data provenance: The document mentions "verification and validation testing" but does not specify the sample size (number of cases/patients) or the data source (e.g., country of origin, retrospective/prospective).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
- 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 describes a "patient localization system" and "monitoring respiratory motion," which suggests it's a device for real-time tracking, not an AI for image interpretation that would typically involve human readers needing improvement with AI assistance. Therefore, an MRMC study in this context is unlikely, and no such study is described or referenced.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The "Summary of Performance Testing" notes that "Results of verification and validation testing demonstrate that the Surface Beacon transponder satisfies the intended use." While this implies standalone performance was evaluated, the details of that evaluation are missing.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not specified. For a tracking system, ground truth would likely involve highly precise physical measurements or a gold-standard tracking system, but this is not detailed.
- The sample size for the training set: The document doesn't mention any training sets, which is typical for a hardware-based tracking system rather than an AI/machine learning model.
- How the ground truth for the training set was established: Not applicable, as no training set is mentioned for this type of device.
In summary, the provided 510(k) summary only states that performance testing was conducted and the device met its intended use. It does not provide the specific details of the acceptance criteria or the study methodology requested.
§ 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.