(61 days)
The Calypso® 4D Localization 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 linear accelerator. The Calypso® System provides accurate, precise and continuous localization of a treatment isocenter by using two or more Beacon transponders.
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.
The Calypso 4D Localization System (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 implanted markers, called Beacon transponders. The Beacon transponders are implanted in or near the treatment target. 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 linear accelerator prior to treatment. This information can also be used to monitor (track) the position of the treatment target during radiation therapy treatment.
The provided 510(k) summary for the Calypso® 4D Localization System (K080726) does not contain detailed information about specific acceptance criteria and a study proving that the device meets these criteria. The document states "Performance testing demonstrated substantial equivalence," but it lacks the specific data, methodology, and results required to answer many of your questions.
Here's an breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
| (e.g., Accuracy, Precision, Response Time, etc., with quantitative thresholds) | (e.g., Achieved accuracy of X, precision of Y, etc.) |
Explanation: The document does not list any specific performance metrics or thresholds that the device was required to meet. It broadly states "Performance testing demonstrated substantial equivalence," but no details on what was tested or the results are provided.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Information not provided. The document does not mention any test set sample sizes, data provenance (country of origin), or whether the study was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Information not provided. The document does not describe any human expert involvement in establishing ground truth for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Information not provided. Since no expert review or test set is described, no adjudication method is mentioned.
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
Not applicable. This device is a patient localization system, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images. The primary function is to track the physical position of a treatment target. The document does not describe any MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device's core function is "algorithm only" in the sense that it automatically detects and tracks transponders. However, the document does not explicitly provide data from a "standalone" performance study in the way this question is typically asked for AI diagnostic tools (i.e., comparing algorithm output to ground truth without human intervention). The "performance testing" mentioned is likely related to the system's ability to accurately and precisely localize the transponders.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Information not provided. The document does not specify how "ground truth" was established for any performance testing. For a localization system, ground truth would likely involve highly accurate physical measurement systems.
8. The sample size for the training set
Information not provided. This device is not described as a machine learning/AI predictive model that would typically have a "training set" in the conventional sense. Its function relies on detecting electromagnetic signals from transponders, not on learning patterns from a large dataset.
9. How the ground truth for the training set was established
Information not provided. As mentioned above, a training set in the AI context is not applicable here given the device's description.
In summary, the provided 510(k) summary is very high-level and focuses on the regulatory aspects of substantial equivalence, rather than providing detailed technical performance study results and methodologies. For a device of this nature (a localization system), the performance testing would typically involve evaluating accuracy, precision, and response time under various conditions (e.g., different transponder configurations, distances, and potential interference). However, these details are not present in this document.
§ 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.