(116 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 permanent implantation in the prostate only.
The Calypso 4D Localization System (Calypso System) is designed 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 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 radiation therapy and to monitor the position of the treatment target during treatment.
The provided text does not contain explicit acceptance criteria or a detailed study description with specific metrics and results that would allow for the completion of the requested table.
The document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to predicate devices and outlining the device's indications for use. It mentions "performance testing" and "clinical and nonclinical testing" but does not provide the specific details needed to answer most of your questions.
Here's an analysis of what is and isn't available:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in the provided text. There are no numerical targets or thresholds mentioned for accuracy, precision, or other performance metrics.
- Reported Device Performance: The text generally states that the system is "accurate and reliable" and "can accurately and reliably provide localization and tracking information." However, it does not provide quantitative results like mean error, standard deviation, sensitivity, specificity, or AUC.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test Set Sample Size: Not mentioned. The text refers to "a subset of the patients" for tracking prostate motion but provides no number.
- Data Provenance: Not mentioned. It's unclear if the data was retrospective or prospective, or from what country.
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):
- Number of Experts: Not mentioned.
- Qualifications of Experts: Not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not mentioned. There is no information on how ground truth was established by experts.
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:
- MRMC Study: Not mentioned. The device is for patient localization and tracking, not for analysis by human readers in the traditional sense of an imaging diagnostic AI. The "human-in-the-loop" would be the operator using the system for alignment and monitoring, but no comparative effectiveness study on their improvement is described.
- Effect Size: Not applicable based on the available information.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device inherently involves a human operator to physically align the patient based on the system's output. Therefore, a purely "standalone" (algorithm only, no human action) performance test as typically understood for an AI diagnosing images, is not directly applicable. The performance described relates to the system's ability to provide localization data, which then enables human action.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated. Given the nature of the device (localization of an implanted transponder), the ground truth for localization would likely be derived from a highly accurate, independent measurement system or fiducial reference, but this is not detailed.
8. The sample size for the training set:
- Not mentioned.
9. How the ground truth for the training set was established:
- Not mentioned.
In summary, the provided document focuses on regulatory compliance (510(k) summary) and broad statements of safety and effectiveness, rather than a detailed scientific study report with specific performance metrics and methodologies. To obtain the requested information, a full clinical study report or a more detailed technical document would be required.
§ 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.