(41 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 (i.e., prostatic bed).
The Calypso System with the Dynamic Edge™ Gating modification enables the Calypso System to interface with radiation therapy systems configured with gating capabilities via an interface to external systems. This modification includes updated computer software and hardware.
All other features of the Calypso System remain as cleared by K060906 and K080726.
The provided text doesn't contain detailed acceptance criteria or a study that proves the device meets those criteria in the typical format of a clinical study with performance metrics. The information focuses on the regulatory submission (510(k)) for the Calypso System with Dynamic Edge™ Gating.
Here's an analysis of what information is available and what is not available based on your request:
1. A table of acceptance criteria and the reported device performance
- Available: The document states, "The Calypso System with the gating interface option utilizes non-ionizing electromagnetic and optical technology to provide accurate, objective, and continuous localization of a treatment target."
- Not available: Specific quantitative acceptance criteria (e.g., target localization accuracy in mm, latency requirements) and reported performance values against these criteria are not provided in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available: This information is not present in the provided text. The document broadly mentions "performance testing, including design verification and validation, software verification and validation, electromagnetic compatibility as well as other assessments." It does not describe a clinical study with a test set of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not available: As no specific clinical study with a test set involving expert review is described, this information is absent.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not available: No test set or adjudication method is described.
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 available: The Calypso System is a patient localization system, not an AI-assisted diagnostic imaging device that involves "human readers." Therefore, an MRMC study or AI assistance effect size is not applicable in this context and is not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Available (implicitly): The device itself is designed for "accurate, precise and continuous localization of a treatment isocenter," suggesting it performs this function independently. The "performance testing" mentioned, including software verification and validation, would evaluate its standalone function.
- Not available (explicit results): While implied, specific standalone performance metrics are not detailed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not available (for clinical ground truth): For a localization system, the "ground truth" would likely involve highly precise physical measurements or gold-standard imaging techniques to verify the system's ability to accurately locate the transponders. The document does not specify the methods used to establish this "ground truth" during testing.
8. The sample size for the training set
- Not available: The document does not mention a training set, as it describes a localization system, not a machine learning or AI-driven diagnostic device that typically requires a large training set of data.
9. How the ground truth for the training set was established
- Not available: Not applicable, as no training set is described.
Summary of what can be inferred from the text:
The document describes a medical device (Calypso System with Dynamic Edge™ Gating) that helps in radiation therapy by accurately locating a patient's position. It is an update to a previously cleared device. The "Summary of Performance Testing" section broadly states that the system underwent various tests (design, software, EMC) to ensure it meets its intended use, is safe and effective, and performs comparably to its predicate device. However, it does not provide specific performance metrics, study designs, or patient data details that would address your specific questions about acceptance criteria and proof of meeting them. This type of detailed performance data is typically found in the full 510(k) submission and associated test reports, which are summarized at a high level 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.