(87 days)
The Calypso system is intended for use as an adjunct in treatment planning and radiation therapy, to align and/or 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.
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 body, specifically in the prostate and peri-prostatic tissue (i.e., prostatic bed), and in soft tissue to align and monitor the treatment isocenter in real time during radiation therapy.
The Soft Tissue Beacon Transponder is a small, radiopaque, echogenic, electromagnetic fiducial marker designed for permanent implantation and intended for radiotherapy target localization to ensure accurate positioning for radiation therapy. It consists of a sealed biocompatible-glass capsule containing a small, passive electrical circuit. The Soft Tissue Beacon Transponder may be used with the Calypso System (3.0 or later) as an electromagnetic fiducial marker, or with radiographic-based systems (e.g., kV x-ray, fluoroscopy, and CT) as a radiographic fiducial marker.
Each transponder is implanted with a separate 14G introducer needle (introducer) in or near the tumor or intended radiation target. Three Soft Tissue Beacon Transponders and three single-use introducers are provided in each Soft Tissue Beacon Care Package. The device is single-use and provided sterile.
This document is a 510(k) summary for Varian Medical Systems' Soft Tissue Beacon Transponder, detailing its substantial equivalence to predicate devices. It does not contain information about a study that proves the device meets specific acceptance criteria with reported performance metrics, expert qualifications, or detailed study design. The document focuses on regulatory approval based on equivalence, not on a performance study against predefined criteria.
Therefore, most of the requested information cannot be extracted from the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be extracted. The document outlines indications for use and device characteristics, but it does not present specific acceptance criteria (e.g., minimum accuracy thresholds, signal strength requirements) or a study reporting performance against such criteria. The entire document is a substantial equivalence comparison, not a performance study report.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be extracted. No performance study or test set is described.
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)
- Cannot be extracted. No ground truth establishment for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be extracted. No adjudication method for a test set 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
- Cannot be extracted. No MRMC study is mentioned. This device is a fiducial marker, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Cannot be extracted. The device is a physical fiducial marker, not an algorithm. Its function is to be implanted and tracked by a separate system (Calypso System or radiographic systems). Standalone algorithm performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be extracted. No ground truth for a performance study is described.
8. The sample size for the training set
- Cannot be extracted. As this is a physical medical device (fiducial marker) and not a machine learning algorithm, the concept of a "training set" in this context does not apply.
9. How the ground truth for the training set was established
- Cannot be extracted. See point 8.
§ 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.