(44 days)
The CT Compatible F/S/D applicator is indicated for use in any case where high dose rate (HDR) radiation treatment of cancer in the cervix and uterus is an accepted clinical practice.
The CT Compatible F/S/D Applicator presented in this 510(k) notification has been developed to function for the positioning of HDR Remote After-Loader sealed sources in the treatment of cancer of the cervix or uterus. The design of these systems is the similar to that of the predicate devices listed below. The delivery of radiation therapy via high dose rate Brachytherapy treatment of the cervix or uterus requires not only a stable system for precise dosimetry but also a reproducible and predictable geometry for positioning of the radioactive source under remote control. The CT Compatible F/S/D Applicator is designed to act as such a device.
This 510(k) submission (K063381) for the CT Compatible F/S/D Applicator does not contain a study demonstrating specific device performance against acceptance criteria. Instead, it relies on a declaration of substantial equivalence to existing predicate devices. Consequently, many of the requested sections regarding performance studies cannot be filled as the information is not present in the provided text.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
No specific acceptance criteria or quantitative device performance data are provided in this 510(k) submission. The submission focuses on demonstrating substantial equivalence to predicate devices rather than providing a performance study with defined criteria. The rationale for approval is based on similarity in design, construction, materials, intended use, and performance characteristics compared to the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No test set or performance study is detailed in the provided document.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. No test set requiring ground truth establishment is detailed.
4. Adjudication Method for the Test Set
Not applicable. No test set or adjudication process is mentioned.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The submission does not describe any human-in-the-loop studies or comparisons of human reader performance with or without AI assistance. The device in question is an applicator for radiation treatment, not an AI-driven diagnostic or interpretative tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The CT Compatible F/S/D Applicator is a physical medical device (an applicator for remote-controlled radionuclide delivery), not an algorithm or software requiring standalone performance evaluation.
7. The Type of Ground Truth Used
Not applicable. As there is no performance study or AI component, the concept of "ground truth" as it relates to expert consensus, pathology, or outcomes data for performance evaluation is not relevant to this submission.
8. The Sample Size for the Training Set
Not applicable. The device is a physical medical instrument, not a machine learning model. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this device.
In summary, the provided 510(k) K063381 for the CT Compatible F/S/D Applicator does not include a performance study with acceptance criteria. The approval is based on substantial equivalence to predicate devices, asserting that the new device shares similar design, construction, materials, intended use, and performance characteristics, without introducing new issues of safety or effectiveness.
§ 892.5700 Remote controlled radionuclide applicator system.
(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.