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Swift is a software application intended for use with Brachytherapy procedures, i.e. intercavitary, interstitial, intraluminal, involving afterloading radioactive sources.

Swift is a software application for Brachytherapy Treatment Planning, for the treatment of cancer, i.e. intercavitary, interstitial, intraluminal, involving radioactive sources.

Swift is a "real time" treatment planning system for brachytherapy especially meant for treatment of cancer in the prostate. Direct 3D Ultrasound imaging of the treatment gives the physician the possibility to update the planning of the dwell positions of the source in the prostate of the patient. The program provides a variety of plan evaluation tools to assist in generating the most optimal dose distribution, i.e. dose volume histograms, dose verification points and dose profiles. The software program provides the physician with anatomical and dosimetric information, to determine the positioning and loading of the radioactive sources, prior to radiation treatment. The program also provides the treatment time and dose distribution for the specified loading. From this the information the patient can be treated with the dwell positions of the source. The modified device is an accessory to an afterloader. The program consists of two modules: Treatment Planning Software: Swift and Database: Smoothbase. The software runs on a Windows XP platform.

It sounds like you're looking for a detailed breakdown of the acceptance criteria and study data for the Nucletron Swift 2.0 device based on the provided text. However, the provided text does not contain the specific information you're asking for regarding acceptance criteria, device performance, study details, and ground truth establishment.

The document is a 510(k) summary for a medical device (Nucletron Swift 2.0), which primarily focuses on:

• Device Identification: Trade name, common name, classification, manufacturer.
• Predicate Device: Identification of the legally marketed device it's substantially equivalent to.
• Description of Modifications: New functionalities added to the previously cleared device (e.g., Encoder, 3D Ultrasound acquisition, 3D VOI contouring, 3D Catheter recognition, Inverse Plan).
• Intended Use: The same as the predicate device, for brachytherapy treatment planning.
• Substantial Equivalence Statement: A declaration that it's equivalent to the predicate.
• FDA Clearance Letter: Formal approval from the FDA.
• Indications for Use Statement: The approved medical use for the device.

There is no information in the provided text about:

1. Acceptance criteria
2. Reported device performance metrics
3. Sample size for test sets or training sets
4. Data provenance (country, retrospective/prospective)
5. Number or qualifications of experts
6. Adjudication method
7. MRMC comparative effectiveness studies (or effect size)
8. Standalone (algorithm only) performance studies
9. Type of ground truth used (pathology, expert consensus, outcomes data)
10. How ground truth was established for training or test sets

This type of detailed performance data is typically found in the full 510(k) submission, specifically in sections related to performance testing, clinical data, or software validation, which are not included in this summary document.

To answer your request, you would need access to the full 510(k) submission documents for K031158 (Nucletron Swift 2.0) and potentially K022739 (Real Time HDR), as the Swift 2.0 is an updated version of the latter.

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