(42 days)
Vitesse 2.0 is a software application used to facilitate intraoperative needle planning and anatomy contouring during the process of planning HDR brachytherapy procedures for patients with prostate cancer. Vitesse will export this data to be utilized for treatment planning.
Vitesse is a software application used to facilitate brachytherapy high dose rate treatment planning for patients with prostate cancer.
Vitesse 2.0 is a computer based software application which will allow for the facilitation of intraoperative needle planning and anatomy contouring during the process of planning High Dose Rate brachytherapy procedures. Vitesse provides image acquisition and needle planning functions. It does not provide any modeling of the HDR source nor dose it calculate radiation dose estimates. Vitesse only exports its images, contours and needle positions using the DICOM RT standard to the planning system where the source positions are modeled, and the dose is calculated, evaluated and the plan is finalized. Vitesse 2.0 does not provide a treatment plan, but instead exports a source location plan to treatment planning systems for completion.
This 510(k) summary for Varian Medical Systems, Inc. Vitesse 2.0 does not contain specific acceptance criteria or a detailed study proving the device meets acceptance criteria in the format requested.
The document focuses on:
- Device Description and Intended Use: Explaining what the Vitesse 2.0 software does (facilitates intraoperative needle planning and anatomy contouring for HDR brachytherapy in prostate cancer) and what it does not do (no dose modeling or calculation, no final treatment plan).
- Technological Characteristics: Stating that the device is substantially equivalent to a predicate device (BrachyVision 6.0 K992762).
- Software Features: Listing the functionalities of the software (image acquisition, contouring, needle placement, visualization, database, etc.).
Information Not Found in the Provided Text:
Therefore, I cannot populate the table or provide answers for most of the requested points based solely on the provided text. The document doesn't include details about a specific study with quantitative performance metrics, acceptance criteria, sample sizes, expert involvement, or ground truth establishment.
Possible Reason:
For certain types of medical device submissions, particularly for software that is deemed "substantially equivalent" to an existing predicate and primarily performs planning and visualization functions without direct diagnostic or therapeutic output (i.e., it exports data to another system for dose calculation and treatment planning), the FDA may not require extensive performance studies with quantitative acceptance criteria, ground truth, or MRMC comparative effectiveness studies as would be expected for a diagnostic AI algorithm. The focus for such devices often lies on software verification and validation, ensuring it functions as intended and interfaces correctly, rather than clinical efficacy studies in the traditional sense.
Summary of available information:
| Requirement | Details from Vitesse 2.0 510(k) Summary |
|---|---|
| 1. Table of Acceptance Criteria & Reported Performance | Not provided. The document states the device is "substantially equivalent" to BrachyVision, implying it meets similar standards, but no explicit acceptance criteria or reported performance metrics (e.g., accuracy, precision) for Vitesse 2.0 itself are given. |
| 2. Sample Size (Test Set) & Data Provenance | Not provided. No details about a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective nature) are included. |
| 3. Number & Qualifications of Experts for Ground Truth | Not provided. No information regarding experts used to establish ground truth is mentioned. This is consistent with the absence of a performance study focused on diagnostic accuracy or clinical outcomes. |
| 4. Adjudication Method | Not provided. As no ground truth establishment by experts is described, there is no mention of an adjudication method. |
| 5. Multi-Reader Multi-Case (MRMC) Study & Effect Size | Not provided. The document does not describe an MRMC study or any assessment of human reader improvement with or without AI assistance. This device is a planning tool, not a diagnostic AI intended to assist human readers in image interpretation. |
| 6. Standalone (Algorithm Only) Performance Study | Not provided. The document describes the software's features and its role in a workflow, but not a standalone performance study with specific metrics, as it is a tool for facilitating planning, not an independent decision-making algorithm. Its "performance" would likely be assessed through software validation rather than clinical studies. |
| 7. Type of Ground Truth Used | Not provided. There is no mention of ground truth established through expert consensus, pathology, or outcomes data. |
| 8. Sample Size for Training Set | Not provided. The document does not discuss a training set, as it describes a software application developed using traditional programming methods (Microsoft Visual C++) rather than a machine learning model that would typically require a training set. |
| 9. How Ground Truth for Training Set Was Established | Not provided. No training set or associated ground truth establishment is mentioned. |
§ 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.