(117 days)
Vitesse is indicated for use as a treatment planning software application used by medical professionals to plan,guide,optimize and document high-dose-rate brachytherapy procedures
The Varian VITESSE 5.0 is a stand-alone application which provides treatment planning features for high dose rate brachytherapy. Vitesse supports real-time ultrasound guided implant procedures as well as image import based workflows based on DICOM RT. Vitesse supports DICOM RT export of the plan to another external dose planning system (e.g., Brachy Vision) or directly to the brachytherapy afterloader treatment unit.
Here's a breakdown of the acceptance criteria and the study information based on the provided text, unfortunately, much of the requested information (like specific performance metrics, sample sizes for test sets, expert details, or ground truth establishment) is not detailed in this 510(k) summary. This document primarily focuses on demonstrating substantial equivalence through software verification and validation, rather than a detailed performance study with quantifiable metrics against a ground truth.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Modification | Method of Evaluation | Acceptance Criteria (Explicitly Stated is Lacking) | Reported Device Performance (as stated) |
|---|---|---|---|
| Export plan to DICOM destination (e.g., Aria, Velocity) over network (DICOM C-STORE) | Software verification and validation covering the performance and use of this feature | Implied: Successful and accurate transfer of treatment plans via DICOM C-STORE. | Software verification and validation demonstrate the feature performs as intended. |
| Populate key elements of patient record from Aria via DICOM query (DICOM C-FIND) | Software verification and validation covering the performance and use of this feature | Implied: Successful and accurate retrieval and population of patient record elements via DICOM C-FIND. | Software verification and validation demonstrate the feature performs as intended. |
| Require user to enter valid Windows credentials and permissions prior to accessing Vitesse | Software verification and validation covering the performance and use of this feature | Implied: Successful enforcement of Windows security credentials and permissions. | Software verification and validation demonstrate the feature performs as intended. |
| Provide more direct visualization of region definitions on the main UI | Software verification and validation covering the performance and use of this feature | Implied: Region definitions are displayed clearly and accurately on the UI. | Software verification and validation demonstrate the feature performs as intended. |
| Provide support for PET images as secondary image volumes | Software verification and validation covering the performance and use of this feature | Implied: Successful import and display of PET DICOM images as secondary volumes without degradation. | Software verification and validation demonstrate the feature performs as intended. |
| Provides support for import of PET DICOM images as secondary image volumes | Software verification and validation covering the performance and use of this feature | Implied: Successful import and display of PET DICOM images as secondary volumes without degradation. (Redundant with previous entry) | Software verification and validation demonstrate the feature performs as intended. |
| Provides support of capturing color images (e.g., from color Doppler) and displaying them as color images | Software verification and validation covering the performance and use of this feature | Implied: Successful capture and accurate display of color images from various imaging modes. | Software verification and validation demonstrate the feature performs as intended. |
| Overall device requirements and risk control measures | Software verification and validation testing | Implied: Performance as intended at a level similar to the predicate device. | "Software verification and validation testing for Vitesse 5.0 demonstrates that the device requirements and risk control measures perform as intended at a level similar to the predicate." |
| Usability | Usability testing (according to IEC 62366) | Implied: Device performs well as intended for intended users, uses, and use environments. | "Usability testing was conducted according to the standard IEC 62366 to verify that the subject device performs well as intended for the intended users, uses, and use environments." |
| Cybersecurity | Assessment per FDA guidances ("Cybersecurity in Medical Devices" series) | Implied: Prevention of unauthorized access, modification, misuse, denial of use, or unauthorized use of information. | "Varian Medical Systems conforms to cybersecurity requirements by implementing a means to prevent unauthorized access, modification, misuse, denial of use or unauthorized use of information stored, accessed or transferred from a medical device to an external recipient." |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in terms of patient data or a dataset of medical images with ground truth for performance evaluation of specific features. The testing described is primarily software verification and validation testing and usability testing.
- Software Verification and Validation: This typically involves testing against software requirements and design specifications, which may use simulated data or previously known cases, but specific sample sizes of patient data are not mentioned.
- Usability Testing: The text states it was conducted, but provides no details on the number of participants or the nature of the test cases.
- Data Provenance: Not applicable in the context of the described software verification and validation, as it doesn't involve clinical data from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The study described is not a performance study against an established medical ground truth, but rather engineering verification and validation of software functionalities.
4. Adjudication method for the test set
This information is not provided as there is no described test set of medical cases requiring adjudication.
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
No, an MRMC comparative effectiveness study was not done. The device is a treatment planning software, not a diagnostic AI system for human readers. No AI assistance or human reader improvement effect size is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This document describes the validation of a standalone software application (Vitesse 5.0) which provides treatment planning features. Its performance is evaluated through software verification and validation testing and usability testing, as opposed to a clinical performance study measuring accuracy against pathology. The software itself is standalone, but it is a "treatment planning software application used by medical professionals," meaning it is intended for human-in-the-loop use. The "standalone" here refers to it being a distinct software product rather than an integrated component of a larger system, not a fully automated AI system without human involvement.
7. The type of ground truth used
The concept of "ground truth" as typically understood in performance studies (e.g., pathology, clinical outcomes) is not applicable here. The primary "truth" against which the software was tested was its software specifications and requirements. The testing ensures the software functions as designed and intended, meets usability criteria, and adheres to cybersecurity standards, rather than assessing its diagnostic or prognostic accuracy against a biological or clinical gold standard.
8. The sample size for the training set
This information is not applicable and therefore not provided. This device is a treatment planning software, not a machine learning or AI model that requires a training set of data.
9. How the ground truth for the training set was established
This information is not applicable and therefore not provided as there is no training set mentioned or implied for this device.
§ 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.