(48 days)
Varian Verification System is designed to assist the operator of a radiation therapy device in providing accurate treatment setups for each patient by monitoring the correct selection of patient, patient-specific accessories, conical collimator accessory and preventing the radiation treatment device from commencing irradiation when the selected patient, patient-specific accessories or conical collimator are out of conformance with the treatment plan.
Varian Verification System (VVS) is a new product combining two existing products: Barcode Conical Collimator Verification (BCCV) and Patient Accessory Verification System (PAVS) under 4D Integrated Treatment Console (4DITC). With VVS the features of both BCCV and PAVS can be present, or alternatively, features of only BCCV or only PAVS. Key features include operator assistance in providing accurate treatment setups for each patient by monitoring the correct selection of patient, patient-specific accessories and conical collimator accessory. Also the system prevents the radiation treatment device from commencing irradiation when the selected patient, patient-specific accessories or conical collimator are out of conformance with the treatment plan.
The Varian Verification System (VVS) is a medical device designed to assist operators of radiation therapy devices in ensuring accurate treatment setups for patients. It does so by monitoring the correct selection of patient-specific accessories and conical collimators and preventing treatment if there's a mismatch with the treatment plan.
Based on the provided Premarket Notification [510(k)] Summary, here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list "acceptance criteria" in a quantitative format with performance values. Instead, it describes the functionalities and safety checks that the VVS provides, implying these functionalities are the "acceptance criteria" that the device must successfully perform. The device's performance is demonstrated through software verification and validation.
Implied Acceptance Criteria (based on Device Description and Intended Use) and Reported Performance:
| Acceptance Criteria (Functionality) | Reported Device Performance (as per document) |
|---|---|
| Correct selection of patient-specific accessories: Ability to monitor and confirm the use of the correct patient-specific accessories (e.g., blocks, boluses, compensators) according to the treatment plan. | VVS allows users to identify accessories (block, bolus, compensator) for patients and interlocks the radiation beam until these devices have been acknowledged. User staff creates labels for accessories using ARIA and a label printer. User scans appropriate accessories for verification. |
| Correct selection of conical collimator accessory: Ability to monitor and confirm the use of the correct conical collimator accessory according to the treatment plan. | VVS allows users to identify conical collimators and interlocks the radiation beam until these devices have been acknowledged. Pre-printed labels for conical collimators are provided as part of the VVS system. User scans appropriate accessories for verification. |
| Prevention of irradiation when out of conformance: The device must prevent the radiation treatment device from commencing irradiation if the selected patient, patient-specific accessories, or conical collimator are not in conformance with the plan. | This is fundamentally covered by the "interlock" mechanism described for both patient accessories and conical collimators. The system "prevents the radiation treatment device from commencing irradiation when the selected patient, patient-specific accessories or conical collimator are out of conformance with the treatment plan." |
| Patient verification: Ability to verify the patient on the treatment schedule with the patient in the treatment room. | VVS supports patient verification between the patient on the treatment schedule and the patient in the treatment room. |
| Support for hand-held barcode scanner: Integration and functionality with a hand-held barcode scanner for verification. | VVS uses a hand-held barcode scanner (Datalogic Gryphon 4400-HC-2D). |
| User-defined accessory configuration: Ability for users to define which accessories require barcode labels to be scanned. | VVS allows users to define which accessories (Conical Collimators and block, bolus, compensator) require a barcode label to be scanned. |
| Support for emergency patient treatment: Provision for emergency treatment when the treatment plan is not present in the Oncology Information System. | VVS supports emergency patient treatment when the treatment plan is not present in the Oncology Information System. |
Description of the Study that Proves the Device Meets Acceptance Criteria:
The key study mentioned is "Software Verification and Validation Testing."
2. Sample Size Used for the Test Set and Data Provenance:
- The document does not specify a sample size for a "test set" in the context of clinical or performance data for the VVS.
- The study described is "Software Verification and Validation Testing," which typically involves testing software functionalities against requirements. It does not refer to a patient dataset in the way a clinical study would.
- Data Provenance: Not applicable in the context of "Software Verification and Validation Testing" as described for a software-based device verification system. No patient data or geographical origin is mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- This information is not provided in the document. Software Verification and Validation Testing for a device like this would typically involve internal software engineers and quality assurance personnel, rather than experts establishing "ground truth" derived from medical images or patient outcomes. The "ground truth" here is the expected behavior and output of the software according to its design specifications.
4. Adjudication Method for the Test Set:
- This information is not provided as it pertains to clinical data or expert consensus, which are not detailed in the context of this software verification and validation.
- For software testing, "adjudication" would typically involve reviewing test results against expected outcomes, bug reporting, and resolution processes by the development and QA teams.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study was done or reported. The document explicitly states: "Clinical Tests No clinical tests have been included in this pre-market submission."
- Therefore, there is no information about the effect size of human readers improving with or without AI assistance. The VVS is a verification system, not an AI-assisted diagnostic or treatment planning system that would involve human readers interpreting output in that manner.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- The "Software Verification and Validation Testing" effectively serves as the standalone performance evaluation of the VVS.
- The system itself is designed to operate without continuous human intervention for its core verification tasks (i.e., it automatically monitors and interlocks based on selected items). The human "in the loop" is the operator who scans barcodes and acknowledges items, but the verification logic itself is standalone. The document states: "The software for this device was considered as a 'major' level of concern." This indicates a high level of rigor in the standalone software testing.
7. Type of Ground Truth Used:
- The ground truth for the "Software Verification and Validation Testing" is the design specifications and functional requirements of the VVS. The software is tested to confirm it correctly implements these predefined rules for monitoring accessory selection, patient verification, and preventing irradiation when conditions are not met.
- It is not based on expert consensus, pathology, or outcomes data, as these are typically associated with clinical performance studies.
8. Sample Size for the Training Set:
- This information is not applicable or not provided. The VVS appears to be a rule-based or deterministic system (i.e., barcode scanning and comparison to a treatment plan database), not a machine learning or AI system that requires a "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established:
- This information is not applicable as the device does not appear to utilize a "training set" in the context of machine learning. The "ground truth" for its operation is embedded in its design specifications and the data it receives from the treatment plan and scanned barcodes.
§ 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.