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510(k) Data Aggregation
(47 days)
The Varian High Energy Linear Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
The Varian High Energy Linear Accelerator models provide various selections among the features, specifications, and accessories that have been most recently cleared as the Varian High Energy Linear Accelerator, K100890.
The changes to the Varian High Energy Linear Accelerator provide support for treatments using the high intensity photon treatment mode, also known as FFF (Flattening Filter Free). Additionally, couch motion rules are modified to enable the use of patient support systems where the targeted anatomy and the treatment isocenter area below the surface of the couch top. Modifications that augment existing safety controls are also included.
All other features of the Varian High Energy Linear Accelerator models remain as cleared by K100890.
Here's a summary of the acceptance criteria and study information for the Varian High Energy Linear Accelerator, based on the provided 510(k) summary:
The 510(k) K112839 describes modifications to the Varian High Energy Linear Accelerator, primarily to support high-intensity photon treatment mode (FFF - Flattening Filter Free) and updated couch motion rules. The submission asserts substantial equivalence to its predicate device, K100890.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly derived from the functional and safety requirements, as well as compliance with applicable international standards. The performance is reported by demonstrating that the modified device functions equivalently or with improved safety features compared to the predicate device.
| Feature and/or Specification | Acceptance Criteria (Predicate Device K100890 Performance) | Reported Device Performance (Modified Device) |
|---|---|---|
| Release version of control software | C-Series 8.0 | C-Series 9.0 (Updated) |
| Gantry rotation collision protection (couch outside boundary) | Motion rules enforced when imaging arms are extended | Motion rules enforced whether imaging arms are extended or retracted (Improved) |
| Extended Travel Range Zone for Third-party Prone Breast Couch Insert | No (Support not present) | Yes (Support added) |
| Interlock preventing additional dose after beam hold | Hardware control | Hardware control plus additional secondary software check (Improved) |
| Software and hardware support for FFF / HIM (Flattening Filter Free/High Intensity Mode) | No (Support not present) | Yes (Support added) |
| Maximum rate at which dose delivery occurs for 10x photon energy | 600 MU per minute | 600 MU per minute (Unchanged) |
| Maximum rate at which dose delivery occurs for 10x FFF photon energy | None | 2400 MU per minute (New capability) |
| Maximum rate at which dose delivery occurs for 6x SRS photon energy | 1000 MU per minute | 1000 MU per minute (Unchanged) |
| Maximum rate at which dose delivery occurs for 6x FFF photon energy | None | 1400 MU per minute (New capability) |
| Maximum field size (3D Conformal Radiation Therapy) | 40cm x 40cm | 40cm x 40cm (Unchanged) |
| Maximum field size (IMRT) | 34cm x 40cm | 34cm x 40cm (Unchanged) |
| Maximum field size (SRS) | 15cm x 15cm | 15cm x 15cm (Unchanged) |
| Maximum allowable dose limit for fixed X treatment type (non-SRS and non-FFF) | 1999 MU | 1999 MU (Unchanged) |
| Maximum programmable dose | 9999 MU | 9999 MU (Unchanged) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical data or patient samples. The testing described is primarily bench testing for verification and validation of functional requirements, use cases, hazard mitigation, and compliance with international standards. Therefore, the concept of sample size and data provenance (country, retrospective/prospective) related to patient data is not applicable here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This submission focuses on engineering and regulatory compliance testing of a medical device, not on diagnostic accuracy requiring expert interpretation of medical images or patient outcomes for a "ground truth" establishment.
4. Adjudication Method for the Test Set
Not applicable. As described above, the testing involved engineering verification and validation against pre-defined specifications and standards, not clinical adjudication of diagnostic or treatment outcomes by experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically used for AI-powered diagnostic devices to assess the impact of AI assistance on human reader performance. The Varian High Energy Linear Accelerator is a treatment delivery device, and the changes described relate to its operational capabilities and safety features, not to diagnostic image interpretation or AI assistance for human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
Not applicable. The device is a linear accelerator for radiation therapy, not a standalone AI algorithm. Its operation inherently involves human-in-the-loop (e.g., medical physicists, radiation oncologists, radiation therapists) for treatment planning and delivery. The "standalone" concept for an algorithm does not fit the nature of this device.
7. Type of Ground Truth Used
The "ground truth" for the performance testing effectively consisted of:
- Pre-defined specifications and functional requirements for the device.
- Hazard mitigation requirements based on risk analysis.
- Applicable international medical device standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-1).
The testing aimed to demonstrate that the device met these engineering and safety benchmarks, rather than clinical outcomes or pathological diagnoses.
8. Sample Size for the Training Set
Not applicable. The Varian High Energy Linear Accelerator is a hardware and software system for radiation therapy delivery. It does not utilize a "training set" in the machine learning sense for its operational functions as described in this submission. Its software development and configuration are based on established engineering principles and requirements, not statistical learning from a large dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of machine learning for this device. The software and hardware capabilities are developed and validated against engineering specifications and regulatory standards.
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