(49 days)
The UNIQUE is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
The UNIQUE is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
The UNIQUE is a Single Energy Linear Accelerator and includes modifications to the previously cleared Varian Trilogy. The UNIQUE provides additional features, safety improvements, and usability improvements. UNIQUE is supported by the following Varian accessories: RPM Respiratory Gating (063270), PortalVision (K091209), 4D Integrated Treatment Console (K091132), Millennium Multi-Leaf Collimator (K050442).
The provided text describes a 510(k) summary for the Varian UNIQUE linear accelerator. It focuses on demonstrating substantial equivalence to a predicate device, the Varian Trilogy, rather than presenting a study with specific acceptance criteria and reported device performance metrics in the way a diagnostic AI device would.
Therefore, much of the requested information regarding sample sizes, expert ground truth, adjudication methods, MRMC studies, and standalone performance for a diagnostic AI device is not applicable to this submission. This is a submission for a physical medical device (linear accelerator) used for radiation therapy, not a diagnostic algorithm.
However, I can interpret the available information to address the spirit of your request as best as possible within the context of a medical device 510(k) submission.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly list quantitative acceptance criteria with corresponding performance metrics in a table. Instead, the "acceptance criteria" are implied by demonstrating that the UNIQUE's performance and safety characteristics are "substantially equivalent" to the predicate device (Varian Trilogy K072916) and that its design meets internal requirements. The "reported device performance" is a general statement that "the results of verification and validation activities demonstrate that the acceptance criteria have been met."
Instead of performance metrics, the document focuses on comparing device characteristics:
| Item | Acceptance Standard (Predicate Device: Trilogy - K072916) | Reported Device Characteristic (UNIQUE) |
|---|---|---|
| C-Series Software | C-Series 7.7 | C-Series 8.0 |
| Photon Energy (MV) available | 4-25 MV | 6 MV |
| Selectable Number of Photon Beams | Two | One |
| Dose Rates | 50-600 MU/min (1000 SRS rate) | 100 - 600 MU/min (No SRS rate) |
| Maximum standard treatment field size | 40cm x 40cm | 40cm x 40cm |
| Electron Treatment | Yes | No |
| Arc Treatments | Yes | Yes |
| Non-arc photon treatment mode programmable MU maximum dose | 999 MU | 1999 MU |
| Patient Support surface: Exact Couch | Yes | Yes |
| Patient support surface: Exact couch pedestal with IGRT couch top for improved MV imaging | No | Yes |
| Drive mechanism | Direct Drive | Clutch |
| Treatment Beam generation | Klystron | Magnetron |
| Support for External System Gating Interface "EXGI" | No | Yes |
2. Sample size used for the test set and the data provenance
Not Applicable (N/A). This K101757 submission is for a physical medical device (linear accelerator) used for radiation therapy. It does not involve a "test set" of medical images or data for an AI algorithm in the typical sense. The "testing" refers to verification and validation of the hardware and software functionality to ensure it meets design specifications and safety requirements, often through engineering tests, rather than a diagnostic performance study on a patient sample.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable (N/A). As above, this device does not utilize a "ground truth" established by experts in the context of diagnostic interpretation. Ground truth for a linear accelerator would relate to its physical performance metrics (e.g., dose accuracy, beam flatness, reproducibility), which are typically verified against established physics and engineering standards, not expert consensus on medical images.
4. Adjudication method for the test set
Not Applicable (N/A). There is no mention of an adjudication method, as it doesn't involve subjective interpretations of medical data requiring such a process.
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
Not Applicable (N/A). This device is a treatment delivery system, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is irrelevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not Applicable (N/A). There is no mention of an "algorithm only" performance study because the device itself is a physical linear accelerator, not a standalone algorithm. Its functionality is integral to the hardware.
7. The type of ground truth used
Not Applicable (N/A) in the diagnostic sense. The "ground truth" for this type of device would be established by engineering specifications, physical measurements (e.g., dosimetry data), and regulatory standards for safety and performance of linear accelerators. The submission states, "Varian design control procedures applied to the development of the UNIQUE include requirements reviews, risk analysis, and verification and validation testing. The results of verification and validation activities demonstrate that the acceptance criteria have been met." This implies the "ground truth" is adherence to these established design and safety requirements.
8. The sample size for the training set
Not Applicable (N/A). As this is a physical medical device and not a machine learning algorithm for diagnostic interpretation, there is no "training set."
9. How the ground truth for the training set was established
Not Applicable (N/A). No training set means no ground truth for it.
In summary: The K101757 submission for the Varian UNIQUE linear accelerator is a 510(k) summary demonstrating substantial equivalence to a predicate device. It focuses on comparing the engineering and functional characteristics of the new device to an existing one, along with stating that internal verification and validation processes confirmed its safety and performance against design requirements. It is fundamentally different from a submission for a diagnostic AI device, which would involve data sets, ground truths, and performance metrics.
§ 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.