(74 days)
The Acuity Radiation Therapy Simulator is to be used in radiation therapy simulation, using a fluoroscopic and/or radiographic x-ray system for visualizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irridation field to be applied. The Acuity ConeBeam Computed Tomography (CBCT) is intended to assist the Radiation Oncologist in acquiring 3D "multislice" planning data in patient set-ups for the purpose of radiation therapy treatment planning and patient positioning.
Acuity with ConeBeam Computed Tomography (CBCT) is intended to assist the Radiation Oncologist in acquiring 3D multislice planning data in patient set-ups where conventional (Computerized Tomography) CT imaging is not possible. CBCT is a new feature to the Varian Medical Systems Radiation Therapy Simulator, "Acuity" (K023052), and acquires CT slice information as digital images from the Acuity simulator. The images can be viewed and manipulated directly on a computer screen and placed into the Vision Image database for the purpose of radiation therapy treatment planning and patient positioning. CBCT provides Acuity the capability of acquiring and reconstructing 15-17cm of volumetric data in one gantry rotation. This represents approximately 340 0.5mm slices. Acuity combines conventional and CT simulation into one product. Acuity can change from radiographic and fluoroscopic mode for isocenter localization to CT acquisition mode for treatment planning. This is accomplished with no movement of the patient from the actual treatment position.
The provided text describes the Acuity with Conebeam Computed Tomography (CBCT) device and its regulatory clearance, but it does not contain detailed information about specific acceptance criteria or a dedicated study proving the device meets those criteria in a typical AI/medical device performance study format.
Instead, the document focuses on regulatory compliance based on existing performance standards for medical devices and a comparison to predicate devices.
Here's a breakdown of what can be extracted and what is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
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Acceptance Criteria (General): The document states that the device was tested in accordance with "21 CFR §1020 - Performance standards for ionizing radiation emitting products. Specifically §1020.30 - Diagnostic x-ray systems and their major components and §1020.33 - Computed tomography (CT) equipment."
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Reported Device Performance: "The results of the tests demonstrated that the Acuity CBCT met the performance standards requirements."
Note: This is a very high-level statement. It does not provide specific metrics (e.g., spatial resolution, contrast resolution, dose, etc.) or quantitative results against which acceptance criteria would typically be measured in a detailed performance study. It's a statement of compliance rather than a report of specific technical performance values.
2. Sample Size Used for the Test Set and Data Provenance
- Not provided. The document does not mention any specific test sets of patient data, their sample size, or their provenance (country of origin, retrospective/prospective). This is because the performance evaluation cited refers to compliance with general regulatory standards for X-ray and CT equipment, not a study evaluating performance on a dataset of clinical cases.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable/Not provided. Since there's no mention of a clinical or image-based test set with ground truth, there's no information about experts establishing that ground truth.
4. Adjudication Method for the Test Set
- Not applicable/Not provided. (See point 3)
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. The document does not describe an MRMC study. The device, an imaging system, would typically have its technical performance (image quality, dose) evaluated, and its clinical utility would be demonstrated by enabling certain procedures (treatment planning, patient positioning), rather than by measuring human reader improvement with an AI algorithm.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable/Not provided. The Acuity with CBCT is a medical imaging device, not an AI algorithm. Performance evaluation for such devices focuses on the technical specifications of the imaging system itself.
7. Type of Ground Truth Used
- Not applicable/Not provided in the context of clinical data. For an imaging device, "ground truth" often relates to physical measurements or phantoms used to assess image quality parameters (e.g., known physical dimensions, contrast differences in a phantom). The document broadly states compliance with general CT equipment standards, which would implicitly involve such physical measurements but does not detail them.
8. Sample Size for the Training Set
- Not applicable/Not provided. This device is an imaging system, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable/Not provided. (See point 8)
Summary of what's present in the document:
The document is a 510(k) summary for a medical device (an X-ray system with Conebeam CT capability). It focuses on:
- Device identification and submitter information.
- Intended use (radiation therapy simulation, acquiring 3D planning data).
- Substantial equivalence to predicate devices (Acuity Radiation Therapy Simulator K023052 and Ximatron Scanvision K981056).
- A statement of compliance with general performance standards for diagnostic X-ray systems and CT equipment (21 CFR §1020.30 and §1020.33). This compliance is the "proof" mentioned in the context of the document, but it's a regulatory "proof" rather than a detailed performance study as one might expect for an AI device.
In conclusion, the document provides evidence of regulatory compliance with existing performance standards for medical imaging equipment, but it does not present a detailed performance study with specific acceptance criteria and results in the format commonly associated with evaluating AI/ML-based medical devices or even a detailed clinical efficacy study.
§ 892.5840 Radiation therapy simulation system.
(a)
Identification. A radiation therapy simulation system is a fluoroscopic or radiographic x-ray system intended for use in localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field produced. 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.