(15 days)
The Integrated Brachytherapy - Digital (IBU-D) is intended to be used for the visualization, localization and confirmation of the volume and the size of the brachytherapy irradiation field(s), using a fluoroscopic and/or radiographic system.
Integrated Brachytherap Unit - Digital (IBU-D) is a modification to the Integrated Brachytherapy Unit (IBU) in which the Image Intensifier of the IBU is replaced by a Flat Panel image detector. The Flat Panel image detector used in the IBU-D is the same Flat Panel image detector as used in Nucletron's Simulix Evolution product (K03347).
The Integrated Brachytherpay Unit – Digital (IBU-D) is a localization and simulation device for a Brachy radiation therapy department. It consists of a gantry that supports an L-arm and a C-arm which can rotate isocentrically. The C-arm houses an X-ray tube housing assembly with collimator on one side and a flat panel image detector. The movements of the IBU-D are manually driven, after the relevant electrical locks are lifted. The mobile IBU patient table has mechanical motions which can be controlled from a hand pendant affixed to the table. Images are displayed and managed by a PC based workstation running specialized software.
The system makes also use of the same third party X-ray tube and X-ray high tension generator as used in the Simulix Evolution system.
The Flat Panel image detector which replaces the current Image intensifier is a Amorphous silicon, digital detector, with a square image area of 41 x 41 cm.
The PC based workstation runs the same software as the workstation of the Simulix Evolution system. It supports the following functionality:
- . Image acquisition
- Image display .
- Image annotation .
- Database and DICOM Import / Export functionality
- Position read out and display of the IBU-D gantry. .
- Control of the IBU-D beam limiting device. .
This 510(k) summary (K072445) describes the Integrated Brachytherapy Unit - Digital (IBU-D), a modification of an existing device. It focuses on the substantial equivalence to a predicate device and does not contain detailed information about specific acceptance criteria or a dedicated study proving device performance against those criteria in a quantitative manner as typically found in clinical validation studies for AI/ML devices.
The submission primarily states that the IBU-D is a modification where the Image Intensifier of the original IBU (K973848) is replaced by a Flat Panel image detector. The flat panel detector and the workstation software are the same as used in Nucletron's Simulix Evolution product (K03347). The "study" here is essentially a demonstration of substantial equivalence based on the technological similarity and identical intended use to legally marketed predicate devices, rather than a clinical trial assessing performance against specific metrics.
Therefore, many of the requested elements (like sample size, number of experts, adjudication methods, MRMC studies, standalone performance with specific metrics, and detailed ground truth establishment for a training set) are not typically found in this type of 510(k) summary for a hardware modification of a conventional medical device. The "reported device performance" is implicitly that it performs equivalently to the predicate devices for its intended use.
However, based on the provided text, I can infer and summarize the acceptance criteria and "study" information as best as possible within the context of this 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this 510(k) is for a hardware modification (swapping an image intensifier for a flat panel detector) and relies on substantial equivalence, explicit quantitative acceptance criteria for performance metrics (like sensitivity, specificity, accuracy) are not provided in this document. The "acceptance criteria" are implicitly met if the device functions as intended and is substantially equivalent to the predicate device.
| Acceptance Criterion (Inferred) | Reported Device Performance (Inferred) |
|---|---|
| Intended Use Equivalence: The modified device has the same intended use as the legally marketed predicate device. | The IBU-D is intended for "visualization, localization and confirmation of the volume and the size of the brachytherapy irradiation field(s), using a fluoroscopic and/or radiographic system," which is stated to be the same as the predicate device. |
| Technological Equivalence: The core technology changes do not raise new questions of safety or effectiveness. | The "Image Intensifier of the IBU is replaced by a Flat Panel image detector." This flat panel detector and the workstation software are the same as used in a previously cleared device (Nucletron's Simulix Evolution product, K033347). The X-ray tube and high tension generator are also the same as in Simulix Evolution. |
| Functional Equivalence: The device performs its functions adequately. | The system supports: image acquisition, image display, image annotation, database and DICOM Import/Export, position read-out and display of the IBU-D gantry, and control of the IBU-D beam limiting device. The last two items are specific to IBU-D, but presumably meet functional requirements. The changes are presented as "modifications" rather than entirely new functionality. |
| Safety and Effectiveness: No new safety concerns are introduced. | The submission implies that by using previously cleared and equivalent components, the new device maintains the same safety and effectiveness profile as the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
This submission does not describe a clinical "test set" in the traditional sense of evaluating diagnostic performance on a patient dataset. The "study" for this 510(k) is a technical and functional verification that the modified device functions correctly and is substantially equivalent to existing devices. Therefore, details regarding sample size, country of origin, or retrospective/prospective nature of a clinical test set are not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. As no clinical test set for diagnostic performance evaluation is described, there is no mention of experts being used to establish ground truth or their qualifications.
4. Adjudication Method for the Test Set
Not applicable. Without a clinical test set requiring ground truth establishment, no adjudication method is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. This submission does not include an evaluation of human readers' performance with or without AI assistance, as it concerns a hardware replacement in a radiation therapy simulation system, not an AI/ML diagnostic aid.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is a hardware system for visualization and localization in brachytherapy, not an AI algorithm. Therefore, a standalone algorithm performance study is not relevant or described.
7. Type of Ground Truth Used
Not applicable. The submission focuses on technological equivalence and functional verification, not on diagnostic accuracy against a specific ground truth like pathology or outcomes data.
8. Sample Size for the Training Set
Not applicable. There is no mention of a "training set" as this is not an AI/ML device that requires data for model training.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set mentioned, there is no information on how its ground truth would have been established.
In summary: K072445 is a 510(k) submission for a hardware modification to an existing medical device. The "study" conducted for this submission is a demonstration of substantial equivalence based on the technological characteristics and identical intended use compared to legally marketed predicate devices. It does not provide the detailed performance metrics, sample sizes, expert qualifications, or study methodologies typically associated with clinical validation of diagnostic or AI/ML devices.
§ 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.