(83 days)
Patients planned for radiation treatment, either to verify a prescribed plan, or to help at the planning at the simulator.
Helax-IMCON is an image workstation that replaces the fluoroscopic monitor at a radiotherapy simulator. It is connected to the video signal from the image intensifier of the simulator and the X-ray images are captured by a frame grabber and converted to digital images.
The provided document is a 510(k) premarket notification for the Helax-IMCON Simulator Workstation (IMCON), dated 1998-08-11. It's a regulatory submission affirming the device's substantial equivalence to a predicate device. It is not a scientific publication detailing a study with specific acceptance criteria and performance metrics in the way a clinical trial or performance study report would.
Therefore, most of the requested information regarding detailed acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert qualifications, and MRMC study details cannot be found in this document.
The document states that "Performance tests were conducted and the results indicated that the system consistently performed within the design parameters and equivalently to the predicate device." However, it does not provide the specifics of these tests.
Below is a breakdown of what can be extracted or inferred from the provided text, and what information is missing.
Acceptance Criteria and Device Performance
| Acceptance Criteria (Stated/Inferred) | Reported Device Performance (Stated/Inferred) |
|---|---|
| Functional Equivalence: The device should perform the same intended use as the predicate device (Varis Images, including Ximatron Digital Imaging). | |
| The intended use is: "a tool for supporting the process of Radiotherapy treatment planning utilising simulator images... used to define the field size and shape... for verification of an established treatment plan." | The document states: "The Helax-IMCON has the same technological characteristics and is similar in design, function, and application to the predicate device." And "The intended use is the same as the predicate devices." |
| This implies functional equivalence was met, though no specific performance metrics (e.g., accuracy of field definition) are provided. | |
| Technological Equivalence: The device should have the same technological characteristics as the predicate device. | "The Helax-IMCON has the same technological characteristics..." and "There are no differences between the technology of the predicate device and the Helax-IMCON and only minor differences in configuration and specifications as noted in the predicate device comparison chart. These differences do not alter the intended use or affect the safety and effectiveness of the Helax-IMCON system when used as labelled." |
| The device was deemed substantially equivalent by the FDA, indicating this criterion was accepted. | |
| Safety and Effectiveness: Minor differences in configuration and specifications compared to the predicate device should not alter the intended use or affect the safety and effectiveness of the system. | "These differences do not alter the intended use or affect the safety and effectiveness of the Helax-IMCON system when used as labelled." |
| The FDA's finding of "substantial equivalence" implies they accepted this claim of continued safety and effectiveness relative to the predicate device. | |
| Compliance with Standards: The device should meet specified electrical medical equipment and radiotherapy equipment standards, and relevant quality system certifications. | |
| Standards include IEC 601-1, IEC 601-1-4, IEC 1217, IEC 878. Quality systems include European EG Medical Device Directive, ISO 9001, EN 46001, and FDA's Reviewer Guidance for Computer Controlled Medical Devices. | "The Helax-IMCON is designed, and manufactured to meet, the following standards: [lists IEC standards]." "Helax AB is certified according to European EG Medical Device Directive... ISO 9001 and EN 46001." "The device and its development process also comply with the FDA, CDRH, ODE, August 23, 1991. Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review." |
| These are statements of compliance/certification, indicating these criteria were met. | |
| Performance within Design Parameters: The system should consistently perform within its design parameters. | "Performance tests were conducted and the results indicated that the system consistently performed within the design parameters..." |
| This statement confirms performance within design parameters, but no quantitative results or specific parameters are provided. | |
| Equivalence to Predicate Device (Overall): The system's performance should be equivalent to the predicate device. | "...and equivalently to the predicate device." |
| This is a direct statement, but without specific metrics from either device, the nature of this equivalence cannot be quantified from this document. |
Missing Information (and why it's missing from this type of document):
The provided text is a 510(k) Premarket Notification, which aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. It typically focuses on comparing the new device's intended use, technological characteristics, and safety/effectiveness to an existing one, rather than presenting a detailed performance study with explicit acceptance criteria and quantitative results from a new clinical or technical trial.
Therefore, the following information is not available in the provided text:
- Sample size used for the test set and the data provenance: Not mentioned. The "performance tests" are only vaguely referenced.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned. No explicit "ground truth" establishment in the context of a performance study is described.
- Adjudication method for the test set: Not mentioned.
- 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 done/mentioned. This device is an imaging workstation, not an AI diagnostic tool in the modern sense.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable/mentioned. This device is explicitly an "imageworkstation" intended to be operated by humans (radiographers, physicists, physicians).
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not mentioned.
- The sample size for the training set: Not mentioned. This is not an AI/ML device in the contemporary sense that would have a "training set" for model development. It's a workstation connected to a simulator.
- How the ground truth for the training set was established: Not applicable/mentioned.
In summary: The document serves its purpose as a 510(k) submission by asserting substantial equivalence and compliance with relevant standards. However, it does not contain the detailed performance study data, acceptance criteria, or methodological specifics that would be found in a research paper or a detailed performance validation report. The "study" mentioned is referred to as "Performance tests were conducted and the results indicated that the system consistently performed within the design parameters and equivalently to the predicate device," which is a high-level summary suitable for a 510(k) submission to demonstrate equivalence, but lacks the granular detail requested.
§ 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.