(15 days)
The intended use of the device is the control of accurate patient positioning with assistance of a 3D Tracking System in a radiotherapy environment
The iGUIDE® System controls the movement of the Medical Intelligence HexaPOD™ RT CouchTop (K041448), a radiographic treatment table with 6 DOFs (Degrees of freedom). With the integrated 3D Tracking System the device controls also the accuracy of the patient positioning.
The iGUIDE® System consists of a PC workstation, a graphics user interface to the treatment table (software) and the NDI Polaris 3D Tracking System.
The iGUIDE® System is integrated into radiation therapy systems of Elekta, Varian, and Siemens and is connected to them with an Interlock connection.
The provided document is a 510(k) summary for the Medical Intelligence iGUIDE® System, submitted in 2006. It focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria and performance data for a standalone AI device.
Therefore, much of the requested information regarding acceptance criteria, specific study design, expert involvement, and AI performance metrics is not available in this document. The document explicitly states:
"No performance data is required for this Class II device nor requested by the Food and Drug Administration (Office of Device Evaluation)"
This indicates that the regulatory pathway for this device at the time did not necessitate a clinical study demonstrating performance against specific acceptance criteria in the way a modern AI/ML device submission would. The focus was on establishing substantial equivalence to existing devices through technological characteristics and intended use.
However, I can extract the information that is present:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria or reported device performance metrics are provided in the document. The submission focuses on establishing substantial equivalence to a predicate device (BrainLab "ExacTrac system" K003285) rather than meeting defined performance thresholds in a clinical study.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable, as no performance data from a test set is reported.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable, as no ground truth establishment for a test set is reported.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no test set requiring adjudication is reported.
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. The iGUIDE® System is described as a device that controls movement and aids in patient positioning during radiation therapy, not an AI system that assists human readers in interpreting medical images or data.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The iGUIDE® System is a standalone device in the context of its function (controlling the treatment table and patient positioning). However, it is not an "algorithm only" device meant for diagnosis or interpretation. It is a system that physically aids in positioning, potentially with automated components, but it's not a diagnostic AI. The document does not describe "standalone" performance in the modern sense of an AI algorithm's diagnostic accuracy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable, as no ground truth for diagnostic or interpretive performance is reported. The "accuracy of patient positioning" is mentioned, which would be the relevant "ground truth" if performance data were collected, but no specific methodology for its establishment is detailed in this document.
8. The sample size for the training set
Not applicable, as this submission pre-dates the common concept of "training sets" for AI/ML models in medical device submissions. The iGUIDE® System is not described as an AI/ML device that requires training data in the modern sense.
9. How the ground truth for the training set was established
Not applicable, as this information is not relevant to the type of device and submission described.
§ 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.