Search Results

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 2.1 System is a powered radiation therapy support assembly which provides patient positioning control prior to radiotherapy treatment. iGUIDE 2.1 System consists of the iGUIDE workstation with software, a tracking system, reference frame, calibration tool, isolation transformer, KVM Extender and monitors for the workstation and terminal.

The iGUIDE software controls the combined working of the HexaPOD evo RT System components and provides status detection via the software GUI to the user. The HexaPOD evo RT System consists of iGUIDE and the HexaPOD evo RT Couchtop, a robotic patient-positioning platform with six degrees of freedom, which is cleared under K072898.

This document is a 510(k) summary for the iGUIDE 2.1 system, a medical device for patient positioning in radiotherapy. It focuses on demonstrating substantial equivalence to a previously cleared predicate device (iGUIDE System, K072079).

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Note: The document explicitly states that "physical parameters characterize the system (e.g. accuracy) and give information about substantial equivalence." While not phrased as strict "acceptance criteria" in the format of a clinical trial, these accuracy metrics are the performance benchmarks against which the new device is compared to its predicate.

2. Sample size used for the test set and the data provenance

The document states, "The Performance Testing is based on Benchmark Testing only." There is no mention of a sample size in terms of patient data or clinical cases. The testing appears to be based on engineering benchmarks, not human subject data. Therefore, there is no data provenance (country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The testing described is "Benchmark Testing" focusing on physical parameters like accuracy, not on expert-interpreted results or clinical ground truth.

4. Adjudication method for the test set

Not applicable, as the testing described focuses on measurable physical parameters and doesn't involve subjective interpretation that would require an adjudication method.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The iGUIDE 2.1 system is a patient positioning device, not a diagnostic AI system that assists human readers in interpreting medical images.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The entire performance assessment for the iGUIDE 2.1 system described in this document appears to be focused on its standalone technical performance (accuracy of positioning) through "Benchmark Testing." There is no discussion of human-in-the-loop performance studies.

7. The type of ground truth used

The "ground truth" for the performance testing appears to be measured physical parameters (accuracy), established through calibrated measurement techniques in "Benchmark Testing."

8. The sample size for the training set

Not applicable. The iGUIDE 2.1 system is described as a "powered radiation therapy support assembly" with software control for positioning. It is not an AI/ML model that would typically have a "training set" of data in the context of learning or inference. The software "controls the combined working of the HexaPOD evo RT System components."

9. How the ground truth for the training set was established

Not applicable, as there is no mention of a training set or AI/ML model training.

Ask a specific question about this device