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510(k) Data Aggregation
(274 days)
The Z-Robot™ Patient Positioning System is an electro-mechanical robotic arm for patient positioning in radiotherapy and medical imaging. It is designed for positioning a patient with a high degree of accuracy and repeatability.
The Z-Robot™ Patient Positioning System (hereinafter referred to as Z-Robot™) is an electro-mechanical robotic arm with the motion capability in six degrees of freedom. These axes allow the couch to be precisely positioned translationally and rotationally within the specified movement limits. Therefore, Z-Robot™ could be used to accurately position patient in radiotherapy and medical imaging.
The requested information is contained within the provided text. The device in question is the "Z-Robot™ Patient Positioning System", which is an electro-mechanical robotic arm for patient positioning in radiotherapy and medical imaging. The acceptance criteria and the study that proves the device meets these criteria are primarily based on non-clinical testing.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly provide a "table of acceptance criteria and reported device performance" for all tests. However, it lists the performance parameters tested and indicates that "All test results were acceptable per the acceptance criteria detailed in the corresponding protocol and test report." It also provides a direct comparison to the predicate device for several key performance metrics, implying these are the relevant acceptance criteria for substantial equivalence.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate & "Same") | Reported Device Performance (Z-Robot™ Patient Positioning System) |
|---|---|---|
| Accuracy | ± 0.5 mm and ± 0.2° | ± 0.5 mm and ± 0.2° (Same as predicate) |
| Linear XYZ maximal medical speed | 10 cm/s | 10 cm/s (Same as predicate) |
| Linear XYZ maximum maintenance speed | 20 cm/s | 20 cm/s (Same as predicate) |
| Angular Yaw Pitch Roll maximum medical speed | 5 °/s | 5 °/s (Same as predicate) |
| Angular Yaw Pitch Roll maximum maintenance speed | 12 °/s | 12 °/s (Same as predicate) |
| Collision detection | Detection of a 150 N force | Detection of a 150 N force (Same as predicate) |
| "Overtravel" in case of emergency stop | <5 mm | <5 mm (Same as predicate) |
| Speed Accuracy | (Not explicitly detailed, but stated "acceptable") | "All test results were acceptable" |
| Translational Accuracy | (Not explicitly detailed, but stated "acceptable") | "All test results were acceptable" |
| Rotational Accuracy | (Not explicitly detailed, but stated "acceptable") | "All test results were acceptable" |
| Repeatability | (Not explicitly detailed, but stated "acceptable") | "All test results were acceptable" |
2. Sample Size Used for the Test Set and the Data Provenance
The document states that "A series of safety and performance tests were conducted on the subject device, Z-Robot™ Patient Positioning System." It does not specify the sample size for these tests (e.g., number of devices tested or number of times each test was performed). The data provenance is also not specified in terms of country of origin or whether it was retrospective or prospective. It is implied to be prospective testing of the manufactured device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable and not provided. The testing described is non-clinical performance testing of a physical device, not a diagnostic or AI-based system requiring expert interpretation or ground truth establishment in the typical sense. The "ground truth" for these tests would be the physical measurements taken during the performance evaluation.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. As the testing is non-clinical performance testing, there's no "adjudication method" in the context of expert review or consensus as there would be for an image classification or diagnostic device.
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 MRMC study was done. The device is a patient positioning system, not an AI-assisted diagnostic or imaging interpretation tool that would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device itself is a mechanical system, not an algorithm in the sense of AI. The performance tests ("Reliability test," "Software Validation test," "Electromagnetic compatibility and electrical safety test," and "Performance test") evaluate the standalone performance of the Z-Robot™ Patient Positioning System, as it is a machine.
7. The Type of Ground Truth Used
The ground truth for the non-clinical performance tests would be precise measurements obtained through calibrated instruments and established engineering standards. For example, for "Accuracy (± 0.5 mm and ± 0.2°)", the ground truth would be the actual position and orientation measured by high-precision sensors, compared against the commanded movements. This is a form of empirical measurement against a known standard.
8. The Sample Size for the Training Set
This information is not applicable. The Z-Robot™ Patient Positioning System is a mechanical device, not an AI or machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable, as there is no "training set" for this device.
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