(15 days)
Indications For Use of GE LightSpeed™ ACT FP16 when configured as a CT System:
The GE LightSpeed™ ACT FP16 is indicated for head and whole body X-ray computed tomography applications.
Indications For Use of GE LightSpeed™ ACT FP16 when configured as a Fluoroscopic System: .
GE LightSpeed™ ACT FP16 is indicated for use in generating fluoroscopic images of SE Elghtopeda. nonedures, and optionally, rotational imaging procedures. It is intended to replace procedures, and optionally, rethnology image intensifier technology and is not intended for mammography applications.
The GE LightSpeed ACT FP16 is a modified CT system intended to be located in close proximity to a GE Innova 4100 Single Plane Digital Fluoroscopic Imaging system utilizing a single patient table which can be configured for interventional x-ray or CT imaging procedures. This modification allows the patient to remain on the x-ray table which can be quickly configured for CT scanning via a movable gantry. Both the CT and X-ray systems are used separately, one at a time, in accordance with their respective indications for use.
This submission describes a modification to an existing CT system (GE LightSpeed ACT FP16) and asserts its substantial equivalence to a predicate device (GE HiSpeed X/i Smart Gantry Option). The information provided largely focuses on demonstrating safety and effectiveness for a 510(k) clearance, which is typically achieved through non-clinical testing for modifications of this nature, rather than extensive clinical studies with specific performance metrics against a ground truth as would be common for novel AI/software devices.
Here's the breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conformance to specifications | Modifications evaluated for conformance to specifications. |
| Overall performance | Modifications evaluated for overall performance. |
| Thermal safety | Modifications evaluated for thermal safety. |
| Electrical safety | Modifications evaluated for electrical safety. |
| Radiation safety | Modifications evaluated for radiation safety. |
| Mechanical safety | Modifications evaluated for mechanical safety. |
| Conformity with applicable medical device safety standards | Product found to conform with applicable medical device safety standards. |
| Performance of equipment movements | Easily evaluated and confirmed with test equipment and personnel. |
| Performance of user controls | Easily evaluated and confirmed with test equipment and personnel. |
| Performance of status display | Easily evaluated and confirmed with test equipment and personnel. |
| Substantial equivalence to predicate device (GE HiSpeed X/i Smart Gantry Option - K012385) in terms of safety and effectiveness. | The GE LightSpeed ACT FP16 has the same technological characteristics, comparable key safety and effectiveness features, similar design, construction, and materials, and shares the same intended use and clinical purpose with the predicate. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable in the context of clinical studies with patient data. The evaluation was done using "bench testing and imaging phantoms". The number of phantoms used is not specified.
- Data Provenance: Not applicable, as no human subject data was used for testing. The testing involved hardware and phantom evaluations, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not explicitly stated as "experts for ground truth" in a clinical sense. However, the evaluation was performed by "employees of the manufacturer and by an independent test agency" for safety and conformance, and "test personnel familiar with clinical practice and procedures" for equipment movement, controls, and display.
- Qualifications of Experts: Employees of the manufacturer, independent test agency personnel, and test personnel familiar with clinical practice and procedures. Specific degrees or years of experience are not provided.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. The evaluation was primarily engineering and performance testing against specifications and safety standards, rather than diagnostic interpretation requiring adjudication of results from multiple readers.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The submission explicitly states "Clinical Tests: None required." and focuses on non-clinical testing and substantial equivalence to a predicate device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a CT system, not an AI algorithm. The performance evaluated was the physical system's functionality and image quality (via phantoms), which inherently operates as a "standalone" system in terms of generating images, but not in the context of an AI algorithm making diagnostic decisions.
7. The type of ground truth used
- Type of Ground Truth: For the non-clinical tests, the ground truth was defined by engineering specifications, applicable medical device safety standards, and the expected performance of physical equipment movements, user controls, and status displays. For imaging performance, imaging phantoms were used as a controlled and known standard for evaluation.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This is a hardware modification, not an AI/machine learning device that requires a training set of data.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as there is no training set for this device.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.