(344 days)
The contrast delivery system Sonic Shot GX is an intravascular injection system intended for the administration of MRI contrast media and normal saline solution used in conjunction with magnetic resonance imaging (MRI).
The contrast delivery system Sonic Shot GX is an intravascular injection system intended for the administration of MRI contrast media and saline used in conjunction with MRI.
The main components of the Sonic Shot GX are the Console, Powerhead and Main Control Unit. The Console resides in the control room or the MR suite, while the Main Unit and Powerhead reside in the scanning room alongside the MR scanning device and the patient. The parameters of the injection, such as volume, flow rate and pressure are programmed by the operator via the graphical user interface with touchscreen input. The Console is powered via 24 volts DC which is derived from a remote AC to DC converter (similar to that used with laptop computers) and communicates with Main Control Unit via a fiber-optic interface. The communication link is used to communicate the user set injection parameters to the Main Control and Powerhead located in the MR suite.
After the injection protocol has been set, the Powerhead performs the injection by driving one or two lead screw rams. The rams push the syringe which expels fluid from the barrel of the syringe.
The provided document describes a contrast delivery system (Sonic Shot GX) and primarily focuses on its substantial equivalence to predicate devices, rather than a detailed study report for meeting acceptance criteria of an AI/ML powered medical device. Therefore, much of the requested information (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, and ground truth for AI models) is not applicable or not present in the provided text, as the device is a hardware injector, not an AI system.
However, I can extract information related to the performance testing done to verify the system meets its specifications.
Here's a breakdown of the available information:
1. Acceptance Criteria and Reported Device Performance
The "Summary of Performance Testing" section describes that the device must be capable of achieving "specification parameters for the system as outlined in the substantial equivalence chart." The "Performed Testing" section describes how the device meets those specifications.
| Characteristic / Feature (Acceptance Criteria Implicit in Design Parameters) | Reported Device Performance |
|---|---|
| Volume Delivery | Successfully delivered volumes within allowable specifications across the programmed range. |
| Flow Rate Delivery | Measured within allowable ranges of specification for all non-pressure limited injections. (Note: Pressure limit injections automatically reduce flow rate to maintain constant pressure). |
| Pressure Monitoring | All pressure readings were within allowable specifications (compared to displayed values and product specifications). |
| Body Weight Protocol Programming Method | Calculates volume based on patient weight and active ingredient units as entered by the operator. Performance implicitly met, as it's a computational function. |
| Drip Mode Performance | Performance was within allowable specification ranges over various Drip Mode parameters. |
| Manual Control Speeds (1ml/sec and 5ml/sec) | Both speeds were confirmed on A and B sides to be within the allowable specification range. |
Note: The document refers to "allowable specifications" and "allowable ranges," implying specific numerical thresholds, but these thresholds are not explicitly stated in the provided text.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document states "During testing" or "Over the range of volumes programmed" but does not provide specific numbers of tests or injections performed.
- Data Provenance: Not specified, but given the manufacturer is Nemoto Kyorindo Co., Ltd. in Japan, it is highly likely the testing was conducted in Japan. The testing described is prospective, as it involves actively performing injections and measuring parameters.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable as the device is a contrast delivery system (hardware), not an AI/ML-driven diagnostic or interpretative device that requires expert-established ground truth for its performance. The "ground truth" here is the physical measurement of fluid dynamics and pressure, compared against engineered specifications.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as above. The performance evaluation relies on objective physical measurements against engineering specifications, not subjective expert judgment requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable. The Sonic Shot GX is a hardware device for injecting contrast media, not a system that assists human readers in interpreting medical images. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not applicable. The Sonic Shot GX is a mechanical injector. Its performance is measured as a standalone system (it delivers fluid autonomously once programmed), but it does not have an "algorithm-only" performance in the context of AI/ML or image interpretation. Its performance is its standalone mechanical and electronic function.
7. The Type of Ground Truth Used
The "ground truth" for the performance testing of the Sonic Shot GX involves objective physical measurements of:
- Delivered volume
- Measured flow rate
- Actual pressure
- Drip mode increments and intervals
- Manual control speeds
These measurements are compared against the engineering specifications defined for the device.
8. The Sample Size for the Training Set
This information is not applicable. The Sonic Shot GX is not an AI/ML device that requires a training set. Its functionality is based on pre-programmed logic and mechanical engineering, not learned patterns from data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above.
§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.