(314 days)
The ACIST GENTOO Contrast Injection System for Computed Tomography is intended for use in the delivery of radiopaque contrast media to selected sites in the vascular system during computed tomography applications.
The ACIST GENTOO is a dual-syringe injector with one contrast syringe and one saline syringe that allows the user to program procedure protocols that specify injection parameters for both contrast and saline, and to allow the technologist to use saline for test injections. The ACIST GENTOO uses a two part injection molded dual syringe kit that incorporates ACIST's Contrast Management System (CMS) technology. The CMS functionality allows the user to disconnect and discard the patient contact portion of the kit at the end of each case, and use the syringe kit for up to 8 cases.
The four basic components of the device are distributed in the user facility between the:
- CT lab [(1) Injector Head and (2) Syringe and Patient Kits] and the .
- Control Room [(3) Remote Display and (4) Power Supply] where the CT imaging . equipment is operated.
The provided text describes a 510(k) summary for the Acist GENTOO Contrast Injection System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than undergoing extensive clinical trials with strict acceptance criteria in the same way a novel drug or high-risk device might. Therefore, the information you're requesting regarding "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics (like sample size for test sets, ground truth establishment, MRMC studies, standalone performance, etc.) is largely not applicable to this document.
The document focuses on comparing the new device's technological characteristics and performance testing to a legally marketed predicate device to demonstrate it is "substantially equivalent." This means the performance tests primarily confirmed that the new device operated within expected parameters and was as safe and effective as the existing, approved devices.
However, I can extract the relevant performance test information and present it in a table format, and then address the other points based on the information provided, or indicate where the information is not present in the document.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparison to the predicate device's performance. The "reported device performance" is not explicitly quantified in this summary (e.g., "flow rate accuracy was X%"), but the summary states that comparative performance testing was done to demonstrate substantial equivalence across many parameters. The implication is that the Acist GENTOO met performance levels comparable to the predicate devices for these parameters.
| Acceptance Criterion (Implied by Performance Test Category) | Reported Device Performance (Implied) |
|---|---|
| Fluid Delivery Volume Range | Substantial equivalence to predicate devices demonstrated. |
| Fluid Delivery Volume Accuracy | Substantial equivalence to predicate devices demonstrated. |
| Flow Rate Range Accuracy | Substantial equivalence to predicate devices demonstrated. |
| Flow Rate Range Duration | Substantial equivalence to predicate devices demonstrated. |
| Pressure Limit Range | Substantial equivalence to predicate devices demonstrated. |
| Pressure Limit Accuracy | Substantial equivalence to predicate devices demonstrated. |
| Autofill Volume Range | Substantial equivalence to predicate devices demonstrated. |
| Autofill Fill Rate Default | Substantial equivalence to predicate devices demonstrated. |
| Autofill Fill Rate Range | Substantial equivalence to predicate devices demonstrated. |
| Test Injection Fluids | Substantial equivalence to predicate devices demonstrated. |
| Test Injection Default | Substantial equivalence to predicate devices demonstrated. |
| Test Injection Flow Rate Range | Substantial equivalence to predicate devices demonstrated. |
| Test Injection Volume Range | Substantial equivalence to predicate devices demonstrated. |
| Test Injection Volume Accuracy | Substantial equivalence to predicate devices demonstrated. |
| Pause Range | Substantial equivalence to predicate devices demonstrated. |
| Pause Accuracy | Substantial equivalence to predicate devices demonstrated. |
| KVO Flow Rate | Substantial equivalence to predicate devices demonstrated. |
| KVO Volume Accuracy | Substantial equivalence to predicate devices demonstrated. |
| Scan Delay Time Range | Substantial equivalence to predicate devices demonstrated. |
| Scan Delay Time Accuracy | Substantial equivalence to predicate devices demonstrated. |
| Syringe Heater Average Fluid Temperature | Substantial equivalence to predicate devices demonstrated. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. For a medical device like an injector system, performance testing typically involves controlled laboratory evaluations rather than clinical studies with patient data. If any human factors or clinical experience data were gathered (which is not explicitly stated here but might be part of an overall submission), details about sample size and provenance would be in a separate, more detailed section.
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 in the 510(k) summary. The performance tests for an injector system (e.g., flow rate accuracy, pressure limits) are typically evaluated against engineering specifications and industry standards, not by expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided in the 510(k) summary. Adjudication methods like 2+1 or 3+1 are used in clinical studies or for complex image interpretation where expert consensus is needed. For an injector system's mechanical and fluid delivery performance, objective measurements are used.
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
This information is not applicable and not provided in the 510(k) summary. MRMC studies and the concept of "human readers improve with AI" are relevant to AI/ML-driven diagnostic or interpretative devices, not to a contrast injection system. This device is an instrument for delivering contrast.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable and not provided in the 510(k) summary. This device is a physical, electromechanical system and does not involve AI algorithms in the sense of image analysis or diagnostic interpretation. It is designed to be operated by a technologist (human-in-the-loop).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance tests of this device would be engineering specifications, established physical principles, and calibration standards for parameters like volume, flow rate, pressure, and temperature. It is not based on expert consensus, pathology, or outcomes data, as those apply to diagnostic or therapeutic efficacy evaluations, usually in a clinical context.
8. The sample size for the training set
This information is not applicable and not provided in the 510(k) summary. The concept of a "training set" applies to machine learning models. This device is an electromechanical system, not an AI/ML product.
9. How the ground truth for the training set was established
This information is not applicable and not provided in the 510(k) summary. As explained above, this device does not utilize machine learning, so there is no "training set" or "ground truth for the training set" in that context.
§ 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.