(429 days)
The ACIST System from Invasatec is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.
The ACIST is an angiographic injector system which supplies radiographic contrast material to a catheter at a clinician determined variable flow rate which can be remotely and continuously varied by the user. The system includes a motorized syringe pump which delivers radiographic contrast material to tubing which is connected to a angiographic catheter. The clinician controls the flow rate of radiographic contrast material from the pump to the catheter with a hand actuated proportional controller. By operating the hand control, the user can vary a command signal in order to adjust the flow rate of radiographic contrast material from the pump to the outlet during the operation of the pump. The remote hand control allows the clinician to interactively adjust flow rate (and thus volume of material delivered to the patient) while observing the angiographic procedure (for example on a fluoroscope monitor). The system also includes a specifically designed disposable kit. The kit includes a syringe and valve assembly, injection manifold assembly, high pressure assembly, tubing assembly and associated caps and connectors. The kit is intended to provide all components necessary to perform an angiographic study.
The provided document is a 510(k) summary for the ACIST Angiographic Injector System. It describes the device, its intended use, and tests conducted to demonstrate substantial equivalence to predicate devices. However, it does not detail specific acceptance criteria for performance metrics nor a comprehensive study design that would directly assess how the device meets such criteria in a robust, quantitative manner typically seen for AI/ML-based medical devices. The testing described is primarily focused on material biocompatibility, physical device integrity, and electrical safety, consistent with a traditional hardware medical device rather than an AI/ML algorithm.
Therefore, much of the requested information regarding acceptance criteria, study design for performance evaluation (especially for AI/ML aspects), sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not present in this document.
Here's an attempt to extract and interpret information related to your request based on the context of a 510(k) submission for a non-AI device:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria (Implicitly based on testing) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with USP Class VI and/or ISO 10993 | "All materials are certified from the vendor as biocompatible based on compliance with USP Class VI and/or ISO 10993. All materials are biocompatible and are suitable for this application." |
| Physical Integrity | Dimensional inspection, bond strength, burst pressure, flow rate capability, performance under simulated conditions | "Physical testing of the system included: dimensional inspection, bond strength testing, burst pressure, flow rate capability, and performance under simulated conditions. All testing of the product yielded acceptable results." |
| Electrical Safety | Compliance with IEC 601-1 | "Electrical safety testing was performed per IEC 601-1. All testing of the product yielded acceptable results." |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 601-1-2 | "electromagnetic compatibility testing per IEC 601-1-2. All testing of the product yielded acceptable results." |
Note: The document states "All testing of the product yielded acceptable results" for various physical and electrical tests. It does not provide specific quantitative thresholds for "acceptable" or the measured performance values for these tests.
2. Sample sizes 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 document. The testing described is for physical and electrical attributes of the device and its components, not for analytical or clinical performance based on patient data. Therefore, concepts like "test set," "data provenance," "country of origin," and "retrospective/prospective" do not apply in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and therefore not provided. The device is a mechanical injector, not an imaging analysis or diagnostic device that would require expert-established ground truth for its performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and therefore not provided. Adjudication methods are typically used in clinical studies or performance evaluations where there is a need to resolve discrepancies in expert interpretations or assessments, which is not relevant for the physical and electrical testing conducted for this 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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done, nor is it applicable. This is not an AI-enabled device. The document states "The clinical indications for use are identical to the predicate devices" and "Invasatec believes this product does not raise any new safety or effectiveness issues," indicating a focus on substantial equivalence based on materials, design, and intended use to existing devices, rather than a novel performance claim requiring a comparative effectiveness study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is an angiographic injector system, not an algorithm. Its operation involves a "human-in-the-loop" interaction where the clinician controls the flow rate using a hand-actuated proportional controller. There is no "algorithm only" performance to evaluate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable. The testing performed (biocompatibility, physical integrity, electrical safety) does not rely on a "ground truth" derived from clinical data or expert interpretation in the way that an AI diagnostic device would. Instead, performance is measured against engineering specifications, material standards, and regulatory safety standards.
8. The sample size for the training set
This is not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
This is not applicable. There is no "training set" or corresponding "ground truth" establishment process for this device.
§ 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.