(462 days)
The Quantum Micro-Cardioplegia Delivery System is intended for delivery of micro-cardioplegia to the heart during open heart surgery lasting up to six hours in duration. It is intended to be used by an experienced and trained clinician. It is not intended to be used by a patient or other untrained personnel.
The Quantum Micro-Cardioplegia Delivery System is intended to assist in arresting a beating heart during cardiac surgery through controlled delivery of cardioplegia. The system consists of the Quantum Workstation, Quantum Micro-Cardioplegia Delivery Module, Quantum Roller Pump 4", Quantum Diagnostic/Ventilation Module, and Quantum Pureflow Cardioplegia Heat Exchanger. The Quantum Micro-Cardioplegia Delivery Module was developed to supplement the existing Quantum technology and to allow users a more integrated way of managing microplegia delivery during cardiopulmonary bypass.
The Quantum Micro-Cardioplegia Delivery System is intended specifically for procedures where microplegia (i.e., whole blood cardioplegia) strategy is used. The Quantum Micro-Cardioplegia Delivery Module adds cardioplegia drugs (i.e., arrest agent and additive) to the main carrier solution (blood) which is circulated by a Quantum Roller Pump. The two devices, working in unison and controlled by the Quantum Workstation, deliver cardioplegia to the patient’s heart.
The premise of the Quantum Micro-Cardioplegia Delivery System is to interlock forward cardioplegia flow with medication delivery rates, ensuring delivery of arrest agent at a given ratio to the blood. The system includes a separate, dedicated heat exchanger, which is intended to be fitted in the cardioplegia blood line to allow for temperature regulation of the cardioplegia solution. The heat exchanger can be connected to any available heater cooler device which will manage the temperature regulation.
This document is an FDA 510(k) clearance letter for a medical device called the "Quantum Micro-Cardioplegia Delivery System." The letter grants clearance based on the device being "substantially equivalent" to legally marketed predicate devices.
Key takeaway regarding your request:
The provided document does not contain the specific acceptance criteria and study results in the detail you are requesting. It only states that a "suite of nonclinical tests was performed" and lists the types of tests conducted, concluding that these tests demonstrate substantial equivalence.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details like sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, or standalone algorithm performance.
The device described is a physical medical device (a system for delivering micro-cardioplegia during open-heart surgery), not an AI/software-driven diagnostic tool that would typically involve the type of performance metrics (sensitivity, specificity, AUC, human reader improvement, etc.) you are asking about.
I can, however, extract what is available about the non-clinical tests and the device's characteristics:
Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria or detailed reported performance metrics. It only states that testing was performed to demonstrate substantial equivalence to the predicate device. The general performance aspects implicitly evaluated would be related to the device's functional integrity, safety (electrical, electromagnetic), and usability.
| Performance Metric Category (Implied) | Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|---|
| Electronic/PCBA Tests | Meets specified electronic design requirements | "Tests performed" to confirm functionality and safety of electronic components |
| IEC 60601-1 Electrical Safety | Complies with IEC 60601-1 standard | "Tests performed" to confirm electrical safety standards are met |
| IEC 60601-1-2 EMC Tests | Complies with IEC 60601-1-2 standard | "Tests performed" to confirm electromagnetic compatibility |
| Functional/Performance Tests | Performs according to design specifications | "Tests performed" to ensure accurate and controlled delivery of cardioplegia, monitoring of parameters (drug concentration, flow, pressure, temperature), and interlock functionality. Accuracy of infusion is mentioned to be "the same" as the predicate. |
| Software Verification Tests | Software functions as intended | "Tests performed" to verify software operates correctly and safely |
| Human Factors/Usability Test | Safe and effective for intended user | "Tests performed" to ensure ease of use and minimize user error |
| Environmental/Storage/Cleaning | Maintains integrity under various conditions | "Tests performed" to confirm device robustness and cleanliness standards |
| Infusion Accuracy | Equivalent to predicate device | "The same infusion accuracy" as the predicate device is claimed. |
| Arrest Agent Concentration Range | 0-25 mEq/L | Reported as 0-25 mEq/L (Predicate: 0-40 mEq/L) |
| Functionality Display | Provides necessary information to user | Information such as temperature, flow, pressure, drug concentration, and delivery route displayed on touchscreen / Quantum Workstation. |
Study Details (Based on the provided document)
Since the device is a physical medical device, not an AI model, many of the requested fields are not applicable or not detailed in a typical FDA clearance letter for such a product.
- Sample size used for the test set and the data provenance: Not mentioned. The testing involves bench and non-clinical evaluations of the device's hardware, software, and performance, not a clinical data set in the context of an AI study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this refers to a physical device performance test, not a diagnostic interpretation. Clinical experts (experienced and trained clinicians) are the intended users, and Human Factors/Usability tests would involve them, but specifics are not provided.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for this type of device and testing.
- 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: Not applicable. This is a physical medical device, not an AI diagnostic tool involving human readers.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device. The "algorithm" refers to the device's control software, which performs its functions whether a human is "in-the-loop" as an operator or not during functional testing.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of a diagnostic AI. For a physical device, the "ground truth" for functional testing would be the engineering specifications, regulatory standards (e.g., IEC 60601-1), and expected physical and chemical performance parameters (e.g., flow rate accuracy, temperature control).
- The sample size for the training set: Not applicable. This is not an AI model requiring a training set in the machine learning sense.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided FDA clearance letter focuses on establishing substantial equivalence for a physical medical device (Quantum Micro-Cardioplegia Delivery System) through non-clinical bench testing, not on the performance of a diagnostic AI tool using clinical data. Therefore, most of the specific metrics and study design details you requested, which are pertinent to AI/software performance, are not present in this document.
§ 870.4240 Cardiopulmonary bypass heat exchanger.
(a)
Identification. A cardiopulmonary bypass heat exchanger is a device, consisting of a heat exchange system used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device.(b)
Classification. Class II (performance standards).