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510(k) Data Aggregation
(158 days)
Quantum Pump Console
The Quantum Pump Console is indicated for use for up to 6 hours in cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
The Quantum Pump Console is a configurable heart-lung machine consisting of various components controlled by a central workstation. The system is intended to be used in any surgery in which the patient's blood is being oxygenated extracorporeally. The modular system consists of a frame, power supply with battery backup, roller pumps, pump control module, diagnostic module and a central workstation with the user interface.
The roller pumps are available in three sizes (4", 6" and 8") and can be controlled via a centralized interface on the Quantum Workstation touchscreen or through the Quantum Pump Console, which contains five knobs and displays in one integrated console.
This document is a 510(k) summary for the Quantum Pump Console, a heart-lung machine. It determines substantial equivalence to a predicate device, the Stöckert S5 System.
Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding device performance for a specific clinical or diagnostic task in the way one might expect for an AI/ML diagnostic device. Instead, the "acceptance criteria" are implied by the demonstration of "substantial equivalence" to a predicate device.
The performance data presented is primarily focused on non-clinical testing to ensure the device performs safely and effectively in its intended function, similar to the predicate.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| Safety and Effectiveness Equivalence: The Quantum Pump Console must demonstrate that differences in technological characteristics from the predicate device (Stöckert S5 System) do not raise new issues of safety or effectiveness. This is assessed by having the same intended use/indications for use, clinical setting, target patient population, principle of operation for the pumps, and same pump speed and accuracy. | The Quantum Pump Console performs the same intended use/indications for use as the S5 System. It operates in the same clinical setting, targets the same patient population, utilizes the same principle of operation for the pumps, and exhibits the same pump speed and accuracy. The differences (centralized touchscreen vs. multiple screens, centralized control module vs. individual pump knobs) are stated not to raise new safety or effectiveness concerns. |
| Electrical Safety: Compliance with relevant standards for electrical safety. | "Electrical safety" testing was performed. (Specific standards or results are not detailed in this summary, but the general statement implies compliance). |
| Electromagnetic Compatibility (EMC): Compliance with relevant standards for EMC. | "Electromagnetic compatibility (EMC)" testing was performed. (Specific standards or results are not detailed). |
| Electrosurgery Interference: Demonstrates proper function and safety in the presence of electrosurgical equipment. | "Electrosurgery interference" testing was performed. (Specific standards or results are not detailed). |
| Hardware Functionality: Ensures proper operation of printed circuit boards. | "Hardware testing of printed circuit boards" was performed. (Specific tests or results are not detailed). |
| Software Verification and Validation: Ensures software functions as intended and meets specifications. | "Software verification and validation" was performed. (Specific tests, methodologies, or results are not detailed). |
2. Sample Size Used for the Test Set and the Data Provenance
This document does not describe a "test set" in the context of clinical data for AI/ML performance. The testing performed is physical/electrical/software verification and validation of the device itself.
- Sample Size for Test Set: Not applicable in the context of clinical/diagnostic performance testing using patient data. The testing involved verification and validation activities on the device hardware and software.
- Data Provenance: Not applicable for patient data. The non-clinical tests were likely conducted in a laboratory or manufacturing setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. The ground truth for the non-clinical tests is based on engineering specifications, regulatory standards, and expected device behavior, rather than expert interpretation of patient data.
4. Adjudication Method for the Test Set
Not applicable. The non-clinical tests involve objective measurements against predefined specifications, not expert adjudication of ambiguous cases.
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
No MRMC comparative effectiveness study was performed or described. This is not an AI-assisted diagnostic device, but a medical device (heart-lung machine console) where the focus is on its physical and software functionality and safety compared to a predicate.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The Quantum Pump Console is not an algorithm-only device. It's a hardware system with integrated software, intended to be operated by a qualified medical professional. Its performance is always with a human-in-the-loop.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests would be:
- Engineering specifications and design requirements: For hardware and software functionality.
- Regulatory standards: For electrical safety, EMC, and other performance characteristics.
- Predicate device's known performance characteristics: To establish equivalence in pump speed, accuracy, and overall operational principles.
8. The Sample Size for the Training Set
Not applicable. This device does not use machine learning in a way that requires a "training set" of patient data.
9. How the Ground Truth for the Training Set was Established
Not applicable, as no training set (in the context of AI/ML) was used.
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