(60 days)
The Quantum Mini Ventilation Module is intended to provide independently regulated O2 outputs for a controlled flow of O2 into the ECC circuit. The Quantum Mini Ventilation Module is an accessory that works with the Quantum workstation.
The following parameters are provided by the Quantum Mini Ventilation Module:
· Control of gas flow (02)
· Extracorporeal gas flow measurements for O2
The Quantum Mini Ventilation Module is only 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 Mini Ventilation Module is a gas control unit that is intended to provide independently regulated oxygen outputs for a controlled flow for procedures involving an extracorporeal circuit.
The Quantum Mini Ventilation Module provides a simplified patient ventilation capability. The device consists of a single O2 input port that receives oxygen from the hospital infrastructure and two (2) oxygen outputs that are designed to provide O2 sweep and pO2 Reg.
The device interfaces with and is powered by any model of the Quantum workstation. The Quantum Mini Ventilation Module does not contain any user interface; instead, all measurements are displayed on the Quantum workstation.
This is a summary of the acceptance criteria and study information for the Quantum Mini Ventilation Module, based on the provided FDA 510(k) summary.
Note: This device is a cardiopulmonary bypass gas control unit, which typically involves engineering performance testing rather than studies involving AI algorithms or human reader performance with medical images. Therefore, many of the requested fields related to AI, medical image analysis, and expert consensus for ground truth are not applicable to this type of device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (if quantifiable) | Reported Device Performance (Summary from Non-Clinical Testing) |
|---|---|---|
| Electrical Safety | Not explicitly detailed in the document. | Testing performed; results support substantial equivalence. |
| Electromagnetic Compatibility (EMC) | Not explicitly detailed in the document. | Testing performed; results support substantial equivalence. |
| Hardware Testing | Not explicitly detailed in the document. | Testing performed; results support substantial equivalence. |
| Software Verification and Validation | Not explicitly detailed in the document. | Testing performed; results support substantial equivalence. |
| Functional Performance | Independently regulated O2 outputs; controlled flow of O2; extracorporeal gas flow measurements for O2. | Achieves intended outputs and measurements. Differences from predicate (e.g., fewer gas supplies, no vacuum management) do not raise new safety/effectiveness issues. |
| Intended Use | To provide independently regulated O2 outputs for a controlled flow of O2 into the ECC circuit. Works with Quantum workstation. | Meets the stated indications for use. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable in the context of a "test set" for an AI algorithm or medical image data. The testing described is engineering performance testing of hardware and software.
- Data Provenance: Not applicable. The testing is internal engineering and software validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not an AI/image-based device where expert consensus on "ground truth" for a test set is typically established.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is not an AI/image-based device requiring an adjudication method for a test set.
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. This is a medical device for controlling gas flow in cardiopulmonary bypass, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a hardware module with embedded software for control and measurement, not a standalone AI algorithm. It operates under the control of an experienced and trained clinician via the Quantum workstation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth Type: For engineering performance testing, the "ground truth" refers to established engineering standards, specifications, and validated measurement techniques ensuring the device functions as designed and meets regulatory requirements for safety and performance (e.g., accurate flow measurements against calibrated instruments, electrical safety compliance, EMC compliance).
8. The sample size for the training set:
- Not applicable. This device does not use a "training set" in the machine learning sense. Software development involves verification and validation against requirements and design specifications.
9. How the ground truth for the training set was established:
- Not applicable. This device does not have a "training set" in the machine learning sense.
§ 870.4300 Cardiopulmonary bypass gas control unit.
(a)
Identification. A cardiopulmonary bypass gas control unit is a device used to control and measure the flow of gas into the oxygenator. The device is calibrated for a specific gas.(b)
Classification. Class II (performance standards).