(26 days)
The intended use of the Quantum Workstation is for the non-invasive continuous monitoring of oxygen saturation and hematocrit / hemoglobin concentration of the blood in an extracorporeal circuit. When using its range of accessories, the Quantum Workstation is configured to measure and display the following measurements:
- SaO2 Arterial Saturation (%)
- Venous Saturation (%) Sv02
- Hb Hemoglobin (g/L and gm/dl)
- Calculated Hematocrit (%) Hct
The Workstation provides monitoring information to trained clinicians and can be configured by them to set parameter specific alarms.
The Workstation's monitoring and alarm functionality does not directly control patient care. The User makes clinical judgments regarding the treatment of the patient as a result of information displayed by the Workstation.
The Quantum Workstation is an online, cardiopulmonary bypass, blood gas monitor. It is used for extracorporeal monitoring of blood oxygen (arterial and venous) saturation, hematocrit, and hemoglobin levels.
The Quantum Workstation consists of a pole-mounted 14 ¾" portrait high definition touch screen. The touch screen displays individual and trend readings with alarm settings. Third party data may also be displayed (without alarms). The Quantum Workstation has a Wi-Fi adapter and provides memory storage via an SD (Secure Digital) card. The Quantum Workstation is powered from the AC Mains supply and also incorporates a battery backup that automatically switches on in the event of an interruption to the mains power supply. The battery backup is provided via two (2) lithium-ion batteries with a two-hour minimum life.
The Quantum Workstation includes the following ports / connections:
- . One (1) sensor port for the Hb / SO2 sensor
- One (1) LAN / Ethernet port
- . Three (3) USB 2.0 ports
- Eight (8) additional LAN ports described as SAP (Spectrum Accessory Ports) to . support a range of Spectrum Medical manufactured modules - these are for future use
Accessories for the Quantum Workstation include the power supply, mounting arm (long or short), and Hb / SO2 sensor. Different Hb / SO2 sensors are available based on the diameter and thickness of the extracorporeal tubing.
The provided text does not contain a detailed description of acceptance criteria for a specific device performance and a study proving it meets these criteria. Instead, it is an FDA 510(k) summary for the "Quantum Workstation," a blood gas monitor. The summary focuses on demonstrating substantial equivalence to a predicate device (M2 Monitor) rather than presenting a performance study against predefined acceptance criteria.
Specifically, the document states:
"In vitro testing was performed to confirm, as shown in Table A, that the SO2 and Hb (with calculated Hct) functional performance for the Quantum Workstation was unchanged from the M2 Monitor."
And further:
"No clinical data were submitted to support the substantial equivalence of the Quantum Workstation to the M2 Monitor."
This indicates that the "performance data" provided refers to the comparison of the Quantum Workstation's functional performance to its predicate device, the M2 Monitor, and not to a study against explicit acceptance criteria with detailed statistical analysis.
However, Table A (on Pages 6 and 7) does provide some performance specifications for the predicate device, which the new device is stated to have "Same" performance as. These can be inferred to be the de-facto performance metrics considered in the comparison:
1. Table of Acceptance Criteria (Inferred from Predicate Performance) and the Reported Device Performance:
| Parameter | Acceptance Criteria (Predicate Performance) | Reported Device Performance (Quantum Workstation) |
|---|---|---|
| SO2 | Range = 20-100% | Same |
| Range Temperature = 15-37°C | Same | |
| Mean Offset = 0.48 | Same | |
| Standard Deviation = ±1.90 | Same | |
| Hb / Hct | Range: 5-15 g/dL / 15-45% (for 9/16" OD tube size) | Same |
| Range: 5-16.6 g/dL / 15-50% (for other sensors) | Same | |
| Range Temperature = 15-37°C | Same | |
| Mean Offset = 0.03 | Same | |
| Standard Deviation = ±0.60 | Same |
Additional context: The document states that the new device uses an "equivalent Hb / SO2 sensor to M2 Monitor" with "improved electrical isolation and different colored cable boot," which likely contributes to the "Same" performance.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "In vitro testing was performed" for SO2 and Hb performance. However, it does not specify the sample size, data provenance, or whether the study was retrospective or prospective.
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 provided in the document. The performance comparison is stated to be against the M2 Monitor's established performance, implying the predicate device itself serves as the reference, rather than independent expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
The document describes a medical monitoring device, not an AI-assisted diagnostic tool for human readers. Therefore, no MRMC comparative effectiveness study was performed or is relevant in this context. The device provides "monitoring information to trained clinicians" and "The User makes clinical judgments regarding the treatment of the patient as a result of information displayed by the Workstation," indicating it's a data display tool for clinicians, not an AI to improve human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The entire performance evaluation, as described, is essentially a standalone (algorithm only) performance comparison against the predicate device's established specifications. The device continuously monitors and displays measurements without requiring human input for its core measurement function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the new device's performance comparison was the established functional performance of the predicate device (M2 Monitor), as detailed in Table A. For blood gas monitors, this typically involves laboratory reference methods for SO2, Hb, and Hct, but the document does not elaborate on how the M2 Monitor's original performance metrics were established. It simply states the new device's performance was "unchanged from the M2 Monitor."
8. The sample size for the training set
The document does not describe the Quantum Workstation as an AI/ML device that requires a "training set." Its function is based on optical measurement principles. Therefore, no training set is mentioned or applicable in the context of this device's stated technology.
9. How the ground truth for the training set was established
As there is no training set, this question is not applicable.
§ 870.4330 Cardiopulmonary bypass on-line blood gas monitor.
(a)
Identification. A cardiopulmonary bypass on-line blood gas monitor is a device used in conjunction with a blood gas sensor to measure the level of gases in the blood.(b)
Classification. Class II (performance standards).