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510(k) Data Aggregation
(29 days)
Quantum Workstation 12 Elite
The intended use of the Quantum Workstation 12" Elite is for the non-invasive continuous monitoring of oxygen saturation and hematocrit / hemoglobin concentration of the blood and in an extracorporeal circuit. When using its range of accessories, the Quantum Workstation 12" Elite is configured to measure and display the following measurements:
- · SaO2 Arterial Saturation (%)
- · SvO2 Venous Saturation (%)
- · Hb Hemoglobin (g/L and gm/dl)
- · Hct Calculated Hematocrit (%)
- · Blood Flow 2 channels with arterial and venous flow differentials
- · Pressure & Temperature 4 channels
The Quantum Workstation 12" Elite 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 iudgments regarding the treatment of the patient as a result of information displayed by the workstation.
The Quantum Workstation 12" Elite is an on-line, cardiopulmonary bypass, blood gas monitor that is used for extracorporeal monitoring of blood oxygen (arterial and venous) saturation, hematocrit, and hemoglobin levels. The device's enhanced functionality includes the ability to control centrifugal or roller pumps and make blood flow, blood pressure and blood temperature measurements.
The Quantum Workstation 12" Elite consists of a pole-mounted 12.1" landscape high definition touch screen. The touch screen displays individual and trend readings with alarm settings. The Quantum Workstation 12" Elite provides memory storage via an SD (Secure Digital) card. The Quantum Workstation 12" Elite is powered from the AC Mains supply and 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 12" Elite includes the following ports / connections:
- One (1) sensor port for the Hb / SO2 sensor
- Two (2) sensor ports for blood flow ●
- Two (2) sensor ports for blood pressure/temperature
- One (1) LAN / Ethernet port ●
- Two (2) USB 2.0 ports ●
- Three (3) Spectrum Medical ports
- One (1) User Serial Port
Accessories for the Quantum Workstation 12" Elite include the power supply, mounting arm (long or short), Hb / SQ2 sensor, flow sensors and pressure/temperature sensors.
I am sorry; this document does not contain the information you are looking for. None of the pages reference acceptance criteria or study data demonstrating that the device meets these criteria.
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(30 days)
Quantum Workstation 12.1
The intended use of the Quantum Workstation 12.1" is for the non-invasive continuous monitoring of oxygen saturation and haemotocrit / haemoglobin concentration of the blood in an extracorporeal circuit. When using its range of accessories, the Quantum Workstation 12.1" is configured to measure and display the following measurements:
SaO2 Arterial Saturation (%)
SvO2 Venous Saturation (%)
Hb Haemogloblin (g/L and gm/dl and mmol/l)
Hct Calculated Haematocrit (%)
The Workstation 12.1" provides monitoring information to trained clinicians and can be configured by them to set parameter specific alarms.
The Workstation 12.1"'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 12.1".
The Quantum Workstation 12.1" 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 12.1" consists of a pole-mounted 12.1" landscape high definition touch screen. The touch screen displays individual and trend readings with alarm settings. The Quantum Workstation 12.1" has a Wi-Fi adapter and provides memory storage via an SD (Secure Digital) card. The Quantum Workstation 12.1" 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 12.1" 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 12.1" 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 Quantum Workstation 12.1" is a medical device for continuous non-invasive monitoring of oxygen saturation and hematocrit/hemoglobin concentration in an extracorporeal circuit during cardiopulmonary bypass. The document provided is a 510(k) Premarket Notification, which demonstrates substantial equivalence to a predicate device rather than presenting a study to prove the device meets specific acceptance criteria in a clinical setting.
Therefore, the information regarding acceptance criteria and performance is derived from a comparison to the predicate device and non-clinical bench testing, not a clinical study with human subjects demonstrating a specific effect size.
Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for the Quantum Workstation 12.1" are implicitly defined by its substantial equivalence to the predicate device, the Quantum Workstation (K163657), and adherence to relevant safety and performance standards. The reported device performance, therefore, matches that of the predicate device.
Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (from Predicate Device Performance) | Reported Device Performance (Quantum Workstation 12.1") |
|---|---|---|
| Blood Oxygen Saturation (SO2) | ||
| Range | 20-100% | Same |
| Range Temperature | 15-37°C | Same |
| Mean Offset | 0.48 | Same |
| Standard Deviation | ± 1.90 | Same |
| Hemoglobin (Hb) / Hematocrit (Hct) | ||
| Range (9/16" OD tube size) | 5-15 g/dL / 15-45% | Same |
| Range (other sensors) | 5–16.6 g/dL / 15-50% (for 5/16", 3/8", 7/16" OD tube size) | Same |
| Range Temperature | 15-37°C | Same |
| Mean Offset | 0.03 | Same |
| Standard Deviation | ± 0.60 | Same |
| Electrical Safety | Complies with: AAMI ANSI ES60601-1:2005/(R)2012 + A1:2012, IEC 60601-1-6:2010 + A1:2013, IEC 60601-1-8:2006 + A1:2012, IEC 60601-2-49:2011 | Complies with listed standards |
| EMC | Complies with: IEC 60601-1-2:2014 | Complies with listed standard |
| Mechanical Integrity | Withstands screen impact, resistant to cleaning products, functions after exposure to non-operational temperature and humidity extremes. | Passes all specified mechanical tests |
| Software Integrity | Class B software (non-serious injury possible) per IEC 62304:2006; verification and validation testing completed, with no risks of death or serious injury from faulty/incorrect data. Clinicians will rely on other devices. | Software confirmed as Class B, V&V testing completed |
Study Details
The substantial equivalence determination for the Quantum Workstation 12.1" was based on non-clinical testing (bench performance testing) and a comparison to a predicate device, not a clinical study involving human patients or a test set of clinical data with ground truth experts.
- Sample size used for the test set and the data provenance: Not applicable. No clinical test set was used. The evaluation was based on bench testing of the physical device and its software.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No human expert-established ground truth was used for a test set as this was not a clinical or AI performance evaluation.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This was a 510(k) submission for a physical medical device, not an AI/imaging diagnostic device requiring MRMC studies.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device provides quantitative measurements, not an algorithmic diagnosis or interpretation that would have standalone performance in the context of AI.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the performance characteristics (SO2, Hb/Hct), the "ground truth" was established by comparing the device's measurements to a reference blood gas analyzer for the predicate device. For the 510(k) of the Quantum Workstation 12.1", the ground truth for its performance was effectively the demonstrated performance of the predicate device and compliance with international standards for electrical safety, EMC, and software.
- The sample size for the training set: Not applicable. This device does not use machine learning that requires a "training set."
- How the ground truth for the training set was established: Not applicable.
In summary, the information provided is typical for a 510(k) submission for a continuous monitoring medical device, focusing on engineering validation, safety, and performance equivalence to a previously cleared predicate, rather than a clinical study evaluating diagnostic accuracy or AI performance in a clinical dataset.
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(26 days)
Quantum Workstation
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.
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