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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

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.

1. 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.
2. 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.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
4. 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.
5. 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.
6. 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.
7. The sample size for the training set: Not applicable. This device does not use machine learning that requires a "training set."
8. 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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