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The CDI OneView Monitoring System is a patient parameter monitoring system to be used on a single patient during cardiopulmonary bypass procedures. By measurement or acquisition from other devices, it displays and outputs information to provide continuous, in-line monitoring of various patient parameters contained within the extracorporeal perfusion circuit and patient. The following parameters are available, based on configuration:
·Potential of Hydrogen (pH)
·Partial Pressure of Carbon Dioxide (pCO2)
·Partial Pressure of Oxygen (pO2)
·Potassium Ion (K+)
·Oxygen Saturation (SO2)
·Hematocrit (HCT)
·Hemoglobin (Hgb)
·Blood Flow Rate (Q)
·Cardiac Index (CI)
·Base Excess (BE)
· Bicarbonate (HCO3- )
·Oxygen Consumption (VO2)
·Indexed Oxygen Consumption (VO2i)
·Oxygen Delivery (DO2)
·Indexed Oxygen Delivery (DO2i)
· Cerebral Regional Oxygen Saturation (rSO2)
·Oxygen Extraction Ratio (O2ER)
· Body Surface Area (BSA)
·Shunt Sensor Temperature

The CDI OneView Monitoring System is an AC-powered (battery back-up) microprocessor-based device used with the following components/accessories:

• . Core: Core Processing Unit, all other elements connect to the Core
• Display: Touchscreen display with cable ●
• . HSAT Probe: Hematocrit/Saturation probe with cable, interfaces with disposable Cuvette(s)
• BPM Probe: Blood Parameter Module with cable, interfaces with disposable . Shunt Sensor
• Calibrator: Gas calibrator for BPM/Shunt Sensor with cable, interfaces with disposable gas bottles
• Flow Module & Sensor: Flow sensor connected to an external interface ● module with cable.
• . HLM External Device Module: Heart Lung Machine (HLM) interfacing module and cable
• DMS External Device Module: Data output for data management system ● (DMS) interfacing module and cable
• rSO2 External Device Module: Cerebral Oximetry device interfacing module ● and cable
• . Mounting accessories: Different mounting features are used to securely mount elements of the system on an HLM pole during a cardiopulmonary bypass (CPB) case.
• Disposable accessories: The CDI OneView Monitoring System hardware ● connects to disposable accessories which are in-line with the extracorporeal circuit. The BPM probe is attached to Shunt Sensors, the HSAT probe is attached to Cuvette(s) during a CPB case for blood parameters measurement during monitoring. Disposable Gas Bottles (Gas 1 & Gas 2) are used with the Calibrator.

The CDI OneView Monitoring System uses the following measurement technologies:

• Optical fluorescence technology to measure partial pressure of oxygen and . carbon dioxide, pH and potassium ion concentration.
• . Optical reflectance technology to measure oxygen saturation, hematocrit, and hemoglobin within the blood.
• Thermistor (resistive) sensing technology to measure blood temperature. ●
• Non-invasive acoustical sensing technology to measure blood flowrate. ●

The CDI OneView Monitoring System measures blood parameters in real time by utilizing a microprocessor-based core, electro-optics modules (i.e., BPM and H/S probe), flow probe (includes flow module and flow sensor), fluorescence chemistry technology, optical reflectance technology and non-invasive acoustical sensing technology. The electro-optics modules connect the core to the disposables (i.e., shunt sensor or cuvette) which are inserted into the extracorporeal circuit. The flow module connects the core to the flow sensor that use clamp-on mechanism to fit around tubing of the extracorporeal circuit. Light is emitted from the modules, optical responses from the blood and the Ultrasonic/acoustical generated signal measurements via the sensor(s) are measured by the core. The blood parameters are measured or calculated by the CDI OneView Processing Core in real time and displayed to the user via a Touchscreen Display.

The provided text is a 510(k) summary for the Terumo CDI OneView Monitoring System. It outlines the device, its intended use, a comparison to a predicate device, and performance data required for substantial equivalence.

Based on the provided text, here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state a table of quantitative acceptance criteria with corresponding device performance for each measured parameter (e.g., specific accuracy ranges for pH, pCO2, pO2). Instead, it relies on general statements about design verification and validation.

However, the "Design Verification and Validation Testing" section states:

• "Design verification testing was conducted and demonstrates that the CDI OneView Monitoring System performs pursuant to the defined design input requirements for the subject device."
• "Design validation, including simulated use testing, was conducted and demonstrates that the CDI OneView Monitoring System meets the defined design input requirements for the subject device."

This implies that there were "defined design input requirements" which served as acceptance criteria, and the device met them. The specific numerical values or ranges for these criteria are not provided in this summary. The "Performance Data" section primarily focuses on:

• Electrical Safety and EMC: Compliance with IEC 60601-1 and IEC 60601-1-2 standards.
• Software Verification and Validation Testing: Successfully completed, with the software considered a "moderate" level of concern.
• Design Verification and Validation Testing: Performed as described above.

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide information on specific sample sizes for test sets used for measuring the accuracy or performance of the individual blood parameters. Given that clinical studies and animal studies were not required or included, the "test set" would likely refer to engineering and simulated use testing.

The data provenance is not explicitly stated in terms of country of origin or whether it's retrospective/prospective clinical data, because clinical studies were not performed. The testing appears to be primarily laboratory-based and simulated use testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided as there were no clinical studies mentioned that would typically involve experts establishing ground truth for patient outcomes or diagnostic accuracy. For engineering and simulated use testing, "ground truth" would likely be established by reference instruments or calibrated standards.

4. Adjudication Method for the Test Set

This information is not provided as there were no clinical studies or multi-reader scenarios described that would necessitate an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement

No MRMC comparative effectiveness study was done. The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence of the CDI OneView Monitoring System to the predicate device and is not included as part of this premarket notification." Therefore, there is no information on human reader improvement with or without AI assistance as this device is a monitoring system and not primarily an AI-driven image interpretation or diagnostic aid tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device is a "monitoring system" that "displays and outputs information to provide continuous, in-line monitoring of various patient parameters." It is not presented as an AI algorithm for diagnosis or interpretation that would have standalone performance measured against human-in-the-loop performance. Its primary function is to measure and display physiological parameters, which is inherently a "standalone" algorithmic function in that the measurements are provided by the device itself.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Given the nature of the device (a blood parameter monitoring system) and the absence of clinical studies, the "ground truth" for verifying the accuracy of the measured parameters (pH, pCO2, pO2, K+, SO2, HCT, Hgb, Blood Flowrate) would implicitly be based on calibrated reference standards and/or laboratory reference methods for these specific physiological measurements during design verification and validation testing. The text does not specify which exact methods were used, but for such devices, it's standard practice to compare the device's readings to highly accurate laboratory analyzers or calibrated simulation fluids.

8. The Sample Size for the Training Set

This information is not applicable/not provided in the context of machine learning training data. The device is a measurement and monitoring system that utilizes "optical fluorescence technology," "optical reflectance technology," "Thermistor (resistive) sensing technology," and "Non-invasive acoustical sensing technology." While these technologies involve algorithms for signal processing and parameter calculation, the document does not describe the use of machine learning models that would require a "training set" in the typical sense of AI/ML devices.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not provided for the same reasons as #8. If any internal algorithms were developed for parameter calculation, their "ground truth" (or basis) would likely stem from established physiological principles, known optical/acoustical properties, and extensive calibration using reference materials, rather than a "training set" with expert-labeled ground truth like in AI/ML applications.

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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

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.

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B-Capta is indicated for supplementary, in-line monitoring of the extracorporeal arterial oxygen partial pressure, venous oxygen saturation, venous hematocrit/hemoglobin, and arterial and venous temperature during cardiopulmonary bypass procedures up to six hours.

B-Capta is intended to be used for in-line continuous monitoring of patient's blood parameters during procedures requiring extracorporeal circulation.

B-Capta is designed to work with a Stöckert S5 System (K071318) heart-lung machine.

Provided in-line measured parameters of B-Capta are: In the Venous line:

• Haematocrit / Haemoglobin (Hct/Hb)
• Venous blood oxygen saturation (sO2)
• Venous blood temperature (venT)

In the Arterial line:

• Arterial blood oxygen partial pressure (pO2)
• Arterial blood temperature (artT)

The duration of application is limited to 6 hours of continuous use.

B-Capta consist of the following components / disposables:

• B-Capta Venous and Arterial Sensors
• B-Capta Sensor Module
• B-Capta Venous and Arterial Reference Element Holders
• B-Capta disposable Venous and Arterial Cuvettes

B-Capta is a microprocessor based device. The venous sensor is an optical sensor which measures, when connected to its dedicated disposable cuvette, hematocrit/hemoglobin and oxygen saturation using an optical reflectance technology. Moreover, an infrared technology is used to measure the temperature of the venous blood.

The arterial sensor is an optical sensor which measures, when connected to its dedicated disposable cuvette, partial pressure of oxygen using an optical fluorescence technology. Moreover, an infrared technology is used to measure the temperature of the arterial blood.

Both sensors are functionally connected to the compatible heart-lung machine via a cable plugged in the sensor module and communicate with B-Capta firmware via a RS232 interface according to a dedicated communication protocol. Data are displayed on the graphical user interface of the heart-lung machine.

The provided text describes a 510(k) premarket notification for the B-Capta device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive de novo clinical study data to establish acceptance criteria and prove device performance against them.

Therefore, many of the requested details about acceptance criteria, specific study designs, sample sizes, and expert qualifications for ground truth are not present in this regulatory document. The document primarily highlights non-clinical testing performed to support substantial equivalence.

Here's a breakdown based on the information available:

1. A table of acceptance criteria and the reported device performance

This information is not explicitly available in the provided text. The document states "Design functionality testing confirms that the product meets its product requirements," but it does not specify what those requirements (acceptance criteria) are or provide quantitative performance results against them.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not available. The document mentions "Design Verification and Validation Testing" and "Software verification and validation testing," but it does not provide details on sample sizes, data provenance, or the nature of these "test sets" for performance evaluation in a clinical or simulated clinical context.

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 available. Given that no clinical testing was required or submitted, there's no mention of experts establishing a ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not available. No adjudication method is mentioned as there's no reported test set requiring expert adjudication.

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

This information is not applicable/not available. The B-Capta is an on-line blood gas monitor, not an AI-assisted diagnostic imaging device that would involve human readers or MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

The B-Capta device itself is a standalone measurement device, intended for in-line continuous monitoring. Its performance is evaluated on its ability to accurately measure blood parameters. While "standalone performance" was implicitly assessed through design verification and validation, the document does not present this as a separate study with specific metrics (e.g., sensitivity, specificity) against a reference standard in the way an AI algorithm's standalone performance might be described. It focuses on functional compliance and safety.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the performance of measuring blood parameters, the ground truth would typically be established by:

• Reference laboratory methods: For blood gas parameters, this usually involves validated laboratory blood gas analyzers.
• Traceable standards: For temperature measurements, calibrated temperature probes.

The document does not explicitly state the specific "ground truth" methods used during its design verification and validation, but these would be the standard approaches for such a device.

8. The sample size for the training set

This information is not available. The B-Capta is described as a "microprocessor based device" with optical and infrared sensors. It's not explicitly framed as a machine learning/AI device requiring a "training set" in the typical sense of deep learning or predictive models. Its functionality is based on established physical principles for sensing.

9. How the ground truth for the training set was established

This information is not available and likely not applicable, as explained in point 8.

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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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The CDI System 550 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hemoglobin and temperature. In addition, calculated values of base excess, bicarbonate, oxygen saturation, oxygen delivery and oxygen consumption may also be provided. These parameters are displayed at either actual temperature or adjusted to 37°C. For documentation purposes, the systems integral printer provides a hard copy of displayed parameters.

The CDI System 550 is an AC-powered (battery back-up) microprocessor-based device used with the following components/accessories:

• CDI 550 Monitor ●
• Arterial and/or Venous Blood Parameter Modules (BPM) ●
• CDI Hematocrit/Saturation (H/S) Probe ●
• CDI 540 Gas Calibrator and Calibration Gases (A and B) ●
• CDI 510H Shunt Sensor ●
• Shunt Bypass Line
• CDI H/S Cuvette with or without extension tubing ●
• Monitor Mounting Hardware (Pole Clamp and Cable Head Bracket) ●
• Printer Paper ●

The CDI System 550 measures blood parameters in real time by utilizing a microprocessor based monitor, electro-optics modules (i.e., BPM and H/S probe), fluorescence chemistry technology, and optical reflectance technology. The electro-optics modules connect the monitor to the disposables (i.e., shunt sensor or cuvette) which are inserted into the extracorporeal circuit. Light is emitted from the modules, and the optical responses from the blood via the sensor(s) are measured by the monitor. The blood parameters are measured or calculated by the CDI 550 Monitor in real time, and displayed to the user via a graphical LED display.

The information provided does not contain a study that proves the device meets specific acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy) for diagnosis or treatment. The document is a 510(k) premarket notification for the CDI Blood Parameter Monitoring System 550, asserting substantial equivalence to a predicate device (CDI Blood Parameter Monitoring System 500, K133658).

The "Performance Data" section primarily addresses:

• Biocompatibility Testing: Not required as the device does not contact the patient and disposables haven't changed.
• Electrical Safety and Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1 and IEC 60601-1-2.
• Software Verification and Validation Testing: Completed successfully as per FDA guidance for "moderate" level of concern software.
• Design Verification and Validation Testing: Conducted to demonstrate the device performs according to defined design input requirements and meets them through simulated use testing.
• Animal Study: Not required.
• Clinical Studies: Not required.

The document discusses modifications to the device (new calculated parameter, alarm scheme updates, expanded operating ranges for hematocrit/hemoglobin, improved temperature correction algorithm, improved pre-in-vivo calibration performance). These modifications resulted in "modified blood parameter module (BPM) accuracy claims" and expanded "hematocrit (HCT) and hemoglobin (Hgb) operating ranges and their corresponding modified accuracy claims." However, the specific acceptance criteria for these accuracy claims or the data supporting these claims are not detailed in the provided text.

Therefore, many of the requested items cannot be fully answered from the given document as it focuses on demonstrating substantial equivalence through engineering and software testing rather than clinical performance studies with defined acceptance criteria.

Here's a breakdown of what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified. The document mentions "Design verification and validation testing" and "simulated use testing" but does not detail the sample sizes for these tests. There were no clinical studies.
• Data Provenance: Not specified. As clinical studies were not performed or required, there is no mention of country of origin or whether data was retrospective/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)

• Not applicable as no clinical studies with expert-established ground truth were performed or referenced for performance evaluation in this document. The testing described is engineering and software validation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable as no clinical studies with adjudicated ground truth were performed or referenced.

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

• Not applicable. This device is a blood parameter monitoring system, not an AI-assisted diagnostic tool involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• The document implies standalone performance testing for the device's measurements and calculations through "Design verification and validation testing." However, the raw data or detailed results of this standalone performance are not provided, only a summary statement of successful completion.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For the engineering and software validation, the "ground truth" would be established by design specifications, industry standards (e.g., IEC 60601-1), and potentially comparison to reference instruments or methods during bench testing. Specific details are not provided in the document. No clinical ground truth (like pathology or outcomes data) was used based on the stated lack of clinical studies.

8. The sample size for the training set

• Not applicable. This is a medical device, not an AI/machine learning algorithm requiring a separate training set in the typical sense. The "training" would be the device's internal calibration and programming based on established physical and chemical principles.

9. How the ground truth for the training set was established

• Not applicable. As above, this is a monitoring device based on established technology, not an AI algorithm that learns from a training set with specific ground truth labels. Its "ground truth" is intrinsically linked to the physical and chemical principles it measures and calculates, developed and verified during its design and engineering phases.

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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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The Quantum Diagnostic Module is intended for the continuous monitoring of critical clinical parameters during procedures that require extracorporeal circulation. The Quantum Diagnostic Module is an accessory that only works with the Quantum Workstation. Parameters provided by the Quantum Diagnostic Module include:

• · Measurement of up to three blood flow channels and arterial and venous flow differential
• · Indication of gas bubbles
• · Extracorporeal gas flow measurements (02, CO2, gas flow, and CO2 removal)
• · Predicted PO2 and PCO2
• · Temperature
• · Up to three circuit pressure channels
• · Reservoir level indication

The Quantum Diagnostic Module is to only be used by an experienced and trained clinician. The device is not intended to be used by the patient or other untrained personnel.

The Quantum Diagnostic Module is an accessory to the Quantum Workstation that provides continuous non-invasive monitoring of critical clinical parameters during procedures requiring extracorporeal circulation. The Quantum Diagnostic Module is connected to the Quantum Workstation via a cable and positioned between the gas blender and the oxygenator devices in the extracorporeal circuit. When paired with the Quantum Workstation, the combination of the Quantum Workstation and Quantum Diagnostic Module is known as the Quantum Diagnostic System.

The Quantum Diagnostic Module performs three functions:

• 1. Provides measurements from embedded and attached sensors to monitor gases into and out of a blood oxygenator.
• 2. Provides measurements from attached sensors for blood flow, bubble detection, pressure, level and temperature to monitor an extracorporeal blood loop.
• 3. Sends these physiological measurements to the Quantum Workstation for display to the user.

The Quantum Diagnostic Module, with its attached sensors, can measure flow, pressure, reservoir level, temperature and gas diagnostics. The Quantum Diagnostic Module only works with the Quantum Workstation.

The provided text is a 510(k) premarket notification summary for a medical device called the Quantum Diagnostic Module. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a comprehensive clinical study as one might expect for a new, novel device.

Therefore, the document does not contain the detailed information required to answer all parts of your request in the format provided, particularly regarding a multi-reader multi-case study, standalone algorithm performance, or extensive ground truth establishment as would be present for an AI/ML device.

However, I can extract the relevant information regarding performance data and the non-clinical testing performed to support substantial equivalence.

Here's a breakdown of what is and isn't available in the document:

1. Table of acceptance criteria and reported device performance:

The document mentions "In vitro evaluation testing (comparison testing)" as non-clinical testing. While this implies performance was assessed, specific acceptance criteria and detailed reported performance metrics (like accuracy, sensitivity, specificity, etc.) are not explicitly listed in a table within this 510(k) summary. The summary states that the Quantum Diagnostic Module and the predicate M4 Monitor have "equivalent sensor performance" and that the "principles of operation of its sensors are identical or equivalent." This suggests a comparative approach rather than meeting predefined numerical thresholds.

2. Sample size used for the test set and data provenance:

The document mentions "In vitro evaluation testing (comparison testing)" but does not specify the sample size used for this test set nor the data provenance (e.g., country of origin, retrospective/prospective).
It also states: "No animal testing was submitted to support the substantial equivalence of the Quantum Diagnostic Module to the M4 Monitor."

3. Number of experts used to establish the ground truth for the test set and their qualifications:

This information is not provided in the document. The nature of the device (a monitor for physical parameters) suggests that ground truth would likely be established through calibrated reference instruments rather than expert human interpretation.

4. Adjudication method 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, and its effect size:

No MRMC study was done or reported. This type of study is typically for image-based diagnostic AI, which this device is not. The document specifically states: "No clinical data were submitted to support the substantial equivalence of the Quantum Diagnostic Module to the M4 Monitor."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device is a monitor that displays physiological measurements to a user. While it generates data, the concept of "standalone algorithm performance" as typically applied to AI/ML is not directly relevant or discussed in this context. The document mentions "Software verification and validation," which would include testing the algorithms within the device, but not in a "standalone" AI sense.

7. The type of ground truth used:

Given the nature of the device (monitoring blood flow, gas, temperature, pressure, reservoir level), the ground truth for "in vitro evaluation testing" would likely be established using calibrated reference instruments or standardized test methods known to provide highly accurate measurements of these physical parameters. Explicit details are not provided.

8. The sample size for the training set:

This information is not provided. The device is a monitor, not an AI/ML model that undergoes a training phase with a dataset.

9. How the ground truth for the training set was established:

This information is not provided, as the concept of a "training set" in the AI/ML sense does not apply to this device.

Summary of Device Performance (Extracted from the document):

The regulatory submission for the Quantum Diagnostic Module argues for substantial equivalence to the predicate device (Spectrum Medical Ltd's M4 Monitor, K110957) based on several factors, including:

• Identical/Equivalent Principles of Operation: "the principles of operation of its sensors are identical or equivalent to those of the M4 Monitor."
• Equivalent Sensor Performance: "Spectrum Medical Ltd's M4 Monitor and Quantum Diagnostic Module have the same manufacturer, clinical application, clinical setting, target patient population, and equivalent sensor performance."
• Non-Clinical Testing:
  • Electrical safety
  • Electromagnetic compatibility (EMC)
  • Electrosurgery interference
  • Hardware testing of printed circuit boards
  • Software verification and validation
  • In vitro evaluation testing (comparison testing)
  • Usability validation

The document concludes that "Based on the indications for use, technological characteristics, results of non-clinical testing, and comparison to predicate devices, the Quantum Diagnostic Module has been shown to be substantially equivalent to legally marketed predicate devices."

In essence, the "study" proving the device meets acceptance criteria in this context is the collection of non-clinical tests demonstrating that the Quantum Diagnostic Module performs equivalently to its predicate and meets safety/performance standards, rather than a clinical trial with specific performance metrics against a defined ground truth for complex diagnostic tasks.

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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:

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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The BioTrend oxygen saturation and hematocrit system measures percent oxygen saturation and hematocrit of the blood in the extracorporeal circuit. The extracorporeal circuit is used for, but is not limited to, cardiopulmonary bypass, closedchest support, and limb perfusion.

The Medtronic Tri-optic Measurement Cell is a sterile, single-use cell used with the BioTrend Oxygen Saturation and Hematocrit System. This 510(k) premarket notification was submitted to add Balance Biosurface to the disposable cell as update the labeling information for all Tri-optic Measurement Cell versions. The disposable cell is coated on its blood contacting surfaces with Balance Biosurface. Previously cleared disposable cells are also available in uncoated form, and with Carmeda BioActive Surface coating or Trillium Biosurface coating.

The provided document is a 510(k) premarket notification for a medical device called the "Tri-optic Measurement Cell with Balance Biosurface," a cardiopulmonary bypass in-line blood gas monitor. The notification aims to demonstrate substantial equivalence to previously cleared predicate devices.

Based on the information provided, here's a breakdown of the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document does not explicitly state numerical acceptance criteria for "Pass" results (e.g., a specific percentage for accuracy, or a specific limit for leaching). The "Pass" indicates the device met the internal Medtronic requirements for these tests.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not explicitly stated. The document refers to "bench testing" but does not provide numbers of units tested for each specific test (Coverage, Leaching, Accuracy).
• Data Provenance: Bench testing. No information on country of origin. The testing is described as occurring prior to submission (February 11, 2014) and is therefore retrospective in nature for the submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

Not applicable. This device is a measurement cell, and the testing described (coverage, leaching, accuracy of flow rate reading) does not involve expert interpretation or diagnosis of images/data for ground truth establishment in the way an AI diagnostic device would.

4. Adjudication Method for the Test Set:

Not applicable. As noted above, this testing does not involve human expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC study was not done. The device is an in-line blood gas monitor, not a diagnostic imaging AI tool that would typically involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Yes, the described "bench testing" represents standalone performance of the physical device components (measurement cell and its coating) as they relate to its function in reading flow rate and ensuring coating integrity. The "algorithm" here implies the underlying technology that reads oxygen saturation and hematocrit, which is considered unchanged from the predicate device.

7. The Type of Ground Truth Used:

• For Coverage and Leaching testing: The ground truth would be based on validated analytical or chemical methods to confirm the presence, uniformity, and adhesion of the coating.
• For Accuracy testing (related to not interfering with the accuracy of reading the flow rate): The ground truth would likely be established through standard metrology or a reference method for flow rate measurement, against which the device's reading (or its lack of interference) is compared. The document implies the "BioTrend instrument" itself provides the reading, and the test is to ensure the coating doesn't degrade this established accuracy.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the conventional sense. The "training" for such a device would be its initial design, engineering, and calibration processes, which are not detailed here.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no specific "training set" in the context of an AI/ML algorithm.

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The CDI System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature. In addition, calculated values of base excess, bicarbonate, oxygen saturation, and oxygen consumption may also be provided. These parameters are displayed at either actual temperature or adjusted to 37°C. For documentation purposes, the system 500's integral printer provides a hard copy of displayed parameters.

The CDI™ System 500 is an AC-powered (battery back-up) microprocessor-based device used with the following components/accessories:

• CDI™ 500 Monitor .
• Arterial and/or Venous Blood Parameter Modules (BPM) .
• CDI™ H/S Probe .
• CDI™ 540 Gas Calibrator and Calibration Gases (A and B) .
• CDI™ 510H Shunt Sensor .
• Shunt Bypass Line .
• CDI™ H/S Cuvette with or without extension tubing .
• Monitor Mounting Hardware (Pole Clamp and Cable Head Bracket) .
• . Printer Paper
  The CDI™ System 500 measures blood parameters in real time by utilizing a microprocessor based monitor, electro-optics modules (i.e., BPM and H/S probe), fluorescence chemistry technology, and optical reflectance technology. The electrooptics modules connect the monitor to the disposables (i.e., shunt sensor or cuvette) which are inserted into the extracorporeal circuit. Light is emitted from the modules, and the optical responses from the blood via the sensor(s) are measured by the monitor. The blood parameters are measured or calculated by the CDI™ 500 Monitor in real time, and displayed to the user via a graphical LCD display.

The provided text describes a 510(k) summary for the CDI™ Blood Parameter Monitoring System 500, a device for continuous, on-line monitoring of various blood parameters during cardiopulmonary bypass. The submission is for "Modifications to previously cleared system" and aims to demonstrate substantial equivalence to predicate devices K123039 and K972962.

Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The document states that the performance testing was conducted to "verify/validate the changes to the CDI™ System 500". The conclusion section further states that the modified device has "substantially equivalent performance specifications as compared to the predicate device." However, no specific quantitative acceptance criteria or detailed results of device performance metrics (e.g., accuracy, precision for each parameter like pH, pO2, pCO2, etc.) are provided in this summary. The document only broadly mentions "System verification testing in a blood loop to simulate clinical use."

Since specific acceptance criteria and detailed device performance are not explicitly stated in the provided text, the table below will reflect the information that is present:

Study Information

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated. The document mentions "System verification testing in a blood loop to simulate clinical use," but does not specify the number of blood samples, runs, or test conditions.
   • Data Provenance: Not explicitly stated, though the testing was described as "in a blood loop," implying an in-vitro or ex-vivo setting rather than live human subjects. This suggests controlled laboratory conditions. The country of origin for the data is not mentioned. It is a retrospective summary of testing performed for the 510(k) submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable/Not mentioned. The testing described is "System verification testing in a blood loop to simulate clinical use." This typically involves comparing the device's measurements against a reference method or standard in the blood loop, not against expert interpretation of data generated by the device itself. Therefore, ground truth would likely be established by precise laboratory reference measurements rather than expert consensus on device output.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable/Not mentioned. Adjudication methods are typically used in studies involving human interpretation (e.g., image reading) to resolve discrepancies. This study focuses on the technical performance of a monitoring device against reference values in a lab setting, where disagreement on "ground truth" (e.g., from a calibrated reference sensor) is not resolved by adjudication.

4. 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. An MRMC comparative effectiveness study is not relevant to this device. This device is a blood parameter monitoring system, not an AI-assisted diagnostic imaging or interpretation tool that assists human readers.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Since this is a monitoring device, its primary function is standalone performance (i.e., the accuracy of its measurements). The "System verification testing" would have assessed the standalone performance of the device in measuring blood parameters in a simulated environment. While not explicitly called "standalone performance," this is the nature of the testing described for such a device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Based on the description "System verification testing in a blood loop to simulate clinical use," the ground truth would most likely be established by reference laboratory methods or highly accurate and calibrated reference sensors/analyzers used to measure the blood parameters (pH, pO2, pCO2, K+, SO2, Hct, Hgb, Temperature) in the blood loop. This ensures an objective and reliable comparison against the device's readings.

7. The sample size for the training set:

   • Not applicable/Not mentioned. This is a monitoring device based on electro-optics modules, fluorescence chemistry, and optical reflectance technology, incorporating a microprocessor for calculations. It's not described as a machine learning or AI-driven algorithm that requires a "training set" in the conventional sense (i.e., for supervised learning). While its internal algorithms and calibrations are developed, this typically involves engineering and validation against physical and chemical principles and reference standards, not a "training set" of patient data.

8. How the ground truth for the training set was established:

   • Not applicable for the reason given in point 7. For algorithms within such a device, "ground truth" during development would be established through meticulous engineering, physical modeling, chemical principles, and calibration against known standards and reference measurements.

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