Search Results

The Quantum Micro-Cardioplegia Delivery System is intended for delivery of micro-cardioplegia to the heart during open heart surgery lasting up to six hours in duration. It is intended 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 Micro-Cardioplegia Delivery System is intended to assist in arresting a beating heart during cardiac surgery through controlled delivery of cardioplegia. The system consists of the Quantum Workstation, Quantum Micro-Cardioplegia Delivery Module, Quantum Roller Pump 4", Quantum Diagnostic/Ventilation Module, and Quantum Pureflow Cardioplegia Heat Exchanger. The Quantum Micro-Cardioplegia Delivery Module was developed to supplement the existing Quantum technology and to allow users a more integrated way of managing microplegia delivery during cardiopulmonary bypass.

The Quantum Micro-Cardioplegia Delivery System is intended specifically for procedures where microplegia (i.e., whole blood cardioplegia) strategy is used. The Quantum Micro-Cardioplegia Delivery Module adds cardioplegia drugs (i.e., arrest agent and additive) to the main carrier solution (blood) which is circulated by a Quantum Roller Pump. The two devices, working in unison and controlled by the Quantum Workstation, deliver cardioplegia to the patient’s heart.

The premise of the Quantum Micro-Cardioplegia Delivery System is to interlock forward cardioplegia flow with medication delivery rates, ensuring delivery of arrest agent at a given ratio to the blood. The system includes a separate, dedicated heat exchanger, which is intended to be fitted in the cardioplegia blood line to allow for temperature regulation of the cardioplegia solution. The heat exchanger can be connected to any available heater cooler device which will manage the temperature regulation.

This document is an FDA 510(k) clearance letter for a medical device called the "Quantum Micro-Cardioplegia Delivery System." The letter grants clearance based on the device being "substantially equivalent" to legally marketed predicate devices.

Key takeaway regarding your request:

The provided document does not contain the specific acceptance criteria and study results in the detail you are requesting. It only states that a "suite of nonclinical tests was performed" and lists the types of tests conducted, concluding that these tests demonstrate substantial equivalence.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details like sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, or standalone algorithm performance.

The device described is a physical medical device (a system for delivering micro-cardioplegia during open-heart surgery), not an AI/software-driven diagnostic tool that would typically involve the type of performance metrics (sensitivity, specificity, AUC, human reader improvement, etc.) you are asking about.

I can, however, extract what is available about the non-clinical tests and the device's characteristics:

Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria or detailed reported performance metrics. It only states that testing was performed to demonstrate substantial equivalence to the predicate device. The general performance aspects implicitly evaluated would be related to the device's functional integrity, safety (electrical, electromagnetic), and usability.

Study Details (Based on the provided document)

Since the device is a physical medical device, not an AI model, many of the requested fields are not applicable or not detailed in a typical FDA clearance letter for such a product.

1. Sample size used for the test set and the data provenance: Not mentioned. The testing involves bench and non-clinical evaluations of the device's hardware, software, and performance, not a clinical data set in the context of an AI study.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this refers to a physical device performance test, not a diagnostic interpretation. Clinical experts (experienced and trained clinicians) are the intended users, and Human Factors/Usability tests would involve them, but specifics are not provided.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for this type of device and testing.
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: Not applicable. This is a physical medical device, not an AI diagnostic tool involving human readers.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device. The "algorithm" refers to the device's control software, which performs its functions whether a human is "in-the-loop" as an operator or not during functional testing.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of a diagnostic AI. For a physical device, the "ground truth" for functional testing would be the engineering specifications, regulatory standards (e.g., IEC 60601-1), and expected physical and chemical performance parameters (e.g., flow rate accuracy, temperature control).
7. The sample size for the training set: Not applicable. This is not an AI model requiring a training set in the machine learning sense.
8. How the ground truth for the training set was established: Not applicable.

In summary, the provided FDA clearance letter focuses on establishing substantial equivalence for a physical medical device (Quantum Micro-Cardioplegia Delivery System) through non-clinical bench testing, not on the performance of a diagnostic AI tool using clinical data. Therefore, most of the specific metrics and study design details you requested, which are pertinent to AI/software performance, are not present in this document.

Ask a specific question about this device

The Spectrum Medical Quantum Heater-Cooler is intended to provide temperature-controlled fluid to compatible Quantum PureFlow heat exchanger devices (cardiopulmonary bypass heat exchangers and cardioplegia heat exchangers) to warm or cool a patient during cardiopulmonary bypass procedures lasting six (6) hours or less.

The Quantum Heater-Cooler is only intended to be used by trained Clinicians in a clinical environment.

The Quantum Heater-Cooler consists of the following components:

• . Quantum Heater-Cooler Unit (including connection hoses and heat transfer fluid)
• . Quantum Pure Flow Heat Exchangers (standard and cardioplegia, manufactured by Qura S.r.l.)
• External cold storage charger .

The Quantum Heater-Cooler is intended for cooling and warming patients during cardiothoracic surgeries requiring cardiopulmonary bypass with extracorporeal circulation (procedures lasting six (6) hours or less). The system regulates the temperature of circulating blood and cardioplegia solution using a proprietary glycol-based heat transfer fluid. Thermal energy carried by the heat transfer fluid is transferred from the heater-cooler unit to the patient perfusion circuit via Quantum PureFlow heat exchangers specifically developed for both the arterial and cardioplegia circuits. The heater-cooler, in conjunction with the heat exchangers, forms a closed circuit and no direct contact with the patient's blood or body fluids takes place at any time.

Heating of the heat transfer fluid is accomplished through electrical heaters. For fluid cooling, the Quantum Heater-Cooler utilizes a Phase Change Material as a cold energy storage. This Phase Change Material needs to be routinely recharged between surgeries using an external cold storage charger outside of the operating room environment.

The provided text is a 510(k) summary for the Spectrum Medical Quantum Heater-Cooler. This document details the device's characteristics, intended use, and comparison to a predicate device to demonstrate substantial equivalence, a process which does not involve clinical studies or a study design with acceptance criteria, sample sizes, or expert adjudication as typically seen in efficacy or diagnostic accuracy studies for AI/ML medical devices.

The document is a submission for a Class II medical device (Cardiopulmonary bypass temperature controller), and the FDA has determined it is substantially equivalent to legally marketed predicate devices. This means that extensive clinical trials, as one might expect for a novel AI/ML diagnostic or prognostic tool, are not reported here.

Therefore, the requested information regarding acceptance criteria, study design for proving device performance (including sample sizes, expert involvement, and ground truth establishment), MRMC studies, or standalone performance evaluation is not applicable to this type of regulatory submission (510(k) for a hardware medical device without AI/ML components for diagnostic purposes).

The performance data listed in Section VII, "PERFORMANCE DATA - NON-CLINICAL TESTING," are engineering and safety tests, not clinical performance studies in the vein of diagnostic accuracy. These include:

• Electrical safety
• Electromagnetic compatibility (EMC)
• Electrosurgery interference
• Hardware testing
• Aerosolization testing
• Software verification and validation
• Evaluation of heat transfer fluid for microbial suppression
• Shelf life testing of heat transfer fluid
• Usability evaluation

These are standard engineering and safety tests for such a device, and the document explicitly states "No clinical data were submitted to support the substantial equivalence of the Quantum Heater-Cooler to the Sorin/LivaNova Stöckert Heater-Cooler System 3T."

In summary, none of the requested information regarding acceptance criteria for diagnostic performance, sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, or standalone performance studies are present in this 510(k) summary because it is not a submission for an AI/ML diagnostic product, but rather for a hardware medical device demonstrating substantial equivalence to a predicate.

Ask a specific question about this device

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.

Ask a specific question about this device

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

• Measurement of up to three blood flow channels and arterial and venous flow differential and gas bubbles
• Extracorporeal gas flow measurements that includes O2 & CO2 and calculated CO2 removal
• Predicted PO2 and PCO2
• Up to three temperature channels
• Up to three circuit pressure channels
• Reservoir level indication
• Two channels of vacuum
• Blend and control gas flow (air/O2/CO2)

The Quantum Ventilation 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 Ventilation Module 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 Quantum Ventilation Module provides gas blending and continuous non-invasive monitoring of critical clinical parameters in extracorporeal circuits used in cardiopulmonary bypass (CPB) or extracorporeal membrane oxygenation (ECMO) procedures. The Quantum Ventilation Module is an accessory to the Quantum Workstation. When paired with the Quantum Workstation, the combination of the Quantum Workstation and Quantum Ventilation Module (QVM2) is known as the Quantum Ventilation System.

The Quantum Ventilation Module performs five 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. Provides gas blending to ensure the precision delivery of FiO2, CO2 and sweep flow rates.
• 4. Provides regulation of vacuum supply to provide two channels of vacuum.
• 5. Sends these physiological measurements to the Quantum Workstation for display to the user.

The Quantum Ventilation Module, with its attached sensors, can measure flow, pressure, reservoir level, temperature and gas diagnostics, in addition to performing electronic gas blending of up to three gases and built-in vacuum management for the removal of waste anesthetic gas. The primary interface for controlling and displaying measurements is the Quantum Workstation; however, the Quantum Ventilation Module also contains a touchscreen display with control knobs. The Quantum Ventilation Module only works with the Quantum Workstation.

This FDA 510(k) summary for the Spectrum Medical Quantum Ventilation Module (K202733) indicates that it is a Class II device intended for the continuous monitoring of critical clinical parameters during extracorporeal circulation. The submission claims substantial equivalence to a legally marketed predicate device, Spectrum Medical Ltd.'s Quantum Ventilation Module (K181942).

Here's an analysis of the requested information based on the provided text:

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

The document does not explicitly state acceptance criteria in a quantitative table format for specific performance metrics (e.g., accuracy, precision for flow, pressure, temperature). Instead, it states that the proposed Quantum Ventilation Module (QVM2) has "equivalent sensor performance" to the predicate device.

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

The document states that "No animal testing was submitted" and "No clinical data were submitted" to support the substantial equivalence. The non-clinical testing mentioned (electrical safety, EMC, hardware, software) refers to engineering verification and validation, not a test set of clinical or animal samples. Therefore, information regarding sample size and data provenance in the context of clinical or animal testing is not applicable here as such studies were not performed.

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

Not applicable. Since no clinical or animal testing with a "test set" and "ground truth" established by experts was performed or submitted, this information is not provided. The assessment was based on non-clinical engineering testing and comparison to a predicate device.

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

Not applicable. No test set requiring expert adjudication was used.

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 medical monitoring and control unit, not an AI-assisted diagnostic imaging or interpretation device. Therefore, an MRMC study is not relevant to its type of performance evaluation.

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

Not applicable. This device is a hardware and software system for continuous monitoring and control during extracorporeal circulation, not a standalone algorithm. Its performance is evaluated through engineering verification and validation of its sensors and control mechanisms.

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

The concept of "ground truth" derived from expert consensus, pathology, or outcomes data is typically associated with diagnostic or prognostic devices that interpret patient data. For this device, the "ground truth" for its performance evaluation would be based on engineering standards, calibrated reference instruments, and defined physical parameters. For example, when testing flow measurement, the "ground truth" would be established by a known, accurately measured flow rate from a reference system.

8. The sample size for the training set

Not applicable. This device is not an AI/ML device that requires a "training set" in the conventional sense for model development. Its software verification and validation would involve testing against requirements, but not training data for a learning algorithm.

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

Not applicable, as there is no "training set" for an AI/ML model for this device.

Ask a specific question about this device

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.

Ask a specific question about this device

The Quantum Centrifugal Drive is a cardiopulmonary bypass speed control device indicated for use for exclusively with the Quantum PureFlow Centrifugal Blood Pump for speedcontrolled pumping through the extracorporeal circuit for typical durations of six hours or less.

The Quantum Centrifugal Drive is a cardiopulmonary speed control device intended to be used for pumping arterial blood through the cardiopulmonary bypass circuit. The Quantum Centrifugal Drive is available in two models - High Pressure and Low Pressure.

The Quantum Centrifugal Drive is designed to work with the Quantum Pump Manager software application, as part of the Quantum Pump Console (K173834). The Quantum Centrifugal Drive is magnetically coupled exclusively with Quantum Pureflow Centrifugal Blood Pumps, designed and manufactured by Qura s.r.l. The operation of the Quantum Centrifugal Drive is managed from the Quantum Workstation (K163657).

The provided document, an FDA 510(k) summary for the Quantum Centrifugal Drive, focuses on establishing substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria for an AI/device's diagnostic or predictive capabilities.

Therefore, the document does not contain the information requested regarding:

1. A table of acceptance criteria and reported device performance related to diagnostic accuracy.
2. Sample sizes and data provenance for a test set.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication methods for a test set.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document states:

• "No animal testing was submitted to support the substantial equivalence of the Quantum Centrifugal Drive to the Sorin/LivaNova Stöckert Centrifugal Pump."
• "The following non-clinical testing was performed to support the substantial equivalence of the Quantum Centrifugal Drive to the legally marketed predicate:
  • Electrical safety
  • Electromagnetic compatibility (EMC)
  • Electrosurgery interference
  • Hardware testing
  • Software verification and validation"
• "No clinical data were submitted to support the substantial equivalence of the Quantum Centrifugal Drive to the Sorin/LivaNova Stöckert Centrifugal Pump."

This indicates that the substantial equivalence was primarily based on non-clinical engineering and software validation tests (electrical safety, EMC, electrosurgery interference, hardware, and software V&V) rather than a study evaluating diagnostic performance parameters against ground truth established by experts or other clinical gold standards. The device is a "Cardiopulmonary bypass pump speed control," which is a mechanical device, not typically a diagnostic AI tool that would involve ground truth derived from expert consensus or pathological findings.

Ask a specific question about this device

The Quantum Smart Occluder is indicated for use as an accessory with the Quantum Pump Console for up to 6 hours in the extracorporeal circulation of blood for cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

The Quantum Smart Occluder is a clamping system for the occlusion of both arterial and venous blood lines. The Quantum Smart Occluder is designed to work with the Quantum Pump Manager software application, as part of the Quantum Pump Console (K173834). The operation of the Quantum Smart Occluder is managed from the Quantum Workstation (K163657).

The Quantum Smart Occluder has the availability for 5 sensor attachments:

• . 2 Flow Sensors
• 2 Pressure Sensors
• 1 Level Sensor .

These sensors are identical with the use of the same sensor PCB boards previously cleared with the Quantum Diagnostic Module (K173591) and Quantum Ventilation Module (K181942). These sensor connections can be used in conjunction with the sensor connections used on the Quantum Diagnostic Module (K173591) or Quantum Ventilation Module (K181942) to provide additional readings. Or used solely on the Quantum Smart Occluder to reduce the amount of cabling that is attached to the Quantum Pump Console (K173834).

This document is a 510(k) summary for the Quantum Smart Occluder. It describes a medical device, its intended use, and compares it to predicate devices to establish substantial equivalence. The document does not contain information related to specific acceptance criteria or a study proving that the device meets those criteria, particularly in the context of an AI/ML device.

The Quantum Smart Occluder is a mechanical device (an electronic tube clamp) that is an accessory to a cardiopulmonary bypass system. The performance data mentioned relates to non-clinical testing of electrical safety, EMC, electrosurgery interference, hardware, and software verification/validation. This is standard for a non-AI/ML medical device.

Therefore, I cannot provide the requested information from this document. The questions you've asked are typically relevant for AI/ML-driven devices where performance is measured against clinical ground truth and involves statistical analysis of algorithm output. This document describes a traditional medical device submission.

Ask a specific question about this device

The Quantum Ventilation Module is intended for the continuous monitoring of critical clinical parameters during procedures that require extracorporeal circulation. The Quantum Ventilation Module is an accessory that only works with the Quantum Workstation. Parameters provided by the Quantum Ventilation 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
• Two channels of vacuum
• · Blend and control gas flow (air/O2/CO2)

The Quantum Ventilation 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 Ventilation Module provides gas blending and continuous non-invasive monitoring of critical clinical parameters in extracorporeal circuits used in cardiopulmonary bypass (CPB) or extracorporeal membrane oxygenation (ECMO) procedures. The Quantum Ventilation Module is an accessory to the Quantum Workstation or can be used in place of the Quantum Diagnostic Module as part of the Quantum Pump Console. When paired with the Quantum Workstation, the combination of the Quantum Workstation and Quantum Ventilation Module is known as the Quantum Ventilation System.

The Quantum Ventilation Module performs five 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. Provides gas blending to ensure the precision delivery of FiO₂ (21 to 100%), CO₂ and sweep flow rates.
• 4. Provides regulation of vacuum supply to provide two channels of vacuum. One is flow-regulated to remove waste anesthesia gas, the other pressure-regulated for applications including Vacuum-Assisted Venous Drainage (VAVD) and hemoconcentration.
• 5. Sends these physiological measurements to the Quantum Workstation for display to the user.

The Quantum Ventilation Module, with its attached sensors, can measure flow, pressure, reservoir level, temperature and gas diagnostics, in addition to performing electronic gas blending of up to three gases and built-in vacuum management for the removal of waste anesthetic gas. The primary interface for controlling and displaying measurements is the Quantum Workstation: however, the Quantum Ventilation Module also contains a display with control knobs. The Quantum Ventilation Module only works with the Quantum Workstation.

The provided document is a 510(k) Premarket Notification for a medical device called the Quantum Ventilation Module. This type of submission is for demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials as would be required for a Premarket Approval (PMA) application.

Therefore, the document does not describe a study involving an AI algorithm or meeting the typical acceptance criteria for AI/ML device performance. Instead, it focuses on non-clinical performance data to demonstrate the device's functionality and safety as a medical instrument.

Given this context, I will address the questions to the best of what can be inferred from the provided text, noting where the information is absent due to the nature of a 510(k) submission for a non-AI hardware device.

Acceptance Criteria and Device Performance (Based on Non-Clinical Testing for a Hardware Device)

The document primarily discusses non-clinical performance data, which are typically tests to ensure the device performs as intended and is safe. The "acceptance criteria" here are implied by the successful completion of these tests.

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

Since this is a hardware device (Ventilation Module) and not an AI algorithm, the acceptance criteria are not in terms of common AI metrics like sensitivity, specificity, or AUC, nor is there comparative effectiveness data against human readers. The criteria are related to the device's physical and electronic performance, along with its software validation. The document states:

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

This information is not applicable in the context of an "AI test set" here. The "test set" would refer to the physical units of the device subjected to non-clinical tests. The tests performed ("Electrical safety", "Electromagnetic compatibility", "Electrosurgery interference", "Hardware testing of printed circuit boards", "Software verification and validation", "Usability validation") are typically laboratory-based engineering and software validation tests. The document does not specify the number of units tested, the conditions, or the specific "data provenance" (e.g., country of origin) beyond the manufacturer being in the UK. These are not data-driven performance studies on patient cohorts.

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

This is not applicable as this is a hardware device. Ground truth, in the context of AI, refers to annotated data. For a hardware device, "ground truth" might refer to established measurement standards or known physical properties used for calibration and validation of sensors. The document does not specify the number or qualifications of experts involved in these engineering validation processes.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing consensus among human readers for image labeling or clinical decision-making ground truth in AI studies. For hardware testing, performance is measured against engineering specifications and industry standards, not through expert adjudication in this manner.

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 hardware medical device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is not relevant, and the concept of human readers improving with AI assistance does not apply.

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

This refers to an AI algorithm's performance. The Quantum Ventilation Module is a hardware device with embedded software, but it's not an AI algorithm that makes diagnostic decisions or interpretations in the way this question implies. Its performance is the measurement and control capabilities of the instrument itself.

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

Not applicable. For a hardware device, the "ground truth" for non-clinical performance validation would be derived from:

• Engineering specifications and design documents.
• International and national standards for electrical safety, EMC, and medical device performance (e.g., IEC standards).
• Calibration standards for sensors (e.g., precision gas mixes, flow simulators, temperature baths, pressure gauges).
• Bench testing and physical measurements.

8. The sample size for the training set

Not applicable. This device is not an AI/ML model trained on a dataset. It's a hardware device with firmware.

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

Not applicable. As there is no "training set" in the AI sense, this question is not relevant. The "ground truth" for developing the device's functionality would stem from engineering principles, clinical requirements for extracorporeal circulation, and established medical device design practices.

Ask a specific question about this device

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.

Ask a specific question about this device

The Quantum Pump Console is indicated for use for up to 6 hours in cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

The Quantum Pump Console is a configurable heart-lung machine consisting of various components controlled by a central workstation. The system is intended to be used in any surgery in which the patient's blood is being oxygenated extracorporeally. The modular system consists of a frame, power supply with battery backup, roller pumps, pump control module, diagnostic module and a central workstation with the user interface.

The roller pumps are available in three sizes (4", 6" and 8") and can be controlled via a centralized interface on the Quantum Workstation touchscreen or through the Quantum Pump Console, which contains five knobs and displays in one integrated console.

This document is a 510(k) summary for the Quantum Pump Console, a heart-lung machine. It determines substantial equivalence to a predicate device, the Stöckert S5 System.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance for a specific clinical or diagnostic task in the way one might expect for an AI/ML diagnostic device. Instead, the "acceptance criteria" are implied by the demonstration of "substantial equivalence" to a predicate device.

The performance data presented is primarily focused on non-clinical testing to ensure the device performs safely and effectively in its intended function, similar to the predicate.

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

This document does not describe a "test set" in the context of clinical data for AI/ML performance. The testing performed is physical/electrical/software verification and validation of the device itself.

• Sample Size for Test Set: Not applicable in the context of clinical/diagnostic performance testing using patient data. The testing involved verification and validation activities on the device hardware and software.
• Data Provenance: Not applicable for patient data. The non-clinical tests were likely conducted in a laboratory or manufacturing setting.

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

Not applicable. The ground truth for the non-clinical tests is based on engineering specifications, regulatory standards, and expected device behavior, rather than expert interpretation of patient data.

4. Adjudication Method for the Test Set

Not applicable. The non-clinical tests involve objective measurements against predefined specifications, not expert adjudication of ambiguous cases.

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 MRMC comparative effectiveness study was performed or described. This is not an AI-assisted diagnostic device, but a medical device (heart-lung machine console) where the focus is on its physical and software functionality and safety compared to a predicate.

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

This question is not applicable. The Quantum Pump Console is not an algorithm-only device. It's a hardware system with integrated software, intended to be operated by a qualified medical professional. Its performance is always with a human-in-the-loop.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests would be:

• Engineering specifications and design requirements: For hardware and software functionality.
• Regulatory standards: For electrical safety, EMC, and other performance characteristics.
• Predicate device's known performance characteristics: To establish equivalence in pump speed, accuracy, and overall operational principles.

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning in a way that requires a "training set" of patient data.

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

Not applicable, as no training set (in the context of AI/ML) was used.

Ask a specific question about this device