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The Warrior Blood and Fluid Warmer device is intended for warming blood products, and intravenous fluids prior to administration in adults and pediatic patients. It is intended to be used by healthcare professionals in hospital, clinics, field and transport environments to help prevent hypothermia.

The Warrior EXTREME Blood and Fluid Warmer device is intended for warming blood, blood products, and intravenous fluids prior to administration in adults and pediatic patients. It is intended to be used by healthcare professionals in hospital, clinics, field and transport environments to help prevent hypothermia.

The Warrior Lite Blood and Fluid Warmer device is intended for warming blood, blood products, and intravenous fluids prior to administration in adults and pediatic patients. It is intended to be used by healthcare professionals in hospital, clinics, field and transport environments to help prevent hypothermia.

The QinFlow Blood and Fluid Warmer (Warrior / Warrior lite) is a portable sterile fluid path, inline blood and fluid warmer intended for warming blood, blood products, and intravenous fluids prior to administration. The device is composed of the following main components:

1. Disposable Unit (DU) / Compact Disposable Unit (CDU)
2. Base Unit (BU)
3. Power source
4. Connecting Cable (CC)
5. The CDU can be connected directly onto the Warrior Lite BU or using an Extension cable accessory. The DU can be connected to the Warrior Lite using the Extension cable only.

The provided text describes a 510(k) premarket notification for a medical device, the QinFlow Blood and Fluid Warmer (Warrior, Warrior EXTREME, and Warrior Lite). This document asserts that the new device is substantially equivalent to a previously cleared predicate device (K180154).

The information provided focuses on the device's technical characteristics and performance testing to demonstrate substantial equivalence to a predicate device, rather than a study validating a new acceptance criterion for an AI/ML algorithm or a typical clinical efficacy study. Therefore, many of the requested items related to AI/ML specific studies (e.g., sample size for training set, number of experts for ground truth, MRMC studies, effect size of AI assistance) are not applicable in this context.

However, I can extract the relevant information regarding performance criteria and the testing performed for this medical device submision.

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

The document doesn't explicitly list "acceptance criteria" in a separate table, but rather describes the performance testing requirements and states that the device meets them. The comparison to the predicate device serves as the primary means to demonstrate substantial equivalence.

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

The document describes "Performance Data" which includes various types of engineering and laboratory testing (functional, electrical safety, EMC, software V&V, hemocompatibility, usability, shelf-life, sterilization).

• Sample Size: The specific sample sizes for each type of functional or safety test are not provided in this summary. It states "Testing to verify that the device functions as intended, and all design and functional specifications are met for all models/system configurations" and "shelf-life testing and Sterilization assessment... was conducted with acceptable results."
• Data Provenance: This is not a data-driven clinical study in the sense of patient data. The data provenance is from laboratory and engineering testing of the devices themselves. There is no mention of country of origin of data, or if it was retrospective or prospective in the context of clinical patient data, because this is about device performance characteristics, not clinical trial data.

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

• Not applicable. This submission focuses on the engineering and functional performance of a fluid warming device, not on diagnostic accuracy based on expert interpretation of medical images or data. Ground truth here refers to objective measurements against engineering specifications and industry standards, not expert medical consensus.

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

• Not applicable. See point 3.

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 is not an AI/ML diagnostic or assistive device.

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

• Not applicable. While the device does contain software, the submission reviews its performance as an integrated medical device for fluid warming, not as a standalone AI algorithm for analysis or decision-making without a human in the loop. The software V&V ensures the software functions correctly within the device.

7. The type of ground truth used:

• The "ground truth" for this device's performance evaluation comes from established engineering specifications, recognized industry standards (e.g., IEC 60601 series, ISO 11135, IEC 62304, IEC 62366), and direct physical/electrical measurements. For example, the "ground truth" for temperature accuracy is the target temperature, measured by calibrated instruments. For hemocompatibility, the "ground truth" is the absence of adverse interactions with blood products, demonstrated through specific testing.

8. The sample size for the training set:

• Not applicable. This refers to a traditional medical device submission, not an AI/ML algorithm development. There is no "training set" in the context of machine learning. The device's software is developed and validated through traditional software engineering V&V processes.

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

• Not applicable. See point 8.

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The QiF Blood and Fluid Warmer device is intended for warming blood, blood products, and intravenous fluids prior to administration. It is intended to be used by healthcare professionals in hospital, clinics, and field environments, to help prevent hypothermia.

The Quality in Flow QiF Blood and Fluid Warmer is a portable sterile Fluid Path, in-line Blood and Fluid Warmer. The QiF device is composed of the following main components:

1. Disposable Unit (DU) - The disposable cartridge is made of a plastic oval box encasing a spiral Stainless Steel (SS) heat exchanger tube. The DU is located between the fluid container (intravenous solution or blood product) and the treated patient, outside of the patient body. The DU has a standard intravenous tube extension. The DU comprises the temperature sensors.
2. Base Unit (BU) – The BU controls the performance of the system and the outflow fluid temperature. The power source is a rechargeable detachable battery located within the BU or an AC power supply module; the BU contains firmware (SW) and electronics (HW).
3. Connecting Cable (CC) - a cable that connect between the BU and the DU to facilitate the transfer of data and electrical current.

The provided text concerns a 510(k) premarket notification for a medical device (QiF Blood and Fluid Warmer), focusing on its substantial equivalence to a predicate device. This type of document is for regulatory approval and does not describe a clinical study comparing AI performance. Therefore, many of the requested elements for describing an AI study will not be present.

Instead, the document details performance testing of the device itself to demonstrate its safety and effectiveness, particularly after adding an AC power supply module.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Key Finding: The subject device demonstrated equivalent performance to the predicate device in all performance tests, including heating fluid to set-point temperature from various inlet temperatures in various flow rates and system performance through flow rate irregularities.

Regarding AI-specific questions (2-9):

The provided text does not describe an AI medical device or an AI performance study. It describes a physical medical device (blood and fluid warmer) and its regulatory submission for a modification (adding an AC power supply). Therefore, information related to AI model acceptance criteria, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable and not present in this document.

The "Conclusions" section clearly states: "The modifications to the device do not raise different questions of safety and effectiveness and are supported by risk management activities. The QiF Blood and Fluid Warmer is substantially equivalent to the QiF Blood and Fluid Warmer, cleared under K171215." This confirms the focus is on the equivalence of the hardware device, not an AI algorithm.

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The QiF Blood and Fluid Warmer device is intended for warming blood, blood products, and intravenous fluids prior to administration. It is intended to be used by healthcare professionals in hospitals, clinics and field environments, to help prevent hypothermia.

The Quality in Flow QiF Blood and Fluid Warmer is a portable sterile Fluid Path, in-line Blood and Fluid Warmer. The QiF device is composed of the following main components: 1. Disposable Unit (DU) The disposable cartridge is made of a plastic oval box encasing a spiral Stainless Steel (SS) heat exchanger tube. The DU is located between the fluid container (intravenous solution or blood product) and the treated patient, outside of the patient body. The DU has a standard intravenous tube extension. The DU comprises the temperature sensors. 2. Base Unit (BU) The BU controls the performance of the system and the outflow fluid temperature. The power source is a rechargeable detachable battery located within the BU: the BU contains firmware (SW) and electronics (HW). 3. Connecting Cable (CC) a cable consisting of data and power wires connects between the BU and the DU to facilitate the transfer of data and electrical current.

Let's break down the acceptance criteria and the supporting study for the QiF Blood and Fluid Warmer based on the provided 510(k) summary.

Key takeaway: This 510(k) submission is primarily focused on changing a contraindication to a precaution statement regarding plasma warming. The performance study is to demonstrate that the device still warms plasma to the specified temperature, thus maintaining equivalent performance to the predicate device. It is not a complex AI/imaging system.

Here's the information extracted and organized:

Acceptance Criteria and Reported Device Performance

Given that this is a medical device for warming fluids, the primary performance criterion is the ability to warm the fluid to a specified temperature.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance:

• Test Set Sample Size: The document does not specify a numerical sample size for the performance tests. It broadly states that "Performance tests were performed."
• Data Provenance: The document does not specify the country of origin or whether the data was retrospective or prospective. It implies an experimental setup to test fluid warming.

3. Number of Experts and Qualifications for Ground Truth:

• Not Applicable: This is a physical device warming a fluid to a specific temperature. The "ground truth" is established by direct temperature measurement using calibrated equipment, not by expert interpretation. There are no human experts involved in establishing this "ground truth."

4. Adjudication Method for the Test Set:

• Not Applicable: As there are no expert interpretations or subjective assessments involved, no adjudication method is necessary. The performance is measured objectively.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No: This is not an imaging device or an AI assistant for human readers. Therefore, an MRMC study is not relevant or performed.

6. Standalone Performance (Algorithm Only):

• Yes (in concept, but not an "algorithm" as typically defined for AI): The device's primary function is to warm fluid to a set temperature. The performance study measures the device's ability to achieve this independent of human interaction (beyond initial setup and monitoring). The "algorithm" here would be the internal control system ensuring the desired temperature. The study directly assesses the device's own output temperature against the set point.

7. Type of Ground Truth Used:

• Objective Measurement/Physical Standard: The ground truth is the precise measurement of the warmed plasma's temperature, verified against the engineering specification of 38 ± 2 °C. This is a direct physical measurement.

8. Sample Size for the Training Set:

• Not Applicable: This is a hardware device with firmware, not a machine learning model that requires a "training set" in the common sense of data for a learning algorithm. The device's internal control system would have been developed through engineering design, not data-driven machine learning.

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

• Not Applicable: As there is no "training set" in the machine learning context, this question is not relevant. The device's operational parameters (like the target temperature and its tolerance) are engineering specifications.

Summary of the study: The study performed was a verification test to ensure that the QiF Blood and Fluid Warmer consistently warms plasma to the specified temperature range (38 ± 2 °C). This was critical because the purpose of the 510(k) was to change a contraindication against plasma warming to a precaution, requiring proof that the warming function itself was adequate for plasma. The document explicitly states: "In all instances, the device functioned as intended and demonstrated equivalent performance."

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The QiF Blood and Fluid Warmer device is intended for warming blood, blood products, and intravenous fluids prior to administration. It is intended to be used by healthcare professionals in hospital, clinics and field environments, to help prevent hypothermia.

The Quality in Flow QiF Blood and Fluid Warmer is a portable sterile Fluid Path, in-line Blood and Fluid Warmer. The QiF device is composed of the following main components: 1. Disposable Unit (DU) The disposable cartridge is made of a plastic oval box encasing a spiral Stainless Steel (SS) heat exchanger tube. The Disposable Unit is located between the fluid container (intravenous solution or blood product) and the treated patient, outside of the patient body. The Disposable Unit has a standard intravenous tube extension. The Disposable Unit comprises the temperature sensors. 2. Base Unit (BU) The Base Unit controls the performance of the system and the outflow fluid temperature. The power source is a rechargeable detachable battery located within the Base Unit; the Base Unit contains firmware (SW) and electronics (HW). 3. Connecting Cable (CC) - a cable consisting data and power wires connects between the Base Unit and the Disposable Unit to facilitate the transfer of data and electrical current.

The provided text is a 510(k) summary for a medical device (QiF Blood and Fluid Warmer). It details modifications made to a previously cleared device and asserts substantial equivalence to its predicate. However, it does not contain the specific information required to answer your request about acceptance criteria and a study proving the device meets those criteria for characteristics typically evaluated in AI/ML medical devices.

The document focuses on the physical and functional aspects of the fluid warmer, such as battery upgrades, integrated disposable units, extended shelf life, and operating conditions, with performance data centering on these hardware and software changes.

Here's why the requested information isn't present in the document:

• Type of Device: The QiF Blood and Fluid Warmer is a physical medical device (hardware with embedded software for control), not an AI/ML diagnostic or predictive algorithm. Therefore, the types of "performance data" and "acceptance criteria" discussed are related to its physical operation (e.g., heating to a set temperature, battery life, environmental robustness), rather than metrics like sensitivity, specificity, AUC, or the performance of human readers with/without AI assistance.
• Acceptance Criteria & Reported Performance: While the document has a "Risk" and "Mitigation" table and discusses "Verification endpoints," these are not presented as typical acceptance criteria with reported performance values as would be expected for an AI/ML algorithm. For example, it confirms "Warming to set point temperature" and "Warming rates" were verified, but doesn't quantify them against specific pass/fail thresholds.
• Study Design for AI/ML: The document does not describe a study involving a test set, ground truth established by experts, an adjudication method, or a multi-reader multi-case (MRMC) comparative effectiveness study, as these are methodologies relevant to AI/ML performance evaluation, not a fluid warmer.
• Training Set Information: Since this is not an AI/ML algorithm that "learns" from data, there's no concept of a "training set" for the device's core functionality as described. The software validation mentioned is traditional software testing, not machine learning model training.

In summary, the provided document does not contain the specific information you requested because the device (QiF Blood and Fluid Warmer) is not an AI/ML medical device that would be evaluated with such criteria.

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The QiF Blood and Fluid Warmer device is intended for warming blood, blood products, and intravenous fluids prior to administration. It is intended to be used by healthcare professionals in hospital, clinics and field environments, to help prevent hypothermia.

The Quality in Flow Ltd. QiF Blood and Fluid Warmer device is a portable, sterile Fluid Path, in-line Blood and Fluid Warmer. The device is comprised of a Base Unit and a sterile disposable cartridge (Disposable Unit). The device is located between the fluid container (intravenous fluid, blood or blood product) and treated patient, outside of the patient's body. The Disposable Unit is composed of a plastic oval box encasing a spiral stainless steel heat exchanger tube. The Base Unit contains Firmware (software) and electronics (HW). The base Unit controls the performance of the system and the fluid outflow temperature. The power source is a rechargeable detachable battery located within the Base Unit. The disposable unit cartridge (blood/fluid) is provided with inlet and outlet luers that connect to standard IV tubing.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: QiF Blood and Fluid Warmer

1. Table of Acceptance Criteria and Reported Device Performance

Study That Proves the Device Meets Acceptance Criteria:

The document describes a series of bench testing and design control activities performed by Quality In Flow Ltd. to evaluate the QiF Blood and Fluid Warmer device. These tests were conducted according to established international standards and internal product design input requirement specifications.

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

• Sample Size: The document does not explicitly state the sample sizes used for each specific test (e.g., number of units tested for hemolysis, temperature accuracy). It refers to "all samples" meeting criteria for hemolysis and leachability, suggesting multiple samples were indeed tested.
• Data Provenance: The studies were performed by Quality in Flow Ltd., the device manufacturer. The data is prospective, as it was generated specifically for the 510(k) submission to demonstrate device performance. The country of origin of the data is Israel, where Quality in Flow Ltd. is based.

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

This information is not provided in the document. The "ground truth" for these performance tests is typically the measured physical properties against objective standards or specifications, rather than expert consensus on subjective interpretations. For example, for hemolysis, the ground truth is the chemical measurement of free hemoglobin in the fluid.

4. Adjudication Method for the Test Set:

Not applicable. The tests performed are objective performance measurements against defined criteria, not subjective assessments requiring 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:

Not applicable. This device is a medical warming device, not an imaging or diagnostic AI device that would involve human readers.

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

Not explicitly stated in these terms. However, the performance data presented (hemolysis, temperature accuracy, etc.) represents the intrinsic performance of the device's hardware and software (algorithm only) without direct human intervention during the measurement process, aside from setting up and operating the device. The software verification and validation is a key component of this "algorithm only" assessment.

7. The Type of Ground Truth Used:

The ground truth used for these performance tests is primarily objective physical and chemical measurements against:

• Established international standards (e.g., ASTM 2172 for hemolysis and fluid path integrity, ISO 10993 for biocompatibility, IEC 60601 for electrical safety).
• The manufacturer's own product design input requirement specifications (e.g., for temperature indication accuracy, outflow temperature profile, battery capacity).

8. The Sample Size for the Training Set:

Not applicable. This is a medical device (fluid warmer), not an AI/ML model that requires a training set in the conventional sense. The "training" for such a device would be its iterative design, engineering, and prototyping phases.

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

Not applicable, as there is no "training set" in the context of an AI/ML model for this device. The design and performance specifications were established through engineering principles, regulatory requirements, and user needs for a medical fluid warmer.

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