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The °M Warmer System is indicated for use to warm blood, blood products, colloids and crystalloid solutions prior to parenteral administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia. The field environment includes road, rotary and fixed-wing ambulances.

The °MEQU °M Warmer System consists of three components:

• a single-patient use, disposable warmer unit
• a multi-patient, reusable, rechargeable battery pack for powering the warmer
• a reusable charger for recharging the battery pack.
  The warmer contains a sterile fluid path with standard Luer lock connectors allowing it to be connected in the infusion fluid line. The fluid path includes a parylene coated aluminium heating chamber in which fluids passing through the warmer are heated. Heat is generated using resistive heating elements, using power supplied by the rechargeable battery pack.
  The warmer contains the electronics and software to control the temperature of the chamber and thus the temperature of the outgoing fluid.
  Remaining power in the battery pack is indicated to the user during use. When depleted, the battery pack can be re-charged using the charger.

The provided text does not include information about acceptance criteria or a study proving that an AI device meets acceptance criteria. The document is an FDA 510(k) clearance letter for the °M Warmer System, which is a medical device designed to warm fluids for intravenous administration, not an AI or software as a medical device (SaMD).

Therefore, I cannot fulfill your request for the following information as it is not present in the provided text:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs. without AI assistance.
6. If a standalone (algorithm only) performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

The document discusses performance in the context of non-clinical studies for a traditional medical device (like sterilization, electrical safety, biocompatibility, and heater safety testing) and concludes that the device is substantially equivalent to a predicate device. It explicitly states, "The claim of substantial equivalence is not based on an assessment of clinical performance data." and also "The software control the heating process and the operation of the device." which refers to the embedded software within the warmer, not an AI or diagnostic algorithm.

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The Fluido Compact Blood and Fluid Warming System can be used in adult patients that need fluid warming pror to administration of blood, blood products and IV fluids to help prevent hypothermia. The system is intended to be used by healthcare professionals, e.g., nurses, medical specialists, doctors. Only medical professionals shall interact with the system. The devices must only be used on the order of a physician.

The Fluido® Compact System consists of Fluido Compact Warming Module, Fluido Compact Control Module and Fluido Compact Standard Set (disposable).

The Fluido Compact system is designed to supply warm fluids at 39°C set point with flow rates from 5 to 100 ml/min. The sterile disposable set consist of a plastic housing and biocompatible coated aluminum heater plate. Heat from the warming module is transferred through the heat transfer part into the fluids that is circulating through the inner part of the cassette. The disposable is connected to the blood or fluid source (infusate reservoir) and the patient line on the other end. The disposable has standard luer lock fittings on both ends. The Control Module serves as the power supply for the Warming module.

Fluid and blood are warmed during infusion or transfusion. The delivery of heat is done by heat exchange. A warming module exchanges heat to a disposable set, which is connected to the fluid reservoir and the patient line via conduction warming technology The fluid temperature is controlled by closed loop software and guarded by sensors and has a redundant safety module for fluid overtemperature shutoff.

This describes the Fluido Compact Blood and Fluid Warming System, a medical device for warming fluids prior to administration, and outlines the testing performed to demonstrate its substantial equivalence to a predicate device.

Here's a breakdown of the requested information based on the provided text:

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

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

The document does not specify the sample size for the individual non-clinical performance tests (Temperature, Flow rates, Alarms, Usability, Heater Safety, Electrical/EMC). Only "Performance testing according to applicable testing met all acceptance criteria" is stated.

The data provenance is from non-clinical bench testing, conducted for the purpose of demonstrating substantial equivalence to a predicate device. No country of origin is explicitly mentioned for the testing itself, but the submitter is based in the Netherlands. The testing is retrospective in the sense that it was conducted after the device design was finalized to meet established standards.

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

This information is not applicable as the provided document describes performance testing of a physical medical device (fluid warming system) against technical standards and specified operational parameters, not an AI device requiring expert ground truth for classification or diagnostic accuracy.

4. Adjudication method for the test set

This information is not applicable for the same reason as point 3. The device's performance was measured directly against objective technical criteria and operational specifications, not against human interpretation or a consensus of experts.

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 as the device is not an AI-assisted diagnostic or classification tool for human readers. It is a physical medical device designed to warm fluids.

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

This information is not applicable as the device is not an AI algorithm. It is a physical medical device.

7. The type of ground truth used

The "ground truth" for this device's performance is established by objective technical standards and predefined operational specifications. For example:

• Temperature accuracy is measured against a set point (e.g., 39°C ± 2°C).
• Flow rates are measured against a specified range (e.g., 5 to 100 ml/min).
• Heater safety is assessed against the requirements of ASTM F2172-02.
• Electrical/EMC performance is assessed against IEC 60601-1 and IEC 60601-1-2.

8. The sample size for the training set

This information is not applicable as the device is a physical medical device, not a machine learning model that requires a training set.

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

This information is not applicable for the same reason as point 8.

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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 Smisson-Cartledge Biomedical ThermaCor® 1200 Rapid Thermal Infusion System is indicated for use over a full range of flow rates from slow feed to rapid, high flow infusion of: crystalloid, colloid, or blood product, including packed red blood cells [not in additive . solutions and stored up to 21 days with anticoagulants], as volume replacement for patients suffering from blood loss due to trauma or surgery; warmed fluid to rewarm patients after surgery or for hypothermia; warmed fluid for irrigation in urology procedures.

The ThermaCor® 1200 Disposable Sets are intended for use only with the Smisson-Cartledge Biomedical (SCB) ThermaCor® 1200 Rapid Thermal Infusion System. The Disposable Sets consist of configurations that include cassettes with tubing connectors, various patient lines, and supply lines capable of interfacing with intravenous (IV) bags or optional-use reservoir equipment. Use of the ThermaCor® 1200 Disposable Sets ensures the intended use of the ThermaCor® 1200 Rapid Thermal Infusion System is met. The ThermaCor® 1200 Disposable Sets are provided sterile, non-pyrogenic and are single patient use only. They are sterilized by Ethylene Oxide (EO) sterilization method.

The Smisson-Cartledge Biomedical ThermaCor® 1200 Rapid Thermal Infusion System is a portable or pole-mounted device intended for use in the hospital emergency room (ER), operating room (OR), intensive care unit (ICU), and Labor and Delivery (L&D) environments.

The system consists of an infusion device and a compatible, single patient use sterile disposable set with supply lines capable of interfacing with intravenous (IV) bags or an optional reservoir. The ThermaCor® 1200 Infuser may be used with a Footswitch (optional accessory) to allow hands-free, user-controlled delivery.

The ThermaCor® 1200 Infuser can deliver flow rates from 10 mL per Hour to 1200 mL per Minute selectable in 10mL/hr in Slow mode and 20mL/min in Rapid mode at normothermic temperatures and is intended for continuous operation. The ThermaCor® 1200 Rapid Thermal Infusion System is driven by a volumetric pump capable of variable-rate continuous infusion up to approximately 100 Liters total volume per Cassette. The system is also capable of delivering discrete bolus infusions. The user can select Bolus Mode to deliver a fixed, predetermined bolus of up to 1 Liter at a default or adjustable rate. When connected to alternating current (AC) power, the ThermaCor® 1200 Infuser can deliver fluids warmed to body temperature under most conditions. The Infuser can also run on battery power (heating capabilities will be disabled) to allow transport of the patient. A lithium-ion battery pack provides the power backup.

This document describes the acceptance criteria and study proving the device meets these criteria for the ThermaCor® 1200 Disposable Sets for the ThermaCor® 1200 Rapid Thermal Infusion System (K202461).

1. Table of Acceptance Criteria and Reported Device Performance

The submission focuses on a component modification (Parylene coating on the heat exchanger) within an existing device, emphasizing that this modification did not change the performance of the Disposable Sets. Therefore, the acceptance criteria are implicitly met by demonstrating equivalency to the previously cleared device without performance degradation, and by confirming the safety of the new coating.

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

The document does not explicitly specify the sample size for each individual test conducted (biocompatibility, mechanical integrity, bond strength, particulate matter, aluminum ion leaching, and heat transfer equivalency). However, it broadly states that "performance and safety testing was conducted on the ThermaCor® 1200 Disposable Sets with Parylene Coated Heat Exchangers" and "performance verification testing was conducted with the ThermaCor® 1200 Rapid Thermal Infusion System."

The provenance of the data is not explicitly stated (e.g., country of origin). The studies appear to be prospective as they were specifically conducted to evaluate the modified device for this 510(k) submission.

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

This submission does not involve diagnostic imaging or clinical interpretation by experts to establish a "ground truth" in the traditional sense of AI/clinical studies. The ground truth here is based on objective measurements and established standards (e.g., ISO, ASTM, USP, FDA guidance for biocompatibility). Therefore, no "readers" or "experts" for ground truth establishment are applicable in this context. The testing was carried out in accordance with recognized industry standards and regulatory guidance.

4. Adjudication Method for the Test Set

Not applicable, as this is not a study requiring human adjudication for ground truth (e.g., image interpretation). The "adjudication" is based on the results meeting predefined quantitative or qualitative standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This type of study is not relevant for evaluating a material modification to an infusion system component. The submission focuses on the safety and functional equivalence of the modified component, not on human interpretive performance with or without AI.

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

Not applicable. This device is a medical hardware component (disposable set) and not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth used for evaluating the modified device stems from objective, quantitative, and qualitative measurements against established medical device standards and regulatory guidance.

• Biocompatibility: Conformance to ISO 10993 and ASTM F756 standards, and additional FDA requests, reflecting generally accepted scientific principles for material safety in contact with the body.
• Mechanical Integrity/Bond Strength: Conformance to ASTM D3359 and ISO 8536-4 standards.
• Particulate Matter: Conformance to USP standard.
• Aluminum Ion Leaching: Measured values demonstrating an improvement in safety margin compared to previous versions, implicitly against a predefined safety threshold.
• Heat Transfer Equivalency: Measurement comparing the performance of the new heat exchanger to the cleared predicate device, demonstrating equivalence.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set" for an algorithm. The "training" for the device's design and manufacturing is derived from engineering principles, prior experience with the predicate device, and regulatory standards.

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

Not applicable, as there is no training set for an AI algorithm in this context.

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The Barkey S-Line blood / fluid warming system is intended to deliver warm blood, blood products, and liquids to adult and pediatric patients. It delivers the fluid via intravenous (IV) administration in hospitals and clinical settings where warmed intravenous fluids are required.

The Barkey S-line is a blood and infusion fluid warmer. The infused fluid flows through a standard IV set. The IV line is inserted into a groove in a warming sleeve, referred to as the Sline. The warming sleeve is made of silicon with embedded heating wires. There is no direct contact between the heat exchanging tube and the fluids. The fluid only contacts the off-the-shelf 510(k) I.V. extension set. There is no software / firmware in the device. The S-line operates on 100 - 240 VAC. 50/60 Hz powering an IEC 60601-1 compliant internal power supply. The set temperature is set to 39 ℃ which is not user selectable. The fluid is warmed to approximately 39 ℃ as it travels a path through the heating sleeve. The temperature is constantly monitored and adjusted. The temperature is measured at the end of the extension set, where it leaves the heated sleeve prior to delivery to the patient. The S-line unit weighs approximately 1.3 kg and is equipped with a knob clamp at the back of the devices for attachment to an I.V. pole, the S-line may also be clamped to a bedrail. Independent overtemperature protector monitors the temperature in the warming section. In case of a fault, there is a second overtemperature safety feature which if a temperature of 43°C +/- 1°C is reached, the warming section's heater is switched off, the luminous ring in the display and control panel shows yellow and an acoustic alarm sounds.

The provided text is a 510(k) Premarket Notification for the Barkey S-Line blood/fluid warming system. This document is a submission to the FDA demonstrating that a new medical device is substantially equivalent to a legally marketed predicate device.

Crucially, this document does not describe a clinical study or a study proving the device meets acceptance criteria in the context of typical AI/ML medical device performance studies. Instead, it describes non-clinical testing (electrical/EMC and performance testing) to demonstrate the device's basic functionality and safety, and compares its specifications to a predicate device to establish substantial equivalence.

Therefore, many of the requested items (e.g., sample size for test set, number of experts, MRMC study, ground truth for training set) are not applicable to the type of device and submission described in this document. The Barkey S-Line device is a fluid warmer, not a diagnostic AI/ML system that would typically undergo such a rigorous performance validation involving human experts and clinical datasets.

However, I can extract the "acceptance criteria" in a broad sense from the non-clinical testing sections and the comparison to the predicate.

Non-Applicable Information for this Device/Submission Type:

• Sample sized used for the test set and the data provenance: Not a clinical study involving a test set of patient data.
• Number of experts used to establish the ground truth: Not applicable, no ground truth based on expert review of medical images/data.
• Qualifications of those experts: Not applicable.
• Adjudication method for the test set: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is not an AI/ML diagnostic device requiring an MRMC study.
• Effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as there's no complex algorithm. The "electronics" section explicitly states "No microprocessor" and "The temperature regulation is realized by hardware comparator circuit."
• The type of ground truth used: Not applicable in the sense of clinical ground truth (e.g., pathology, expert consensus). The "ground truth" here is the physical measurement of temperature and electrical properties against specified ranges.
• The sample size for the training set: Not applicable; there is no machine learning model requiring a training set.
• How the ground truth for the training set was established: Not applicable.

Acceptance Criteria and Reported Device "Performance" (as per the non-clinical testing and comparison):

Based on the nature of this 510(k) submission for a fluid warmer, the "acceptance criteria" are derived from relevant electrical/safety standards and the device's ability to maintain a target temperature within specified limits, similar to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

• 1.7 ml/min, 37°C
• 25 ml/min, 29°C
• 100 ml/min – N/A
  (Compared to predicate's performance at max 41°C: 1.7 ml/min, 37°C; 25 ml/min, 37.5°C; 100 ml/min, 36°C). Despite differences in specific performance values for flow rates, these are typically considered sufficient for the stated indications when compared for substantial equivalence. The document doesn't explicitly state the thresholds for "acceptable" performance for each flow rate but implied sufficiency. |
  | Ingress Protection (Water/Particulate): Adequate protection against ingress of foreign objects and water. | IPX2 (compared to predicate's IPX4). Deemed "adequate ingress protection" given the device's design and intended use. |
  | Protection Against Electric Shock: Classification of protection against electric shock. | Type BF (Similar to predicate). |
  | Alarm Functionality: Timely and appropriate audible/visual alerts for fault conditions (e.g., overtemperature). | Audible and Visual alarms for "Overtemperature" and "Fault" conditions. (Similar to predicate's Audible and Visual alarms for Low temp (42.0C)). |
  | Compatibility with Accessories: Proper function with specified IV sets. | "Used with user supplied FDA cleared IV sets" from Biegler (K954769), which are cleared for use with fluid warmers. (Similar to predicate). |
  | Dimensions: Appropriate physical size for intended use (implied, not a direct safety/performance criterion but part of equivalence). | 90 x 60 x 160 mm ("Dimensions not critical" compared to predicate's 228 x 278 x 132mm, as long as it functions). |
  | Operational Power Requirements: Compatibility with standard hospital power supply. | 100 - 240 VAC, 50/60 Hz (Similar to predicate's 110/220 VAC). |
  | Indications for Use, Patient Population, Environments of Use: Alignment with the predicate device and appropriate for intended context. | "Similar" in all these aspects to the predicate device. |
  | Fundamental Warming Methodology & Principle of Operation: Maintain a similar, safe approach to fluid warming. | "Similar technology of heat exchanger." The difference (heating within the controller vs. heating the line) "does not raise different risk concerns." |
  | Fluid Contact Materials: (Crucial for patient safety) Ensuring no hazardous materials in contact with fluids or that proper clearances exist for compatible accessories. | "The subject device has no fluid contacting materials" as it heats the IV line, which is an FDA-cleared accessory. (Predicate uses accessory extension sets that contact fluid). This is a design difference but deemed safe and equivalent. |

2. Sample Size and Data Provenance:

• Sample Size: This document does not specify a "sample size" in the context of clinical data for an AI/ML device. The "testing" involves internal non-clinical validation of the device's physical and electrical properties. The number of units tested for electrical safety, temperature accuracy, or flow rate performance is not explicitly stated but would be part of a quality management system.
• Data Provenance: Not applicable in the context of clinical data. The performance claims are based on non-clinical testing performed internally by the manufacturer (Barkey GmbH & Co. KG), presumably in Germany given their address. The testing reports (e.g., electrical, performance testing) would be available internally.

3. Number of Experts and Qualifications:

• Not applicable. This device does not rely on expert interpretation of medical data for its function or validation for regulatory submission. The "experts" involved would be engineers and quality assurance personnel performing the non-clinical tests.

4. Adjudication Method:

• Not applicable.

5. MRMC Comparative Effectiveness Study:

• No. This type of study is for evaluating the impact of AI on human reader performance, which is not relevant for a fluid warming device.

6. Standalone Performance:

• Yes, in a very literal sense. The device's performance in heating fluids and its safety features (e.g., overtemperature cutoff, alarms) are evaluated as a standalone product against engineering specifications and relevant standards. There is no AI/ML component or complex algorithm, it's a hardware-based direct warming device.

7. Type of Ground Truth Used:

• The "ground truth" for this device's performance relies on physical measurements against engineering specifications and regulatory standards. For example:
  • Temperature: Measured temperature must fall within a specified range (e.g., 39°C +/- tolerance) and safety cutoffs (e.g., 43°C +/- 1°C).
  • Electrical Safety: Electrical parameters (e.g., leakage current, insulation resistance) must meet the limits specified by IEC 60601-1.
  • Flow Rate vs. Temperature: Measured output fluid temperature at various input fluid temperatures and flow rates.
• This is not "expert consensus," "pathology," or "outcomes data."

8. Sample Size for the Training Set:

• Not applicable. There is no training set as there is no machine learning component. The device's temperature regulation is achieved through a "hardware comparator circuit" rather than a software algorithm.

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

• Not applicable.

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The Quantum" Blood and Fluid Warming System is indicated for warming blood, blood products and intravenous solutions prior to administration in adult and pediatic patients greater than 28 days old of normal birth weight. It is intended for use by healthcare professionals in hospital, clinical, field, and transport environments to help prevent hypothermia.

The Quantum is not for use with neonates (birth to 28 days old) or infants of low birth weight.

The Quantum Blood and Fluid Warming System is a light weight, portable, battery powered, in-line fluid warming system in which specially designed thermal IV administration tubing is integrated with a warming element. The device is prescription only. The Quantum is comprised of the following components: Controller, Battery, Charger, and Quantum thermal tubing available in two configurations: TIS (Thermal Infusion Set) and TTS-B (Thermal Transfusion Set for blood) with standard IV administration components. The microprocessor and algorithm in the Quantum Controller continually receive and assess temperature input from thermistors located on the tubing segments. In response to this input, the Controller regulates the energy applied to the tubing to reach and/or maintain a pre-set temperature range of 38 °C ± 2 °C at delivery. A double-extrusion process results in tubing configuration with an inner tubing layer and an outer tubing laver. The warming element is in between but does not contact the fluid. Warming begins at the fluid source and continues the length of the tubing until near the point of patient entry. The TIS an TTS-B tubing perform the same function as standard IV tubing, however, when warming is desired, the TIS or TTS-B is simply connected to the Quantum Controller is connected to the Battery. The TIS and TTS-B tubing sets are provided sterile (i.e., fluid path) for single patient use. The Controller, Battery and Battery Chargers are reusable.

The provided document K192325 is a 510(k) premarket notification for the "Quantum Blood and Fluid Warming System". The submission concerns a change in the Indications for Use to include pediatric patients greater than 28 days old of normal birth weight. The device itself is "identical in design and technological features" to the predicate device (K181775). Therefore, the study described here primarily addresses the safety and effectiveness of using the existing device for this expanded patient population.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The core acceptance criterion for this submission is that the Quantum Blood and Fluid Warming System effectively warms blood and fluid for pediatric patients (greater than 28 days old of normal birth weight) to a target temperature without introducing new risks or exacerbating existing risks beyond acceptable levels. The performance of the device in meeting its primary function (warming) is assumed to be equivalent to the predicate device for adult use, and the performance for pediatric use is assessed by whether the device's capabilities accommodate pediatric physiological needs regarding flow rates and volumes.

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 does not describe a specific clinical study with a test set of patient data. This submission is a "Special 510(k)" which generally indicates a change to a currently cleared device that does not affect its fundamental scientific technology. The primary assessment made is a risk analysis and a comparison of the device's existing specifications against the physiological requirements of the new patient population.

Therefore, there is no sample size of patients in a traditional sense, nor data provenance (country, retrospective/prospective) for a clinical test set. The "test set" here refers to the parameters of pediatric physiology (flow rates, volumes, body weights) against which the device's known performance was evaluated.

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 in the context of a traditional clinical study. The "ground truth" used here is established medical knowledge regarding pediatric physiology, resuscitation guidelines (e.g., AHA Pediatric Advanced Life Support Guidelines mentioned in the risk table), and medical device safety standards. The document doesn't specify the number or qualifications of experts who conducted this particular risk analysis, but it would typically be performed by a team including engineers, regulatory affairs specialists, and possibly medical advisors with expertise in device design and pediatrics.

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

Not applicable. There was no clinical test set requiring adjudication of patient cases or outcomes. The assessment was based on existing technical specifications and medical knowledge.

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 fluid warming system, not an AI-assisted diagnostic or therapeutic device that would involve human readers or AI assistance.

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

Not applicable. This is a hardware medical device with software control, not an AI algorithm. Its performance is inherent to its design and how it delivers warmth, independent of human interaction once parameters are set, but it is always used "human-in-the-loop" as healthcare professionals administer fluids.

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

The ground truth for this submission primarily consists of:

• Established Medical Standards and Guidelines: Specifically, pediatric resuscitation guidelines (e.g., AHA Pediatric Advanced Life Support Guidelines are referenced in the risk analysis table).
• Physiological Data: Known ranges for pediatric body weights, fluid volumes, and flow rates.
• Device Specifications: The inherent technical capabilities and validated performance of the Quantum Blood and Fluid Warming System as previously cleared for adult use.
• Risk Analysis Principles: Standard methodologies for identifying, evaluating, and mitigating risks associated with medical devices.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. No training set for an AI/ML model was used.

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The MAC Medical D-Series Blanket and Solution Warming Cabinets are designed to store and warm blankets, hospital linens, irrigation fluids, and/ or injection fluids in accordance with the recommended warming temperatures and storage guidelines provided by the manufacturers of such products.

The MAC Medical D-Series Blanket and Solution Warming Cabinets are designed to store and warm sterile IV solutions, surgical irrigation solutions, linens and/ or blankets to an acceptable level for hospital and surgical outpatient center applications.

The MAC Medical D-Series Warming Cabinets are constructed with stainless steel panels, headers and doors. The Warming Cabinets are doubled walled constructed and are fully insulated to provide uniform heating. Optional glass doors are double paned tempered glass with aluminum.

A pull-out shelf inside the top of the cabinet contains the heating element, fan, thermostat, and temperature sensor. The electronics are located on the outside of the cabinet and the power cable is connected in the back of the cabinet. The wheeled baskets run on mounted rails and automatically stop when they reach the full out position. The shelves and baskets can be removed for cleaning and repositioning.

This document describes the premarket notification (510(k)) for the MAC Medical D-Series Blanket and Solution Warming Cabinets. It focuses on demonstrating substantial equivalence to predicate devices rather than proving novel clinical effectiveness with detailed AI or human reader studies. Therefore, many of the requested elements for an AI/MRMC study are not applicable or not present in this type of submission.

Here's a breakdown based on the provided document:

Acceptance Criteria and Device Performance

The acceptance criteria for this device are based on demonstrating substantial equivalence to legally marketed predicate devices, primarily regarding safety and performance specifications related to warming and temperature control. The performance is assessed through non-clinical bench testing.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a warming cabinet and not an AI-driven diagnostic device, the "acceptance criteria" are primarily based on meeting safety standards and functional specifications similar to predicate devices. The document compares technical characteristics.

• 0/ - 3° F - For settings 110° F to 150° F | +0/ - 2.7° F |
  | Installation | Free Standing or Recessed | Free Standing (Mobile) or Recessed | Free Standing or Recessed |
  | Controls | Electronic temperature controller with LED display. Element on the red neon indicator display. | Electronic control consists of 4 digit LED display, on/off keys, integrated lock feature and a series of prompt sequence indicators. | Electronic temperature controller with LED display. Illuminated power switch/ breaker (red). Amber neon indicator for element on red neon indicator for trouble. |
  | Unit Configuration | Single/ Dual/ Triple | Single | Single/ Dual |
  | Unit Depth | Inside Cavity 18" or 24"
  Overall 20.5" or 26.5" | 34.9" | 22" or 28" for table top and full-size cabinets. |
  | Cabinet Volume | Triple compartment capacity - 14.01 cu ft overall
  Upper - 3.89 cu ft
  Middle - 3.73 cu ft
  Lower - 6.4 cu ft | Single compartment - 7.8 cu ft | Dual compartment capacity - 18.1 cu ft overall
  4.3 cu ft upper
  13.8 cu ft lower |
  | Voltage Requirements | 120 VAC 50/60 HZ or 240 VAC 50/60 HZ | 120 VAC 50/60 HZ or 230 VAC 50/60 HZ | 120 VAC 60 HZ |
  | Expected Life | 10 years | Not available | Not available |

2. Sample Size for Test Set and Data Provenance

This is a warming cabinet, not a device processing patient data. The "test set" refers to the specific warming cabinet units manufactured by MAC Medical that underwent non-clinical bench testing.

• Sample Size: Not explicitly stated as a number of units, but implies that the tests were performed on representative units of the D-Series.
• Data Provenance: Not applicable in the context of patient data. The provenance is from internal testing performed by MAC Medical. The document does not specify the country of origin of the testing, but the company is based in Illinois, USA. The testing is prospective for the purpose of this submission.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This device does not generate diagnostic interpretations requiring expert ground truth in the way AI algorithms do. Ground truth here refers to metrological standards for temperature measurement and adherence to electrical safety standards.

4. Adjudication Method for Test Set

Not applicable. This is not a study involving human interpretation. The "adjudication" is through engineering and quality control procedures confirming the device meets specified performance criteria and safety standards.

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

Not applicable. This device is a warming cabinet, not an AI-assisted diagnostic tool for medical imagery or patient interpretation. There is no human reader component that would be "assisted" by this device.

6. Standalone Performance (Algorithm Only)

Not applicable. There is no AI algorithm in this device. Its performance is measured directly through its physical function (heating, temperature control, safety).

7. Type of Ground Truth Used

The "ground truth" for the non-clinical bench testing is based on:

• Engineering specifications and design requirements.
• International safety standards (e.g., IEC 61010-1 for electrical safety, IEC 61326 for EMC).
• Metrological accuracy for temperature measurements (e.g., using calibrated temperature probes).
• Functional verification against specified temperature ranges and alarm conditions.

8. Sample Size for Training Set

Not applicable. This is not an AI/machine learning device. There is no "training set" in the context of data for an algorithm. The design and manufacturing processes are refined through engineering, quality control, and adherence to established medical device manufacturing practices.

9. How Ground Truth for Training Set Was Established

Not applicable, as there is no training set for an AI algorithm. The device's design is based on established engineering principles for warming cabinets and safety standards.

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The Quantum Blood and IV Fluid Infusion Warmer is indicated for warming blood, blood products and intravenous solutions prior to administration in adult patients. It is intended to be used by healthcare professionals in hospital. clinical. field and transport environments to help prevent hypothenmia.

The Quantum Blood and IV Fluid Infusion Warmer is a light weight, portable, battery powered, in-line fluid warming system in which specially designed thermal IV administration tubing is integrated with a warming element. The device is prescription only. The Quantum is comprised of the following components: Controller, Battery, Charger, and Quantum thermal tubing available in two configurations: TIS (Thermal Infusion Set) and TTS-B (Thermal Transfusion Set for blood) with standard IV administration components. The microprocessor and algorithm in the Quantum Controller continually receive and assess temperature input from thermistors located on the proximal, medial and distal tubing segments. In response to this input, the Controller regulates the energy applied to the tubing to reach and/or maintain a pre-set temperature range of 38 °C ± 2 °C at delivery. A double-extrusion process results in tubing configuration with an inner tubing layer and an outer tubing layer. The warming element is in between but does not contact the fluid. Warming begins at the fluid source and continues the length of the tubing until near the point of patient entry. The TIS an TTS-B tubing perform the same function as standard IV tubing, however, when warming is desired, the TIS or TTS-B is simply connected to the Quantum Controller and the Controller is connected to the Battery. The TIS and TTS-B tubing sets are provided sterile (i.e., fluid path) for single patient use. The Controller, Battery Chargers are reusable.

Apologies, but the provided text from the FDA 510(k) summary (K181775) for the "Quantum Blood and IV Fluid Infusion Warmer" does not contain the information necessary to address your specific request about acceptance criteria and a study proving a device meets them, especially in the context of an AI/human-in-the-loop system.

This document describes a medical device (a fluid warmer) and its regulatory clearance process based on "substantial equivalence" to a predicate device. It details:

• Device Description: What the fluid warmer is, its components, and how it works.
• Indications for Use: For warming blood, blood products, and IV solutions prior to administration in adult patients to prevent hypothermia.
• Comparison to Predicate Device: Highlights similarities and differences in common name, regulation, product code, indications, intended use, user population, environment, user interface, feedback, system components, infusion temperature, fluid path, flow rate, heating method/control, power source, biocompatibility, sterilization, and product standards.
• Performance Testing Summary: Lists the various engineering, biocompatibility, electrical safety, and EMC standards the device conforms to, along with the types of tests performed (e.g., cytotoxicity, sensitization, systemic toxicity, hemolysis).

Crucially, this document does NOT discuss:

• AI/Machine Learning: There is no mention of AI, algorithms for image analysis, or any form of diagnostic or assistive AI.
• Acceptance Criteria for AI Performance: Since no AI is described, there are no AI-specific performance criteria.
• Test Sets, Training Sets, Ground Truth, Expert Consensus: These concepts relate to the validation of AI/ML models, which are not relevant to the described device or the information provided in this 510(k) summary.
• MRMC Studies or Human Reader Improvement with AI: Also irrelevant as no AI is involved.

Therefore, I cannot provide the requested information based on the given input. The document is about a hardware medical device (fluid warmer) and its regulatory pathway, not an AI-powered diagnostic or assistive tool.

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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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