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• Infusion of crystalloid, colloid or blood product, including packed red blood cells, as volume replacement for patients suffering from blood loss due to trauma or surgery.
• Infusion of warmed fluid to patients with the ability to prevent hypothermia.

The Fluido® AirGuard System (FAS) is a pressurized infusion system intended for warming blood and fluids prior to administration to help prevent perioperative hypothermia. The FAS uses infrared heating technology to safely warm blood and fluids; the system detects air to prevent it from entering the patient.

The FAS consists of the Fluido Pressure Chambers, Fluido Blood and Fluid Warmer, Fluido AirGuard, Fluido Compressor, Fluido IV Pole, and Fluido Single-Use (Disposables): Standard Set and Trauma Set.

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The Mistral-Air® Warming System is a forced air warming device and comprises of a warming unit and a variety of blankets. It is intended to raise and maintain patient temperature by means of surface warming.

The Mistral-Air® Warming System comprises of the following devices:

• One warming unit of models: ● MA1200-PM Mistral-Air® - SYK (forced air warming unit 100-125 V~, 50/60 Hz) c Connected to
• One warming blanket of models: Non-sterile Accessory: Stryker REF / Stryker Proprietary name MA02010-PM Faceshield - SYK Non-sterile blankets: Stryker REF / Stryker Proprietary name MA0220-PM / Adult White - SYK MA0230-PM / Paediatric White - SYK MA0250-PM / Lower Body White - SYK MA0260-PM / Upper Body White - SYK MA0265-PM / Half Upper Body White - SYK MA0270-PM / Torso White - SYK MA0290-PM / Surgical Access White - SYK MA0320-PM / Adult Reflective - SYK MA0330-PM / Paediatric Reflective - SYK MA0340-PM / Neonatal Reflective - SYK MA0350-PM / Lower Body Reflective - SYK MA0360-PM / Upper Body Reflective - SYK MA0365-PM / Half Upper Body Reflective - SYK MA0400-PM / Full Underbody Reflective - SYK MA0450-PM / Underbody Reflective - SYK MA0510-PM / Tube - SYK Sterile blankets: Stryker REF / Stryker Proprietary name MA0280-PM / Surgical Access White (sterile) - SYK MA0285A-PM / Lower Surgical Access White (sterile) - SYK MA0286-PM / Cardiac Blanket (sterile) - SYK Non-sterile blankets: Stryker REF / Stryker Proprietary name MA1610-PM / Premium Warming Suit S - SYK MA1620-PM / Premium Warming Suit M - SYK MA1630-PM / Premium Warming Suit L - SYK MA1640-PM / Premium Warming Suit XL - SYK MA1710-PM / Warming Suit S - SYK MA1720-PM / Warming Suit M - SYK MA1730-PM / Warming Suit L - SYK MA1740-PM / Warming Suit XL - SYK Non-sterile blankets: Stryker REF / Stryker Proprietary name MA2220-PM / Adult Plus - SYK MA2230-PM / Paediatric Plus - SYK MA2240-PM / Neonatal Plus - SYK MA2250-PM / Lower Body Plus - SYK MA2260-PM / Upper Body Plus - SYK MA2265-PM / Half Upper Body Plus - SYK MA2270-PM / Torso Plus - SYK MA2290-PM / Surgical Access Plus - SYK MA2400-PM / Full Underbody Plus - SYK MA2450-PM / Half Underbody Plus - SYK MA2475-PM / Paediatric Underbody Plus - SYK MA3320-PM / Premium Adult - SYK MA3330-PM / Premium Paediatric - SYK MA3340-PM / Premium Neonatal - SYK MA3350-PM / Premium Lower Body - SYK MA3360-PM / Premium Upper Body - SYK MA3365-PM / Premium Half Upper Body - SYK MA3400-PM / Premium Full Underbody - SYK MA3450-PM / Premium Half Underbody - SYK MA3475-PM / Premium Paediatric Underbody - SYK Sterile blankets: Stryker REF / Stryker Proprietary name MA2280-PM / Surgical Access Plus (sterile) - SYK MA2285-PM / Lower Surgical Access Plus (sterile) - SYK MA2286-PM / Cardiac Blanket Plus (sterile) - SYK
  The principle of operation is an electrically powered forced air warming unit (consists of a control circuit, an air filter, a fan, a heating element and temperature sensors) that propels warmed air via a flexible hose to a warming blanket (sterile or non-sterile, depending on the model) draped over the patient. Some warming blankets allow for the patient to be placed on top of the blanket or surrounded by a warming tube. All warming blankets are intended for single patient use only.

This document describes the premarket notification for the Mistral-Air Warming Unit, a medical device for patient warming. The document is a 510(k) submission to the FDA, which demonstrates substantial equivalence to a legally marketed predicate device.

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

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

The document doesn't present an explicit table of acceptance criteria with numerical targets and direct measurement results in the way one might expect for an AI/ML device's performance metrics (e.g., sensitivity, specificity). Instead, it states that the device was tested against recognized standards and specifications for medical electrical equipment and patient warming devices.

The acceptance criteria are implicitly defined by compliance with these standards and the demonstration of equivalent performance to the predicate device.

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

The document describes bench tests (non-clinical tests) to verify the performance of the device. It does not mention a "test set" in the context of patient data or clinical trials, nor does it specify sample sizes for these bench tests. The provenance of this data is effectively internal laboratory testing conducted by The Surgical Company International BV. The study is prospective in that the tests were conducted specifically to demonstrate compliance for this 510(k) submission.

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. The "ground truth" for this device's performance is established by objective engineering and safety standards (e.g., temperature measurements, airflow properties, electrical safety, EMC compatibility). It's not based on expert consensus for interpreting medical images or clinical outcomes.

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

Not applicable. This is not a study requiring adjudication of expert opinions or labels.

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 warming unit, not an AI-powered diagnostic or assistive tool for human readers.

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

The performance evaluation is entirely "standalone" in the sense that the device's operational parameters (e.g., temperature output, airflow) are measured directly against specifications and standards, independent of human interaction beyond operating the device for the testing. There is no algorithm providing diagnoses or interpretations where "human-in-the-loop" performance would be a separate consideration.

7. The type of ground truth used:

The ground truth for the device's performance is based on:

• Engineering specifications and design requirements: For parameters like air flow, air pressure, temperature, and endurance.
• Recognized industry standards (Table 1): These standards define safety, essential performance, electromagnetic compatibility, usability, software lifecycle processes, biological compatibility, and packaging requirements for medical devices. Compliance with these standards serves as the "ground truth" for acceptable and safe device operation.

8. The sample size for the training set:

Not applicable. This device is a mechanical/electrical warming unit, not an AI/ML model that requires a training set.

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

Not applicable, as no training set for an AI/ML model is involved.

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The Mistral-Air® Warming System is a forced air warming device and comprises of a warming unit and a variety of blankets. It is intended to raise and maintain patient temperature by means of surface warming.

The Mistral-Air Warming System comprises of the following devices:

• MA1100-US Mistral-Air Plus Warming Unit 110-120V~, 60Hz .
• Mistral-Air Adult Blanket (white) MA0220 .
• Mistral-Air Paediatric Blanket (white) MA0230 .
• Mistral-Air Lower Body Blanket (white) MA0250 ●
• Mistral-Air Upper Body Blanket (white) MA0260 ●
• Mistral-Air Half Upper Body Blanket (white) MA0265 .
• Mistral-Air Torso Blanket (white) ● MA0270
• Mistral-Air Full Body Surgical Access Sterile (white) MA0280 .
• MA0290 Mistral-Air Full Body Surgical Access - Non-sterile (white) .
• Mistral-Air Adult Blanket (silver) MA0320 ◆
• Mistral-Air Paediatric Blanket (silver) MA0330
• Mistral-Air Neonatal Blanket (silver) MA0340 ●
• Mistral-Air Lower Body Blanket (silver) MA0350 ●
• Mistral-Air Upper Body Blanket (silver) MA0360
• Mistral-Air Half Upper Body Blanket (silver) MA0365
• MA0400 Mistral-Air Full Underbody (silver) .
• Mistral-Air Underbody (silver) MA0450 .
• Mistral-Air Tube (blue) MA0510

The principle of operation is an electrically powered unit (the Mistral-Air Plus Warming Unit) consisting of a fan and heating element that propels warmed air via a flexible hose to a blanket (the Mistral-Air Blanket) draped over the patient. Some configurations allow for the patient to be placed on top of the blanket or surrounded by a warming tube. Almost all types of Mistral-Air Blankets types are provided non-sterile. However, one type of Mistral-Air Blankets is provided sterile. The Mistral-Air Blankets (both non-sterile versions) are intended for single patient use only.

The provided text is a 510(k) Summary for the Mistral-Air Warming System, a medical device. This document describes the device, its intended use, technological characteristics, and a summary of non-clinical tests. However, it does not contain the detailed information required to answer your specific questions regarding acceptance criteria and a study proving device performance in the context of AI/ML devices.

The document discusses "performance specifications" for bench tests but does not provide a table of acceptance criteria or reported device performance in the format you requested, nor does it describe a study involving a test set, ground truth, experts, or AI/ML performance metrics.

Here's a breakdown of why I cannot answer your request based on the provided text:

• No mention of AI/ML: The device described is a forced-air warming system, which is a physical medical device, not an AI/ML-driven diagnostic or prognostic tool. Therefore, concepts like "test set," "ground truth," "number of experts," "adjudication method," "MRMC study," "standalone performance," and "training set" are not applicable in the context of this device.
• Focus on bench tests: The "Summary of the main non-clinical tests and results" section lists bench tests like "Air flow performance," "Air pressure performance," "Filtering performance," and "Temperature performance." It states that the device "is in compliance with the set performance specifications," but it does not detail those specifications or the specific results. This is typical for a 510(k) submission for a non-AI device, where the focus is on demonstrating equivalence to predicate devices through engineering and performance testing.
• Device Type: This is a hardware device (a warming system), not a software or AI-based diagnostic tool. The performance criteria and study designs for hardware devices differ significantly from those for AI/ML algorithms.

Therefore, I cannot provide the requested information from the given text.

To answer your questions, I would need a document that describes the development and validation of an AI/ML medical device, which would typically include sections on:

• Clinical Performance Study: Details about how the device performed in a clinical setting.
• Validation Cohort: Information on the test data used, including size, provenance, and characteristics.
• Ground Truth Establishment: How the definitive diagnosis or outcome for each case was determined.
• Performance Metrics: Specific metrics like sensitivity, specificity, AUC, F1-score, etc., and the acceptance thresholds for these.
• Reader Studies: If the AI is used in conjunction with human readers.
• Training Data: Details about the data used to train the AI model.

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