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.

Device Description

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.

AI/ML Overview

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.

Summary

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Beeldschermweg 6F 3821 AH Amersfoort The Netherlands

T +31 (0)33 450 72 50 F +31 (0)33 450 72 60 contact@tsci.nl, www.tsci.n

K101705

510(k) Summary

Applicant:

JUL -- 2 2010

The Surgical Company International BV (TSCI) Beeldschermweg 6F 3821 AH Amersfoort The Netherlands

Contact Person:	Adriaan P. Intveld, Regulatory Affairs & Quality Assurance Manager
Telephone:	+31-33-4507 266
Fax:	+31-33-4507 260
E-mail:	intveld.adriaan@tsci.nl
Date Prepared:	25 January 2010

Device name:

Proprietary Name:	Mistral-Air Warming System
Common/Usual Name:	Heating pad control unit, air: (GMDN-code: P 36954)Heating pad system under/overlay, air (GMDN-code: P 36931)
Classification Name:	Thermal regulating system (21 CFR 870.5900)
Product Code:	DWJ

Predicates:

Soft-Air Patient Warming System Model SA 4000 [K073712] .
Bair Hugger Model 750 Total Temperature Management System [K001149] .
CSZ WarmAir Hyperthermia System [K942599 and K942790] .

Device description:

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

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Beeldschermweg 6F 3821 AH Amersfoort The Netherlands

Intended use:

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.

Technological characteristics:

The main technological characteristics of the Mistral-Air Plus Warming Unit are:

metal, electronics and ABS. . Materials:
HEPA . Air filter:
Single phase AC, 75 W Motor: .
1000W resistive Heater: ●
microprocessor-based Control circuitry: .

The main technological characteristics of the Mistral-Air Blankets are:

polypropylene and polyethylene. Materials: .
These and other technological characteristics are the same or similar as the predicate devices.

Summary of the main non-clinical tests and results:

In order to verify the performance of the Mistral-Air Warming System the following bench tests were conducted:

Air flow performance .
Air pressure performance .
Filtering performance �
Temperature performance .
Endurance test ●
Extreme Temperatures .
Keyboard test .

It was demonstrated that the Mistral-Air Warming System is in compliance with the set performance specifications.

Conclusion:

The Mistral-Air Warming System has the same intended use and performance as the predicate devices. The Surgical Company International BV believes these proposed devices do not raise any new safety or effectiveness issues.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right. The eagle is composed of three thick, curved lines that suggest the shape of the bird in flight.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

The Surgical Company International B.V. c/o Mr. Casey Conry Underwriters Laboratories Inc. 71285 Walt Whitman Rd Melville, NY 11747

JUL .- 2 2010

Re: K101705

Trade/Device Name: Mistral Air Warming System Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II (two) Product Code: DWJ Dated: June 16, 2010 Received: June 17, 2010

Dear Mr. Conry:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Casey Conry

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical .device=related adverse.events) (21-CFR-803); good-manufacturing-practice-requirements as-setforth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

· Enclosure

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The Surgical Company International B.V.

Beeldschermweg 6F 3821 AH Amersfoort The Netherlands

T +31 (0)33 450 72 50 F +31 (0)33 450 72 60 contact@tsci.nl, www.tsci.n

Indications for Use Statement

510(k) Number: to be determined

Mistral-Air® Warming System Device Name:

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

Prescription Use(Part 21 CFR 801 Subpart D)	X
AND/OR
Over-The-Counter Use(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

WME

iovascular Devices 510(k) Number

Regulation Number and Section

§ 870.5900 Thermal regulating system.

(a)
Identification. A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature.(b)
Classification. Class II (performance standards).