The Rapid Thermal Exchange System is designed to noninvasively lower or raise a patient's temperature and/or maintain a desired patient temperature. This is accomplished with local application of negative pressure and heating/cooling to a distal appendage.

Device Description

The Rapid Thermal Exchange (RTX) System consists of three main parts. The 1) Field Controller unit is the vacuum source; it also regulates and pumps the temperaturecontrolled water through the 2) Attachment Hoses that are connected to 3) the Thermal Exchange Chamber (identified in earlier submissions as the Palmo Thermoregulating Accessory).

The patient inserts his/her hand through the arm seal of the Thermal Exchange Chamber. The palm is placed on the temperature-controlled thermal exchange surface. A light vacuum is created by connecting the Thermal Exchange Chamber to the Field Controller Unit's vacuum pump via the inline vacuum control valve. The physician can monitor the adequacy of the vacuum and seal from the dial on the mechanical vacuum gauge mounted to the top of the Thermal Exchange Chamber. A light vacuum (25 inches of water, 47mmHg) is applied to increase the amount of blood available in the appendage.

This combination of light vacuum and a thermal exchange surface provides a rapid and noninvasive mechanism for changing the temperature of the blood flowing through the appendage. This, in turn, changes the temperature of the body core.

The arm seal of the Thermal Exchange Chamber is available in three different sizes (small, medium & large) to accommodate the range of possible hand and wrist sizes of athletes. A variation of the Chamber can be applied to the foot in a similar manner.

AI/ML Overview

The provided text describes a medical device, the Rapid Thermal Exchange (RTX) System, and its substantial equivalence to a predicate device, the Palmo Thermoregulating Accessory. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the format typically used for AI/ML device evaluations (e.g., accuracy, sensitivity, specificity, F1 score).

Instead, the submission focuses on:

Device Description: How the RTX System works, its components, and its similarities to the predicate.
Indications for Use: What the device is intended for.
Testing in Support of Substantial Equivalence: This section mentions "bench testing" to support operating characteristics and compliance with IEC 60601-1. It also refers to "human studies reported in a predicate submission" that demonstrated the effectiveness of the predicate's underlying mechanism.
Substantial Equivalence Conclusion: The core argument is that the RTX System is substantially equivalent to the predicate because it has the same intended use, uses identical technology and operating parameters, and incorporates the exact same components.

Given this, I cannot fill out the requested table for acceptance criteria and reported device performance, nor can I provide information on sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth for test sets, training set size, or how ground truth was established for the training set. These elements are standard for evaluating AI/ML models but are not present in this 510(k) submission for a non-AI medical device.

Here's a breakdown of what can be extracted from the text, framed within your request, but with the caveat that it does not align with AI/ML evaluation metrics:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (as implied by the submission)	Reported Device Performance
Maintain desired operating characteristics (e.g., vacuum pressure, temperature control of water)	"The results of bench testing support the claims that the RTX System can maintain the desired operating characteristics." (Specific numeric performance values for vacuum or temperature control are not provided in this summary).
Compliance with safety standards	"the manufacturer claims that the RTX system has been designed, tested and manufactured in compliance with the FDA consensus standard IEC 60601-1 (Medical Electrical Equipment -- Part 1: General requirements for safety)." and "AVAcore Technologies certifies that the RTX System is in compliance with the following FDA recognized consensus standard: IEC 60601-1: Medical Electrical Equipment – Part 1: General requirements for safety."
Effectiveness in changing/maintaining body core temperature	"human studies reported in a predicate submission have demonstrated that the simultaneous application of light vacuum and thermal exchange can effectively and noninvasively change the body core temperature of a patient." (This refers to predicate device studies, not new studies for the RTX System itself, as the RTX uses "identical technology, methods and temperature/vacuum settings".) The RTX System is stated to use "the same technique and operating parameters as the Palmo Thermoregulating Accessory (Palmo)" which successfully demonstrated this effectiveness.
Substantial Equivalence to Palmo Thermoregulating Accessory (K014210)	"Substantial equivalence is based on the fact that the RTX System has the same intended use as the Palmo Thermoregulating Accessory (K014210)." and "The RTX System uses the same technique and operating parameters as the Palmo Thermoregulating Accessory (Palmo). The Palmo consisted of a vacuum chamber for the distal appendage that served as the thermal exchange surface, an arm seal, an in-line vacuum relief valve and Attachment hoses. The RTX System uses the exact same components." Also states: "The Palmo and the RTX System use identical technology, methods and temperature/vacuum settings to exchange thermal energy with the body core of the patient. There are no new questions of safety or efficacy raised between the two systems."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The summary mentions "bench testing" for operating characteristics but provides no details on sample sizes or data provenance.
It also refers to "human studies reported in a predicate submission" for effectiveness, but these were for the predicate device, not the RTX System itself. No details about these predicate studies' sample size or provenance are given in this document.

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)

This information is not provided as the submission focuses on functional equivalence to a predicate, not clinical performance evaluation against a defined ground truth set by experts.

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

Not applicable/Not provided.

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 thermal regulation system, not an AI-powered diagnostic tool involving human readers.

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

Not applicable. This is a physical medical device, not an algorithm.

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

For the "effectiveness" claim, the ground truth for the predicate device's human studies would likely have been measured changes in body core temperature or maintenance of desired temperature in human subjects (outcomes data). The RTX System relies on the predicate's demonstration of this.
For safety and operating characteristics, the ground truth would be physical measurements against engineering specifications and regulatory standards (e.g., precise temperature control, vacuum pressure, electrical safety tests per IEC 60601-1).

8. The sample size for the training set

Not applicable. This is not an AI/ML device with a "training set."

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

Not applicable.

Summary

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SECTION 2 - 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 8807.92

Contact Person JAN 2 3 2003 Craig Coombs Vice President, Regulatory/Clinical Affairs & Quality Assurance 415.531.1932 650.321.3908 fax cicoombs@aol.com

· Device Name Trade Name: Rapid Thermal Exchange System Common Name: System, Thermal Regulating Classification Name: Thermal Regulation System Accessory (21 CFR 870.5900)

Predicate Devices Palmo Thermoregulating Accessory

K014210

Device Description

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Indications for Use

Testing in Support of Substantial Equivalence Determination

The thermal exchange chamber (aka the Palmo) is unchanged since the predicate submission. The operating characteristics are also unchanged.

The results of bench testing support the claims that the RTX System can maintain the desired operating characteristics. In addition, the manufacturer claims that the RTX system has been designed, tested and manufactured in compliance with the FDA consensus standard IEC 60601-1 (Medical Electrical Equipment -- Part 1: General requirements for safety).

Additionally, human studies reported in a predicate submission have demonstrated that the simultaneous application of light vacuum and thermal exchange can effectively and noninvasively change the body core temperature of a patient.

Substantial Equivalence Conclusion

Substantial equivalence is based on the fact that the RTX System has the same intended use as the Palmo Thermoregulating Accessory (K014210).

The RTX System uses the same technique and operating parameters as the Palmo Thermoregulating Accessory (Palmo). The Palmo consisted of a vacuum chamber for the distal appendage that served as the thermal exchange surface, an arm seal, an in-line vacuum relief valve and Attachment hoses. The RTX System uses the exact same components.

The Palmo Thermoregulating Accessory was cleared as an accessory to the Cincinnati SubZero Blanketrol II. The Blanketrol II pumped its temperature-controlled water through the Palmo thermal exchange chamber. The RTX System has a water heater/cooler in its Field Controller Unit (FCU) that pumps temperature-controlled water through the same Palmo thermal exchange chamber. The Palmo Thermoregulating Accessory was cleared to use a hospital's central vacuum as a vacuum source for the Palmo thermal exchange chamber. The FCU has its own vacuum pumps as a vacuum source for the same Palmo thermal exchange chamber. Since the RTX provides both temperature-controlled water and vacuum sources in a suitcase-sized, wheeled, Field Control Unit, it can be applied in a wider range of locations.

The RTX System requires the prescription or order of a physician to be applied in response to medical conditions.

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The Palmo and the RTX System use identical technology, methods and temperature/vacuum settings to exchange thermal energy with the body core of the patient. The technology uses a local application of negative pressure and a thermal exchange surface to a distal appendage. There are no new questions of safety or efficacy raised between the two systems.

AVAcore Technologies certifies that the RTX System is in compliance with the following FDA recognized consensus standard: IEC 60601-1: Medical Electrical Equipment – Part 1: General requirements for safety.

The predicate device is classified as a "Thermal Regulating System" (per 21CFR870.5900), as is the RTX. Therefore, it can be concluded that the RTX System is substantially equivalent to the predicate device.

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Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

JAN 2 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AVACore Technologies, Inc. c/o Mr. Michael Kwan Underwriters Laboratories Inc. 1655 Scott Boulevard Santa Clara, CA 95050

Re: K023934

Trade Name: Rapid Thermal Exchange (RTX) System Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulation System Regulatory Class: Class II (two) Product Code: DWJ Dated: January 13, 2002 Received: January 14, 2003

Dear Mr. Kwan:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Michael Kwan

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); good manufacturing practice requirements as set forth 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrl/dsma/dsmamain.html

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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INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name: Rapid Thermal Exchange (RTX) System

Indications for Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR 801.109)
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Over-the-Counter Use(Optional Format 1-2-96)
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(Division Sign-Off)
Division of Cardiovascula cos

510(k) Number	K023954
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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).