The Game Ready System combines cold and compression therapies. It is intended to treat post-surgical acute injuries to reduce edema, swelling, and pain where cold and compression are indicated. It is intended to be used by or on the order of healthcare professionals in hospitals, outpatient clinics, athletic training settings, or home settings.

Device Description

The Game Ready System is comprised of the following components: Control Unit, with AC Adapter (to convert line power to DC input power), Connector Hose (connects Control Unit to Wrap), Wrap (Heat Exchanger + Sleeve), Optional Carry Bag, Optional Battery Pack. The Game Ready System is a DC-powered device that provides intermittent compression and controlled cold therapy by controlling fluid flow and air pressure through a Wrap that is specially designed for a specific body part or location (e.g., shoulder, elbow, knee, ankle, back). A Wrap is comprised of a Sleeve (the outer covering for the Heat Exchanger) and a Heat Exchanger. Cooling is provided by circulating ice water from the Control Unit through the Connector Hose to the Wrap. Compression is provided by an intermittent-cycling pneumatic pump that pumps air from the Control Unit through the Connector Hose to the Wrap. The user can adjust the amount of compression, the amount of cooling, and the treatment time. The Control Unit software is designed to protect both the user and the Control Unit from harm by shutting off the system and sounding an alarm if there is insufficient fluid flow or in case of an over-pressure or under-pressure situation. The software detects other. less-serious error conditions and sounds a warning beep to alert the user, so that the error condition can be corrected. The Game Ready System is available in two configurations: the Game Ready Professional Therapy System (P/N 550100) and the Pre-Programmed Game Ready Professional Therapy System (P/N 550350)

AI/ML Overview

The provided text is a 510(k) Summary for the Game Ready System. This type of regulatory submission in the U.S. demonstrates substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through clinical studies in the same way a novel high-risk device might.

Therefore, many of the requested elements about acceptance criteria, sample sizes, expert ground truth, adjudication, and comparative effectiveness studies are not applicable or not present in this type of document for this specific device.

However, I can extract the information that is available and clarify what is not.

Game Ready System 510(k) Summary Analysis

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present a table of specific quantitative acceptance criteria or detailed device performance metrics typically found in clinical trials for novel devices. The basis for clearance is "substantial equivalence" to predicate devices, focusing on design, function, and intended use.

The document states:

"Design Verification Testing showed that the Game Ready System performed according to specification."
"Bench testing was performed at both the sub-assembly and assembly level. The testing showed that the Game Ready System met its requirements."

However, the specific "specifications" or "requirements" (e.g., target temperature range, compression pressure accuracy, cycle times) are not detailed in this summary.

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

Test Set Sample Size: Not applicable/not provided. This submission relies on "Bench testing" and "Design Verification Testing" to demonstrate that the device itself performs as expected, not on a test set of patient data.
Data Provenance: Not applicable. No clinical data or patient data was used.

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

Not applicable. No expert ground truth was established for a test set, as no clinical testing data was used.

4. Adjudication Method for the Test Set

Not applicable. No adjudication method was used for a test set, as no clinical testing data was used.

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

No MRMC study was done. The document explicitly states: "No clinical testing data are submitted, referenced, or relied on to determine substantial equivalence." Therefore, no effect size for human readers with or without AI assistance is provided.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical cold/compression therapy system, not an AI algorithm. Its performance is related to its mechanical and electrical functions, not algorithmic output on data.

7. Type of Ground Truth Used

This concept is not applicable in the context of this 510(k) Summary. The "truth" being established is that the device functions as designed and is substantially equivalent to existing legally marketed devices, based on bench testing of its physical properties and performance against its own specifications, not against a clinical "ground truth."

8. Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable. As there is no training set, there is no ground truth establishment for it.

Summary of Device-Specific Information from the Text:

Device Name: Game Ready System (Game Ready Professional Therapy System, Pre-Programmed Game Ready Professional Therapy System)
Intended Use: To treat post-surgical acute injuries to reduce edema, swelling, and pain where cold and compression are indicated. To be used by or on the order of healthcare professionals in hospitals, outpatient clinics, athletic training settings, or home settings.
Components: Control Unit (with AC Adapter), Connector Hose, Wrap (Heat Exchanger + Sleeve), Optional Carry Bag, Optional Battery Pack.
Functionality: DC-powered, provides intermittent compression and controlled cold therapy by controlling fluid flow and air pressure through a Wrap. User can adjust compression, cooling, and treatment time. Software includes safety shut-offs for insufficient fluid flow, over/under-pressure, and warning beeps for less serious errors.
Predicate Devices: CRYOPress (K951769) and Polar Care 500 (K961855).
Basis for Clearance: Substantial Equivalence to predicate devices in design, function, and indications for use/intended use, supported by non-clinical bench testing and design verification testing. No clinical testing was performed or relied upon.

Summary

{0}------------------------------------------------

510(k) Summary of Safety and Effectiveness

Game Ready System

JUN 2 9 2007

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is:

A. Submitter: CoolSystems, Inc. 2201 Dwight Way Berkeley, CA 94704
Phone: 510-868-5378 Fax: 510-984-5330 Email: mbaldwin@gameready.com Contact: Marianne Baldwin, VP, QA/RA/CA

June 11, 2007 Date Prepared:

B. Device Names:

Trade Name:	Game Ready System
Common/usual Name:	Cold/compression therapy system
Classification Name:	Cold water circulating pack / Powered inflatable tube massager

C. Predicate Device:

The Game Ready System is substantially equivalent to the following predicate devices:

Device, K#	Manufacturer	Product Code(s)
CRYOPress, K951769	Grimm Scientific	ILO/IRP
Polar Care 500, K961855	Breg, Inc.	ILO

D. Device Description:

The Game Ready System is comprised of the following components:

. Control Unit, with AC Adapter (to convert line power to DC input power)
Connector Hose (connects Control Unit to Wrap) .
Wrap (Heat Exchanger + Sleeve) ●
. Optional Carry Bag
· Optional Battery Pack

The Game Ready System is a DC-powered device that provides intermittent compression and controlled cold therapy by controlling fluid flow and air pressure through a Wrap that is specially designed for a specific body part or location (e.g., shoulder, elbow, knee, ankle, back). A Wrap is comprised of a Sleeve (the outer covering for the Heat Exchanger) and a Heat Exchanger. Cooling is provided by

{1}------------------------------------------------

circulating ice water from the Control Unit through the Connector Hose to the Wrap. Compression is provided by an intermittent-cycling pneumatic pump that pumps air from the Control Unit through the Connector Hose to the Wrap. The user can adjust the amount of compression, the amount of cooling, and the treatment time. The Control Unit software is designed to protect both the user and the Control Unit from harm by shutting off the system and sounding an alarm if there is insufficient fluid flow or in case of an over-pressure or under-pressure situation. The software detects other. less-serious error conditions and sounds a warning beep to alert the user, so that the error condition can be corrected.

The Game Ready System is available in two configurations: the Game Ready Professional Therapy System (P/N 550100) and the Pre-Programmed Game Ready Professional Therapy System (P/N 550350)

E. Intended Use:

F. Comparison with the Predicate Device:

The Game Ready System is substantially equivalent to the predicate devices in design, function, and indications for use/intended use.

G. Non-Clinical Testing

Bench testing was performed at both the sub-assembly and assembly level. The testing showed that the Game Ready System met its requirements. Design Verification Testing showed that the Game Ready System performed according to specification.

H. Clinical Testing

No clinical testing data are submitted, referenced, or relied on to determine substantial equivalence.

-Conclusions

There are no significant differences between the Game Ready System and the predicate devices that would adversely affect the use of the proposed device. The Game Ready System is substantially equivalent to the predicate devices in design, function, and indications for use/intended use.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with three lines extending from its head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

CoolSystems, Inc % Ms. Marianne Baldwin Vice President, RA/QA/CA 2201 Dwight Way Berkeley, California 94704

JUN 2 9 2007

Re: K071050

Trade/Device Name: Game Ready Professional Therapy System, Model 550100, Game Ready Pre-programmed Professional Therapy System Regulation Number: 21 CFR 890.5650 Regulation Name: Powered inflatable tube massager Regulatory Class: II Product Code: IRP, ILO Dated: May 30, 2007 Received: May 31, 2007

Dear Ms. Baldwin

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.

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.

{3}------------------------------------------------

Page 2 - Ms. Marianne Baldwin

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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number:	K071050
Device Name:	Game Ready TM System

Indications for Use:

The Game Ready System combines cold and compression therapies. It is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain where cold and compression are indicated. It is intended to be used by or on the order of healthcare professionals in hospitals, outpatient clinics, athletic training settings, or home settings.

Prescription Use X (Part 21 CFR 801 Subpart D)

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)

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number_

Regulation Number and Section

§ 890.5650 Powered inflatable tube massager.

(a)
Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.(b)
Classification. Class II (performance standards).