The Cowboy XV is designed to enhance blood circulation in the venules and arterioles in the lower extremities. The Cowboy XV Is designed to only patients with diabetic ulcers of the lower extremities.

Cowboy XV is intended for patient's in the home who would benefit from increased blood flow to:

treat and assist healing of cutaneous ulceration (wounds).
reduce wound healing time.
enhance arterial circulation (blood flow).
prevent venous stasis (slowing of blood flow).
reduce compartmental pressures.
reduce edema (swelling).
reduce post-operative pain and swelling.
reduce the need for anticoagulant medications (medications that thin the blood).
prevent Deep Venous Thrombosis (DVT) (blood clots in deep veins).

Device Description

The Cowboy XV pump is connected through tubing to a foot wrap(s). When inflated, these wraps mimic the normal physiological actions of walking, thus helping to open up and improve blood flow and circulation in the venules and arterioles in the lower extremities. This improved blood flow means a greater chance of prolonging the time before or preventing amputation as their wounds heal.

Cowboy XV functions as an intermittent pneumatic compression device that enhances lower extremity blood circulation. Cowboy XV is not a life-supporting or life-sustaining device. Cowboy XV is not an implant (short-term or long-term), nor is it a sterile device. Cowboy XV is an electrically-operated (designed to meet UL 1431), software-driven, prescription device, which is used in the home environment. Cowboy XV is comprised of two major components – the reusable pump unit and a single-patient use inflatable foot wrap. Neither component contains a drug nor biological product as a subcomponent.

Cowboy XV uses a 16 foot hospital grade power cord to supply a voltage of 115 volts AC at a frequency of 60 Hz with a maximum current consumption of 0.33 amperes and a maximum electrical leakage of less than 100 microamperes from its power source. An exterior shell made of Prism CM-200 material, measuring 12" long by 10 % " wide by 7" high, houses the 11 pound unit.

The compressor inflates one or more of the wraps in minimum intervals of 20 seconds at a pressure of not less than 15 mmHg and not more than 180 mmHg (± 15 mmHg).

The unit features a microprocessor that controls the unit's operation. The frequency and intensity of the compressions, as well as the duration of the compressions, are all preset values which are monitored and controlled by the microprocessor. The microprocessor also has detection capabilities to monitor the pressure in the wrap(s), adjusting the in and out flow of air as needed. If for any reason the target pressure cannot be maintained, the microprocessor alarm capabilities will activate both visual and audio alarms. These alarm capabilities are built into the unit to alert the user of any unit malfunction situations, should they ever occur.

The non-sterile inflatable foot wraps are for single-patient use only. Each wrap is designed to fit around and compress the veins of the foot. The foot wrap is wrapped around the foot. Hook and loop fasteners are used to hold the foot wrap comfortably around the foot. This air bladder is RF-welded to create an air-tight seal, which can then be inflated by Cowboy XV. This air bladder is designed to create a pressure against the body.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device called "Cowboy XV," an intermittent, external pneumatic compression device. It describes the device, its intended use, and claims substantial equivalence to a predicate device, the "Cowboy X" (PlexiPulse® Acute Care Unit).

Based on the nature of this document (a 510(k) summary for a pneumatic compression device), it is highly unlikely to contain information about acceptance criteria and a study proving device performance in the context of advanced AI/ML algorithms, multi-reader multi-case studies, or the methodologies typically associated with assessing the performance of such algorithms (e.g., sample sizes of test/training sets, expert ground truth, adjudication methods).

The "performance" described in this document relates to the mechanical function of the device (inflation pressure, intervals, alarm capabilities) and its clinical intended use (enhancing blood circulation, treating and healing ulcers, etc.), which would have been assessed through different types of studies (e.g., clinical trials for efficacy, engineering tests for safety and functionality) as part of the 510(k) clearance process. However, the provided summary does not include details about these studies or specific acceptance criteria with reported device performance data in a quantitative manner as you've requested for AI/ML devices.

Therefore, I cannot populate the table or answer the specific questions about AI/ML study design, sample sizes, expert qualifications, or adjudication methods, as this type of information is not present in this 510(k) summary.

Here's what I can extract from the provided text about the device and its intended function, acknowledging that it doesn't fit the AI/ML framework of your request:

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

Feature/Criterion (Implied)	Reported Device Performance (as described in text)
Inflation Intervals	Minimum intervals of 20 seconds.
Inflation Pressure	Less than 180 mmHg (± 15 mmHg).
Deflation Intervals	Minimum intervals of 120 seconds.
Pressure Monitoring	Microprocessor monitors pressure in wrap(s).
Target Pressure Maintenance	If target pressure cannot be maintained, microprocessor activates visual and audio alarms.
Electrical Leakage	Less than 100 microamperes from its power source.
Power Consumption	Maximum current consumption of 0.33 amperes.
Voltage/Frequency	115 volts AC at 60 Hz.
Safety Standard	Designed to meet UL 1431.

(Note: These are functional descriptions, not formal acceptance criteria with specific thresholds and associated study results for AI/ML performance metrics like sensitivity/specificity.)

Study that proves the device meets the acceptance criteria:

The document does not explicitly describe a specific study with detailed methodology, sample sizes, and results to prove the device meets these functional criteria. The 510(k) process typically relies on demonstrating substantial equivalence to a predicate device, supported by various tests and documentation proving safety and effectiveness. The text states:

"The predicate device to which substantial equivalence is being claimed is Cowboy X (a.k.a. PlexiPulse® Acute Care Unit), also manufactured for NuTech by KCI. The PlexiPulse® Acute Care Unit is the hospital version of Cowboy XV and has been in hospitals for approximately 6 years." This implies that the predicate's established performance and safety are leveraged for the new device.
The description of the device's operational parameters (inflation pressure, intervals, alarm systems) serves as a statement of its design and expected performance, which would have been validated through engineering testing, but details of such studies are not provided.

Regarding the AI/ML specific questions (2-9):

Sample sizes used for the test set and the data provenance: Not applicable. This device is a mechanical pneumatic compression pump, not an AI/ML algorithm that processes data like images or patient records.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of AI/ML, refers to labels for data. This device does not use labeled data in this manner.
Adjudication method: Not applicable.
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 does not involve human readers interpreting data with or without AI assistance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable. The device doesn't "learn" from a training set in the AI/ML sense.
How the ground truth for the training set was established: Not applicable.

In summary, the provided 510(k) document is for a traditional medical device, not an AI/ML powered one. Therefore, the specific questions related to AI/ML study methodologies cannot be answered from this text.

Summary

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4/23/99

K981311

510(k) Summary

(21 CFR 807.92c.)

APPLICANT [As Required by 21 CFR 807.92 a(1)]

Applicant:

KCi New Technologies, Inc. (NuTech) (NoTCon)
Establishment Registration No. 1648561

Intermittent, External Pneumatic Compression

Address:

Telephone Number:

210-255-4450 fax Judith Harbour

April 8, 1998

Cowboy XV

Device

(subject to change)

Compressible Limb Sleeve

(per 21 CFR section 870.5800)

210-255-4468

Regulatory Affairs

8023 Vantage Dr.

San Antonio, TX 78230-4726

Company Contact:

Date:

DEVICE NAME [As Required by 21 CFR 807.92 a (2)]

Proprietary Name:

Common Name:

Classification Name:

CLASSIFICATION OF DEVICE [As Required by 21 CFR 807.87(c)]

Review Panel:

Classification:

Product Code:

MANUFACTURING FACILITY [As Required by 21 CFR 807.87(h)]

Kinetic Concepts, Inc. 4958 Stout Dr. San Antonio, TX 78219 Cardiovascular

Class II

74JOW

210-662-9191 210-662-0215 fax

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

IDENTIFICATION OF PREDICATE DEVICE [As Required by 21 CFR 807.92 a(3)]

The predicate device to which substantial equivalence is being claimed is Cowboy X
The predication of Canate Care Unit), olso manufactured for NuTech by KCI. The The predicate device to which substantial equivalence for NuTech by KCI. The
(a.k.a. PlexiPulse® Acute Care Unit), also manufactured for NuTech by KCI. The (a.k.a. PlexiPulse® Acute Care Unit), also manufacturer nor Norvoor of Corporation of See at
PlexiPulse® Acute Care Unit is the hospital version of Cowboy XV and has at PlexiPulse® Acute Care Unit is the hospital version of Councy of Chiles and Care Unites and Chiles
hospitals for approximately 6 years. The PlexiPulse® Acute Care Uncreased hospitals for approximately 6 years. The PlexiPulse= Acule Ouro Univers
compression device used for non-ambulatory, resting patients who require increased blood flow in the calf and foot.

The 510(k) number for Cowboy X is: K944567

DEVICE DESCRIPTION DEVICE DESOrty 21 CFR 807.92 a(4)]

General

General
The Cowboy XV pump is connected through tubing to a foot wrap(s). When inflated, these The Cowboy XV pump is connected through tubling, thus helping to open up the wraps mimic the normal physiological actions of walent, this and circulation in the venules and atterioles in the lower extremines in the proventing
improved blood flow means a greater chance of prolonging the time before or preventing
im improved bioos putation as their wounds heal.

Cowboy XV functions as an intermittent pneumatic compression device that enhances
and interest and interest the Regions XV is not a life-supporting or life-sustaining Cowboy XV functions as an intermittent pheumans confire or life-sustaining
lower extremity blood circulation. Cowboy XV is not a life-sustaining lower extremity blood circulation. Cowboy XV is not a fine sterile device.
device. Cowboy XV is not an implant (short-term or long-term), nor is it a sterile device. device. Cowboy XV is not an implant (snot to nong ton ;) (1431), software-driven.
Cowboy XV is an electrically-operated (designed to meet UL 1431), softwares ( Cowboy XV is an electrically-operated (designed to the home in the morised
prescription device, which is used in the home environment. Cowboy XV is comprised prescription device, which is used in the nome environimes onlient use inflatable
of two major components – the reusable pump unit and a single-patient use inflatable
s a of two major components – the reusable pump ank and a component as a
foot wrap. Neither component contains a drug nor biological product as a subcomponent.

Cowboy XV uses a 16 foot hospital grade power cord to supply a voltage of 115 volts AC at
and a Cowboy XV uses a 16 foot nospilal grant consumption of 0.33 amperes and a
a frequency of 60 Hz with a maximum current consumption of 0.33 ampersource a frequency of 60 Hz with a maximum current on or eroto and the source. An
maximum electrical leakage of less than 100 microamperes from its powers source. An maximum electrical leakage of less than Too microamported how no your unde by 7"
exterior shell made of Prism CM-200 material, measuring 12" long by 10 % " wide by 7" exterior shell made of i nom on. Lowboy XV 11 pound unit.

The compressor inflates one or more of the wraps in minimum intervals of 20 seconds at a
nd the compressor in the 120 seconds of 15 mmHg\ The compressor immates one of there than 180 mmHg (± 15 mmHg).

The unit features a microprocessor that controls the unit's operation. The frequency and The unit features a microprocessor that control the compression, are all preset
intensity of the compressions, as well as the compressions. The microprocessor intensity of the compressions, as well as the curroressor. The microprocessor also
values which are monitored and controlled by the microprocessor also values which are monitored and controlled by the wrap(s), adjusting the in and out has detection capabilities to monitor the pressure in the will be results of the summer of

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

for any reason the target pressure cannot be maintained, the microprocessor alarm for any reason the target pressure cannot be maintained, the mark capabilities are built
capabilities will activate both visual and audio alarms. These alarm capabilities ar capabilities will activate both neads and daily unit malfunction situations, should they ever occur.

The non-sterile inflatable foot wraps are for single-patient use only. Each wrap is I he non-sterife innatable loot wape and for easy of the veins of the foot. The foot. The foot wrage designed to if around and compress the lost as worked by around the foot. The foot wrap is
loop fasteners are used to hold the foot wrap comfortably around the foot. This ai loop lastellers are used to notation the the treat then be inflated by Cowboy XV. This air NI -welded to oroate an as a seessure against the body.

STATEMENT OF INTENDED USE

[As Required by 21 CFR 807.92 a(5)]

Patient Population

Cowboy XV is intended for patients with diabetic and arterial ulcers of the lower extremities.

Indications

Cowboy XV is designed to enhance blood circulation in the venules and arterioles in the lower extremities of patients with diabetic and/or arterial ulcers.

Cowboy XV is intended for patient's in the home who would benefit from increased blood flow to:

treat and assist healing of cutaneous ulceration (wounds). .
reduce wound healing time. .
enhance arterial circulation (blood flow). .
prevent venous stasis (slowing of blood flow). .
reduce compartmental pressures. ◆
reduce edema (swelling). .
reduce post-operative pain and swelling. .
reduce posicoperative pain and owening.
reduce the need for anticoagulant medications (medications that thin the blood). .
prevent Deep Venous Thrombosis (DVT) (blood clots in deep veins). .

Contraindications

Patient conditions for which Cowboy XV is contraindicated include:

presumptive evidence of congestive heart failure. .
suspected pre-existing Deep Vein Thrombosis (blood clots in deep veins). .

Differences in Indications

The indications for Cowboy XV are the same as those for the predicate device.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol that resembles three parallel lines curving upwards, with the bottom of each line ending in a wave-like shape.

4 1999 AUG

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Judith A. Harboour Regulatory Assistant KCI New Technologies, Inc. 8023 Vantage Drive San Antonio, TX 78230

K981311 Re: Cowboy XV Regulatory Class: II (Two) Product Code: 74 JOW Dated: February 16, 1999 Received: February 18, 1999

Dear Ms. Harbour:

This letter corrects our substantially equivalent letter off Inis lecter corrects our band on bean and sees and seeve April 23, 1977, regarming
device. The indication for use form included in the original device. The Indication for about revised to include the patient sabblances for which the device was intended for.

We have reviewed your Section 510(k) notification of intent to market we nave reviewed your boose and we have determined the device is the device referenced above and we maintations for use stated in the first in enclosure) to legally marketed predicate devices marketed in enclosure) co regally marketed productions the enactment date of the interstate commerce prior to hap 20, as that have been reclassified in Medical Device Amendments of our active of the Federal Food, articles to the accordance with the presente, market the device, subject to the Act (ACC). Tourmay) corress of the Act. The general controls general controls provisions of equirements for annual registration, provisions of the not in manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special If your device is Crabberroa (see approval) it may be subject to such t hit of class in (Fremazion ispeciality) a frecting your device additional concrols. Enroyang major and can be round in the ecal or resemination assumes compliance co 895. A substancially Cquiralist arequirements, as set forth in the with the Good Handressons - 3
Quality System Regulation (QS) for Medical Devices: General (QS)

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

Page 2 - Ms. Judith A. Harboour

regulation (21 CFR Part 820) and that, through periodic QS regulation (21 Crk Farc 620) and chael of Failure to comply with inspections, FDA Will Verlify Bach assist action. In addition, the che onr regaracter may 2016 (FDA) may publish further announcements . this Food and Drug Adminiberation (Federal Register, Please not affect concerning your device in the ification submission does not affect any response to your premained with sections 531 through 542 of the Act obligation you might information Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to continue marketing your device as a Inis lected will ation you be over the Fores on the FDA finding of described in your 510(x) promantial in a legally marketed predicate substantial equivalence of your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling II you desire specific and additionally 809.10 for in vitro regulation (21 Crk rule 601 annual the Office of Compliance at (301) ulaghostic devices , For questions on the promotion and 394-4640. "Addicionally" ac "quinded the Office of Compliance at (301) 594-4639. Other general information on your responsibilities (301) 394-4057. Ocher general from the Division of Small Manufacturers of under the nay be career (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Sincerely, yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Page _ of _

510(k) Number (if known): K981311

Device Name: _Cowboy XV

Indications for Use:

If ideatorio to 11.
The Cowboy XV is designed to enhance blood circulation in the venules and arterioles in
the Cowboy of the local the lower extremities. The Cowboy XV Is designed to only
patients with diabetic ulcers of the lower extremities.

patients with diabone of flow to:

treat and assist healing of cutaneous ulceration (wounds).
. reduce wound healing time. .
reduce wound neamig in thiosed flow).
enhance afterial enclaims of blood flow). .
prevent vonsarimental pressures. .
reduce edoma (swelling). .
reduce edema (Swoning).
reduce post-operative pain and swelling. .
reduce post-operative pain and swelling.
reduce the post-operative pain and swelling.
The second of the subscribesis (DVT) (blood clots in deep veins). reduce the need for anticoagulant medications (includes in deep veins).
prevent Deep Venous Thrombosis (DVT) (blood clots in deep veins).
Thrombosis Thrombosis (DVT) (blood c .
.

(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) Blvinion Sign-Off) (DIVIsion of Cardiovascular, Respiratory, and Neurological Devices Kag 1 311 310(k) Number, Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ OR Prescription Use_

(Optional Format 1-2-96)

(Per 21 CFR 801.109)

Regulation Number and Section

§ 870.5800 Compressible limb sleeve.

(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).