Reprocessed Compression Sleeves are intended to help prevent deep vein thrombosis and pulmonary embolism by supplying a measured, intermittent pressure into the compression sleeves worn on the lower extremities of a recumbent patient, resulting in a gradient, sequential, repetitive squeezing and relaxing action, simulating normal muscle contractions.

Reprocessed Compression Sleeves are indicated for use in providing external compression therapy to reduce the incidence of deep vein thrombosis and resulting pulmonary embolism in patients at risk for thrombosis formation.

Device Description

Compression sleeves are part of an external compression system, in which intermittent or sequential compression is provided using a pump/controller and limb garment. The system consists of the following three main components: a control unit, inflatable limb sleeves and conduit tubing with detachable connections. Only the compression sleeves are reprocessed.

AI/ML Overview

The provided text describes the 510(k) summary for "Reprocessed Compression Sleeves" by Alliance Medical Corporation. This submission focuses on demonstrating substantial equivalence to a predicate device rather than a new AI-powered diagnostic device. Therefore, many of the requested categories for AI-specific studies (like sample size, ground truth, expert adjudication, MRMC studies, standalone performance, and training set details) are not applicable or not detailed in this document.

However, I can extract the relevant information regarding acceptance criteria and the studies performed to meet them for this reprocessed medical device.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Performance Tests)	Reported Device Performance (Conclusion)
Biocompatibility	Performance testing demonstrates that Reprocessed Compression Sleeves perform as originally intended. Alliance Medical Corporation concludes that the modified devices (Reprocessed Compression Sleeves) are safe, effective and substantially equivalent to the predicate devices.
Sterilization Validation	Performance testing demonstrates that Reprocessed Compression Sleeves perform as originally intended. Alliance Medical Corporation concludes that the modified devices (Reprocessed Compression Sleeves) are safe, effective and substantially equivalent to the predicate devices.
Function Test(s)	Each individual compression sleeve is tested for appropriate function of its components prior to packaging, labeling, and sterilization operations. Performance testing demonstrates that Reprocessed Compression Sleeves perform as originally intended. Alliance Medical Corporation concludes that the modified devices (Reprocessed Compression Sleeves) are safe, effective and substantially equivalent to the predicate devices.
Packaging Validations	Performance testing demonstrates that Reprocessed Compression Sleeves perform as originally intended. Alliance Medical Corporation concludes that the modified devices (Reprocessed Compression Sleeves) are safe, effective and substantially equivalent to the predicate devices.
Overall Safety and Effectiveness	"Alliance Medical Corporation concludes that the modified devices (Reprocessed Compression Sleeves) are safe, effective and substantially equivalent to the predicate devices as described herein."

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

The document states that "Bench and laboratory testing was conducted." It does not specify the sample sizes used for these tests.
Data provenance is not explicitly mentioned (e.g., country of origin, retrospective/prospective), as the testing appears to be internal laboratory and bench testing of the reprocessed sleeves themselves.

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):

Not applicable as this is not a diagnostic device relying on expert-established ground truth from patient data. The ground truth for performance tests (like function, sterility) would be established by validated test methods and specifications.

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

Not applicable. This is not a study requiring expert adjudication of patient cases.

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 is not an AI-powered device or a study involving human readers.

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

Not applicable. This is not an algorithm or AI device. The "standalone" performance refers to the reprocessed sleeve's ability to meet its functional and safety specifications. The document states that "Each individual compression sleeve is tested for appropriate function of its components prior to packaging, labeling, and sterilization operations."

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

The "ground truth" for this device's performance is based on established specifications and validated test methods for biocompatibility, sterilization, functionality, and packaging integrity. For example, for "Function Test(s)", the ground truth would be that the sleeve performs according to its original design specifications (e.g., pressure output, inflation/deflation cycles).

8. The sample size for the training set:

Not applicable. This is not an AI device trained on data.

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

Not applicable. This is not an AI device.

Summary

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

K 624074

PART B: 510(k) SUMMARY

MAR 0 7 2003

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

Image /page/1/Picture/0 description: The image shows the logo for Alliance Medical Corporation. The logo consists of three curved lines above the company name. The lines are thick and black, and they are arranged in a slightly arched shape. The text "ALLIANCE MEDICAL CORPORATION" is in a simple, sans-serif font.

510(k) SUMMARY

10232 South 51st Street

TEL 480.763.5300
FAX 480.763.5310
Toll Free 888.888.3433
www.alliance-medical.com

Submitter:	Alliance Medical Corporation10232 South 51st StreetPhoenix, Arizona 85044
	Phoenix, Arizona
	TEL 480.763
	FAX 480.763
	Toll Free 888.888
	www.alliance-medic
Contact:	Moira BartonRegulatory Affairs Specialist(480) 763-5300 (o)(480) 763-5310 (f)
Date of preparation:	October 11, 2002

Trade/Proprietary Name: Reprocessed Compression Sleeves Name of device: Common or Usual Name: Compression Sleeve Classification Name: Compressible Limb Sleeve

Predicate device(s):

and the may be the state of the states of the states of

K Number	Device Description
K961405	Albahealth™ PAS Wrap System

Device Compression sleeves are part of an external compression system, in description: which intermittent or sequential compression is provided using a pump/controller and limb garment. The system consists of the following three main components: a control unit, inflatable limb sleeves and conduit tubing with detachable connections. Only the compression sleeves are reprocessed.
Intended use: Reprocessed Compression Sleeves are intended to help prevent deep vein thrombosis and pulmonary embolism by supplying a measured, intermittent pressure into the compression sleeves worn on the lower extremities of a recumbent patient, resulting in a gradient, sequential, repetitive squeezing and relaxing action, simulating normal muscle contractions.
Indications Reprocessed Compression Sleeves are indicated for use in providing statement: external compression therapy to reduce the incidence of deep vein thrombosis and resulting pulmonary embolism in patients at risk for thrombosis formation.
Technological The design, materials, and intended use of Reprocessed characteristics: Compression Sleeves are identical to the predicate devices. The mechanism of action of Reprocessed Compression Sleeves is identical to the predicate devices in that the same standard

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

mechanical design, materials and sizes are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation.

Alliance Medical Corporation's reprocessing of compression sleeves includes removal of adherent visible soil and decontamination. Each individual compression sleeve is tested for appropriate function of its components prior to packaging, labeling, and sterilization operations.

Performance Bench and laboratory testing was conducted to demonstrate data: performance (safety and effectiveness) of Reprocessed Compression Sleeves.

Biocompatibility ●
Sterilization Validation .
. Function Test(s)
. Packaging Validations

Performance testing demonstrates that Reprocessed Compression Sleeves perform as originally intended.

Conclusion: Alliance Medical Corporation concludes that the modified devices (Reprocessed Compression Sleeves) are safe, effective and substantially equivalent to the predicate devices as described herein.

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

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 0 7 2003

Alliance Medical Corporation c/o Ms. Moira Barton Regulatory Affairs Specialist 10232 South 51st Street Phoenix, AZ 85044

Re: K024074

Trade Name: Reprocessed Compression Sleeves Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: December 9, 2002 Received: December 10, 2002

Dear Ms. Barton:

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.

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

Page 2 - Ms. Moira Barton

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/cdrh/dsma/dsmamain.html

Sincerely yours.

Нетм
Bram D. Zuckerman, M.D.
Director
Divison of Cardiovascular Devices
Office of Device Evaluation
Center for Devices and

Radiological Health

Enclosure

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

Indications for Use Statement ll.

510(k) Number (if known):

Device Name: Alliance Medical Corporation Reprocessed Compression Sleeves

Indications for Use: Reprocessed Compression Sleeves are indicated for use in providing external compression therapy to reduce the incidence of deep vein thrombosis and resulting pulmonary embolism in patients at risk for thrombosis formation.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Oletin

510(k) Number K024074/

Prescription Use
(per 21 CFR 801.109)

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

Alliance Medical Corporation Reprocessed Compression Sleeves Traditional 510(k)

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).