The Flowtron ACS900 is a pneumatic pump that supplies compressed air to inflate compression garments that are attached to patient's limbs. It is designed to work with the ArjoHuntleigh ranges of DVT calf/thigh compression garments, Foot compression garments and Tri Pulse calf/thigh compression garments. The pump automatically senses the type of compression garment connected and adjusts the pressure/time cycle accordingly. Each garment is compressed alternately, applying pressure to the patient's limb to help prevent deen vein thrombosis.

AI/ML Overview

The provided document is a 510(k) summary for the Flowtron ACS900, a pneumatic pump designed to prevent Deep Vein Thrombosis (DVT). The document describes the device, its intended use, and the testing performed to demonstrate its substantial equivalence to a predicate device.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics in a way typical for diagnostic or AI-driven devices. Instead, it lists various "Testing conducted" with a binary "Result" (Passed or Complies with Standard). The acceptance criteria are implicitly defined by compliance with established medical device standards and the functional validation of the pump's software/hardware.

Here's the information parsed into a table format as requested, interpreting "acceptance criteria" as the tests performed and "reported device performance" as the outcome:

Acceptance Criteria (Test Conducted)	Reported Device Performance (Result)
Full validation of pump software / hardware functionality, including: - Garment detection - Therapy delivery	Passed
Performance testing garments – Pressure cyclic test: - with Tri Pulse garments - with Foot garments - with DVT garments	Passed
Electrical Testing to Standard AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012	Complies with Standard
EMC testing to Standard IEC 60601-1-2, 2007	Complies with Standard
Environmental Stability testing: - Storage / Distribution Test - Operational Temperature / Humidity Test	Passed

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

The document does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective) relating to clinical performance or patient data. The tests described are primarily engineering and hardware/software validation tests, not clinical efficacy trials with patient populations.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The tests described are for a physical medical device (a pneumatic pump and its associated garments) and involve engineering validation and standard compliance, not interpretation of clinical data by experts to establish ground truth for a diagnostic output.

4. Adjudication method for the test set

Not applicable. There is no mention of adjudication as the tests performed are primarily objective engineering and performance evaluations against predefined standards or functional specifications.

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. The Flowtron ACS900 is a physical medical device (a pump for DVT prevention), not an AI-driven diagnostic tool that would involve human readers or MRMC studies.

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

Not applicable. This device is not an algorithm, but a hardware product.

7. The type of ground truth used

The "ground truth" for this device's evaluation is defined by:

Functional specifications: Ensuring the pump correctly detects garments and delivers therapy as designed.
Performance specifications: Ensuring the compression garments maintain specific pressure cycles.
Regulatory standards: Compliance with electrical (AAMI / ANSI ES60601-1) and EMC (IEC 60601-1-2) standards.
Environmental stability requirements: The device's ability to withstand storage, distribution, and operational conditions.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not an AI/ML device requiring data for model training.

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

Not applicable, for the same reason as point 8.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. 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 three human profiles facing to the right, with flowing lines connecting them.

June 23, 2015

Public Health Service

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

Getinge (Suzhou) Co., Ltd % David Moynham Senior Regulatory Affairs Engineer Arjohuntleigh AB 35 Portmanmoor Road Cardiff, CF24 5HN GB

Re: K143438

Trade/Device Name: Flowtron ACS900 Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: May 29, 2015 Received: June 1, 2015

Dear Mr. Moynham,

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.

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

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

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 of medical devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

M. A. Hillebrand

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

Enclosure

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

GE INGL

510(k) Number: K143438

Device Name: Flowtron ACS900

Indications for Use:

To help prevent Deep Vein Thrombosis (DVT)

Prescription Use YES (Part 21 CFR 801 Subpart D)

AND/OR

NO (Part 21 CFR 801 Subpart C)

Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

ARJOHUNTLE GETINGE GROUP

510K Summary Flowtron ACS900

Name & Address:	Getinge (Suzhou) Co., LtdNo. 158 Fangzhou Road, Suzhou, 215024JiangsuChina
Telephone:	+(44) 2920 485885
Fax:	+(44) 2920 492520
Prepared:	26 November 2014
Contact:	David Moynham – Regulatory Affairs Engineer
Device Name:	Flowtron ACS900
Common Name	Compressible Limb Sleeve
Classification	Class	Product Code	Classification Regulation
	II	JOW	870.5800
Classification Name:	Sleeve, Limb, Compressible
Predicate Device:	Flowtron ACS800 pump (K133119) cleared 28 Feb 2014, manufacturedby ArjoHuntleigh AB.This predicate has not been subject to a design-related recall.
Indications for Use:	To help prevent Deep Vein Thrombosis (DVT)
Description :	The Flowtron ACS900 is a pneumatic pump that supplies compressedair to inflate compression garments that are attached to patient'slimbs.It is designed to work with the ArjoHuntleigh ranges of DVT calf/thighcompression garments, Foot compression garments and Tri Pulsecalf/thigh compression garments.The pump automatically senses the type of compression garmentconnected and adjusts the pressure/time cycle accordingly.Each garment is compressed alternately, applying pressure to thepatient's limb to help prevent deen vein thrombosis.

Models:

Model REF	Device	Features
526000-01	Flowtron ACS900	AC powered pump
526000-02	Flowtron ACS900	AC powered pump with longer length connectiontubes

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

ARIOHUN GETINGE GROUP

Substantial Equivalence: Flowtron ACS900 is substantially equivalent to cleared device Flowtron ACS800 +Tri Pulse pump (K133119). The Flowtron ACS900 pump has the same compression pressure / time profiles for the DVT. Foot and Tri Pulse Garments.

Testing to demonstrate equivalence included:

	Testing conducted	Result
	Full validation of pump software / hardwarefunctionality, including- Garment detection- Therapy delivery	Passed
	Performance testing garments – Pressure cyclictest.with Tri Pulse garmentswith Foot garmentswith DVT garments	Passed
	Electrical Testing to Standard AAMI / ANSIES60601-1:2005/(R)2012 and A1:2012	Complies withStandard
	EMC testing to Standard IEC 60601-1-2, 2007	Complies withStandard
	Environmental Stability testing.	Passed
	-Storage / Distribution Test.-Operational Temperature /Humidity Test.
Technologies Summary:	The Flowtron ACS900 contains an air compressor, air distribution valveand a microprocessor based control system, housed in a durableplastic casing.
	The control system sets and monitors the air pressure cycle applied tothe compression garments. It also monitors for faults caused byincorrect user set-up, compression garment failures and pump systemproblems.
	Automatic compression garment recognition is achieved by sensing aspecific value inductor. The value inductor is built into thecompression garment hose connector.
Conclusion:	The data detailed within submission including that drawn from thenonclinical tests demonstrate that the device is as safe and effectiveas the legally marketed predicate devices.

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).