Specific indications include: When surgery is contraindicated While waiting for surgery Intermittent claudication Rest pain Diabetic foot Ischemic neuritis Arterial ulcers Gangrene Poor runoff

Device Description

The ArtAssist device is a pneumatic compression device that applies pressures to the limbs in timed sequences. There is a pump controller that contains a housing, an air pump, an air reservoir, electrical power supply, pressure regulation, timing regulation and safety circuitry. A set of limb cuffs contains air bladders that fill and apply pressure. A tubing set delivers the air from the pump controller to the limb cuffs. The ArtAssist device increases blood flow to the limb. This is achieved by applying rapid compression to the soft tissues of the limb. The ArtAssist device empties the veins and reduces venous pressure. The reduced venous pressure results in an increased driving pressure to greatly improve blood flow.

AI/ML Overview

Here's an analysis of the provided text regarding the ArtAssist device's acceptance criteria and studies:

Assessment of the Provided Information:

The provided document describes a 510(k) submission for a medical device (ArtAssist) that seeks substantial equivalence to a predicate device. This type of submission relies heavily on demonstrating that the new device is as safe and effective as a legally marketed predicate. Therefore, the "acceptance criteria" discussed are primarily focused on demonstrating this equivalence rather than establishing de novo performance thresholds against a disease state or outcome.

The text does not contain information about:

A table of acceptance criteria and reported device performance in the traditional sense of evaluating diagnostic accuracy (e.g., sensitivity, specificity, AUC).
Sample sizes for a test set (clinical data).
Data provenance for a test set.
Number of experts or their qualifications for ground truth establishment.
Adjudication methods.
Multi-reader multi-case (MRMC) comparative effectiveness studies.
Standalone algorithm performance.
Sample size for a training set.
How ground truth for a training set was established.

This is because the submission is for a pneumatic compression device, not an AI or imaging diagnostic tool. The performance evaluation focuses on physical characteristics and safety, not on interpreting images or making diagnostic predictions.

Based on the provided text, here is what can be extracted and inferred regarding the acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Demonstrates Substantial Equivalence to Predicate)	Reported Device Performance
Technological Characteristics:
- Apply pressures to limbs in timed sequences similar to predicate.	- "The device has the same technological characteristics as the predicate device except that it has been modified to include changes in the control mechanism from mechanical pressure regulation to electronic type and from discrete electronics to microcontroller based."
- Achieve increased blood flow to the limb similar to predicate.	- "Pressure/timing graphs obtained in the laboratory demonstrate substantial equivalence to the predicate device."
- Empty veins and reduce venous pressure similar to predicate.	- "Pressure/timing graphs obtained in the laboratory demonstrate substantial equivalence to the predicate device."
Safety:
- Meet UL 60601-1 safety requirements.	- "The device has been tested to safety requirements (UL 60601-1)"
Electromagnetic Compatibility (EMC):
- Meet IEC 60601-1-2 EMC requirements.	- "EMC requirements (IEC 60601-1-2)"
Overall Performance Equivalence:
- Perform as well as the predicate device by applying equivalent pressures and timing.	- "The laboratory test results demonstrate that the device performs as well as the predicate device since it applies equivalent pressures and timing and is therefore as effective as the predicate device."

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

Not Applicable / Not Provided. The study described is a laboratory-based equivalency comparison focusing on the device's physical functions (pressure and timing) and electrical characteristics, not a clinical study on a patient test set.
Data Provenance: Laboratory data from ACI Medical, LLC.

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

Not Applicable / Not Provided. The "ground truth" here is the physical performance and safety standards, not an expert-derived diagnosis or lesion classification. The assessment was against established technical specifications and standards (UL 60601-1, IEC 60601-1-2) and comparison to the predicate device's known performance characteristics.

4. Adjudication Method for the Test Set

Not Applicable / Not Provided. As noted above, this was not a study requiring human adjudication of clinical outcomes or images.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No. This type of study is typically performed for diagnostic imaging devices where human interpretation is involved. The ArtAssist device is a treatment device, and its evaluation focuses on its physical operating parameters and safety.

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

Yes, in essence. The "Performance data" section refers to "Pressure/timing graphs obtained in the laboratory," which evaluates the device's inherent function (algorithm/control mechanism) directly. There is no human-in-the-loop for the primary performance evaluation.

7. The Type of Ground Truth Used

Engineering/Technical Specifications and Safety Standards, and Predicate Device Performance. The ground truth for this device's evaluation is primarily:
- The expected pressure and timing profiles for pneumatic compression devices.
- Compliance with recognized electrical safety standards (UL 60601-1).
- Compliance with electromagnetic compatibility standards (IEC 60601-1-2).
- The known performance characteristics of the legally marketed predicate device (ArtAssist K942530).

8. The Sample Size for the Training Set

Not Applicable / Not Provided. The device is a hardware pneumatic compression device, not an AI model that requires a "training set" in the machine learning sense. The "training" for the device's control mechanism would be its design and calibration processes, not a data-driven training set.

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

Not Applicable / Not Provided. Similar to point 8, the concept of a "training set" and its "ground truth" is not relevant to this type of medical device submission. The device's operational parameters would have been designed and validated against engineering principles and intended physiological effects.

Summary

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FEB 1 0 2014

Image /page/0/Picture/1 description: The image shows the logo for ACI Medical. The logo has the text "ACI MEDICAL" in bold, with the words "innovate, engineer, deliver" in a smaller font underneath. The logo is surrounded by a curved line on the left and right sides.

ACI Medical, LLC 1857 Diamond St. San Marcos, CA 92078 USA Tel. 760.744.4400 Fax 760.744.4401 ed@acimedical.com

510(k) SUMMARY

K131146

510(k) owner's name: ACI Medical, LLC 1857 Diamond St. San Marcos, CA 92078 Tel. 760 744 4400 Fax 760 744 4401 Contact name: Ed Arkans Prepared: February 7, 2014

Trade name ArtAssist .
Common name Compressible limb sleeve or Pneumatic compression . device
. Classification name - Compressible limb sleeve (21 CFR 870.5800, Product Code JOW)

The legally marketed devices to which our firm is claiming equivalence is the ArtAssist device (K942530).

Device description

The ArtAssist device increases blood flow to the limb. This is achieved by applying rapid compression to the soft tissues of the limb. The ArtAssist device empties the veins and reduces venous pressure. The reduced venous pressure results in an increased driving pressure to greatly improve blood flow.

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Intended use of the device

Specific indications include: When surgery is contraindicated While waiting for surgery Intermittent claudication Rest pain Diabetic foot Ischemic neuritis Arterial ulcers Gangrene Poor runoff

Summary of the technological characteristics

The device has the same technological characteristics as the predicate device except that it has been modified to include changes in the control mechanism from mechanical pressure regulation to electronic type and from discrete electronics to microcontroller based.

Performance data

Pressure/timing graphs obtained in the laboratory demonstrate substantial equivalence to the predicate device. The device has been tested to safety requirements (UL 60601-1) and EMC requirements (IEC 60601-1-2)

Conclusions drawn from testing

The laboratory test results demonstrate that the device performs as well as the predicate device since it applies equivalent pressures and timing and is therefore as effective as the predicate device. The risk analysis, safety and EMC tests performed demonstrate the device is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

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

February 10, 2014

ACI Medical, LLC c/o Mr. Ed Arkans 1857 Diamond St. San Marcos, CA 92078

Re: K131146

Trade Name: ArtAssist Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: December 24, 2013 Received: December 27, 2013

Dear Mr. Arkans:

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. Iisting 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 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Ed Arkans

forth in the quality systems (OS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

M.A. Hillenbrand

for

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

Device Name: ArtAssist 510(k) number: K131146

Specific indications include: When surgery is contraindicated While waiting for surgery Intermittent claudication Rest pain Diabetic foot Ischemic neuritis Arterial ulcers Gangrene Poor runoff

Prescription Use:_ YES (Part 21 CFR 801 Subpart D)

M. Azbilliem

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).