The ActiveCare®++ System is a prescriptive device that induces Continuous Enhanced Circulation Therapy of the lower limbs. The ActiveCare®++ System is intended for use in:

Preventing Deep Vein Thrombosis (DVT). .
Enhancing blood circulation. .
Diminishing post-operative pain and swelling. .
Reducing wound-healing time. .
Treatment and assistance in healing: stasis dermatitis; . venous stasis ulcers; arterial and diabetic leg ulcers.
Treatment of chronic venous insufficiency. .
Reducing edema. .

Device Description

The ActiveCare®++ is a prescriptive, pneumatic compression device designed to apply sequential compression to the lower limb. The control unit of the ActiveCare®++ is light and compact, thus making it a portable ambulant system. The ActiveCare®++ provides the user with an option of battery operation in addition to the operation from the mains option. The ActiveCare®++ is easy to use and provides the user with several treatment options: compression of the foot - single or double (either regular foot or foot booster), compression of the calf - single or double, compression of the Thigh - single or double, and combined compression of any combination of two sleeves.
The foot compression program is sequential intermittent pressure pulse application to a single celled foot sleeve. The calf and thigh compression program is a sequential intermittent gradient application of a pressure (s) a three-celled calf sleeve.

AI/ML Overview

The provided text describes the Medical Compression Systems (DBN) Ltd ActiveCare®++ System, but it does not contain a table of acceptance criteria or a detailed study proving the device meets specific acceptance criteria in the manner requested.

Instead, the submission for K060146, filed in 2006, focuses on demonstrating substantial equivalence to previously cleared predicate devices. The changes made to the ActiveCare®++ system compared to its predecessors (ActiveCare® System, Wizair Compression System, Wizair DVT, or ProAir 3000) are primarily software updates, a new user interface, a compliance indicator, and a new calf sleeve.

The document states:
"A series of safety and performance testing, including bench testing and clinical comparison in healthy volunteers, were performed to demonstrate that the modified ActiveCare®++ System does not raise any new questions of safety and efficacy. These tests include:

Electrical and electromagnetic testing
Software verification and validation
Performance testing of the output parameters and pressure profile"

However, it does not provide the specific acceptance criteria for these tests nor the detailed results or methodologies of the studies performed (e.g., sample sizes, expert involvement, particular metrics used for "performance testing of output parameters and pressure profile").

Therefore, I cannot fulfill all parts of your request based on the provided text.

Here's a breakdown of what can and cannot be answered:

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

Cannot be provided. The document states that "No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act." While it mentions compliance with voluntary standards (IEC 60601-1, IEC 60601-2, AAMI / ISO 14971-1), these are general safety and risk management standards and not specific performance criteria for the device's therapeutic effect. The "performance testing of the output parameters and pressure profile" is mentioned, but no specific criteria or results are given.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "clinical comparison in healthy volunteers" as part of the safety and performance testing.
Sample Size: Not specified.
Data Provenance: The applicant is based in Israel (Medical Compression Systems (DBN) Ltd. and Biomedical Strategy (2004) Ltd.), suggesting the studies likely occurred there, but this is not explicitly stated for the "clinical comparison."
Retrospective or Prospective: The "clinical comparison in healthy volunteers" implies a prospective study.

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/Not specified. The nature of the device (pneumatic compression for DVT prevention, circulation enhancement, etc.) does not typically involve image interpretation or diagnosis that would require expert "ground truth" establishment in the cognitive sense. The "performance testing" would likely involve objective biomechanical or physiological measurements.

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

Not applicable/Not specified. Adjudication methods are typically used when there is subjective interpretation or a need to resolve discrepancies in expert opinions, which does not appear to be the case for the described tests on a pneumatic compression device.

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

No. This device is not an AI-powered diagnostic tool, so an MRMC study is irrelevant.

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

Not applicable. This device is a physical medical device, not an algorithm, so "standalone performance" in that context is not relevant. The "software verification and validation" would assess the algorithm's correct functioning within the device.

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

For the "performance testing of output parameters and pressure profile" in healthy volunteers, the ground truth would likely be objective physiological measurements (e.g., blood flow velocity, pressure readings, temperature changes) and device output parameters measured by calibrated equipment. The document does not elaborate on these specifics.

8. The sample size for the training set

Not applicable. This device does not use machine learning in a way that would require a "training set" for an AI model. "Software verification and validation" would be based on established software engineering principles, not statistical training data.

9. How the ground truth for the training set was established
* Not applicable. See point 8.

Summary

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K060146

2006 MAR 8

510(K) SUMMARY Medical Compression Systems (DBN) Ltd ActiveCare®++ System

7.1.1 Applicant's Name:

Medical Compression Systems (DBN) Ltd. 2 Ha'Ilan Street, PO Box 75, Or Akiva 30600, Israel Tel: +972 (4) 6266630 Fax: +972 (4) 6266640 E-mail: mcs@mcsmed.com

7.1.2 Contact Person:

Dorit Winitz, Ph. D Biomedical Strategy (2004) Ltd. Moshe Aviv Tower, 34th Floor, 7 Jabotinsky Street Ramat Gan 52520, Israel Tel: +972-3-612-3281 Fax: +972-3-612-3282 dorit@ebms.co.il

7.1.3 Date Prepared:

January, 2006

7.1.4 Trade Name:

ActiveCare®++ System

7.1.5 Classification Name:

Sleeve, Limb, Compressible

7.1.6 Classification:

Class II; Product Code JOW; Regulation No. 870.5800 Panel: Cardiovascular

7.1.7 Predicate Devices

Medical Compression Systems (DBN) Ltd. Systems (ActiveCare® System, incured - Compression System, Wizair DVT or ProAir 3000), cleared under K023573, K012994, K002287 and K993758.

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7.1.8 Device Description:

The foot compression program is sequential intermittent pressure pulse application to a single celled foot sleeve. The calf and thigh compression program is a sequential intermittent gradient application of a pressure (s) a three-celled calf sleeve.

7.1.9 Intended Use:

The ActiveCare®++ System is a prescriptive device that induces Continuous Enhanced Circulation Therapy of the lower limbs.

The ActiveCare®++ System is intended for use in:

Preventing Deep Vein Thrombosis (DVT). .
Enhancing blood circulation. .
Diminishing post-operative pain and swelling. .
Reducing wound-healing time. .
Treatment and assistance in healing: stasis dermatitis; . venous stasis ulcers; arterial and diabetic leg ulcers.
Treatment of chronic venous insufficiency. ◆
Reducing edema. .

7.1.10 Contraindications:

The ActiveCare®++ System should not be used in the following cases: fresh pre-existing DVT, pulmonary embolism, leg gangrene, recent skin grafi, acute thrombophlebitis and in medical situations where increased venous and lymphatic return is undesirable

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8.11 Performance Standards:

No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act. However, the ActiveCare®++ System complies with the voluntary standards such as IEC 60601-1, IEC 60601-2 and AAMI / ISO 14971-1.

8.11 Performance Data & Substantial Equivalence

The ActiveCare®++ System is substantially equivalent in all aspects, e.g., technological characteristics, mode of operation, performance characteristics, intended use, etc., to the commercially available Medical Compression Systems (DBN) Ltd.'s Systems (ActiveCare® System, previously named WizAir Compression System, Wizair DVT or ProAir 3000), cleared under K023573, K012994, K002287 and K993758.

The principle changes between the devices include:

The software programming language was changed from Assembler to ■ ANSI C.
A capability to synchronize the compression cycles with the respiratory 배 related. natural phasic venous flow, was added
The user interface of the Control Unit was modified to include a Liquid 트 Crystal Display (LCD).
I A Compliance status indicator was added.
A new calf sleeve, the TripleActive, was added. 트

A series of safety and performance testing, including bench testing and clinical comparison in healthy volunteers, were performed to demonstrate that the modified ActiveCare®++ System does not raise any new questions of safety and efficacy. These tests include:

Electrical and electromagnetic testing 트
Software verification and validation 트
Performance testing of the output parameters and pressure profile ■

Based on these tests results, Medical Compression Systems (DBN) Ltd. believes that the modified ActiveCare®++ System is substantially equivalení to the cleared ActiveCare® Systems (WizAir Compression System, Wizair DVT or ProAir 3000 Systems), without raising new safety and/or effectiveness issues.

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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 stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 8 2006

BioMedical Strategy (2004) Ltd. c/o Dorit Winitz, Ph.D. Company Consultant Moshe Aviv Street, 34th Floor 7 Jabotinsky Street Ramat Gan 52520, Israel

Re: K060146

Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (Two) Product Code: JOW Dated: January 16, 2006 Reccived: January 19, 2006

Dear Dr. Winitz:

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 Codc of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the

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Page 2 - Dorit Winitz, Ph.D.

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 (240) 276-0120. Also, please note the regulation extilled, "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

Sincerely yours,

Dona R. Victner

1 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

510(k) Number (if known): K06014-6

ActiveCare®++ System Device Name:

Indications for Use:

The ActiveCare®++ System is a prescriptive device that induces Continuous Enhanced Circulation Therapy of the lower limbs. The ActiveCare®++ System is intended for use in:

Preventing Deep Vein Thrombosis (DVT). .
Enhancing blood circulation. .
Diminishing post-operative pain and swelling. .
Reducing wound-healing time. .
Treatment and assistance in healing: stasis dermatitis; . venous stasis ulcers; arterial and diabetic leg ulcers.
Treatment of chronic venous insufficiency. .
Reducing edema. .

Prescription Use _ ਵ (Part 21 C.F.R. 801 Subpart D) AND/OR

Over-The-Counter Use_ (Part 21 C.F.R. 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duma 12 Johner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K060146

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).