LUCAS 2 Chest Compression System is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness. LUCAS 2 must only be used in cases where chest compressions are likely to help the patient.

Device Description

LUCAS 2 is an electrically powered mechanical chest compression system providing controlled automated chest compressions on adult patients who have acute circulatory arrest. LUCAS 2 consists of an upper part containing the electrically driven piston rod, which acts on the patients chest via a pressure pad. The pressure pad is surrounded by a suction cup. The support legs of the upper part are fastened to the back plate prior to starting compressions.

AI/ML Overview

The provided text describes the Jolife LUCAS 2, an electrically powered mechanical chest compression system. However, the document only discusses the device's design, intended use, and substantial equivalence to predicate devices, along with regulatory approval. It does not include detailed information about specific acceptance criteria or a study proving the device meets those criteria in the way typically expected for a medical device performance study, especially for AI/algorithm-based devices.

The "Testing" section broadly states that "Appropriate product testing was conducted and included a number of function tests during different operating conditions. These tests demonstrated that the functionality, safety, efficacy and capability of LUCAS 2 comply with the product specifications and safety standards and support substantial equivalence to predicate devices." This is a general statement and does not provide the specifics requested in your prompt.

Therefore, I cannot fully answer your request based on the provided text. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to previously cleared devices rather than providing a detailed de novo clinical or performance study report with specific acceptance criteria and detailed study methodology.

Below is a breakdown of what can be inferred or what is explicitly missing based on your questions:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not Specified	The document states: "In all instances, the LUCAS 2 functioned as intended and all results observed were as expected." This is a general statement and does not provide specific performance metrics or acceptance criteria.
Functionality, Safety, Efficacy, and Capability	"Comply with the product specifications and safety standards and support substantial equivalence to predicate devices." (No specific metrics provided).

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

Not specified. The document mentions "a number of function tests during different operating conditions" but does not give sample sizes for any test sets or specific data provenance (e.g., country of origin, retrospective/prospective).

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

Not applicable/Not specified. This type of information is relevant for studies involving human interpretation or expert-driven assessments, typically for diagnostic or imaging devices. The LUCAS 2 is a mechanical chest compression system, and its performance evaluation would likely involve engineering and physiological metrics, not expert ground truth in the diagnostic sense. The document does not mention any expert panel for ground truth.

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

Not applicable/Not specified. Similar to point 3, adjudication methods are typically used for expert assessments, which are not detailed or implied for this device's testing.

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. An MRMC study is not relevant for a mechanical chest compression device. This type of study assesses reader performance, typically in imaging. The LUCAS 2 is a standalone mechanical device, not an AI or imaging assistance tool for human readers.

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

Yes, effectively. The "Testing" section implies standalone testing of the device's mechanical functions: "Appropriate product testing was conducted and included a number of function tests during different operating conditions." The device itself is a standalone mechanical system. The performance evaluated would be the device's ability to deliver compressions according to guidelines, maintain consistent operation, and ensure safety, independent of human interaction during the compression delivery. The function tests described are inherently standalone performance evaluations for a mechanical device.

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

Not explicitly stated, but implied to be engineering/physiological specifications. For a mechanical chest compression device, "ground truth" would likely refer to its ability to meet predefined physical compression parameters (depth, rate, recoil) as per AHA guidelines, safety standards, and product specifications. This would be measured instrumentally rather than through expert consensus, pathology, or outcomes data in the traditional sense used for diagnostic devices.

8. The sample size for the training set:

Not applicable/Not specified. This device is a mechanical system, not an AI/machine learning algorithm that requires a "training set."

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

Not applicable/Not specified. As there is no AI/ML component or "training set" mentioned, this question is not relevant.

Summary of what is known from the document regarding testing:

Device: LUCAS 2, an electrically powered mechanical chest compression system.
Purpose of testing: To demonstrate functionality, safety, efficacy, and capability, and to support substantial equivalence to predicate devices (LUCAS 1, Thumper 1008, Autopulse Model 100).
Nature of testing: "A number of function tests during different operating conditions."
Outcome: "In all instances, the LUCAS 2 functioned as intended and all results observed were as expected."
Type of equivalence: Substantial equivalence to predicate devices is claimed, meaning the new device has "the same intended use and substantially similar indications for use, basic overall function, and performance." It is compared to predicate devices like LUCAS 1 (cleared under K062401).

The provided text focuses on regulatory clearance via the 510(k) pathway, which often relies on demonstrating equivalence rather than extensive de novo clinical trials with detailed performance metrics and acceptance criteria for a novel technology.

Summary

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2009-02-16

jolife
1090422
JUN 1 7 2009

510(k) SUMMARY

Jolife's LUCAS 2

This document provides a brief summary of the LUCAS 2 device and its supporting information.

1) GENERAL DATA

510(k) submitter

Jolife AB Ingmar Malm Ideon Scheelevägen 17 SE-223 70 Lund Sweden

Phone: + 46 46 286 50 00 Cell phone: + 46 70 721 22 24 Fax: + 46 46 286 50 10

e-mail: ingmar.malm@jolife.com

Contact person

Howard Holstein Hogan & Hartson Columbia Square 555 Thirteenth street NW Washington DC 20004-1109

Phone: (202) 637-5813

Date when prepared

February 13, 2009

Trade name

LUCAS 2

DRM

Common name

Chest Compression System

Classification name

Product code

Predicate devices

● Lucas 1 cleared under K062401

Thumper model 1008 cleared under K073079
External cardiac compressor (21 CFR 870.5200)

Autopulse model 100 cleared under K072527 ●

JOLIFE AB, Ideon Science Park, SE-223 70 Lund, Swedon, Visiting Address: Scheelevagen 17 Tel: +46 (0) 46 286 50 00, Fax: +46 (0) 46 286 50 10, E-mail: info@jotife.com, jolife.com 1 (3)

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2) DESCRIPTION OF THE DEVICE

LUCAS 2 is an electrically powered mechanical chest compression system providing controlled automated chest compressions on adult patients who have acute circulatory arrest,

LUCAS 2 consists of an upper part containing the electrically driven piston rod, which acts on the patients chest via a pressure pad. The pressure pad is surrounded by a suction cup.

The support legs of the upper part are fastened to the back plate prior to starting compressions.

LUCAS 2 is designed to:

· Provide effective, consistent and uninterrupted compressions according to the guidelines given by American Heart Association (AHA);
· Provide good circulation during the patient transport process;
· Provide safety during transportation for both emergency medical personnel and patient, allowing emergency medical personnel to wear safety belts during transportation while LUCAS 2 delivers continuous, consistent and uninterrupted compressions;
· Provide hands-free compressions in any situation.
· Be applied to the patient with interruption of less than 20 seconds.

3) INTENDED USE / INDICATIONS FOR USE

LUCAS 2 must only be used in cases where chest compressions are likely to help the patient.

4) COMPARISON TO PREDICATE DEVICES

The LUCAS 2 and its predicates have basically the same performance characteristics.

The LUCAS 2 has the same performance characteristics as the previuosly cleared LUCAS 1 device.

The LUCAS 2 and Thumper 1008 act on the chest via a pressure pad, while Autopulse acts on the chest via a circumferential belt.

The LUCAS 2 and Autopulse are battery powered, while the Thumper 1008 is powered by compressed oxygen while the previously cleared LUCAS 1 is powered by compressed air.

JOLIFE AB, Ideon Science Park, SE-223 70 Lund, Sweden, Visiting Address: Scheelevägen
Tel: +46 (0) 46 286 50 00, Fax: +46 (0) 46 286 50 10, E-mail: info@jolife.com. jolife.co
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5) SUMMARY OF SUBSTANTIAL EQUIVALENCE

LUCAS 2 is substantially equivalent to the predicate devices. The LUCAS 2 has the same intended use and substantially similar indications for use, basic overall function, and performance as its predicate devices.

6) MATERIALS

All materials used in the manufacture of LUCAS 2 are suitable for its purpose and are well known and are the same as those materials and intended use as the materials included in the 510(k)-cleared LUCAS I (K062401). .

7) TESTING

. (

Appropriate product testing was conducted and included a number of function tests during different operating conditions. These tests demonstrated that the functionality, safety, efficacy and capability of LUCAS 2 comply with the product specifications and safety standards and support substantial equivalence to predicate devices.

In all instances, the LUCAS 2 functioned as intended and all results observed were as expected,

JOLIFE AB, Ideon Science Park, SE-223 70 Lund, Sweden, Visiting Address: Scheelevagen 17 Tel: +46 (0) 46 286 50 00, Fax: +48 (0) 46 286 50 10, E-mail: Info@jolife.com, Jolife.com 3 (3)

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

MAR 3 1 2011

Jolife AB c/o Mr. Howard M. Holstein Hogan Lovells US LLP Columbia Square 555 13" Street, NW Washington, DC 20004

Re: K090422

LUCAS 2 Regulation Number: 21 CFR 870.5200 Regulation Name: External Cardiac Compressor Regulatory Class: Class III Product Code: DRM Dated: May 18, 2009 Received: May 18, 2009

Dear Mr. Holstein:

This letter corrects our substantially equivalent letter of June 17, 2009.

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 (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 additional controls. Existing major regulations affecting your device can be

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Page 2 - Mr. Howard M. Holstein

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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. S. Kelleher

An 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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510(k) LUCAS 2

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Indications for Use ·

510(k) Number (if known): _ Ko9 0 422

Device Name: LUCAS 2

Indications for Use:

LUCAS Chest Compression System is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness.

LUCAS must only be used in cases where chest compressions are likely to help the patient.

Prescription Use	X	AND/OR	Over-The-Counter Use
(Part 21 CFR 801 Subpart D)			(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number	K090922
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JOLIFE AB, Ideon Science Park, SE-223 70 Lund, Sweden, Visiting Address: Scheelevägen 17
Tel: +46 (0) 46 286 50 00, Fax: +46 (0) 46 286 50 10, E-mail: info@lolife.com, www.jolife.com
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Regulation Number and Section

§ 870.5200 External cardiac compressor.

(a)
Identification. An external cardiac compressor is an externally applied prescription device that is electrically, pneumatically, or manually powered and is used to compress the chest periodically in the region of the heart to provide blood flow during cardiac arrest. External cardiac compressor devices are used as an adjunct to manual cardiopulmonary resuscitation (CPR) when effective manual CPR is not possible (e.g., during patient transport or extended CPR when fatigue may prohibit the delivery of effective/consistent compressions to the victim, or when insufficient EMS personnel are available to provide effective CPR).(b)
Classification. Class II (special controls). The special controls for this device are:(1) Nonclinical performance testing under simulated physiological conditions must demonstrate the reliability of the delivery of specific compression depth and rate over the intended duration of use.
(2) Labeling must include the following:
(i) The clinical training necessary for the safe use of this device;
(ii) Adjunctive use only indication prominently displayed on labels physically placed on the device and in any device manuals or other labeling;
(iii) Information on the patient population for which the device has been demonstrated to be effective (including patient size and/or age limitations,
e.g., adult, pediatric and/or infant); and(iv) Information on the time necessary to deploy the device as demonstrated in the performance testing.
(3) For devices that incorporate electrical components, appropriate analysis and testing must demonstrate that the device is electrically safe and electromagnetically compatible in its intended use environment.
(4) Human factors testing and analysis must validate that the device design and labeling are sufficient for effective use by the intended user, including an evaluation for the time necessary to deploy the device.
(5) For devices containing software, software verification, validation, and hazard analysis must be performed.
(6) Components of the device that come into human contact must be demonstrated to be biocompatible.