The Medley System with Bar Code Module is intended for use in today's growing professional healthcare environment for facilities that utilize infusion devices for the delivery of fluids, medications, blood and blood products.

The Medley System with Bar Code Module is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data. All data entry and validation of infusion parameters is performed by the trained healthcare professional according to a physician's order.

Device Description

The Medley Bar Code Module functions as part of the Medley System and can operate as a fifth module (when all four infusion and/or monitoring positions are in use). The Medley Bar Code Module attaches to and receives its power from the Medley System consistent with the modular design. The Bar Code Module does not directly interface with the Medley System; all communications are routed using a separate and dedicated communications interface channel resident in the Medley System.

Through the dedicated communications channel, the Medley Bar Code Module exchanges information between itself and other sources, such as the patient wristband, medication or device packaging, Medley, or MMS System components such as the ALARIS Server and Hospital Information Management Systems. As with the Medley System with MMS, there is an information protocol for proprietary data exchange and a method to verify the integrity of the information sent or received prior to programming a Medley System infusion module. The software incorporates error checking to ensure the correct acquisition, exchange, and integrity of acquired bar coded data.

All data entry and verification of infusion parameters using the Medley System with Bar Code Module is performed by trained healthcare professionals prior to administration of medication(s). The Medley Bar Code Module does not affect the operation of the Medlev System. All Medley System functionality and performance specifications remain unchanged.

An attachable/detachable handheld scanner will be provided as an accessory to the Medley System with Bar Code Modulc as alternative way to acquire bar code data.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device (ALARIS Medical Systems® Medley™ System with Bar Code Module) from 2004. This type of document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting detailed acceptance criteria and performance studies in the way you've outlined for AI/ML-based devices.

Therefore, many of the specific details you requested (like effect size of AI assistance, sample size for AI training sets, expert compensation, etc.) are not available in this type of regulatory submission for this device. The regulatory pathway for this device predates the widespread use of sophisticated AI/ML in medical devices, and the focus is on hardware and software functionality for automating infusion parameter entry.

However, I can extract the available information and indicate where details are not provided.

Here's a summary based on the provided text:

Acceptance Criteria and Study Information (ALARIS Medical Systems® Medley™ System with Bar Code Module)

This 510(k) submission primarily focuses on demonstrating substantial equivalence to predicate devices for the Medley™ System with Bar Code Module. The performance data presented indicates that the device meets specified requirements to establish this equivalence, rather than providing detailed clinical study results with explicit numerical acceptance criteria and a detailed study protocol for AI/ML performance.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria (Inferred/Stated)	Reported Device Performance (Summary from document)
Functional Performance	- Exchange information between sources (patient wristband, medication/device packaging, Medley/MMS System components).	- "exchanges information between itself and other sources..."
	- Verification of integrity of information sent/received prior to programming.	- "method to verify the integrity of the information sent or received prior to programming a Medley System infusion module."
	- Correct acquisition, exchange, and integrity of acquired bar coded data.	- "The software incorporates error checking to ensure the correct acquisition, exchange, and integrity of acquired bar coded data."
Safety	- Not affect the operation of the core Medley System.	- "The Medley Bar Code Module does not affect the operation of the Medley System. All Medley System functionality and performance specifications remain unchanged."
Intended Use	- Provide a way to automate programming of infusion parameters.	- "intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data."
	- All data entry and validation performed by trained healthcare professional according to physician's order.	- "All data entry and verification of infusion parameters using the Medley System with Bar Code Module is performed by trained healthcare professionals prior to administration of medication(s)... All data entry and validation of infusion parameters is performed by the trained healthcare professional according to a physician's order."
Technological Equivalence	- Comparable technological characteristics to predicate devices.	- "The results of this comparison demonstrate that the Medley™ Bar Code Module is equivalent to the marketed predicate devices in technological characteristics."
Overall Performance	- Meet specified requirements and be substantially equivalent to predicate devices.	- "The performance data indicate that the Medley™ Bar Code Module meets specified requirements, and is substantially equivalent to the predicate devices."

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

Sample Size: Not specified in the provided document. The document refers to "Performance Data" but does not detail the nature or size of any test sets used.
Data Provenance: Not specified. This type of submission generally doesn't detail the origin of data beyond internal testing in this context.

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

This concept of "ground truth" and expert adjudication is typically relevant for interpretative AI/ML devices. For this infusion pump module, the "ground truth" would likely be based on engineering specifications and direct comparison of barcoded data to expected values.
The document mentions "trained healthcare professionals" for data entry and validation during use, but not for establishing ground truth in a formal test set for the device's bar code module performance.

4. Adjudication method for the test set:

Not applicable/addressed in this document. Adjudication methods like 2+1 or 3+1 are used for expert consensus on image interpretation or complex clinical assessments, which is not the primary function of this device.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is an infusion pump module with a bar code reader, designed to automate data entry. It does not employ AI in the manner that would necessitate an MRMC study comparing human readers with and without AI assistance for interpretation. Its function is to reduce manual steps for entering infusion data, not to assist in diagnostic interpretation.

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

The device's core function is to acquire and process barcoded data. The performance of the bar code module itself (reading accuracy, error checking) would inherently be a standalone test. However, the overall intended use always involves a "trained healthcare professional" for validation. The document states: "All data entry and verification of infusion parameters using the Medley System with Bar Code Module is performed by trained healthcare professionals prior to administration of medication(s)." Therefore, while the component can be tested standalone for its technical performance, its clinical use is human-in-the-loop.

7. The type of ground truth used:

For the bar code module, the ground truth would typically be the known, correct data encoded in the bar codes being scanned. The "error checking" software would verify that the acquired data matches this known correct information.

8. The sample size for the training set:

Not applicable/specified. This device is not described as using machine learning that requires a "training set" in the modern sense. Its software likely relies on programmed logic and error checking rather than learned patterns.

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

Not applicable. As no training set is indicated, this question is not relevant to the information provided for this device.

Summary

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JUL - 6 2004

ORIGINAL PREMARKET 510(K) NOTIFIC MEDLEY SYSTEM w/BAR CODE MODULE

SUMMARY OF SAFETY AND EFFECTIVENESS ALARIS Medical Systems® Medley" System with Bar Code Module

SUBMITTER INFORMATION

A.	Company Name:	ALARIS Medical Systems, Inc.
B.	Company Address:	10221 Wateridge CircleSan Diego, CA 92121-2733
C.	Company Phone:Company Fax:	(858) 458-7830(858) 458-6114
D.	Contact Person:	Stacy L. LewisSr. Regulatory Affairs SpecialistALARIS Medical Systems, Inc.
E.	Date Summary Prepared:	May 10, 2004

DEVICE IDENTIFICATION

A.	Generic Device Name:	Infusion Pump
B.	Trade/Proprietary Name:	MedleyTM System with Bar Code Module
C.	Classification:	Class II
D.	Product Code:	FRN, Infusion Pump

DEVICE DESCRIPTION

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SUMMARY OF SAFETY AND EFFECTIVENESS ALARIS Medical Systems® Medley" System with Bar Code Module Page 2 of 3

An attachable/detachable handheld scanner will be provided as an accessory to the Medley System with Bar Code Modulc as alternative way to acquire bar code data.

SUBSTANTIAL EQUIVALENCE

The ALARIS Medical Systems® Medley" Bar Code Module is of comparable type and is substantially equivalent to the following predicate devices:

Predicate Device	Manufacturer	510(k) No.	Date Cleared
Medley System w/ MMS	ALARIS MedicalSystems, Inc.	K030459	April 4, 2003
Horizon Outlook 200	B. Braun	K011975	Sept. 19, 2001

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SUMMARY OF SAFETY AND EFFECTIVENESS ALARIS Medical Systems® Medley™ System with Bar Code Module Page 3 of 3

INTENDED USE

TECHNOLOGICAL CHARACTERISTICS

A comparison of the technological characteristics of the Medley " Bar Code Module and the predicate devices has been performed. The results of this comparison demonstrate that the Medley" Bar Code Module is equivalent to the marketed predicate devices in technological characteristics.

PERFORMANCE DATA

The performance data indicate that the Medley" Bar Code Module meets specified requirements, and is substantially equivalent to the predicate devices.

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Image /page/3/Picture/1 description: The image is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the top half of the circle. In the center of the seal is a stylized image of an eagle with its wings spread. The eagle is facing to the right and is composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 6 2004

Ms. Stacy L. Lewis Senior Regulatory Affairs Specialist ALARIS Medical Systems, Incorporated 10221 Wateridge Circle San Diego, California 92121-2772

Re: K041241

Trade/Device Name: Medley™ System with Bar Code Module Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: May 10, 2004 Received: May 11, 2004

Dear Ms. Lewis:

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.

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Page 2 - Ms. Lewis

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) 594-4618. 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

Sincerely yours,

Shih-Liang P1.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Medley™ System with Bar Code Module Device Name:

Indications For Use:

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anta V.m.

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K041241

Page 1 of 1

Regulation Number and Section

§ 880.5725 Infusion pump.

(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).