The Jaundice Meter (JM-103) is a non-invasive transcutaneous bilirubinometer. It measures yellowness of subcutaneous tissue in newborn infants and displays a measured value which has been shown to correlate with serum bilirubin. The device is for use in the hospital to assist clinicians in monitoring the status of newborn infants for the development of hyperbilirubinemia. The device is not intended as a standalone for diagnosis of hyperbilirubinemia. It is to be used in conjunction with other clinical signs and laboratory measurements. Newborn infants whose Jaundice Meter (JM 103) test results are indicative of hyperbilirubinemia are evaluated by their doctor(s) for appropriate patient management. Bilirubin levels should be confirmed by other methods, such as serum bilirubin, prior to treatment determinations. This device is not intended for home use. This is a prescription device.

Device Description

The JM 103 Jaundice Meter is designed to provide a non-invasive measurement of the yellowness of subcutaneous tissue. This measurement is converted to an estimated bilirubin concentration and displayed in units of mg/dL or umole/L. This measurement is taken using a dual path optical system. The measurements from each path are then subtracted to minimize the impact of skin pigmentation. The software in the device then computes the estimated bilirubin concentration based on an established correlation coefficient.

AI/ML Overview

Acceptance Criteria and Study for Minolta Hill-Rom Air Shields JM 103 Jaundice Meter

This document outlines the acceptance criteria for the Minolta Hill-Rom Air Shields JM 103 Jaundice Meter and details the clinical study performed to demonstrate its performance.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined acceptance criteria in terms of specific thresholds for correlation coefficient (r) or standard deviation (SD). However, the clinical study's results (correlation and SD) serve as the device's demonstrated performance, indicating what was considered acceptable by the FDA for market clearance. The predicate device (JM 102) itself is the benchmark for "substantial equivalence."

Metric	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (Site A Forehead, n=513)	Reported Device Performance (Site A Sternum, n=513)	Reported Device Performance (Site B Forehead, n=100)	Reported Device Performance (Site B Sternum, n=100)
Correlation Coefficient (r) between JM 103 and Total Serum Bilirubin (TSB)	(Not explicitly stated, but expected to be high, similar to predicate)	0.914	0.946	0.84	0.89
Standard Deviation (SD) between JM 103 and TSB	(Not explicitly stated, but expected to be low)	1.29	1.02	2.14	1.85
Regression Equation Slope	(Expected to be close to 1)	1.05	1.07	1.07	1.16
Regression Equation Intercept	(Expected to be close to 0)	-0.35	-0.74	0.00	-0.43

Note: The acceptance criteria are "implied" because the document focuses on demonstrating correlation and performance, rather than setting a pass/fail threshold. The FDA's clearance indicates that these demonstrated performance metrics were deemed substantially equivalent to the predicate device.

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

Sample Size:
- Site A: 513 (for both forehead and sternum measurements per patient, presumably)
- Site B: 100 (for both forehead and sternum measurements per patient, presumably)
- Total: 613 patients across two sites.
Data Provenance: The study was a prospective clinical assessment performed at two study sites. The specific country of origin is not explicitly stated, but given the manufacturer (Hill-Rom Air Shields, Hatboro, PA) and the FDA submission, it is highly probable the studies were conducted in the United States.

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

The document does not provide details on the number of experts or their qualifications for establishing the ground truth. It states that the JM 103 estimated bilirubin concentration was correlated with total serum bilirubin concentration. This indicates that the ground truth was derived from laboratory measurements of total serum bilirubin, which is a standard and objective clinical assay, rather than expert consensus on transcutaneous measurements. Therefore, direct "experts" for ground truth establishment in the traditional sense (e.g., radiologists assessing images) would not be applicable here.

4. Adjudication Method for the Test Set

Since the ground truth was established by total serum bilirubin (TSB) laboratory measurements, an adjudication method (like 2+1 or 3+1 for expert review) is not applicable or mentioned. TSB results are quantitative and typically considered definitive for bilirubin levels in this context.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no indication of an MRMC comparative effectiveness study being performed. The study aimed to establish the correlation between the JM 103 device and serum bilirubin, not to compare human reader performance with and without AI assistance. The JM 103 is a measurement device, not an AI-assisted diagnostic tool that aids human interpretation.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was done. The clinical assessment directly demonstrates the performance of the JM 103 device (algorithm only, as it's a physical device with embedded software) in correlating its transcutaneous bilirubin measurements with total serum bilirubin (ground truth). The reported "r" and "SD" values represent this standalone performance. The device is intended to assist clinicians, but its correlation and accuracy are assessed independently of human interpretation of its raw output.

7. Type of Ground Truth Used

The type of ground truth used was laboratory measurements of Total Serum Bilirubin (TSB). This is a direct, objective biochemical measurement of bilirubin concentration in the blood, considered the clinical standard for establishing bilirubin levels.

8. Sample Size for the Training Set

The document does not specify a separate training set or its sample size. The clinical assessment described appears to be the primary dataset used to demonstrate the device's performance and correlation. It's possible the "established correlation coefficient" mentioned in the device description refers to internal data or previous models (e.g., from the JM 102), but this is not detailed. The provided study focuses on validation/performance assessment of the device as a whole. Without a clear indication of a distinct training phase/set, it's assumed the device's underlying algorithm was potentially developed using other data, but the performance reported relates to the final product on the described clinical study population.

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

As a separate "training set" is not explicitly mentioned or detailed, the method for establishing its ground truth cannot be determined from the provided text. If the "established correlation coefficient" refers to the model built into the device, it would likely have been established through a similar process of correlating transcutaneous measurements with laboratory-confirmed total serum bilirubin (TSB).

Summary

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K021622

Section I 510(k) Summary of Safety and Effectiveness

Applicant:

APR 0 1 2003

Hill-Rom Air Shields 330 Jacksonville Road Hatboro, Pa 19040

Registration No: 2510954

Contact Person:

Monica Ferrante Phone 215-682-8691 Fax 215-681-8689

Device trade/proprietary name:

Minolta Hill-Rom Air Shields JM 103

Device common/usual/classification name:

Jaundice Meter

Classification:

Clinical Chemistry Test Systems 21 CFR 862.1113 Bilirubin in the Neonatal Test System, MQM, Class I

Performance Standards:

None applicable

Predicate Device:

JM 102 Jaundice Meter K972309

Device Description:

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pigmentation. The software in the device then computes the estimated bilirubin concentration based on an established correlation coefficient.

Intended Use:

JM 103 is a non-invasive transcutaneous bilirubinometer. It measures yellowness of subcutaneous tissue in newborn babies and displays a measured value which has been shown to correlate with serum bilirubin. The device is for use in the hospital to assist clinicians in monitoring the status of newborn babies for the development of hyperbilirubinenmia. The device is not intended as a standalone for diagnosis of hyperbilirubinemia. It is to be used in conjunction with other clinical signs and laboratory measurements. Newborn infants whose JM 103 test results are indicative of hyperbilitubinemia are evaluated by their doctor(s) for appropriate patient management. Bilirubin levels should be confirmed by other methods (e.g., serum bilirubin) prior to treatment determinations.

Description of Modifications

The primary difference between the JM 102 and the JM 103 is that the JM 102 employed a single optical path for measurement and the JM 103 employs a dual optical path.

Performance Assessment

Non-Clinical assessment of this device was performed to ensure that the device operated as intended. In addition, all aspects of the system features and functionality have been bench tested. Software development, validation and verification has been performed.

Clinical Assessment of this device was performed at two study sites to establish correlation between the JM 103 estimated bilirubin concentration and total serum bilirubin concentration. The study also demonstrates that the device can be used effectively across diverse populations.

(attach graphs of total population for each site forehead and sternum – 4 charts)

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Image /page/2/Figure/0 description: This image shows a scatter plot with a negative correlation. The x-axis is labeled "TSB" and ranges from 0 to 20, while the y-axis is labeled "103F(MP)" and ranges from 0 to 25. The plot shows data from a clinical study at Site A for the forehead, with a sample size of 513, a correlation coefficient of 0.914, a standard deviation of 1.29, and a regression equation of y=1.05x-0.35.

linical Study Site A Forhead all
r=0.914 SD=1.29 y=1.05x-0.35
n=

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n=513 Site A Sternum all
SD=1.02 y=1.07x-0.74 Clinical Study | r=0.946

Image /page/3/Figure/1 description: This image is a scatter plot with a negative correlation. The x-axis is labeled "TSB" and ranges from 0 to 20. The y-axis is labeled "103S (MP)" and ranges from 0 to 25. The data points are clustered along a line that slopes downward from left to right, indicating that as TSB increases, 103S (MP) tends to decrease.

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Image /page/4/Figure/0 description: This image is a scatter plot titled "Study Site B Forehead All n=100". The x-axis is labeled "TSB" and ranges from 0 to 20. The y-axis is labeled "JM-103" and ranges from 0 to 25. A line of best fit is plotted on the scatter plot, and the equation for the line is y=1.07x-0.00, with R=0.84 and SD=2.14.

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Image /page/5/Figure/0 description: This image shows a scatter plot with a regression line. The x-axis is labeled TSB and ranges from 0 to 20, while the y-axis is labeled JM-103 and ranges from 0 to 25. The plot is titled "Study Site B Sternum All n=100 R=0.89 SD=1.85 y=1.16x-0.43".

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Image /page/6/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle image.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Monica Ferrante Regulatory Affairs Hill-Rom® Air Shields 330 Jacksonville Road Hatboro, PA 19040

APR 0 1 2003

Re: K021622

Trade/Device Name: JM 103 Jaundice Meter Regulation Number: 21 CFR 862.1113 Regulation Name: Bilirubin (total and unbound) in the neonate test system Regulatory Class: Class I Product Code: MQM Dated: January 10, 2003 Received: January 13, 2003

Dear Ms. Ferrante:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. 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 http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Gutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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SMDA Requirements Section A

A.1 Indication for Use Staternent

510(k) Number:

Device Name: JM 103 Jaundice Meter

Indications for Use:

This device is not intended for home use.

This is a prescription device.

(Please do not write below this line continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

tion Use

Han Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K021622
OB OVE

Prescription Use (Per 21 CFR 801.109) OR

Over-the-Counter Use

(Optional Format 1/2/96)

Regulation Number and Section

§ 862.1113 Bilirubin (total and unbound) in the neonate test system.

(a)
Identification. A bilirubin (total and unbound) in the neonate test system is a device intended to measure the levels of bilirubin (total and unbound) in the blood (serum) of newborn infants to aid in indicating the risk of bilirubin encephalopathy (kernicterus).(b)
Classification. Class I.