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The Jaundice Meter (JM-105) is a non-invasive transcutaneous bilirubinometer. It measures yellowness of subcutaneous tissue in newborn infants. The unit pro-vides a visual digital measurement that has been shown to correlate with serum bilirubin in newborn infants.

The device is intended for use in hospitals, clinics or doctor's offices under a physicians supervision / direction to assist clinicians in monitoring of newborn infants. 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-105 Jaundice Meter test results are indicative of hy-perbilirybinemia should be evaluated by their physician(s) for appropriate patient management. Specific neonatal patient Bilirubin levels should be confirmed by other methods, such as serum bilirubin, prior to treatment determinations.

The JM 105 is a prescription medical device

• The JM 105 is not intended for home use.
  The JM 105 may only be used at the sternum measurement site for Physician's office applications.

The Jaundice Meter is a non-invasive transcutaneous bilirubinometer. It measures yellowness of subcutaneous tissue in newborn infants. The unit provides a visual digital measurement that has been shown to correlate with serum bilirubin in newborn infants.

The JM-105 is a portable, hand held, battery powered device that includes a docking station with a built in reading checker. The JM-105 batteries can be charged using a battery charger or an optional USB cable.

The basic functionality including measurement of the JM-105 is equivalent to the JM-103. The display of the JM-105 has been improved (larger screen, touchscreen) and data storage and transmission functionality was added. The measuring probe, hardware, and software used to process the measurements are identical and therefore use the same measuring principle. The JM-103 and JM-105 determines the yellowness of subcutaneous tissue by using two optical paths to measure the optical density difference at two wavelengths. The measuring principle is further described in the "Principles of Operations" section of the Instructions for Use.

In addition to the features offered with the JM-103, the JM-105 provides the following.

• Internal memory up to 100 patient files
• Data transfer via HL7
• Easily mark & ID babies that need special attention with patient flagging
• Cost-efficient screening

There are no sterile or single-use components or accessories for the JM-105.

Here's an analysis of the acceptance criteria and study information for the Draeger Medical Systems Jaundice Meter JM-105, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Notes on Acceptance Criteria: The document primarily refers to the JM-103's performance criteria as the basis for substantial equivalence for the JM-105, stating that the measuring principle and core functionality are identical. The accuracy mentioned is specifically for infants > 35 weeks gestation.

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

• Hospital Studies (JM-103):

  • Sample Size: Not explicitly stated as a number of patients or measurements. The document mentions "All patients meeting the above criteria were included in the study."
  • Data Provenance: Not explicitly stated, but the context of an FDA submission for a US market device generally implies studies either conducted in or accepted by the US regulatory framework. It's retrospective inference, as the studies were performed previously for the predicate JM-103.
  • Retrospective/Prospective: The initial studies for the JM-103 would have been prospective, as new data was collected to demonstrate performance. The JM-105 relies on this previously collected data.

• Doctor's Office Studies (JM-103):

  • Sample Size: Not explicitly stated as a number of patients or measurements.
  • Data Provenance: Not explicitly stated, but implies clinical sites (doctor's offices) where the device was intended for use.
  • Retrospective/Prospective: Same as hospital studies, likely prospective for the JM-103, now serving as retrospective for JM-105.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: Not explicitly stated. The ground truth method (serum bilirubin) implies that clinical laboratory professionals would be involved in generating the comparison data, and physicians would be involved in determining the need for serum bilirubin tests.

4. Adjudication Method for the Test Set

• No specific adjudication method (e.g., 2+1, 3+1) is mentioned or implied for either the transcutaneous bilirubin readings or the serum bilirubin ground truth. The comparison is directly between the device measurement and the laboratory measurement.

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

• No MRMC comparative effectiveness study is mentioned. The device, a Jaundice Meter, provides a direct measurement and is not an imaging or diagnostic AI requiring human interpretation or assistance for its primary function. Its use is to assist clinicians in monitoring, not to replace their diagnostic decision-making or enhance their reading of complex medical images. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not directly apply in this context.

6. Standalone Performance Study (Algorithm only without human-in-the-loop performance)

• Yes, the clinical performance data described for the JM-103 (and relied upon for the JM-105) is a standalone performance study. The device provides a direct measurement (transcutaneous bilirubin), which is then compared against the established ground truth (serum bilirubin). There is no "human-in-the-loop" interaction for interpreting the device's reading itself; the reading is digital and absolute. The clinicians then use this reading in conjunction with other clinical signs.

7. Type of Ground Truth Used

• Ground Truth: Laboratory measured total serum bilirubin (TSB).

8. Sample Size for the Training Set

• The document does not describe a "training set" in the context of an AI/ML algorithm. The JM-103/JM-105 is a device based on an optical measurement principle, not a machine learning model that undergoes a training phase. Its internal parameters would be set during design and calibration, not through iterative training on a dataset in the modern AI sense.

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

• As noted above, there is no mention of a "training set" for an AI/ML algorithm. The device's measurement principle (optical density difference at two wavelengths) is based on established biophysical principles, not an AI model that learns from data.

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