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The Jaundice Meter (JM-103) is a non-invasive transcutaneous bilirubinometer. It measures yellowness of subcutaneous tissue as a shown to correlate with serum bilirubin in newborn infants. The device is intended for use in hospitals, clinics or doctor's offices under a physician's direction to assist clinicians in monitoring of newborn infants. The device is not intended as a standalone for diagnosis of hyperbilirubinemia. The device is intended to be used in conjunction with other clinical signs and laboratory measurements. Newborn infants whose JM-103 Jaundice Meter test results are indicative of hyperbilliubinemia should be evaluated by their physician(s) for appropriate patient management. JM-103 test results should be confirmed by other methods, such as serum bilirubin, prior to treatment determinations. The JM 103 is a prescription Medical Device. The JM 103 is not intended for home use. The JM 103 may only be used at the sternum measurement site for Physician's office applications.

The JM-103 Jaundice Meter is designed to provide a transcutaneous measurement of bilirubin displayed in Mg/dl or umol/L. This measurement is intended as a screening tool to determine when a serum bilirubin measurement should be taken, or, sequential bilirubin measurements over time to provide indication of change. This device is not intended for determinations of whether treatment is indicated. The determination of treatment must be based on a serum bilirubin measurement.

The provided text does not contain detailed information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary for the Draeger Air Shields Infant Care Inc. Minolta Draeger Air Shields JM 103 Jaundice Meter. It primarily focuses on demonstrating substantial equivalence to a predicate device (K021622 JM 103 Jaundice Meter) and provides an "Indications for Use Statement."

Here's an analysis based on the absence of the requested information:

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

• Information not provided. The document does not specify any quantitative acceptance criteria or report specific performance metrics from a study conducted for this 510(k) submission. It states "No modification to hardware, software, or procedures for use were implemented for this submission on the JM 103 Device previously cleared by the FDA as a medical device," implying that performance was established during the predicate device's clearance.

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

• Information not provided. No details are given about a test set sample size or its provenance.

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)

• Information not provided. The document does not mention the use of experts or ground truth establishment for a test set.

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

• Information not provided. There is no mention of adjudication methods.

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

• Not applicable. The device is a Jaundice Meter, a non-AI diagnostic tool for transcutaneous bilirubin measurement, not an AI-assisted imaging device or system. No MRMC study would be relevant in this context.

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

• Not applicable. The JM 103 is a standalone device in that it provides a measurement directly. However, it's explicitly stated that it's "not intended as a standalone for diagnosis" and its results "should be confirmed by other methods, such as serum bilirubin, prior to treatment determinations." This indicates it's a screening tool that operates independently but requires human medical interpretation and follow-up. Since it's not an AI algorithm, "algorithm only" performance is not a relevant concept here.

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

• Information not provided for this submission. The document states the device "has been shown to correlate with serum bilirubin in newborn infants." This implies that the ground truth for its initial development and validation (likely for the predicate device) would have been serum bilirubin measurements, which are established clinical standards for diagnosing hyperbilirubinemia.

8. The sample size for the training set

• Information not provided. The device is not an AI/machine learning device, so the concept of a "training set" in that context does not apply.

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

• Information not provided. As above, the concept of a training set is not applicable.

Summary based on the provided text:

The submission for the JM 103 Jaundice Meter is a 510(k) for a device that had "No modification to hardware, software, or procedures for use" from a previously cleared device. Therefore, the core performance characteristics and "acceptance criteria" are presumed to have been met by the predicate device (K021622 JM 103 Jaundice Meter). This 510(k) is about demonstrating substantial equivalence rather than presenting new performance data from clinical studies. The device's function is to provide a transcutaneous bilirubin measurement that correlates with serum bilirubin, acting as a screening tool, not a definitive diagnostic or treatment determination device.

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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.

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.

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."

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).

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