(459 days)
The JM-102 Jaundice Meter is a diagnostic device intended for use on infants suspected of having jaundice to provide an objective index of icterus. This index can be used by a medical practitioner to identify infants who should be given a serum bilirubin test and to identify those infants who do not need a serum test.
The JM-102 Jaundice Meter provides an objective index of icterus in infants and when used in conjunction with other clinical signs and/or laboratory measurements, can assist the physician in making clinical decisions regarding the need for serum bilirubin measurements medior therep
The Air-Shields JM-102 Jaundice Meter is a hand-held non-invasive device for the measurement of the level of jaundice in an infant. The system consists of the hand-held meter with digital display, the charger for recharging the NiCd battery pack in the device, a calibration checker, and a carrying case. The device measures the yellowish tint in jaundiced skin by analyzing the light reflected off the skin. The fiberoptic probe on top of the device is held against the infant's skin and an internal flash lamp sends a pulse of light through the outer part of an optical wave guide to the skin where the light is reflected back through the inner part of the optical wave guide and to the spectral analysis section of the device.
This 510(k) summary for the JM-102 Jaundice Meter outlines the device's substantial equivalence to a predicate device (JM-101) rather than establishing new performance acceptance criteria for an innovative device. Therefore, the information provided focuses on demonstrating equivalence through comparison, not on proving the device meets novel acceptance criteria in a standalone study.
Here's an analysis based on the provided text, addressing the requested points:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission, the "acceptance criteria" are implicitly equivalence to the predicate device in terms of spectral response and clinical correlation.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Spectral responses of green and blue pathways are the same as the predicate device (JM-101). | Testing with a spectrophotometer has demonstrated that the spectral responses are the same. |
| High degree of correlation between readings from JM-101 and JM-102 on infants. | A clinical study showed a high degree of correlation between readings on infants taken with the JM-101 and JM-102. (No specific correlation coefficient or statistical measure is provided in this summary.) |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "In addition, a clinical study showed a high degree of correlation between readings on infants taken with the JM-101 and JM-102."
- Sample Size for Test Set: Not specified. The summary only mentions "a clinical study" without detailing the number of infants.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. The study's purpose was to compare the JM-102 with the JM-101, not to establish a new ground truth using expert consensus. The "ground truth" (or reference standard) would have been the readings from the predicate device (JM-101).
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The study was a comparison between two devices, not an assessment requiring adjudication of interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC study was not described. The study compared two devices, not the effect of AI assistance on human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study: Yes, in effect. The "clinical study" described compared the performance of the JM-102 independently (as a device) against the JM-101. It was not a human-in-the-loop assessment.
7. Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for the comparison was the measurements obtained from the predicate device, the JM-101 Jaundice Meter.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is a measurement instrument, not an AI/machine learning algorithm that requires a training set in the conventional sense. Its "training" or development would have involved engineering design and calibration, not data-driven model training.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as it's not an AI/ML algorithm requiring a training set. The engineering specifications and calibration of the device would have been established through validated measurement standards.
§ 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.