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The WatchChild™ System is a complete Obstetrical Information Management System which has the ability to record, store, and display data from fetal monitors and maternal vital signs monitors, and manages patient information from the initial Fetal Stress Tests through post delivery discharge. WatchChild organizes clinical data which would normally be provided on paper records or other clinical systems and devices. This system serves as a decision support tool as well as an electronic medical record. This device is intended for use in a hospital/clinical environment.

The WatchChild™ Obstetrical Patient Data Management System is a data management system that interfaces with patient monitoring equipment to record, display and/or archive the data. The system is a computer based system that contains software for easy data storage and retrieval of fetal/maternal data. The system is comprised of, in addition to the software, an IBM RISC System/6000, redundant disk drives to assure reproducibility of information, X-terminal graphics workstation, optical disk drive, and laser printer. WatchChild archives all fetal monitor data, maternal hemodynamic and waveform data (NIBP and SaO2), patient charting, admission forms, examinations, flowsheets, medications, lab results, discharge information, and notes. WatchChild automatically reads NIBP, SaO,, and heart rate at hospital defined intervals.

The WatchChild™ Obstetrical Patient Data Management System is a data management system designed to interface with patient monitoring equipment to record, display, and archive fetal/maternal data. It functions as a complete Obstetrical Information Management System and a decision support tool, intended for use in a hospital/clinical environment.

Here's an analysis of its acceptance criteria and the study proving it meets them:

1. Table of Acceptance Criteria and Reported Device Performance

As per the provided document, the device's acceptance criteria are primarily based on its substantial equivalence to six predicate devices. Therefore, the "performance" in this context refers to its ability to perform similar functions and produce comparable data to these established systems.

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

• Sample Size: Not applicable/Not mentioned. The document explicitly states "Clinical testing: None required."
• Data Provenance: Not applicable.

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

• Number of Experts: Not applicable.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No clinical testing or ground truth establishment by experts was performed for a test set.

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

• MRMC Study Done: No. The document states "Clinical testing: None required." The device is cleared based on substantial equivalence and non-clinical software verification and validation, not a comparative effectiveness study involving human readers.
• Effect Size of Human Readers Improvement: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone Study Done: No. While the device is a "system" with software, the evaluation was not a standalone algorithm performance study in the sense of demonstrating diagnostic accuracy or efficacy. The "non clinical testing" refers to software verification and validation, not a performance study against a reference standard.

7. Type of Ground Truth Used

• Type of Ground Truth: Not applicable. No specific ground truth (like expert consensus, pathology, or outcomes data) was established or used for performance evaluation, as no clinical testing was required in this submission. The "ground truth" for showing equivalence was the functionality and capabilities of the predicate devices.

8. Sample Size for the Training Set

• Sample Size: Not applicable/Not mentioned. No details on a "training set" are provided as this is a software system for data management and display, not an AI/ML diagnostic or predictive algorithm that typically requires a training set for model development.

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

• How Ground Truth Was Established: Not applicable. There is no mention of a training set or ground truth for such a set.

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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.

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.

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The DUO-LITE™ Phototherapy System is designed to provide treatment in the form of Phototherapy to those infants that have been identified as having elevated bilirubin levels (hyperbilirubinemia). Phototherapy as a means for reducing bilirubin levels is a well established treatment modality. The output of the light has been optimized for maximum absorption by the skin in order to reduce the bilirubin levels as quickly as possible.

The DUO-LITE™ Phototherapy System provides the option to select white or blue light via a selector switch. This provides the caregiver with the option to give high output phototherapy for some infants (or early in the treatment cycle) followed by more moderate phototherapy for other infants (or later in the treatment cycle). By contrast, other phototherapy lamp products give the option of either White or Blue light which needs to be set up by an engineer in advance of the treatment. The DVO-LITE™ has combined these two light sources into one housing for the convenience of the caregiver.

The DUO-LITE™ Phototherapy System can be placed on the hood of an infant incubator, mounted on the Air-Shields Rail System, or positioned over an open warming bed or crib.

The DUO-LITE" Phototherapy System provides light output for maximum absorption by the infant's skin in order to reduce bilirubin levels. The DUO-LITE™ is designed for use in conjunction with a variety of other products. Perhaps the most common application is when placed on the hood of an incubator, or fitted to a rail system and appitioned over the hood of the incubator. The DUO-LITT:" can also be mounted to a mobile stand, thus extending its applications to use with Open Warmers and Open Bassinets.

The product is L 23 x W 10 x H 5 (inches) and weighs approximately 15 Lbs. It is available in 100, 120 and 220/240V 50/60 Hz. The DUO-LITE™ is comprised of three 75W quartz halogen bulbs. The light emitted from these bulbs is filtered through IR/UV and Dichroic filters. The output of the bulbs is dependent on the driving voltage which is regulated by the internal power supply.

The user can select the use of White light or Blue light using the selector switch on the front of the lamp housing. The different color lights give different therapeutic outputs depending on the individual needs of the patient. Adjacent to the On/Off switch is a digital counter which can be set to display exposure time and bulb life remaining.

The DU1)-LIT!:" uses quartz halogen technology since the irradiance remains constant over the life of the bulb. By way of comparison, fluorescent bulbs degrade rapidly over the course of time and as such need to be continually monitored to ensure the output is therapeutically acceptable.

The provided text describes the Air-Shields Duo-Lite™ Phototherapy System, a medical device for treating neonatal hyperbilirubinemia. The submission is a 510(k) summary, which aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than proving a device meets novel acceptance criteria through a clinical study. Therefore, some of the requested information, such as sample size for test and training sets, number of experts for ground truth, adjudication methods, and MRMC studies, is not applicable to this type of regulatory submission.

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, the "acceptance criteria" are typically defined by demonstrating that the device performs comparably to predicate devices in key specifications, rather than setting specific numerical thresholds for a novel device. The Duo-Lite™ compares its performance against several predicate devices. The critical performance metric highlighted is irradiance.

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

This is a non-clinical test of the device's physical performance, not a study involving patient data. Therefore, typical "sample size" and "data provenance" as applied to clinical studies are not applicable.
The tests involved measurements of the Duo-Lite™ Phototherapy System under various configurations (filter color, voltage, distance). The data provenance is from an "outside test house" for spectral irradiance measurements and "in-house laboratory" for mattress mapping.

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

Not applicable. The "ground truth" here is the physical performance of the device (e.g., spectral irradiance) as measured by specialized equipment and methodologies, not human expert interpretation of clinical data.

4. Adjudication Method for the Test Set

Not applicable. This was a non-clinical device performance test, not a clinical study requiring adjudication of expert opinions.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This 510(k) submission focuses on demonstrating the physical and functional equivalence of the device to existing predicate devices through engineering specifications and non-clinical testing.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in a sense. The "standalone performance" in this context refers to the intrinsic physical performance of the device itself (e.g., its irradiance output). The "spectral irradiance measurements conducted by an outside test house" and "Mattress mapping done in our in-house laboratory" represent this standalone assessment of the device's output. There is no algorithm or human-in-the-loop component relevant to these performance tests.

7. The Type of Ground Truth Used

The "ground truth" for this non-clinical testing is the objective, measurable physical properties and output of the device, obtained through:

• Spectral irradiance measurements: Using specialized photometers/spectroradiometers.
• Mattress mapping: To assess the distribution of irradiance.
• Engineering specifications: (e.g., bulb life, voltage, power consumption) as verified by testing or design.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

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