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The Versalet 7700 Care Center is a mobile, caster mounted, neonatal device, which is used to assist in maintaining an infant's skin temperature and thermal environment. The device accomplishes this using radiant or convective heat. Accessories and options to the device permit environmental control and monitoring and may include optional features such as humidification and in-bed scale. It is intended for inpatient use in maternity nurseries, and neonatal care environments of hospitals or other healthcare facilities. This device is not intended for home use.

The Versalet™ 7700 Care Center is a warming device that combines the heating technologies of both incubators and radiant warmers into one product. The Versalet™ 7700 Care Center provides thermal isolation through a convective air system with canopies and side panels forming an enclosure that isolates the air surrounding the infant from the room air, much the same as a traditional infant incubator. The Versalet™ 7700 Care Center offers access to the infant in the incubator mode by allowing the caregiver to open port holes or side panels. If more access is needed, the device can then be transitioned into a radiant warmer device by opening the canopies and raising the over head arm. This allows full access to the infant. The over head arm contains two infrared heaters that provide radiant heat only when the canopies are opened and the over head arm is fully raised. Thus the Versalet™ 7700 Care Center offers the caregiver excellent access while providing good thermal stability. While the device is in the transition mode from incubator to warmer there is a continued supply of convective heat to minimize the heat loss during this period.

The provided text for K053399 states that "The Versalet 7700 Care Center technology is well established in clinical practice, therefore, pre-clinical and clinical testing are not required to establish the performance of the device."

This means that a detailed study proving the device meets specific acceptance criteria, as usually understood in terms of new device performance evaluation, was not performed, nor was it deemed necessary for this 510(k) submission.

Therefore, many of the requested elements about acceptance criteria and study details cannot be directly extracted from this document, as they were not part of the submission's requirements for this particular device.

Here's an attempt to answer based on the provided information, indicating when information is explicitly stated as not applicable or not provided:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample size for test set: Not applicable/Not provided. Clinical testing was not required.
• Data provenance: Not applicable/Not provided. Pre-clinical and clinical data were not required.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable/Not provided, as formal pre-clinical or clinical testing requiring expert ground truth establishment was not performed.

4. Adjudication method for the test set

• Not applicable/Not provided, as formal pre-clinical or clinical testing requiring adjudication was not performed.

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. This device is an infant warming device, not an AI-assisted diagnostic tool. No MRMC study was mentioned or performed.

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

• Not applicable. This device is an infant warming device, not an algorithm. No standalone algorithm performance study was mentioned or performed.

7. The type of ground truth used

• Not applicable/Not provided, as formal pre-clinical or clinical testing requiring ground truth was not performed. The basis for safety and effectiveness primarily relies on substantial equivalence to predicate devices and established technology.

8. The sample size for the training set

• Not applicable/Not provided, as this is not an AI/machine learning device that would typically involve a training set.

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

• Not applicable/Not provided, as this is not an AI/machine learning device.

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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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