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NaviCare® WatchChild™ is indicated for use in a hospital/clinical environment. NaviCare® WatchChild™ is intended to be used as a complete Obstetrical Data Management System, which has the ability to record, store and display data from fetal and maternal vital signs monitors. It manages patient information from the initial prenatal care to post-delivery discharge. NaviCare® WatchChild™ organizes clinical data that would normally be provided on paper records or other clinical systems and devices. This system also serves as a decision support tool and electronic medical record.

NaviCare® WatchChild™ is intended to be used as a complete Obstetrical Data Management System, which has the ability to record, store and display data from fetal and maternal vital signs monitors. It manages patient information from the initial prenatal care to post-delivery discharge. NaviCare® WatchChild™ organizes clinical data that would normally be provided on paper records or other clinical systems and devices. This system also serves as a decision support tool and electronic medical record.

I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter for the NaviCare® WatchChild™ Obstetrical Data Management System, which primarily confirms substantial equivalence to a predicate device and outlines regulatory compliance. It does not include details of performance studies, sample sizes, expert qualifications, or ground truth establishment.

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The intended use of the WatchChild™ Obstetrical Patient Data Management System is a complete obstetrical information 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. The WatchChild™ System 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 (The WatchChild™ System) is a complete Obstetrical Information Management System that has the capability to record, store, and display fetal and maternal data from initial fetal stress tests through labor, delivery and discharge. Specifically, data from fetal monitoring and maternal vital signs monitoring equipment can be recorded, stored, and displayed on The WatchChild™ System via automation of the following areas:

• Admission/Discharge/Transfer (ADT) .
• Labor and Delivery notes .
• Nursing notes ●
• . Physician's notes
• Fetal Strip faxing .
• Obstetrical statistical trend reports, e.g., patient enrollments and discharges over ● time
  The WatchChild™ System has the ability to simultaneously display graphic and text data on the same screen permitting the clinician to view a patient's fetal strip along with her medical data. Interaction with The WatchChild™ System is accomplished through a graphical user interface (GUI). The user activates buttons on the screen utilizing either a light pen or a mouse. The WatchChild™ System is offered with an optional optical disk archiving system (WORM technology) that replaces conventional paper storage. In addition, an optional physician's remote access is also available. Using a personal computer, a physician can call from outside the hospital and display real time and/or trended data for any patient connected to the system, as well as perform annotations to the patient's fetal strip.
  The WatchChild™ System can be installed as a stand-alone system or connected to the Hospital's Information System.

The provided text is a 510(k) summary for the WatchChild™ Obstetrical Patient Data Management System. It explicitly states that clinical testing is not applicable for this device. As such, the document does not contain information about acceptance criteria or a study proving the device meets those criteria in a clinical context.

Therefore, many of the requested fields cannot be filled based on the provided text.

Here's a breakdown of what can be extracted:

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

• Acceptance Criteria: Not applicable/not provided for clinical performance as clinical testing was deemed unnecessary. The submission focuses on substantial equivalence to a predicate device and software verification/validation.
• Reported Device Performance: Not applicable for clinical performance. The device's performance is described in terms of its features and capabilities (recording, storing, displaying data, organizing clinical information, decision support, EMR functionality).

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

• Not applicable as no clinical test set was used.

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)

• Not applicable as no clinical test set was used.

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

• Not applicable as no clinical test set was used.

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 an information management system, not an AI-assisted diagnostic tool for human readers.

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

• Not applicable for clinical performance. The "standalone" mentioned refers to its ability to be installed as a standalone system or integrated with hospital information systems, not its performance as an algorithm without human interaction for clinical decision-making.

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

• Not applicable for clinical performance. The "ground truth" for this device would relate to the accuracy of data acquisition, storage, and display, which would be verified through software testing and functional validation, not clinical ground truth like pathology.

8. The sample size for the training set

• Not applicable as no machine learning/AI training set is mentioned for this device.

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

• Not applicable as no machine learning/AI training set is mentioned for this device.

Summary of what is present:

• Nonclinical Testing: "Testing was conducted to verify and validate the software." This is the only type of "testing" mentioned.
• Predicate Device: The system is compared to "The WatchChild™ System Obstetrical Patient Data Management System cleared for marketing by FDA in 510(k) K014094 on January 11, 2002." The submission claims substantial equivalence based on having "the same capabilities to record, display, and archive data collected from fetal and maternal monitors, nurse's and doctor's notes and annotations."
• Conclusion: The manufacturer concluded that the device is "as safe, as effective, and performs as well as or better than the legally marketed predicate device."

In essence, this is a re-submission or update of an existing device, and the regulatory pathway chosen (510(k)) and the nature of the device (data management system) meant that clinical effectiveness studies were not required to demonstrate substantial equivalence. The focus was on software validation and functional equivalence to the predicate device.

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The Air Shields ISOLETTE® Infant Incubator is designed to care for the smaller premature baby as well as the healthier full term baby. It does this by providing a controlled environment, one in which the baby can be provided with the necessary care as well as being left undisturbed in the security of the incubator.

It is to this end that the product can be used in any department of the hospital that provides neonatal and infant care. One would typically expect the ISOLETTE® to be used in the NICU/SCBU (Neonatal Intensive Care Unit and/or the Special Baby Care Unit). The design lends itself to all levels of care in the NICU making it suitable for use in level I, II, III, and IV where applicable. Other departments would include the Step Down Nursery, Newborn Nursery and Pediatrics.

This device, when fitted with the battery backup feature, may be used to move the infant from one area of the hospital to another while maintaining the controlled environment.

This device is not intended for home use.

This is a prescription device.

The C2000e is an enhancement to the currently marketed C2000 Isolette Infant Incubator originally cleared under 510(k) K960980. The features, functions, and performance of the C2000 incubator remain the same. The C2000e enhancements are additions to the C2000 product features. These additions are a horizontal rail system for attachment of accessories and a battery back up for the unit to maintain the controlled environment in the event of a power failure or to move the infant within the hospital environment.

The provided text describes a 510(k) submission for the C2000e Isolette® Infant Incubator, an enhancement to an already marketed device. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through clinical studies in the same way a new, high-risk device might.

Therefore, the document does not contain the kind of information requested in the prompt (acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, training sets, etc.). The focus is on the modifications made and how they relate to the predicate device.

Here's why the requested information is absent and what the document does provide:

• No Acceptance Criteria or Reported Device Performance Table: The document doesn't define specific performance metrics or acceptance criteria for the C2000e beyond the general statement that "The features, functions, and performance of the C2000 incubator remain the same." The enhancements are merely additions (horizontal rail and battery backup).
• No Clinical Study Details: There is no mention of a formal clinical study to prove the device meets acceptance criteria. The 510(k) process for device enhancements often relies on engineering testing and comparison to the predicate, not clinical trials with human subjects to establish diagnostic performance.
• No Sample Sizes, Data Provenance, Expert Ground Truth, Adjudication, MRMC, or Standalone Performance: These are all concepts related to clinical performance studies, typically for diagnostic or predictive AI/ML devices. An infant incubator, particularly an enhanced version of an existing one, would not undergo such evaluation in a 510(k) submission.
• No Training Set Information: As there's no AI/ML component described, there's no training set.
• No Ground Truth Type: Similarly, ground truth is a concept for evaluating diagnostic accuracy, which is not applicable here.

What the document does provide in relation to regulatory approval:

• Predicate Device: K960980 C2000 Isolette® Infant Incubator. The C2000e is an enhancement, meaning its substantial equivalence hinges on the original C2000's proven safety and effectiveness.
• Modifications: Addition of a horizontal rail system and a battery backup.
• Intended Use Statement: Describes the incubator's purpose (controlled environment for infants) and where it can be used (NICU, SCBU, Step Down Nursery, Newborn Nursery, Pediatrics). It also clarifies that the battery backup allows for safe transport within the hospital.
• Regulatory Classification: Class II device, specifically a Neonatal Incubator (21 CFR 880.5400).
• Performance Standards: "None applicable" (referring to specific mandatory standards for the device's original submission, though general requirements like GMP still apply).

In summary: The nature of this 510(k) submission for an enhanced infant incubator does not require or include the detailed performance study information requested in your prompt. The regulatory approval is based on demonstrating that the new features do not raise new questions of safety or effectiveness and that the device as a whole is substantially equivalent to a legally marketed predicate.

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The intended use of the WatchChild™ Obstetrical Patient Data Management System is a complete Obstetrical Information 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. Information from the system 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 (The WatchChild™ System) is a complete Obstetrical Information Management System that has the capability to record, store, and display fetal and maternal data from initial fetal stress tests through labor, delivery and discharge. Specifically, data from fetal monitoring and maternal vital signs monitoring equipment can be recorded, stored, and displayed on the WatchChild System via automation of the following areas:

• . Admission/Discharge/Transfer (ADT)
• Labor and Delivery notes ●
• Nursing notes ●
• Physician's notes .
• Fetal Strip faxing ●
• r etail Obstetrical trend reports (e.g., patient enrollments and discharges over . time)
  The WatchChild™ System has the ability to simultaneously display graphic and text The Viatenonilia - Oystem has the clinician to view a patient's fetal strip along with her medical data. Interaction with the WatchChild™ System is accomplished with her modiour data. Interface (GUI). The user activates buttons on the screen through a graphiodi ason internationse. The WatchChild™ System is offered with an utilizing entrer a light pon of a modeo. WORM technology) that replaces conventional paper storage. In addition, an optional physician's remote access is also available. paper storage. In addition, a physician can call from outside the hospital and display real time and/or trended data for any patient connected to the system, as well as perform annotations to the patient's fetal strip.
  The WatchChild™ System can be installed as a stand-alone system or connected to the Hospital's Information System.

The information provided indicates that no clinical testing was performed or deemed applicable for the Hill-Rom Manufacturing, Inc. The WatchChild™ System (K014094). The submission focused on demonstrating substantial equivalence to a predicate device through nonclinical testing, primarily software verification and validation. Therefore, an acceptance criteria table, details on sample sizes, ground truth establishment, expert involvement, and MRMC studies are not available, as they are typically associated with clinical performance evaluations.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Not applicable. The provided document explicitly states, "Clinical testing is not applicable for this device." The submission is for substantial equivalence based on technological characteristics and nonclinical software verification. Therefore, no clinical performance metrics or acceptance criteria are reported.

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

Not applicable for clinical efficacy. The "testing" mentioned refers to nonclinical software verification and validation. Details on the sample size for this nonclinical testing are not provided, nor is information on data provenance from a clinical context.

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

Not applicable. No clinical testing involving expert-established ground truth was conducted.

4. Adjudication Method for the Test Set:

Not applicable. No clinical testing with an adjudication method was 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. No MRMC comparative effectiveness study was conducted. The device is an Obstetrical Patient Data Management System, not designed for AI-assisted image interpretation by human readers.

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

The device is an "Obstetrical Patient Data Management System" which records, stores, and displays fetal and maternal data. It is a system intended to manage and organize clinical data, rather than a standalone algorithm making diagnostic decisions. Its performance demonstration was through nonclinical software verification and validation, ensuring its functionality as a data management system. Therefore, a standalone "algorithm only" performance study in the typical sense (e.g., for diagnostic accuracy) was not performed.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

Not applicable for clinical efficacy. The "ground truth" for the nonclinical software verification and validation would relate to expected software behavior, functional correctness, and data integrity, rather than medical ground truth like pathology or expert consensus on clinical outcomes.

8. The Sample Size for the Training Set:

Not applicable. This device is an Obstetrical Patient Data Management System. There is no indication of machine learning or AI components that would require a "training set" in the context of diagnostic algorithm development. The testing focused on software verification and validation.

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

Not applicable. As no training set for an AI/ML algorithm was mentioned, the method for establishing its ground truth is irrelevant.

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