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The Novii+ Pod is an antepartum and intrapartum Maternal/Fetal Monitor that non-invasively measures fetal heart rate (FHR), uterine activity (UA) and maternal heart rate (MHR). The Novii+ Pod acquires the FHR tracing from abdominal surface electrodes that pick up the fetal ECG (fECG) signal. Using the same surface electrodes, the Pod also acquires the UA tracing from the uterine electromyography (EMG) signal and the MHR tracing from the maternal ECG signal (mECG). The Pod is indicated for use on women who are at 34 weeks and 0/7 days and greater with singleton pregnancies, using surface electrodes on the maternal abdomen.

The Novii Patch is an accessory to the Novii+ Pod that connects directly to the Novii+ Pod and contains the surface electrodes that attach to the abdomen.

The Novii+ Interface is an accessory to the Novii+ Pod which provides a means of interfacing the wireless output of the Novii+ Pod to the transducer inputs of a Maternal/Fetal Monitor. The Novii+ Interface enables signals collected by the Novii+ Pod to be printed and displayed on a Maternal/Fetal Monitor and sent to a central network, if connected.

The Novii+ Pod Maternal/Fetal Monitor and its accessories are intended for use by healthcare professionals in a clinical setting.

The Novii+ Wireless Patch System (Novii+ system) is a battery-powered maternal-fetal monitoring system that measures abdominal fetal heart rate (FHR), abdominal uterine activity (UA), and abdominal maternal heart rate (MHR). The Novii+ Wireless Patch system is designed as an ambulatory device for the monitoring of a pregnant mother. The monitor enables the abdominal electrophysiological signal to be picked up from three different positions on the maternal abdomen using the 5 electrodes on the Novii Patch. The monitor filters the abdominal signals, converts the abdominal electrophysiological data into a digital format and then processes it in real time to extract the fetal heart rate, maternal heart rate and uterine activity. The result of the processing is transmitted via a Bluetooth connection to the Novii+ Interface device which is an accessory to the Novii+ Pod.

The Novii+ Pod (proposed device) is indicated for use on women who are at 34 weeks and 0/7 days and greater with singleton pregnancies with cephalic fetal presentation.

Here's a breakdown of the acceptance criteria and study details for the Novii+ Wireless Patch System, based on the provided FDA 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

Note:

• PA: Percent Agreement
• RI: Relative Interpretability
• PPA: Positive Percent Agreement
• RMSE: Root Mean Square Error
• MAE: Mean Absolute Error
• GS: Gold Standard

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

• Sample Size for Clinical Study: 30 subjects
  • 14 subjects with threatened pre-term labor (non-laboring)
  • 16 subjects with pre-term labor and delivery
• Data Provenance: The document does not explicitly state the country of origin. Given that GE HealthCare is the submitter and their address is in Wauwatosa, WI, USA, it is likely the study was conducted in the United States. The study type is prospective clinical study.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth in the clinical study. Instead, the ground truth was established by comparator devices:

• FHR ground truth: Doppler Fetal Heart Rate device
• MHR ground truth: SpO2 Maternal Heart Rate device and 12-lead ECG data (Gold Standard)
• UA ground truth: TOCO Uterine Activity device

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (e.g., 2+1, 3+1). The primary comparison was against established medical devices (Doppler, SpO2, TOCO, 12-lead ECG) which inherently serve as the reference/ground truth.

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. The study's focus was on the Novii+ Wireless Patch System's equivalence to existing, established monitoring devices (Doppler, SpO2, TOCO, ECG) for capturing physiological data, not on how human readers' interpretations improve with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The study implicitly evaluated the standalone performance of the Novii+ Wireless Patch System. It directly compared the measurements generated by the Novii+ algorithms (FHR, UA, MHR) against the measurements from the comparator devices. There is no mention of human-in-the-loop performance evaluation in this specific context.

7. The Type of Ground Truth Used

• Fetal Heart Rate (FHR): Doppler Fetal Heart Rate device
• Maternal Heart Rate (MHR): SpO2 Maternal Heart Rate device, and a 12-lead ECG data (referred to as "MECG Gold Standard (GS)")
• Uterine Activity (UA): TOCO Uterine Activity device

8. The Sample Size for the Training Set

The document does not provide information on the sample size used for the training set. This particular document focuses on the performance evaluation of the device in a clinical study for premarket notification, not the development or training of its underlying algorithms.

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

The document does not provide information on how the ground truth for the training set was established, as details about the training process are not included in this 510(k) summary.

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The Giraffe OmniBed Carestation is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the on user's demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology.

Incubators provide an enclosed, temperature-controlled environment and warmers provide infrared heat in an open environment. They may also be used for short periods of time to facilitate the neonate's transition from the uterus to the external environment.

This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).

The Giraffe Incubator Carestation is an enclosed infant bed, which provides thermal support for infants who are unable to provide for their own heat requirements. The device maintains the infant's temperature by circulating heated air within the closed bed compartment. The operator may select either the air or skin temperature control method. Depending on the control method selected, heat is regulated based on either the air temperature or the infant's skin temperature compared to the operator selected control temperature. Physical access to the patient is obtained through the side portholes or by opening one of the side doors. The Giraffe Incubator Carestation has a color touchscreen user interface (UI) and includes a Hands-Free Alarm Silence (HFAS) feature. The incubator includes a mattress for patient comfort. The Giraffe Incubator Carestation incorporates an optional weighing scale, Servo O2, Uninterruptible Power Supply (UPS) & Shuttle, Mounting Accessories Rail and Shelves and Storage drawers.

The provided document describes the Giraffe Incubator Carestation CS1, a medical device. The submission focuses on modifications to the porthole and wall latches of an existing predicate device (K152809). The document does not describe the device's main performance in terms of medical outcomes but rather the safety and functionality of the latch modifications.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of numerical acceptance criteria for the overall medical device performance (e.g., temperature control accuracy, humidity control). Instead, it focuses on demonstrating that the modified latch mechanisms continue to meet existing safety and performance standards, and that their functionality is equivalent or improved compared to the predicate without introducing new risks.

However, the document lists system performance specifications that are identical to the predicate device, implying these are the baseline acceptance criteria for the overall incubator function. For the latch modifications, the acceptance criteria are demonstrated through successful completion of various tests.

Acceptance Criteria (Implied from "Identical" or "Meets all performance and standards requirements") and Reported Performance for the General Device:

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

The document describes non-clinical testing which includes various functional and reliability bench tests for the modified latches, as well as summative usability testing.

• Test Set Sample Size: The document does not specify a numerical sample size for the bench tests (e.g., number of latches tested, number of cycles for reliability). It lists the types of tests performed. For the "Summative Usability Testing," the sample size of participants is not provided.
• Data Provenance: The testing appears to be prospective and conducted by GE Healthcare (the submitter) in their own labs, as part of their quality system. The country of origin of the data is not explicitly stated but can be inferred to be internally generated by the manufacturer.

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

• Number of Experts: Not specified for the bench tests. For the "Summative Usability Testing," the number of participants is not provided, and whether these participants are considered "experts" (e.g., clinicians) or typical end-users is not detailed.
• Qualifications of Experts: Not specified.

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of expert opinions (e.g., for image interpretation). The testing involves physical and functional evaluation against established standards and internal quality criteria. For usability, the findings are reported, implying evaluation against predefined usability metrics and safety outcomes.

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 submission is for an infant incubator with modified latches, not an AI-powered diagnostic or interpretive device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

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

• Not applicable. This device does not have an "algorithm only" component that would require standalone performance evaluation typical of AI/ML software.

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

For the latch modifications, the "ground truth" is defined by:

• Compliance with Voluntary Standards: IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-19.
• Engineering Specifications: Internal design requirements for load, torque, cycles, and physical dimensions that ensure safety and functionality.
• Risk Analysis: Identification and mitigation of potential risks associated with the changes.
• Usability Objectives: Ensuring the modified latches do not introduce new use errors or significantly alter the user experience negatively.

8. The sample size for the training set

• Not applicable. This device submission does not involve a "training set" in the context of machine learning or AI.

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

• Not applicable. As there is no training set mentioned or relevant for this device, there is no ground truth established for one.

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The Giraffe Incubator Carestation is an Infant Incubators provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. They achieve this by providing an enclosed temperature controlled environment to the infant. This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide a stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).

The Giraffe OmniBed Carestation is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user's demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo- regulate based on their own physiology. Incubators provide an enclosed, temperature-controlled environment and warmers provide infrared heat in an open environment. They may also be used for short periods of time to facilitate the neonate's transition from the uterus to the external environment. This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).

The Giraffe OmniBed Carestation is a device that can function as an incubator (in the closed mode) or as an infant radiant warmer (in the open mode) based on the user's selection.

Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology.

In the closed bed mode of operation, the bed functions as an incubator, maintaining the infant's temperature by circulating heated air within the enclosed bed compartment. Warm air is circulated through the closed patient compartment. The operator may select either the air or skin temperature control method. Depending on the control method selected, heat is regulated based on either the air temperature or the infant's skin temperature compared to the operated selected control temperature. Physical access to the patient is obtained through the side portholes or by opening one of the side doors.

In the open bed mode, this bed operates like a conventional open, radiantly heated infant bed. Radiant heat from an infrared heat source is focused onto the bed to warm the patient. The Giraffe OmniBed Carestation incorporates an optional weighing scale, Servo O2, Uninterruptible Power Supply (UPS) & Shuttle, Mounting Accessories Rail and Shelves and Storage drawers.

This document is a 510(k) premarket notification for the "Giraffe Incubator Carestation CS1" (K213553). The submission seeks to demonstrate substantial equivalence to a legally marketed predicate device, the "Giraffe Omnibed Carestation CS1" (K152814), specifically concerning modifications to porthole and wall latches.

Device Description:
The device, Giraffe OmniBed Carestation CS1, is a combination of an infant incubator and an infant radiant warmer. It provides a temperature-controlled environment for neonates. The modified device primarily features changes to the porthole latch design (from "press to open" to "turn to open") and the wall latches (addition of a secondary "catch" mechanism on the north side). The overall dimensions have also slightly increased in width from 66 cm to 68 cm.

Acceptance Criteria and Reported Device Performance:

The provided document defines acceptance criteria through compliance with voluntary standards and system performance metrics, and the reported device performance is that it meets these criteria.

Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is a series of non-clinical performance and reliability bench tests and a summative usability study.

1. Compliance with Voluntary Standards:

   • The device was designed and tested for compliance with:
     • AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And 1. A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD)
     • AAMI / ANSI / IEC 60601-1-2 Edition 4.0 2014-02 Medical Electrical Equipment --Part 1-2: General Requirements For Basic Safety And Essential Performance --Collateral Standard: Electromagnetic Disturbances -- Requirements And Tests
     • IEC 60601-2-19 Edition 2.1 2016-04. CONSOLIDATED VERSION Medical Electrical Equipment - Part 2-19: Particular Requirements For The Basic Safety And Essential Performance Of Infant Incubators
     • IEC 60601-2-21 Edition 2.1 2016-04, CONSOLIDATED VERSION Medical Electrical Equipment - Part 2-21: Particular Requirements For The Basic Safety And Essential Performance Of Infant Radiant Warmers [Including: Amendment 1 (2016)]
   • Manufactured under Quality System Regulations of 21CFR 820 and ISO 13485, with quality assurance measures including:
     • Risk Analysis
     • Requirements Reviews
     • Design Reviews
     • Performance Testing (Verification)
     • Safety/Reliability Testing (Verification)
     • Summative Usability Testing (Validation)

2. Verification and Validation Testing (Non-Clinical Testing):

   • Evaluations: Safety and effectiveness of the modified wall and porthole latches were evaluated using controlled performance and reliability testing under worst-case conditions.
   • Test Methods:
     • Performance Tests: Rough Handling Testing (Ascending Step Shock, Descending Step Shock, Door Frame Shock as per IEC 60601-1 Cl 15.3.5a, 15.3.5b, 15.3.5c and IEC 60601-2-19), Check for Rough surfaces, sharp corners and edges (IEC 60601-1 Clause 9.3), Humidifier Operating Time, Air Velocity, Opening and Closing of E/W Doors and South Wall, Opening of Doors and Portholes, E/W Doors latch mechanism and N/S Walls as Barriers (IEC 60601-2-19 Clause 201.9.8.3.101), Porthole latch mechanism as Barriers (IEC 60601-2-19 Clause 201.9.8.3.101), Removing of E/W Doors and infant compartment design, E/W Doors remains secure even if the North Wall and South Wall receptacle is not latched, Maximum sidewall upright angle.
     • Reliability Tests: Porthole Latch: Over Torque Test; Wall Latch and Porthole Latch: Vibration / Reliability Threshold Test; Porthole Latch: Push Load; Porthole Latch: Pull Load for Cleaning; Porthole Latch: Open Close Cycles of Knob Latch; Porthole Latch: Cleaning Pull Cycles of Knob Latch; Wall Latch: Handling Load Test; Wall Latch: Pull and Push Loads with chemical exposure; Wall Latch: Handling Load on Snap; Wall Latch: Pinch Action Open Close Cycles; Wall Latch: Push Close Cycles (Push to Close from Secondary Latch Position to Primary Latch Position).
   • Results: The proposed device "successfully completed all testing per our quality system," and the evaluations "substantiate the performance of the new latches in worst-case conditions."

3. Human Factors Analysis (Summative Usability Study):

   • Study Purpose: To evaluate the modified wall and porthole latches and their instructions for use.
   • Results: The study "successfully completed a summative usability study," and "There were no findings from the summative usability testing that led to changes in wall latches, porthole latches, or on-product labeling. The latch modifications did not introduce any new risks or use-related issues."

Detailed Information for the Study:

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

• Test Set Sample Size: Not explicitly stated for each individual bench or reliability test. The tests were performed on the "modified wall and porthole latches," implying testing on the physical components of the device. For the Summative Usability Study, the sample size of users is not provided in this document.
• Data Provenance: The studies are laboratory and human factors evaluations conducted by the manufacturer (GE Healthcare). The data is presumably retrospective in nature, as it's part of the design verification and validation process for a modified existing product. Country of origin for the data is not specified but would be where GE Healthcare conducts its product testing.

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

• This information is not provided in the document. For bench/reliability tests, "experts" typically refers to test engineers and quality control personnel, whose qualifications are inherent to their roles in device manufacturing and verification. For the human factors study, the qualifications of the "users" involved are not detailed.

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

• Not applicable in the context of engineering bench and reliability testing or human factors usability studies as described. These are objective tests against predefined specifications or assessments of user interaction, not expert consensus for diagnostic interpretation.

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 is not an AI-assisted diagnostic device, and no MRMC study was conducted. The device is a neonatal incubator/warmer; the changes are mechanical (latches) and do not involve "human readers" or "AI assistance."

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

• Not applicable. This device is not an algorithm, and its performance involves direct physical interaction and function.

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

• Ground truth for the engineering tests was based on objective performance specifications derived from international standards (IEC 60601 series) and internal quality system requirements. For example, "Temp Control accuracy: ± 1.0ºC" is an objective metric.
• For the Human Factors Analysis, the ground truth was the observed user interaction and direct feedback regarding the usability and safety of the modified latches. The absence of findings that required design changes indicates that the user experience met safety and usability requirements.

8. The sample size for the training set:

• Not applicable. This device does not use machine learning or AI models, so there is no "training set."

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

• Not applicable for the same reason as above.

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