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INVU by Nuvo™ is a maternal-fetal mon-invasively measures and displays fetal heart rate (FHR), maternal heart rate (MHR) and Uterine Activity (UA).

The INVU Sensor Band™ acquires the fetal heart electrocardiogram and maternal heart electrocardiogram signals from abdominal surface electrodes and the fetal phonocardiogram and the maternal phonocardiogram signals from surface acoustic sensors. The FHR, MHR and UA tracings are derived from these signals and presented.

INVU by Nuvo™ is indicated for use by pregnant women who are in their 32nd week of gestation (or later), with a singleton pregnancy.

The INVU by Nuvo™ maternal-fetal monitor is intended for use by healthcare professionals in health care facilities and by the patient in the patient's home, on the order of a physician.

The INVU by Nuvo™ is indicated for antepartum fetal surveillance (i.e. non-stress testing).

This system does not prevent the onset of preterm labor nor will it prevent the occurrence of preterm birth.

INVU by Nuvo™ is a non-invasive medical device that acquires and displays vital signs of the pregnant woman and her fetus. It measures and processes signals picked up on the abdominal surface using highly sensitive sensors, special electronic circuitry, and processing software. Two types of sensors pick up the signals: ECG-like sensors that pick-up bio-potential signals, and acoustic sensors. The bio-potential (ECG-like) sensors pick up the fECG (of the fetus), the mECG signals (of the pregnant woman) and the acoustic sensors measure the sounds from the pregnant woman's abdomen (PCG -phonocardiogram and fPCG - fetal PCG). The FHR, MHR, and UA tracings are derived from these signals and presented.

INVU by Nuvo™ is an integrated platform that uses a signal acquisition tool to provide input related to fetal heart rate (FHR), maternal heart rate (MHR), to two separate software applications, one for the patient (INVU App) and one for the physician (INVU-Pro application), which also provides uterine activity (UA) tracings. Sensors are incorporated in a belt that is worn on the abdomen of the pregnant woman, where it acquires both biopotential and acoustic signals. The signals are processed at a cloudserver level. The sensors are attached to the pregnant woman's abdomen by a belt (INVU by Nuvo™ sensory band). An integrated electronic module receives, processes and transmits the measured data to algorithmic modules at cloud servers, where the inputs from the sensors are processed, merged, and sent to the INVU by Nuvo™ (patient) application to display the average FHR and average MHR after a 30 minute (minimum) monitoring session and to the INVU by Nuvo™ Pro (physician) application to display the complete FHR, MHR, and uterine activity data from a monitoring session. A monitoring session can only be scheduled by a health care provider.

The purpose of this special 510(k) is to implement several minor improvements to straps, buckles and LED used in the device. There have also been several minor changes to the software.

The provided text describes a Special 510(k) submission (K221046) for the INVU by Nuvo™ maternal-fetal monitor, which is an updated version of a previously cleared device (K210025). The focus of this submission is on minor improvements to straps, buckles, LED, and software, rather than significant changes to the core functionality or algorithms. As such, the performance data presented is primarily focused on demonstrating that these minor changes do not negatively impact safety and effectiveness and that the device remains substantially equivalent to its predicate.

Therefore, the acceptance criteria and study details provided in the document are not structured in a way that directly addresses the comprehensive set of questions about device performance in terms of accuracy or efficacy against a ground truth, as would be expected for a de novo device or a submission with significant algorithmic changes.

Here's a breakdown of the information available based on your request:

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

The document does not specify quantitative "acceptance criteria" for clinical performance (e.g., FHR accuracy, UA detection sensitivity/specificity) or report specific device performance metrics against such criteria in the way you might expect from a comprehensive clinical validation study. Instead, the performance data focuses on demonstrating that the modifications to the device (straps, buckles, LED, software) do not compromise the safety and effectiveness relative to the predicate device.

The study listed in the document for performance evaluation include:

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

The document does not mention specific sample sizes for test sets related to human subjects or patient data. The performance data described are related to engineering and software validation tests for the modifications, not a clinical trial on a large patient cohort. Therefore, details like country of origin or retrospective/prospective nature of data for clinical performance are not provided.

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)

This information is not provided in the document. The listed tests (biocompatibility, software validation, mechanical, electrical) do not typically involve experts establishing clinical ground truth for diagnostic accuracy in the way a clinical study would.

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

This information is not applicable/provided. The performance data pertains to technical verification and validation of device changes, not the adjudication of clinical outcomes or interpretations by multiple experts.

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

There is no indication that an MRMC comparative effectiveness study was conducted or that the device involves "AI assistance" in a way that would alter human reader performance. The device is described as measuring and displaying FHR, MHR, and UA, with signals processed at a cloud server level, but the submission focuses on hardware and minor software changes rather than new AI algorithms for interpretation or augmentation of human readers.

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

The document describes the device as a "maternal-fetal monitor that non-invasively measures and displays fetal heart rate (FHR), maternal heart rate (MHR) and Uterine Activity (UA)." While signals are processed at a "cloud server level," the submission's focus on hardware and minor software changes to an existing device means that a standalone algorithm performance study, distinct from overall device function, is not described or required for this particular 510(k). The device presents tracings that healthcare professionals use for "antepartum fetal surveillance (i.e. non-stress testing)."

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

Given that the listed performance data relates to engineering and software validation of device modifications, rather than clinical efficacy studies, there is no mention of clinical ground truth (like expert consensus, pathology, or outcomes data) in the context of device performance reporting for this submission. The "ground truth" for the tests performed would be established by standard engineering and testing protocols related to biocompatibility, mechanical properties, and electrical performance.

8. The sample size for the training set

This information is not provided. The document doesn’t mention a training set, as the evaluation focuses on verifying hardware and minor software modifications to an already cleared device, rather than the development or re-training of a new diagnostic algorithm.

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

This information is not provided, as there is no mention of a training set or its associated ground truth in the context of this 510(k) submission.

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INVU by Nuvo™ is a maternal-fetal monitor that non-invasively measures and displays fetal heart rate (FHR), maternal heart rate (MHR) and Uterine Activity (UA).
The INVU Sensor Band™ acquires the fetal heart electrocardiogram and maternal heart electrocardiogram signals from abdominal surface electrodes and the fetal phonocardiogram and the maternal phonocardiogram signals from surface acoustic sensors. The FHR, MHR and UA tracings are derived from these signals and presented.
INVU by Nuvo™ is indicated for use by pregnant women who are in their 32nd week of gestation (or later), with a singleton pregnancy.
The INVU by Nuvo™ maternal-fetal monitor is intended for use by healthcare professionals in health care facilities and by the patient in the patient's home, on the order of a physician.
The INVU by Nuvo™ is indicated for antepartum fetal surveillance (i.e. non-stress testing).
This system does not prevent the onset of preterm labor nor will it prevent the occurrence of preterm birth.

INVU by Nuvo™ is a non-invasive medical device that acquires and displays vital signs of the pregnant woman and her fetus. It measures and processes signals picked up on the abdominal surface using highly sensitive sensors, special electronic circuitry, and processing software. Two types of sensors pick up the signals: ECG-like sensors that pick-up bio-potential signals, and acoustic sensors. The bio-potential (ECGlike) sensors pick up the fECG (of the fetus), the mECG signals (of the pregnant woman) and the acoustic sensors measure the sounds from the pregnant woman's abdomen (PCG -phonocardiogram and fPCG fetal PCG). The FHR, MHR, and UA tracings are derived from these signals and presented.
lt is an integrated platform that uses a signal acquisition tool to provide input related to fetal heart rate (FHR), maternal heart rate (MHR), to two separate software applications, one for the patient (INVU App) and one for the physician (INVU-Pro application), which also provides uterine activity (UA) tracings. Sensors are incorporated in a belt that is worn on the abdomen of the pregnant woman, where it acquires both biopotential and acoustic signals. The signals are processed at a cloud-server level.
The sensors are attached to the pregnant woman's abdomen by a belt (INVU by Nuvo™ sensory band). An integrated electronic module receives, processes and transmits the measured data to algorithmic modules at cloud servers, where the inputs from the sensors are processed, merged, and sent to the INVU by Nuvo™ (patient) application to display the average MHR after a 30 minute (minimum) monitoring session and to the INVU by Nuvo™ Pro (physician) application to display the complete FHR, MHR, and uterine activity data from a monitoring session can only be scheduled by a health care provider.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Device: INVU by Nuvo™ (Maternal-fetal monitor)

Performance Metrics of Interest for this Documentation: Uterine Activity (UA) detection. The text mentions FHR and MHR performance was addressed in a prior K-submission (K191401), so this summary focuses on UA as per the provided study details.

1. Table of Acceptance Criteria and Reported Device Performance

Conclusion from Table: INVU by Nuvo™ met its performance goal for Positive Percent Agreement. The False Positive Rate was higher than the TOCO device, but the overall conclusion stated that INVU™ is comparable to the standard of care TOCO device and meets the required accuracy for its intended use.

2. Sample Size and Data Provenance

• Test Set Sample Size: 80 (Validation Phase)
• Data Provenance: Not explicitly stated regarding country of origin. The study was a "pivotal clinical study," suggesting it was prospective.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. (The ground truth was established by a medical device, IUPC, not human experts for this specific test.)

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/None mentioned for the UA data itself. The ground truth for Uterine Activity was established directly by an Internal Uterine Pressure Catheter (IUPC), which is the "gold standard" device. There's no indication of human adjudication of this instrumental ground truth.

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

• Was an MRMC study done? No. This study focuses on the device's accuracy in detecting Uterine Activity compared to an instrumental gold standard and a standard-of-care device. It does not evaluate human reader improvement with or without AI assistance.

6. Standalone (Algorithm Only) Performance

• Was a standalone performance study done? Yes. The study directly assessed the INVU by Nuvo™ platform's ability to collect and display UA data and compared its performance (specifically the algorithm's output) against the IUPC (gold standard) and TOCO devices.

7. Type of Ground Truth Used

• Type of Ground Truth: Instrumental Gold Standard. Uterine activity was measured by an Internal Uterine Pressure Catheter (IUPC), which is explicitly referred to as the "gold standard" for uterine activity measurement.

8. Sample Size for the Training Set

• Training Set Sample Size: 40

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

• Method for Training Set Ground Truth: The text states, "During the training phase, uterine activity data was collected to 'train' the UA algorithm to identify uterine contractions." While not explicitly stated, it is highly implied that the same method for ground truth establishment as the validation phase (IUPC) would have been used to provide accurate Uterine Activity data for algorithm training.

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PregSense is a maternal-fetal monitor that non-invasively measures and displays fetal heart rate (FHR) and maternal heart rate (MHR). The PregSense acquires and displays the FHR and MHR tracings from abdominal surface electrodes that pick up the fetal heart biopotential and maternal heart biopotential signal, and from surface acoustic sensors that pick up the fetal PCG (fPCG; phonocardiogram) and the maternal PCG (mPCG; phonocardiogram) signals.

PregSense is indicated for use by pregnant women who need documentation of fetal heart rate activity, and who are in their 32nd week of gestation (or later), with a singleton pregnancy. PregSense is intended to be used for a maximum of five minutes.

The PregSense maternal-fetal monitor is intended for use in the antepartum period by healthcare professionals in health care facilities and by the patient in the patient's home, on the order of a physician.

The PregSense is not intended for use in critical care situations or in laboring patients hospitalized for or suspected to have preterm labor.

PregSense is not intended to be used for antepartum monitoring (e.g., non-stress testing).

PregSense™ is a non-invasive medical device that acquires and displays vital signs of the pregnant woman and of her fetus. It measures and processes signals picked up on the abdominal surface using sensors, electronic circuitry and processing software. Two types of sensors pick up the signals: electrocardiogram (ECG)-like sensors that capture bio-potential signals, and acoustic sensors. The biopotential (ECG-like) sensors capture fECG (heartrate of the fetus) and mECG signals (heartrate of the pregnant woman). The acoustic sensors measure the sounds from the pregnant woman's abdomen, (PCG -phonocardiogram and fPCG -fetal PCG). Monitoring of the fetal and maternal heart rate using PregSense is limited to a five-minute session.

PregSense™ is an integrated platform that uses a signal acquisition tool to provide input to two separate software applications, one for the patient (PregSense™ ME) and one for the physician (PregSense™ MD). The sensors are incorporated in a belt (PregSense™ Belt) that is worn on the abdomen of the pregnant woman, where it acquires both biopotential and acoustic signals are processed at the cloud-server level where the inputs from the sensors are processed, merged and downloaded to the mobile devices of the pregnant woman and her health care provider. The PregSense™ ME application (for the patient) allows the pregnant woman to view the average maternal and fetal heart rate after a five minute session has been completed and PregSense™-MD application (for the health care provider) allows the health care provider to view the complete fetal and maternal heart rate data from the five minute session online and remotely via the internet. A monitoring session can only be initiated by a health care provider.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Study Details:

1. Sample sized used for the test set and the data provenance:

   • Feasibility Study: 76 subjects. The text mentions "two in the United States and two outside the United States" for the pivotal study settings, which suggests a global data provenance, but it's not explicitly stated for the feasibility study. The feasibility study seems to have been retrospective based on the reporting ("510 recording sessions were executed").
   • Pivotal Study: 149 subjects. The study was conducted in four healthcare settings (two in the United States and two outside the United States), indicating a prospective, multi-site approach.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   The document does not explicitly state the number or qualifications of experts used to establish ground truth for the test set. However, the pivotal study compared PregSense's performance to a "standard of care" monitoring device (CTG), implying that the CTG readings served as the reference standard, which would typically be interpreted by trained healthcare professionals.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   The document does not specify an adjudication method like 2+1 or 3+1. The comparison was directly against a "standard of care" CTG system.

4. 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:
   No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study focuses on the standalone performance of the PregSense device in measuring FHR and MHR compared to a standard, rather than evaluating how human readers' performance changes with AI assistance.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Yes, the performance data presented is for the standalone device (PregSense™ system, including its embedded sensors and associated software for analysis) compared to a "standard of care" CTG. The "PregSense ME App" and "PregSense MD App" are for displaying data, not for human interpretation during the measurement process that would alter the algorithm's output. The usability study involved lay users, but that was to ensure proper device handling, not to assess a human-in-the-loop diagnostic process.

6. The type of ground truth used:
   The ground truth was established by comparison to a "standard of care" monitoring device, specifically CTG (Cardiotocography). This is a widely accepted clinical method for monitoring fetal heart rate.

7. The sample size for the training set:
   The document does not provide information regarding the sample size used for the training set for the PregSense algorithms. It only discusses the clinical studies conducted for performance validation.

8. 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 set itself are absent.

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