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The Avalon CL Fetal & Maternal (F&M) Pod & Patch is a device indicated for use by healthcare professionals in a clinical setting for non-invasive monitoring of maternal heart rate (aHR), fetal heart rate (aFHR), and uterine activity (aToco) in women who are at >36 completed weeks, in labor, with singleton pregnancy, using surface electrodes on the maternal abdomen.

The Avalon CL Fetal & Maternal (F&M) Pod and the Avalon CL Fetal & Maternal (F&M) Patch is a beltless battery-powered maternal-fetal monitoring system that non-invasively measures abdominal fetal heart rate (aFHR), abdominal uterine activity (aToco), and abdominal maternal heart rate (aHR). The Avalon CL Fetal & Maternal (F&M) Patch is a single-use disposable adhesive electrode patch designed to be affixed to the maternal abdomen. The Avalon CL Fetal & Maternal (F&M) Pod is a reusable device which, when connected to the Avalon CL Fetal & Maternal (F&M) Patch, picks up electrical signals and converts it to Short Range Radio (SRR). The Avalon CL Fetal & Maternal Pod communicates the data measurement values to the Avalon CL Base Station using Short-Range Radio (SRR). The Avalon CL Base Station in turn relays the information to the connected Philips Fetal-Maternal (FM) Monitor (i.e., FM20, FM30, FM40, and FM50).

The provided FDA 510(k) summary for the Philips Avalon CL Fetal & Maternal (F&M) Pod & Patch focuses heavily on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of technical characteristics rather than a detailed clinical study report with specific acceptance criteria and performance metrics for the device's accuracy in monitoring FHR, MHR, and UA.

Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance (e.g., accuracy, sensitivity, specificity, agreement with ground truth for FHR, MHR, and UA) is not explicitly detailed in this document. The document primarily discusses non-clinical tests for safety, electrical performance, and biocompatibility.

However, based on the information provided, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with specific clinical performance acceptance criteria (e.g., accuracy ranges for FHR) and reported device performance from an effectiveness standpoint. Instead, it details non-clinical technical acceptance criteria related to safety, electrical performance, and biocompatibility, which the device met.

Regarding MHR/FHR/UA accuracy, the document states for "Performance Bench" that "MHR/FHR/UA accuracy after stored in room (23℃), high (32℃) and low (2-8℃) temperature" were conducted and "met the acceptance criteria as defined in the test requirements." However, the specific numerical acceptance criteria for accuracy (e.g., mean absolute difference, percentage agreement, etc.) and the reported numerical performance regarding MHR/FHR/UA accuracy are not provided in this summary. This suggests that these accuracy tests were likely bench tests under controlled conditions, not a clinical trial comparing device readings to a clinical ground truth.

2. Sample Size for Test Set and Data Provenance

The document does not explicitly mention a "test set" in the context of a clinical performance study with human subjects to evaluate the accuracy of FHR, MHR, and UA measurements. The in-vivo testing mentioned under "Performance Bench" refers only to "integrity, detachment/reattachment, and performance (impedance, noise level, MHR, conductivity) after shower and usage (8 hours/32 hours) for the patch (Novii Patch)." This does not sound like a large-scale clinical accuracy study.

Therefore, based on the provided text alone:

• Sample size for the test set: Not explicitly stated for clinical performance as commonly understood for device accuracy. The "in vivo testing" details are too limited to determine sample size or its direct relation to device accuracy claims.
• Data provenance: Not explicitly stated. The type of testing suggests it might be internal company testing rather than an independent clinical trial.

3. Number of Experts and Qualifications for Ground Truth

Given the lack of a detailed clinical performance study report, there is no information provided regarding the number or qualifications of experts used to establish ground truth for a clinical test set for FHR, MHR, or UA.

4. Adjudication Method

Again, due to the absence of a detailed clinical performance study, there is no information provided on any adjudication method (e.g., 2+1, 3+1) for a clinical test set.

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

No. The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss human readers or AI assistance in this context. This device appears to be a monitoring system for physiological parameters, not an AI-assisted diagnostic imaging or interpretation tool.

6. Standalone Performance

The device itself is a "standalone" monitoring system in the sense that it performs its measurements (aHR, aFHR, aToco) via its electrodes and pod, then relays this data to a Philips Fetal-Maternal (FM) Monitor for display. The performance tests ("Performance Bench") assess the device's ability to measure these parameters. However, the exact "standalone" clinical accuracy metrics (e.g., sensitivity, specificity, accuracy vs. a gold standard) are not provided. The phrase "standalone performance" is generally associated with diagnostic algorithms, which doesn't seem to be the primary claim here.

7. Type of Ground Truth Used

For the non-clinical performance "MHR/FHR/UA accuracy after stored in room (23℃), high (32℃) and low (2-8℃) temperature," the type of ground truth used is not specified. It likely refers to controlled laboratory measurements against calibrated reference standards, rather than clinical ground truth like pathology, expert consensus, or outcomes data. For clinical performance data (which is not detailed), common ground truths for FHR, MHR, and UA would be internal fetal monitoring (IUPC for UA, fetal scalp electrode for FHR) or expert interpretation of existing monitoring tracings (though this isn't mentioned).

8. Sample Size for the Training Set

No information is provided about a "training set." This term is typically associated with machine learning or AI algorithm development. While the device uses signal processing (template matching, filtering, confidence tagging) to identify fECG and mECG complexes, the document does not describe the development or training of such algorithms or any associated data sets used for this purpose.

9. How Ground Truth for the Training Set Was Established

As no training set is discussed, there is no information provided on how ground truth for a training set was established.

In summary, the provided FDA summary focuses on demonstrating substantial equivalence through technical and non-clinical performance and safety testing. It lacks detailed clinical performance data (e.g., accuracy, sensitivity, specificity) against a clinical ground truth, specific sample sizes for clinical evaluations, or information about expert consensus or adjudication methods for such clinical data, which are typically found in clinical study reports for devices claiming diagnostic or interpretative capabilities.

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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

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smart-sync is intended to generate a gating signal for MR scanners (1.5T and 3T) for motion compensation by detecting the heartbeat of a patient using Doppler ultrasound. Thus, smart-sync is intended to improve the image quality by reducing movement artefacts for MR images of the whole body, where motion compensation of the heart movement is necessary.

smart-sync is intended to be used on pregnant women, where the fetus is examined. smart-sync is also intended to be used for adult MR examinations.

smart-sync is not intended to monitor any physiological parameters.

smart-sync is an MRI-compatible Doppler ultrasound system that determines the cardiac cycle of patients and synchronizes it with the MRI imaging, smart-sync can be used for the synchronization of the heartbeat both for fetuses and adults.

The heartbeat of the patient is detected by positioning an ultrasound sensor above the patient's heart. The ultrasound sensor is fixated with a flexible belt. The reflection of Doppler ultrasound signals is analyzed, and a trigger signal is derived for every heartbeat. smart-sync sends the Doppler ultrasound signal and the trigger signal (synchronization signal) to the MRI scanner utilizing a wireless connection.

The provided document is a 510(k) summary for the device "smart-sync." It describes the device's intended use, technological characteristics, and a summary of non-clinical and clinical performance data. However, it does not provide detailed information about specific acceptance criteria or a comprehensive study report with quantitative performance metrics for the AI component of the device.

Based on the provided text, the "smart-sync" device does not appear to be an AI/ML-driven device in the context of image analysis or diagnostic aid. It is described as a Doppler ultrasound system that generates a gating signal for MR scanners to compensate for motion by detecting a patient's heartbeat. Its primary function is to improve image quality by reducing movement artifacts, not to perform analysis or diagnosis using AI.

Therefore, many of the requested points regarding AI/ML device testing (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable to the "smart-sync" device as described in this 510(k) summary.

Here's what can be extracted and inferred from the provided text, addressing the points where information is available or can be logically deduced:

Device Name: smart-sync
Product Code: LNH
Regulation Name: Magnetic resonance diagnostic device

Acceptance Criteria and Device Performance (as far as can be inferred for this type of device):

The "acceptance criteria" for a motion-gating device like smart-sync would primarily revolve around its ability to reliably detect the heartbeat and provide an accurate gating signal to the MRI machine, leading to improved image quality. The document refers to "clinical performance" and "effectiveness in improving image quality," but it does not specify quantitative metrics or thresholds for these.

Since this is a non-AI device focused on mechanical/electrical performance, traditional AI performance metrics (like sensitivity, specificity, AUC) are not directly relevant. The "performance" is about its ability to generate a correct and timely gating signal and the resulting visual improvement in MR images.

1. A table of acceptance criteria and the reported device performance:
See table above. Quantitative acceptance thresholds (e.g., minimum percentage reduction in motion artifact, or specific ECG/gating signal accuracy) are not provided in the document. The performance is described qualitatively as "effective in improving image quality" and "safe."

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

• Sample Size for Test Set: Not explicitly stated in terms of a numerical count of patients or studies. The text mentions "Clinical studies from clinicians at different hospitals across Europe and the US." This implies a multi-site study, but without specific numbers.
• Data Provenance: "Europe and the US" (country of origin). The studies appear to be "clinical studies," implying a prospective or at least a clinical trial setting rather than purely retrospective database analysis.

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

• Not Applicable in the context of AI/ML-driven diagnostic device evaluation.
• For a device like smart-sync, the "ground truth" would be the actual cardiac rhythm and the resulting improvement (or lack thereof) in image quality as assessed by radiologists in a clinical setting. The document mentions "clinicians at different hospitals" and "radiographers and radiologists" as the intended user group who would assess image quality.

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

• Not Applicable (as this is not an AI diagnostic device and no AI-specific adjudication of ground truth for classification tasks is described).

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 motion compensation tool, not an AI assistance tool for human readers. No MRMC study comparing human performance with/without AI assistance is mentioned because AI assistance is not its function.

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

• Not Applicable. The device is described as generating a gating signal for the MR scanner, which is a standalone function in this context (i.g., it produces a signal based on its sensor input). However, this is not an "AI algorithm only" performance test in the typical sense of diagnostic AI. The performance is then assessed in a clinical context by human readers evaluating the resulting MR images.

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

• The "ground truth" for the device's effectiveness appears to be primarily clinical assessment of image quality by clinicians/radiologists based on whether motion artifacts are reduced and images are improved. The accuracy of heartbeat detection would be the underlying "ground truth" for the device's direct function.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device that requires a "training set" in the context of machine learning model development.

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

• Not Applicable. As per point 8.

Summary of Key Findings from the Document regarding "smart-sync":

• Device Type: MRI-compatible Doppler ultrasound system for cardiac gating.
• Purpose: To generate a gating signal for MR scanners (1.5T and 3T) to compensate for heart movement, thereby improving image quality by reducing motion artifacts.
• Patient Groups: Adults and pregnant women (fetus examined from 30th gestational week).
• Technology: Uses Doppler ultrasound to detect myocardial wall and blood flow motion, deriving a trigger signal. Wireless transmission to MRI scanner.
• Performance Evaluation:
  • Bench Tests: Demonstrated effectiveness in providing gating signals and compliance with safety standards.
  • Clinical Studies: Conducted at hospitals in Europe and the US, indicating effectiveness in improving image quality for cardiac MRI examinations in the intended patient population.
  • Usability Tests: Confirmed safe use by radiographers and radiologists.
• Substantial Equivalence: Claimed based on clinical evidence, non-clinical bench testing, electrical safety, electromagnetic compatibility, product verification and validation, showing it does not raise different questions of safety and effectiveness compared to predicate devices (ECG-based gating cables) and a reference device (Doppler-based fetal monitors). The different acquisition method (Doppler ultrasound vs. ECG) was addressed through comparison with a Doppler reference device and analytical comparison showing similar cardiac information can be derived.

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