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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 Elettra Ultrasound System is intended for diagnostic imaging or fluid flow analysis of the human body including: Fetal, Abdominal, Intraoperative, Intraoperative Neurological, Pediatric, Small Organ, Neonatal Cephalic, Cardiac, Peripheral Vessel, Musculoskeletal (Conventional), Musculoskeletal (Superficial).

The Penrith Elettra is a compact diagnostic ultrasound device. It includes a system console housing electronic circuitry, a video display, power supply, and user controls. This connects to the transducers and together these generate the ultrasound image.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Penrith Elettra Diagnostic Ultrasound System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary (K100598) is a premarket notification for a diagnostic ultrasound system. For this type of device, the primary "acceptance criteria" for clearance through the 510(k) pathway is demonstrating substantial equivalence to a predicate device. This means the device is as safe and effective as a legally marketed device.

Therefore, the acceptance criteria are implicit:

• The device must perform in a manner substantially equivalent to predicate devices.
• The device must meet applicable medical device safety standards for acoustic output, biocompatibility, cleaning, disinfection, sterilization, thermal, electrical, mechanical safety, and electromagnetic compatibility.
• All claimed indications for use must be covered by the predicate devices.

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

This document describes a 510(k) premarket notification for an ultrasound system, which primarily relies on demonstrating substantial equivalence to predicate devices, rather than a clinical study comparing the device to a "gold standard" or a control group.

• No specific "test set" sample size is mentioned in the document for performance comparison in a clinical trial sense. The evaluation for substantial equivalence is based on technical, functional, and safety comparisons to already cleared devices.
• Data provenance: Not applicable in the context of a prospective clinical "test set" as none is detailed. The performance claims are backed by adherence to standards and comparison of specifications to predicate devices.

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

• Not applicable. The document does not describe a clinical study involving a test set with expert-established ground truth. The "ground truth" for a 510(k) submission like this is the established safety and effectiveness of the predicate devices and the adherence to relevant medical device standards.

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set and no expert adjudication process are described in this 510(k) summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. The document does not mention any MRMC comparative effectiveness study. This type of study is more common for AI/CADe devices that assist human readers in interpretation. The Penrith Elettra is a diagnostic imaging system itself, not an AI interpretation tool.

6. If a Standalone Performance Study (Algorithm Only Without Human-in-the-Loop) Was Done

• Not applicable. The Penrith Elettra is a diagnostic ultrasound system, not an AI algorithm. Its "standalone performance" is its ability to generate images and perform measurements, which is assessed through technical evaluation and comparison to predicate devices, rather than a specific algorithm-only study. The document states it was "evaluated for acoustic output, biocompatibility, cleaning, disinfection, and sterilization effectiveness, as well as thermal, electrical and mechanical safety, and electromagnetic compatibility."

7. The Type of Ground Truth Used

• For the purpose of this 510(k) submission, the "ground truth" is primarily:
  • The established safety and effectiveness of the identified predicate devices (Acuson Sequoia K022567, Acuson Cypress K052331, Philips Avalon CTS K023931).
  • Compliance with recognized medical device safety and performance standards (e.g., Track 3 method for acoustic output, electrical/physical safety standards).

8. The Sample Size for the Training Set

• Not applicable. This document describes a traditional diagnostic ultrasound system, not an AI/machine learning device that requires a training set.

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

• Not applicable. As no training set is involved for this device, there is no ground truth establishment for a training set.

In summary: The provided document is a 510(k) premarket notification for a diagnostic ultrasound system. It demonstrates safety and effectiveness by establishing substantial equivalence to existing, legally marketed predicate devices through technical comparisons, adherence to standards, and matching indications for use. It does not involve a clinical study with specific test sets, expert ground truth development, or AI algorithm performance evaluation the way a more modern AI/CADe submission might.

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