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The Fetal Monitors are intended for non-invasive monitoring of fetal and maternal physiological parameters during antepartum examination, labor and delivery. They are intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms.

The proposed fetal monitors, including F30, F45, F50, F85 and F90 are intended for providing continuous monitoring, displaying, printing and recording of basic fetal and maternal parameters. including uterine activity (UA), dual fetal heart rate (FHR) and fetal movement (ITM), and extended maternal parameters, including electrocardiograph (ECG), non-invasive blood pressure (NIBP) . Pulse Oxygen Saturation (SpO2) , Pulse Rate (PR), Temperature (TEMP) and Respiration Rate (RESI').

This looks like a 510(k) premarket notification for a medical device, which typically does not include detailed clinical study data in the public summary. Instead, it focuses on demonstrating "substantial equivalence" to a predicate device based on technical characteristics and adherence to recognized standards. Therefore, many of your requested details about studies, ground truth, and expert evaluation will likely not be present in this type of document.

Based on the provided text, here's what can be extracted and what cannot:

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

The document provides a comparison table (Table 3-1) where the "acceptance criteria" are implied by compliance with various international standards, and the "reported device performance" is a statement of compliance. No specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy) are reported for the device's medical functions, as the submission relies on demonstrating equivalent technical specifications to a predicate device.

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

• Not provided. The document focuses on non-clinical tests (e.g., electrical safety, EMC, biocompatibility) rather than clinical performance data from a test set of patient cases.

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

• Not provided. This information would be relevant for a clinical performance study, which is not detailed here.

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

• Not provided. This information would be relevant for a clinical performance study, which is not detailed here.

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 / Not provided. This device is a fetal monitor for measuring physiological parameters, not an AI-assisted diagnostic tool for human readers. No MRMC study is mentioned or implied.

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

• Not applicable / Not provided. This device is a monitoring system and does not appear to involve a standalone algorithm in the sense of AI performance evaluation. The "non-clinical tests" mentioned (IEC and NEMA standards) are performed on the device itself to verify its design specifications and electrical/biocompatibility safety.

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

• Not explicitly stated in the context of clinical accuracy. For the non-clinical tests, "ground truth" would be the established specifications and limits defined by the referenced standards (e.g., a specific threshold for electromagnetic emissions, a defined limit for acoustic output).

8. The sample size for the training set

• Not applicable / Not provided. This document describes a traditional medical device (fetal monitor) rather than an AI/ML-based device that would require a "training set."

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

• Not applicable / Not provided. As above, no training set for an AI/ML model is involved here.

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The F2 and F3 Fetal Monitor are intended for non-invasive and invasive monitoring of fetus during antepartum examination, labor and delivery. They are intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms.

They both provide Non-stress testing for pregnant women from the 28th week of gestation. They can externally monitor the FHRs using ultrasound and uterine activity via a TOCO transducer. Alternatively, they can internally monitor one of the FHRs with DECG and uterine activity with an IUPC.

With non-invasive ultrasound Doppler, external TOCO and direct fetal ECG technique, Fetal Monitor provides Non-Stress testing for pregnant women from the 28th week of gestation. You can externally monitor the fetal heart rate using ultrasound and uterine activity via a TOCO transducer. Alternatively, you can internally monitor one of the fetal heart rate with direct fetal ECG technique and uterine activity with an Intrauterine Pressure Catheter.

The Fetal Monitor has six models: Cadence, Cadence DUAL, Cadence PRO, Cadence II, F2 and F3. The former four models Cadence, Cadence DUAL, Cadence PRO, Cadence II have already been cleared under K082369, while the other two models F2, F3 are new models of Fetal Monitor in this Traditional 510(K) application, which have the same intended use and constructions to the existing models.

The Fetal monitor can be connected with Central Monitoring System via RJ45 interface. Also it can be connected to wireless network module via a DB9 interface, and the wireless network module will complete the data switch of the monitor and the Obstetrical Central Monitoring System.

The provided text describes the regulatory submission for the F2 and F3 Fetal Monitors. It outlines their intended use and states that they are substantially equivalent to previously cleared devices (Cadence series). However, the document does not contain specific acceptance criteria, performance metrics, or details of a clinical study demonstrating the device meets such criteria.

The submission focuses on establishing substantial equivalence to a predicate device (K082369) through design and technological similarity, rather than presenting a de novo clinical study with specific performance benchmarks.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's an analysis of what can be inferred or explicitly stated:

Information that CANNOT be extracted from the provided text:

• A table of acceptance criteria and the reported device performance: The document does not define specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy for FHR detection) nor does it provide a table of measured performance against such criteria.
• Sample sized used for the test set and the data provenance: No test set (clinical or otherwise) with specific sample sizes or data provenance is mentioned for the F2/F3 models' performance evaluation. The focus is on equivalence to an existing device.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no such test set or ground truth establishment process is described.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
• 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. Fetal monitors are monitoring devices, not AI-assisted diagnostic tools for human readers.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a monitor, not an algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• The sample size for the training set: Not applicable, as no AI/algorithm training is described.
• How the ground truth for the training set was established: Not applicable.

Information that CAN be extracted or inferred:

While the document doesn't present a traditional acceptance criteria table and study results, it demonstrates "acceptance" through the substantial equivalence pathway.

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

The implicit "acceptance criteria" is that the F2 and F3 Fetal Monitors perform equivalently to the predicate devices (Cadence, Cadence DUAL, Cadence PRO, Cadence II cleared under K082369) for their stated intended use. The "reported device performance" is essentially that they function in the same manner as the predicate.

2. Sample sized used for the test set and the data provenance:
Not explicitly stated for the F2/F3 models' performance. The submission relies on the established performance of the predicate devices. The "Test Summary" mentions "Verification and validation testing was done on the Fetal Monitor models F2, F3" (Page 2), but does not provide details on the sample size or type of data used for this testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable as no clinical study with expert-established ground truth for F2/F3 is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable.

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:
No. This device is a monitor, 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:
No. The device is a physical monitor with associated transducers.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable for this submission in terms of a new clinical study. The FDA's clearance is based on the "substantial equivalence" of the device's technology and intended use to a previously cleared device. The performance of the predicate device would have been established at its time of clearance using appropriate methods (which are not detailed in this document).

8. The sample size for the training set:
Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established:
Not applicable.

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