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The Fetal & Maternal Monitor is intended for non-invasive and invasive monitoring of fetus during antepartum examination, labor and delivery. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms.

Fetal & Maternal Monitor provides Non-Stress testing for pregnant women from the 28th week of gestation. It can externally monitor the FHRs using ultrasound and uterine activity via a TOCO transducer. Alternatively, it can internally monitor one of the FHRs with DECG and uterine activity with an IUPC.

The Fetal & Maternal Monitor provides the following primary features that can be available for the multiple configurations:

• Basic parameters: FHR, TOCO, Event Mark, AFM
• Optional Dual FHR monitoring
• Optional Internal parameters: IUP/DECG
• 12 hours waveforms playback
• Optional Built-in wireless module
• Software for data transmission to PC
• Quick printing for stored waveform
• Lithium battery for 4 hours continuous working
• Probe rack and wall mounting rack
• Optional Fetal Stimulator
• FHR limit alarm
• Pulse wave Doppler waterproof transducer for FHR detection

The provided text does not contain specific acceptance criteria or a detailed study proving the device meets those criteria. The document is a 510(k) summary for the Edan Instruments Fetal & Maternal Monitor (Models F6 and F9), which outlines the device's features, comparison to predicate devices, and a general statement about verification and validation testing.

Here's a breakdown of what is and is not in the document, based on your requested information:

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

• Not present. The document states: "Verification and validation testing was done on the Fetal & Maternal Monitor. This premarket notification submission demonstrates that Fetal & Maternal Monitor is substantially equivalent to the predicate device." However, it does not provide specific acceptance criteria (e.g., minimum accuracy, sensitivity, or specificity thresholds) nor detailed performance metrics from these tests.

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

• Not present. The document does not mention the sample size, data provenance, or whether the tests were retrospective or prospective.

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)

• Not present. The document does not describe how ground truth was established, nor does it mention any experts involved in such a process.

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

• Not present. There is no information about any adjudication methods used.

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 present. This device is a Fetal & Maternal Monitor, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.

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

• Not applicable/Not present. As this is a medical monitoring device, not an algorithm in the sense of AI, the concept of "standalone algorithm performance" doesn't directly apply. The document implies performance of the device itself (hardware and embedded software) rather than a separate algorithm. It states "Software testing" and "Hardware testing" were performed.

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

• Not present. The document does not specify the type of ground truth used for its verification and validation. Given the nature of a fetal monitor, performance would likely be assessed against established physiological measurements or another reference standard, but this is not detailed.

8. The sample size for the training set

• Not present. The document does not mention any training set or its size, which is typical for traditional medical devices that do not involve machine learning or AI models requiring explicit training data.

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

• Not present. As there's no mention of a training set, there's no information on how its ground truth would have been established.

In summary, the provided 510(k) document is a high-level summary demonstrating substantial equivalence to predicate devices rather than a detailed report of specific performance studies including acceptance criteria, sample sizes, expert involvement, or adjudication methods. It merely states that "Verification and validation testing was done" and led to the conclusion of substantial equivalence.

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