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The Huntleigh Healthcare Ltd Sonicaid FM820 and FM830 Encore fetal monitors are indicated for use by trained healthcare professionals in non-invasive monitoring of physiological parameters in pregnant adult human females, and fetuses, during the intrapartum and antepartum periods of pregnancy. The devices are intended for use in clinical and hospital-type facilities. They are not intended for use in intensive care units, operating rooms or in transport monitoring applications.

Sonicaid FM820E is suitable for use when there is a need to monitor the following physiological parameters:

• . Single or twin fetal heart rates by means of ultrasound
• ◆ Fetal or maternal heart rate via ECG
• Uterine activity externally or internally sensed .
• . Fetal movement - maternally sensed.

Sonicaid FM830E is suitable for use when there is a need to monitor the following physiological parameters:

• . Single or twin fetal heart rates by means of ultrasound
• . Fetal or maternal heart rate via ECG
• Uterine activity externally or internally sensed .
• Fetal movement - maternally sensed.
• . Maternal heart rate and oxygen saturation via pulse oximetry
• . Maternal non-invasive blood pressure

The FM820E and FM830E are fetal/maternal monitors designed for use in clinical and hospital environments during the ante-partum and intra-partum phases of pregnancy.

Both units are designed for use at the bedside and the range includes a wall mounting bracket and a trolley for fixed or transportable use. The units may also be used free-standing on a work surface.

The FM820E and FM830E are powered from the local mains electrical supply.

The FM820E includes the following facilities:

• Monitoring of one or two fetal heart rates via two independent ultrasound transducers. .
• Monitoring of maternal uterine activity either via external (Toco) or internal (IUP) transducers. .
• Monitoring of maternal or fetal heart rate via ECG.
• . Capture of maternally sensed fetal movements via cabled switch.
• Display of vital signs parameters via colour LCD screen. .
• t Control interface via combination of dedicated and "soft" function buttons in conjunction with on-screen prompts.
• . Chart printout via inbuilt thermal printer.
• Connection to Central Monitoring System possible via RS232 or Ethernet. .
• Audio and visual alerts (user set limits).

The following facilities are provided on the FM830E model in addition to the above:

• . Monitoring of maternal oxygen saturation and heart rate via pulse oximetry sensor.
• Monitoring of maternal Non-Invasive Blood Pressure (NIBP) via inflatable cuff. .

The connections for the additional facilities are incorporated in a "side pod", which extends the area of the front panel. Field upgrade of the FM820E to FM830E specification is not allowed.

The provided text describes the Sonicaid FM800, a fetal/maternal monitor, and its comparison to predicate devices, but it does not include detailed acceptance criteria or a dedicated study definitively proving the device meets specific performance criteria in the format requested.

Instead, the document focuses on demonstrating substantial equivalence to existing legally marketed devices (Sonicaid FM830 (K002150) and RDT Limited Tempus IC™ Patient Monitor (K082718)) for FDA 510(k) premarket notification. This means the manufacturer is asserting their new device is as safe and effective as a device already on the market, rather than conducting a de novo study against pre-defined acceptance criteria for a novel device.

However, I can extract the relevant information and present what is available in a structured manner, highlighting the limitations.

Here's the breakdown of the information requested, based on the provided text:

Acceptance Criteria and Device Performance Study for Sonicaid FM800

Based on the provided FDA 510(k) summary for the Sonicaid FM800, the device aims to demonstrate substantial equivalence to predicate devices rather than meeting specific, explicitly stated acceptance criteria from a de novo study. Therefore, the "acceptance criteria" are implied by the performance of the predicate devices. The study conducted to support this is primarily comparative bench testing and reliance on OEM-provided clinical data.

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

Since specific, quantitative acceptance criteria are not explicitly defined in the document for general device performance (like sensitivity/specificity for a diagnostic device), I will use the comparison to the predicate device's characteristics and the documented performance improvements as a proxy.

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

• Test Set Sample Size:
  • For non-clinical bench testing: The document does not specify a "sample size" in terms of number of cases or patients for the comparative bench testing (document 7515101 - FM800E Comparative Bench Test Summary) or the MsP02 verification protocol (document 7514502), although these would involve laboratory tests on the device itself.
  • For clinical tests: "No specific clinical tests were carried out to determine substantial equivalence." The submission references clinical trials carried out by the OEM providers of the SpO2 technology, but the sample size for these external OEM trials is not provided within this document. User evaluation trials are proposed but not yet completed at the time of submission.
• Data Provenance:
  • Bench Testing: Conducted internally by Huntleigh Healthcare Ltd. (United Kingdom). This would be prospective for the submitted device, comparing it against the predicate.
  • OEM SpO2 Clinical Trials: Conducted by BCI (Smiths Medical). The country of origin and whether these were retrospective or prospective are not specified in this document.

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)

• The document does not mention using experts to establish ground truth for the test set as part of its own substantial equivalence testing. The primary test method was comparative bench testing against a predicate device.
• For the OEM SpO2 clinical trials, details about expert involvement for ground truth are not provided in this submission.

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

• No adjudication method is mentioned for any test set within this submission. The tests performed are primarily engineering bench tests or rely on external OEM clinical data.

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 MRMC study was done. This device is a medical monitor, not an AI-powered diagnostic imaging tool that would typically involve human readers. The document states that user evaluation trials are proposed to verify effectiveness in clinical situations, but these are not described as MRMC studies and were not completed at the time of submission.

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

• The device is a monitor that provides physiological parameters. Its performance is inherent in its measurement accuracy and display, which can be evaluated in a standalone manner (e.g., how accurately it measures heart rate or blood pressure compared to a reference). The "Comparative bench tests" confirm this standalone performance. No specific standalone performance metrics (e.g., algorithm only) as might be seen in an AI context are provided, but the device itself has standalone performance.

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

• For the bench tests, the "ground truth" is typically established by using calibrated reference equipment or standards to ensure the new device's readings are accurate and comparable to the predicate device.
• For the OEM SpO2 clinical trials, the type of ground truth for oxygen saturation would likely involve co-oximetry, the gold standard for blood oxygen measurement. However, this is not detailed in the provided text.

8. The sample size for the training set

• The device is a traditional medical monitor; it is not described as utilizing machine learning or artificial intelligence that would require a "training set" in the computational sense. The "improved signal processing" or "enhanced" algorithms refer to conventional digital signal processing, not AI model training. Therefore, this question is not applicable.

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

• This question is not applicable as there is no "training set" for an AI model mentioned for this device.

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