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The SD5 Ultrasonic TableTop Doppler (hereinafter called "SDS") and SD6 Ultrasonic TableTop Doppler (hereinafter called "SD6") are intended to be used by health care professionals including registered nurses, midwives, ultrasound technicians, and physician assistants, by prescription in hospitals, clinics and private offices.

The 2 MHz and/or 3 MHz obstetrical probes are indicated for the detection of fetal heart rate from early gestation thru delivery and as a general indication of fetal heart well being. They can also be used to verify fetal heart viability.

The SD5&SD6 Ultrasonic Tabletop Doppler is a hand-held device for non-invasive measurement and display of fetal heart rate utilizing the principle of Doppler shift of an ultrasound. The ultrasound is transmitted from the probe to patient body (maternal abdominal wall), and moves through biophysical objects. The acoustic ultrasound is reflected by blood and moving objects such as the fetal heart. The reflected ultrasound is received by the probe and is converted into electric signals. The waveform data are applied to the CPU for all the digital processing on LED Display, operation keys. The audio signal is taken off for the routing to the speaker to generate the analogue signals before digital processing. The system is compatible with 2 MHz or 3 MHz for fetal heart rate. The signal acquired can be transferred to SD5 by wired method, and by Bluetooth to SD6.
The main unit can be powered by main supply (100 V-240 V~) or Ni-MH Battery (7.2 V/2000 mAh). And transducers are powered by 3.7 V/800 mAh Lithium Battery only.

The provided document is a 510(k) Premarket Notification from the FDA for the Edan Instruments, Inc. SD5 & SD6 Ultrasonic Tabletop Doppler. This document describes the device, its intended use, and compares it to a predicate device. It also briefly mentions performance testing.

However, the document does not contain the specific acceptance criteria or the detailed study results that prove the device meets these criteria in a quantitative manner, which is typical for a clinical performance study. The primary focus of this document is to demonstrate substantial equivalence to a previously cleared device (K102138, also an SD5/SD6 Ultrasonic Tabletop Doppler from Edan Instruments).

Based on the information available in the document, here's what can be extracted and inferred, along with the information that is not present:

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

Note: The above table is derived directly from the "FHR Specifications" comparison with the predicate device (K102138). The current device (SD5/SD6) actually specifies a better performance for FHR measuring range and accuracy than its predicate, which supports its substantial equivalence claim. However, these are technical specifications and not necessarily acceptance criteria from a specific clinical performance study. The document states that "all testing passed pre-specified criteria," but does not explicitly list these criteria.

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 states "Clinical test: Not applicable." This indicates that no new clinical study (with a test set of patients) was conducted for this 510(k) submission to assess the device's performance in a clinical setting. The substantial equivalence is based on technical comparisons, safety, and performance bench testing.

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 applicable. As no clinical test data is provided, there is no mention of experts or ground truth establishment for a patient test set.

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

• Not applicable. No clinical test data is provided.

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. The device is a fetal ultrasonic monitor (Doppler) for detecting fetal heart rate. It is a standalone measurement device, not an AI-powered image analysis tool that assists human readers. Therefore, an MRMC study and AI assistance effect size are not relevant to this device type.

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

• Yes, effectively. The performance data related to FHR measuring range, accuracy, and resolution (as shown in the table above) represent the standalone technical performance of the device. This performance is assessed through bench testing and compliance with standards (e.g., IEC 60601-2-37). The device, by its nature, provides a direct measurement (fetal heart rate) rather than involving an "algorithm only" in the sense of image interpretation, but its core function is performed independently to provide the output.

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

• For the technical specifications (FHR measuring range, accuracy, resolution), the ground truth would typically be established by reference measurement techniques using calibrated equipment and simulated fetal heart rate signals during bench testing. The document states "Bench testing was conducted on the SD5&SD6 Ultrasonic Tabletop Doppler, consisting of all the modules and accessories in the system. The system complies with the IEC 60601-2-37: 2007." This standard specifies requirements for the safety and essential performance of ultrasonic diagnostic and monitoring equipment, including accuracy of measurements.

8. The sample size for the training set

• Not applicable. This device is a hardware-based fetal Doppler. It does not appear to employ machine learning or AI algorithms that would require a "training set" of data in the conventional sense. Its functionality relies on established Doppler physics and signal processing techniques.

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

• Not applicable. (See point 8).

Summary of what the document focuses on for acceptance:

The primary method for demonstrating acceptance and substantial equivalence in this 510(k) submission relies on:

• Predicate Device Comparison: Showing that the new device has the same intended use, similar product design, and comparable performance and safety characteristics to a legally marketed predicate device.
• Compliance with Recognized Standards: Mentioning compliance with standards such as IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-2-37 (ultrasonic equipment safety/performance), IEC 62304 (software life cycle), ISO 10993-1, -5, -10 (biocompatibility), and NEMA UD-2 (acoustic output). Passing these tests implicitly means meeting the criteria outlined within those standards.
• Bench Testing: Conducted to ensure the system meets specified technical performance.
• Software Verification and Validation: Performed for the "moderate" level of concern software.

The absence of clinical study data is explicitly noted as "Not applicable," suggesting that the FDA deemed the technical and bench testing sufficient to establish substantial equivalence for this type of device based on its intended use and comparison to the predicate.

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