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Detection of fetal life, detection of multiple pregnancies, fetal screens from early gestation through delivery and general indication of fetal well being. Verify fetal heart viability following patient trauma.

The Echo Sounder ES-101EX Single-handed Fetal Doppler system utilizes the well understood principle of Doppler shift of an ultrasound signal to detect the flow of blood within the fetal heart wall motion and arteries. The unit amplifies the high frequency oscillation output and then supplies this to the transmitter transducer. The high frequency voltage is converted to ultrasound by the transducer and is transmitted to external objects. The ultrasound transmitted by the transducer movers straight through biophysical object(s), and is reflected by the moving object (fetal heartbeat etc.). The reflected ultrasound is received by the receiving transducer and is converted into electronic signals again. The converted electronic signals are amplified and then are detected. After removing unnecessary noise signals and improving S/N ratio at the filter circuit, the Doppler shift signals are amplified and are converted to audible sound pressure through a speaker or a headset. Simultaneously the signals are applied to the heart rate LCD display.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Echo Sounder ES-101EX:

Summary of Device Acceptance Criteria and Performance:

Based on the provided 510(k) submission summary, the Echo Sounder ES-101EX Fetal Doppler is cleared through a substantial equivalence pathway. This means its acceptance criteria are primarily met by demonstrating that it is as safe and effective as a legally marketed predicate device, rather than through independent studies proving specific performance metrics against pre-defined thresholds.

The crucial statement is: "The conclusion drawn from these tests is that the Echo Sounder ES-101EX Singlehanded Fetal Doppler device is equivalent in safety and efficacy to its predicated device."

Therefore, the "acceptance criteria" are implicitly tied to the safety and efficacy profile of the predicate device (K023143, Echo Sounder, Model ES-102EX Fetal Doppler). The submission doesn't define specific numerical performance targets for sensitivity, specificity, accuracy, or other quantitative metrics that are often seen in AI/CADe device submissions.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify a separate "test set" in the context of an AI/algorithm-driven device. The testing described is for the device itself (hardware and its inherent functionality), not for an algorithm that processes external data.

The text states: "The Echo Sounder ES-101X Single-handed Fetal Doppler device has been subjected to extensive safety, performance, and validations prior to release. Final testing for the system includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications."

No details are provided regarding:

• The number of cases or subjects used in these "performance tests."
• The country of origin of any data (if human subjects were involved in testing).
• Whether the data would be considered retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not applicable/not provided. The device is a traditional fetal Doppler, not an AI or imaging device where expert interpretation or "ground truth" derived from expert consensus would typically be established for performance evaluation. The "ground truth" for a fetal Doppler is the presence or absence of a fetal heartbeat, which is directly detected by the device's physical principle.

4. Adjudication Method:

This information is not applicable/not provided. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation of complex data (e.g., medical images) where an algorithm's output is compared to a consensus reading. This device directly detects a physical signal.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not performed, nor is it applicable for this device. This type of study involves assessing how human readers' performance (e.g., diagnostic accuracy) changes with or without AI assistance. The Echo Sounder ES-101EX is a standalone diagnostic tool, not an AI-assistant for human interpretation.

6. Standalone Performance (Algorithm Only):

The device itself operates in a standalone manner to detect fetal heart sounds and display heart rate. However, the term "standalone performance" in the context of AI/CADe usually refers to the algorithm's performance independent of human input. Since this device is a physical diagnostic instrument and not an AI algorithm performing image analysis or similar tasks, the concept of a separate "algorithm only" performance is not directly applicable in the AI/CADe sense. The "performance tests" mentioned in the submission assess the device's ability to accurately detect and display the fetal heart rate, which is its primary function.

7. Type of Ground Truth Used:

The type of ground truth for a fetal Doppler is the actual presence or absence of fetal heart activity and its corresponding rate. This is a physiological signal, not a pathology finding from a biopsy or an outcome derived from long-term follow-up. The device directly measures this physical phenomenon.

8. Sample Size for the Training Set:

This information is not applicable/not provided. The Echo Sounder ES-101EX is a hardware device based on the established principles of Doppler ultrasound. It does not use machine learning or AI, and therefore, there is no "training set" in the computational sense.

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

This information is not applicable/not provided for the same reasons mentioned above. There is no training set for this type of device.

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