Search Results

The device is an ultrasonic fetal heart beat detector, which can detect the Fetal Heart Rate. The built in speaker of the device allows for listening of the fetal heartbeat.

This Doppler tests the fetal heart rate through non-invasive ultrasonic Doppler Effect. As is known, ultrasonic wave propagating at a given frequency will be reflected when encountering an obstacle. If it is still an obstacle, the back wave will share the same frequency with the transmitted wave. Once the obstacle moves, the frequency of the back wave will be changed. The higher rate the object moves at, the bigger frequency change will take place. This is the so-called Doppler Effect. With the apparatus, the ultrasonic probe is placed on the abdomen of the pregnant woman. The ultrasonic probe can perceive the fetal heartbeat. When the transmitted wave encounters the fetal heart, the back wave will develop offset frequency. With the offset frequency, the fetal heart rate and frequency can be worked out.

The provided text from K082055 is a 510(k) summary for the PC-860 Fetal Doppler. It primarily focuses on demonstrating substantial equivalence to a predicate device and safety/performance based on standards.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for Fetal Heart Rate (FHR) detection accuracy. Instead, it broadly states that "Clinical testing was used to validate the effectiveness and accuracy of the device. Specific testing relating to Ultrasound equipment was use to verify performance to recognized standards. All test results were satisfactory."

Given this, the table below reflects what can be inferred or is directly stated:

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

The document states "Clinical testing was used to validate the effectiveness and accuracy of the device" but does not specify the sample size for this clinical testing.

The data provenance (e.g., country of origin, retrospective or prospective) is not mentioned.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not provide any information regarding the number of experts, their qualifications, or their role in establishing ground truth for any test set.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method used for a test set.

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

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being conducted or its results. The device appears to be a standalone Fetal Doppler, not an AI-assisted interpretation tool for human readers.

6. Standalone Performance Study

The document states "Clinical testing was used to validate the effectiveness and accuracy of the device." This implies a standalone performance study was done to evaluate the device's ability to detect Fetal Heart Rate independently. However, specific performance metrics (e.g., sensitivity, specificity, accuracy against a reference) are not provided beyond the general statement of "satisfactory."

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for the clinical testing. Given it's a Fetal Doppler, the ground truth would typically be a reference method for FHR measurement (e.g., a cardiotocograph (CTG), a more advanced ultrasound, or expert auscultation with a stopwatch), but this is not detailed.

8. Sample Size for the Training Set

The document does not mention a training set or its sample size. Fetal Dopplers of this type typically do not involve machine learning models that require a distinct training set in the same way modern AI systems do. Their function is based on physical principles (Doppler effect) and signal processing.

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

Since a training set is not mentioned as part of the device's development or validation, there is no information on how its ground truth might have been established.

Summary of Missing Information:

This 510(k) summary is from 2009, a period before the widespread requirement for detailed AI/ML validation studies. As such, it lacks specific quantitative acceptance criteria, detailed clinical study methodologies (sample size, expert involvement, ground truth specifics), and any information relating to AI-specific study paradigms like MRMC or training sets. The submission focuses on substantial equivalence to a predicate device and adherence to general safety and performance standards for medical devices.

Ask a specific question about this device