(90 days)
Detection of fetal heartbeat from early gestation thru delivery. Verify fetal heart viability after patient trauma. Display of fetal heart rate.
The Sonotrax fetal Doppler uses the tried and true principle of Doppler shift Of an ultrasound signal to deect the blod flow within the fetal heart and arteries. The Sonotrax Fetal Doppler uses a split D piezoelectric transducer. A high frequency oscillator supplies a continuous high frequency voltage to one half of the split D transmitter transducer. The high frequency voltage is converted to an ultrasound acoustic wave by the transducer and is transmitted to biophysical objects thru an applied coupling water based medium and moves thru biophysical objects. The acoustic ultrasound is reflected by blodd , and moving objects such as the fetal heart. The reflected ultrasound is received by the second split D receiver transducer and is converted via the piezoelectric effect into a high frequency electronic signal. The received electronic signal is amplified and detected. The result is a base band audio Doppler shifted signal which is filtered , and converted to audio via a loud speaker. At the same time the fetal heart rate is applied to and displayed on a liquid crystal counter display.
The provided text is a 510(k) submission for the SONOTRAX Ultrasonic Pocket Doppler. It describes the device, its intended use, and its equivalence to predicate devices, but it does not include a study or specific acceptance criteria with reported device performance results in the format requested.
Here's an analysis of the provided information relative to your request:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as quantifiable performance metrics with thresholds in the provided text. The submission broadly states the device "meets all of its functional requirements and performance specifications" and "complies with applicable industry and safety standards."
- Reported Device Performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy for fetal heart tone detection) are reported. The submission indicates "various performance tests" were done but doesn't detail their outcomes.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not applicable, as there's no mention of a test set with ground truth established by experts.
- Qualifications: Not applicable.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable, as no test set with ground truth is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- MRMC Study: No, there is no mention of a MRMC comparative effectiveness study.
- Effect Size of Human Readers Improvement: Not applicable, as no such study was conducted or reported.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: The device itself is a standalone ultrasonic fetal doppler. However, the submission does not report specific standalone algorithm performance metrics in the context of AI, as this device predates widespread AI application in medical devices. The "performance tests" mentioned relate to the device's functional operation.
7. The Type of Ground Truth Used:
- Ground Truth: Not explicitly defined or used in the context of a performance study demonstrating accuracy against a established truth (like pathology or clinical outcomes). The "Test Data" section refers to "safety, performance testing and validations," implying internal testing against design specifications and industry standards, not against a clinical ground truth for diagnostic accuracy.
8. The Sample Size for the Training Set:
- Sample Size: Not applicable. This device is a hardware device based on the Doppler principle, not an AI/machine learning algorithm requiring a "training set."
9. How the Ground Truth for the Training Set was Established:
- Ground Truth Establishment: Not applicable, as there is no training set for this type of device.
In summary:
The 510(k) submission for the SONOTRAX Ultrasonic Pocket Doppler focused on demonstrating substantial equivalence to predicate devices based on similar device characteristics, indications for use, and a review of safety and performance testing. It does not provide the detailed performance study information with quantifiable acceptance criteria, sample sizes, expert ground truth establishment, or AI-related metrics that you requested. Such detailed performance studies, particularly in a structured, quantitative manner, became more common and expected in later regulatory submissions, especially for software as a medical device (SaMD) and AI-powered devices.
§ 884.2660 Fetal ultrasonic monitor and accessories.
(a)
Identification. A fetal ultrasonic monitor is a device designed to transmit and receive ultrasonic energy into and from the pregnant woman, usually by means of continuous wave (doppler) echoscopy. The device is used to represent some physiological condition or characteristic in a measured value over a period of time (e.g., perinatal monitoring during labor) or in an immediately perceptible form (e.g., use of the ultrasonic stethoscope). This generic type of device may include the following accessories: signal analysis and display equipment, electronic interfaces for other equipment, patient and equipment supports, and component parts. This generic type of device does not include devices used to image some relatively unchanging physiological structure or interpret a physiological condition, but does include devices which may be set to alarm automatically at a predetermined threshold value.(b)
Classification. Class II (performance standards).