(113 days)
The F10 Fetal Doppler measures heart rate, which is displayed on a LCD display and provides fetal heart sounds. The fetal heart rate is measured using Doppler ultrasound.
F10 is a pocket-size fetal Doppler that measures the fetal heat rate and outputs the fetal heart sound through built-in speaker. By measuring fetal heart rate(FHR), you are able to predict fetal well-being. F10 irradiates fetal wave to the abdomen of a pregnant woman to detect the Doppler frequency signal and analyze, and displays the heart rate on LCD screen. The device also provides the heart sound from the heart of fetus
The provided text is a 510(k) summary for the Mediana F10 Fetal Doppler. It does not describe a clinical study with acceptance criteria and device performance in the way typically seen for AI/ML medical devices. Instead, it focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and adherence to safety and performance standards.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable or cannot be extracted directly from this document.
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance
The document does not explicitly state quantitative acceptance criteria for clinical performance in terms of metrics like sensitivity, specificity, or FHR accuracy. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices and compliance with relevant safety and performance standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices | The F10 Fetal Doppler has the "same intended use and similar technical characteristics" as the Sonotrax (Edan Instruments, Inc.) and BT-200 (Bistos Co., Ltd.). Similarities include 'Mode of operation', 'System characteristics', 'FHR Monitoring', 'Transducer Type', 'Ultrasound Frequency', 'FHR Detection Method', 'FHR Range', 'Display method', and 'Intended use'. Minor differences in Ultrasound Frequency and Battery type are noted as not affecting efficiency, effectiveness, or safety. |
| Compliance with Electrical, Mechanical, Environmental Safety | Electrical, mechanical, and environmental safety testing according to EN/IEC 60601-1 was performed. |
| Compliance with EMC Standards | EMC testing was conducted in accordance with EN/IEC 60601-1-2(2001). |
| Performance Testing | Performance testing according to EN/IEC 60601-1 was performed. "All test results were satisfactory." |
Study Details (Based on available information)
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Sample size used for the test set and the data provenance: Not applicable. No clinical test set or data provenance from a study evaluating device performance metrics is described. The comparison is primarily based on technical specifications and adherence to standards.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth establishment is described for a test set.
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Adjudication method for the test set: Not applicable. No clinical test set requiring adjudication is described.
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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: Not applicable. This device is a fetal Doppler for measuring heart rate, not an AI/ML imaging or diagnostic aid. There is no mention of human readers or AI assistance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a hardware product that directly measures and displays FHR. There is no "algorithm only" performance reported in the context of an AI/ML device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The validation focuses on technical specifications and regulatory compliance rather than clinical ground truth for diagnostic accuracy. The "ground truth" for its function would be derived from physical measurements (e.g., of sound waves corresponding to heartbeats) rather than expert consensus on images or pathology.
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The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
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How the ground truth for the training set was established: Not applicable. This is not an AI/ML device requiring a training set.
§ 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).