(29 days)
The Sonotrax series of Ultrasonic Pocket Doppler are intended for use by health care professionals including registered nurses, practical nurses, midwives, ultrasound technicians, and physicians assistants, by nurses, midwives, ultrasound volumes. 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 well being. They can also be used to verify fetal heart viability following patient trauma.
The 4 MHz, 5 MHz and/or 8 MHz vascular probes are indicated for the detection of blood flow in veins and arteries for assisting in the detection of peripheral vascular disease.
The Sonotrax series Ultrasonic Pocket Doppler is a hand-held device The Sonotrax Schoolino and display of fetal heart rate and for non-invasive incasurement and inciple of Doppler shift of an ultrasound. The ultrasound is transmitted from the probe to patient Dody (maternal abdominal wall), and moves through biophysical objects. The acoustic ultrasound is reflected by blood and moving objects. The acoustic articles 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 The waveronm 'data- are 'upperation keys. The audio signal is taken processing on LCD Diopia), episer to generate the analogue signals before digital processing.
The following probes are supplied with the Ultrasonic Pocket Doppler:
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2MHz for fetal heart rate.
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3MHz for fetal heart rate
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SIMIZ for fetal neart face taxe
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4MHz for detections of arterial and venous blood flow velocity.
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4MHz for detections of arterial and venous blood flow velocity.
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3MHz for detections of arterial and venous blood flow velocity.
The provided text describes a 510(k) submission for the Sonotrax Series Ultrasonic Pocket Doppler. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed performance metrics as one might expect for a novel device.
Therefore, much of the requested information regarding detailed acceptance criteria, specific device performance numbers, and study design elements (like sample size for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not present in the provided text.
Here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as quantitative criteria. | The submission claims "The Sonotrax Series Ultrasonic Pocket Doppler models... use the same technology and circuitry as the already approved Sonotrax Doppler." |
| Substantial equivalence to predicate device. | "This premarket notification Submission of Ultrasonic Pocket Doppler is substantially equivalent to the predicate device." |
Missing: Specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy, precision) that would typically define acceptance criteria for a diagnostic device. The documentation focuses on technological similarity and safety/effectiveness testing without detailing numerical performance targets.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document mentions "Verification and validation testing" but does not detail the size of any test set (e.g., number of patients or recordings).
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not specified.
- Qualifications of experts: Not specified.
4. Adjudication method for the test set
- Adjudication method: Not specified.
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
- MRMC study done: No. This device is an ultrasonic pocket doppler, not an AI-assisted diagnostic tool for human readers.
- Effect size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance: Not applicable in the AI sense. The device itself is a standalone medical device that provides a fetal heart rate or blood flow detection. The "Test Summary" mentions "Software testing" and "Hardware testing," implying the device's functionality was evaluated, but this isn't analogous to standalone algorithm performance in the context of AI.
7. The type of ground truth used
- Type of Ground Truth: Not explicitly stated. Given it's a Doppler device, the "ground truth" would likely be the actual presence and rate of fetal heartbeats or vascular blood flow, determined by a reference method (e.g., direct auscultation, advanced ultrasound imaging, or other established clinical methods). However, the document does not specify how this ground truth was established for their tests.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable/Not specified. This is not an AI/machine learning device that would typically have a "training set" in the modern sense. The device operates based on physical principles (Doppler shift) and electronic processing, rather than learning from a dataset.
9. How the ground truth for the training set was established
- How ground truth was established for training set: Not applicable/Not specified. Same reason as above.
Summary of Study (Based on available information):
The provided text outlines a 510(k) submission for a medical device modification (Sonotrax Series Ultrasonic Pocket Doppler) rather than a detailed clinical study with performance metrics in the typical sense. The "study" largely consists of verification and validation testing to demonstrate the modified device (including a new 5MHz vascular probe) is substantially equivalent to its previously approved predicate device.
The "Test Summary" lists:
- Software testing
- Hardware testing
- Safety testing
- Environment test
- Risk analysis
- Final validation
These tests are typically internal engineering and quality assurance tests designed to ensure the device functions as intended, meets safety standards, and is manufactured according to specifications. They are not typically clinical trials that generate specific sensitivity/specificity numbers against an established ground truth in a patient population. The core argument for approval is that the new models and probes use the "same technology and circuitry" as the already approved predicate 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).