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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.

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This product will be used to detect fetal heartbeats to help determine fetal viability.

OB1 Obstetrical Doppler is a handheld, internally-powered Doppler audio instrument used for detecting fetal heart beats. There are only four user controls; Up and Down audio volume, Freeze Display, and Power On/Off. A three inch loudspeaker provides good Doppler audio. A digital LCD readout shows the fetal heart rate when it is stable for three or four seconds.

The provided text is a 510(k) summary for the OB1 Obstetrical Doppler, a handheld fetal Doppler. However, it does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and a specific study proving the device meets those criteria.

The 510(k) summary focuses on demonstrating substantial equivalence to existing predicate devices. This means the manufacturer is asserting their device is as safe and effective as devices already on the market, rather than conducting a de novo study to establish new performance metrics against specific acceptance criteria.

Here's a breakdown of what can and cannot be answered based on the provided document:

1. Table of acceptance criteria and the reported device performance:

This information is not present in the document. A 510(k) submission for this type of device typically relies on demonstrating that the new device performs similarly to predicate devices, rather than setting and meeting specific, quantifiable acceptance criteria in a dedicated performance study. The "Technology Summary" states, "Recursive filter techniques are used to detect the fetal heart rate displayed on the digital readout. This achieves similar results as the techniques (not published) in the predicate devices." This implies performance is judged by its similarity to existing, cleared devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not present in the document. Since a specific performance study with a test set is not described, these details are not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not present in the document. As no specific test set or ground truth establishment process is described, this data is unavailable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not present in the document.

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:

This information is not present in the document. An MRMC study is not mentioned. Also, this device is a handheld fetal Doppler, not an AI-assisted diagnostic tool for "human readers." Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply directly to this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not present in the document. The OB1 Obstetrical Doppler is described as a "handheld, internally-powered Doppler audio instrument used for detecting fetal heart beats." It's a direct-use device, and the concept of an "algorithm only" performance study in the context of AI is not relevant here. Its performance would be assessed through its ability to detect fetal heartbeats and display the rate, likely compared to known standards or predicate devices.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

This information is not present in the document. For a device like this, the "ground truth" for basic function would typically involve physical measurements (e.g., accuracy of heart rate detection against a known signal generator or a highly accurate reference method) rather than a clinical ground truth like pathology.

8. The sample size for the training set:

This information is not present in the document. This type of device relies on established Doppler ultrasound technology and recursive filter techniques, not machine learning or AI models that require a training set in the conventional sense.

9. How the ground truth for the training set was established:

This information is not present in the document for the reasons explained in point 8.

Summary regarding the provided text:

The 510(k) summary for the OB1 Obstetrical Doppler demonstrates substantial equivalence to predicate devices (Huntleigh Dopplex II, Medasonics Cadance, Summit LifeDop). The "technology summary" highlights that its Doppler ultrasound technology and recursive filter techniques achieve "similar results" to these predicate devices. The review process involved assessing device features, materials, intended use, and performance characteristics in comparison to these already-cleared devices, as is standard for 510(k) submissions.

The clearance letter also mandates a post-clearance special report containing "complete information, including acoustic output measurements based on production line devices." This indicates that quantifiable performance data (specifically acoustic output) was required, but this is a post-market requirement to ensure the manufactured devices conform to the design, not a pre-market study establishing acceptance criteria in the manner you've described for a diagnostic AI device.

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HandyDop™ is a device designed to transmit and receive ultrasonic energy into and from the pregnant woman, by means of continuous wave (doppler) echoscopy. The device is indicated for use to detect the flow of blood within the body.

When using it with the 2 MHz probe, HandyDop™ is indicated for use for the early detection of fetal life, detection of multiple pregnancies, fetal screening from early gestation through delivery, and general indication of fetal well being.

When using it with the 4 MHz or 8 MHz probes, HandyDop™ is indicated for use for detection of blood flow in the peripheral vascular system for assisting in the detection of peripheral vascular disease.

The Handydop is a handheld, unidirectional, continuous wave (CW) Doppler with three changeable probes. 2MHz CW probe for foetal heartbeat detection, 4MHz CW probe and 8 MHz CW probe for peripheral vascular applications. You can hear the blood flow from a vein as a modulated noise on the speaker of the handydop. The Handydop works cordless with two 9V Battery's or Accumulators. The housings of the Handydop and the probes are made of ABS-plastics. The quartz crystals where encapsulated with Araldit-D (a Duroplastic). As control panel there are only the ON/OFF switch and the loudness wheel.

The provided document is a 510(k) summary for the HANDYDOP, a continuous wave (CW) Doppler device. It primarily focuses on demonstrating substantial equivalence to a predicate device and discussing its intended use and classification.

Critically, the document does not contain information about acceptance criteria, the study design, or device performance against specific metrics. It is a regulatory submission for market clearance, not a clinical study report. Therefore, I cannot extract the detailed information requested in your prompt regarding acceptance criteria and performance data.

Specifically, the following information is missing from the provided text:

• A table of acceptance criteria and the reported device performance: This document only describes the device and its intended uses. It does not provide any performance metrics or acceptance criteria that would typically be found in a study report (e.g., sensitivity, specificity, accuracy, signal-to-noise ratio, etc.).
• Sample size used for the test set and the data provenance: There is no mention of a test set, sample size, or data provenance (country, retrospective/prospective).
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: There is no discussion of ground truth establishment or expert involvement.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: No adjudication method is described.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: This device is a standalone Doppler, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance would not be applicable or present.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The device is a human-operated Doppler; it doesn't have an "algorithm only" performance that would be separated from human interaction in this context. Its function is to transmit and receive ultrasonic energy, with interpretation done by the user.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): As no study details are provided, there is no mention of the type of ground truth.
• The sample size for the training set: This device does not appear to involve machine learning or AI, so there would be no "training set."
• How the ground truth for the training set was established: Not applicable, as there is no training set.

Summary of what is available: The device's intended use.

The document primarily focuses on the intended use of the HANDYDOP device for which substantial equivalence is being claimed:

• When using it with the 2 MHz probe: Early detection of fetal life, detection of multiple pregnancies, fetal screening from early gestation through delivery, and general indication of fetal well-being.
• When using it with the 4 MHz or 8 MHz probes: Detection of blood flow in the peripheral vascular system for assisting in the detection of peripheral vascular disease.

The FDA's letter (pages 2-3) indicates that the device has been found substantially equivalent to the predicate device (Medasonics' Cadence Doppler Ultrasound System, 510k #K991441). This "substantial equivalence" is the primary "proof" for market clearance, rather than a detailed performance study against explicit acceptance criteria in the vein of a novel AI device. The FDA also requests specific post-clearance information regarding acoustic output measurements based on production line devices, which suggests that safety and technical specifications, rather than diagnostic accuracy metrics, were the focus of evaluation for this type of device.

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