Search Results

The Ultrasonic TableTop Doppler is intended to be used by health care professionals including registered nurses, practical nurses, midwives, ultrasound technicians, and physician assistants, by prescription from licensed physicians in hospitals, clinics and private offices. The 2 MHz and/or 3 MHz 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.

Ultrasonic TableTop Doppler (Models SD5, SD6) provides the following primary features:

• Basic parameters: FHR
• 240 seconds fetal heart sound record and playback
• Infrared communication(for SD6 only)
• Ni-MH battery for 20 hours continuous working of main unit
• Li-ion battery for 2.5 hours continuous working of SD6 probe
• Charge the SD6 probe battery by main unit
• Continuous wave Doppler transducer for FHR detection

Here's a breakdown of the acceptance criteria and the study information for the Edan Instruments, Inc. Ultrasonic TableTop Doppler (Models SD5 and SD6), based on the provided text:

Based on the provided text, the submission is a 510(k) Summary of Safety and Effectiveness, which aims to demonstrate substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a clinical study with detailed performance metrics. Therefore, the "acceptance criteria" here refer to the regulatory standard of substantial equivalence, and the "study" is the overall verification and validation testing, not a traditional clinical trial with a test set, ground truth, and statistical analysis of performance metrics.

Acceptance Criteria and Reported Device Performance

Study Details (Based on the provided 510(k) summary)

The provided document describes a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to previously cleared devices rather than a standalone clinical performance study with explicit acceptance criteria for diagnostic accuracy. Therefore, many of the typical elements of a clinical study, such as specific sample sizes for test sets, expert-established ground truth, adjudication methods, or MRMC studies, are not detailed in this summary.

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified in the provided summary.
   • Data Provenance: Not specified. The document only mentions "Verification and validation testing."

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not specified. The 510(k) summary does not detail the methodology for establishing ground truth for any specific performance metrics.

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

   • Not specified.

4. 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:

   • No MRMC comparative effectiveness study was mentioned. This device is a fetal heart rate Doppler, not an AI-assisted diagnostic tool for image interpretation by human readers.

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

   • The document implies general "Hardware testing" and "Software testing," but it does not specify a standalone performance study in the context of an algorithm's diagnostic accuracy. The device itself is a standalone fetal Doppler used by healthcare professionals.

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

   • Not specified. The "Test Summary" only lists generic quality assurance measures like "Software testing," "Hardware testing," "Safety testing," "Environment test," and "Risk analysis." For a fetal Doppler, ground truth might involve comparisons against other established methods for FHR detection, but the details are not provided.

7. The sample size for the training set:

   • Not applicable as this documentation pertains to a traditional medical device (fetal Doppler) and not an AI/ML algorithm that requires a training set.

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

   • Not applicable.

Ask a specific question about this device

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.

Ask a specific question about this device