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The SD1 is a pocket Doppler device used for detecting the fetal heartbeat from the 10th week of gestation. It is intended to be used by medical professionals only.

SD1 Ultrasonic Pocket Doppler is a device prescribed by a licensed physician for use by professional healthcare providers. It is a hand-held, battery powered audio Doppler device integrated with 3 MHz probe and with optional use of Bluetooth/app, used for detecting fetal heart beats. The device is for prescription use and is intended for use at or after 10 weeks gestation.

The provided text describes the SD1 Ultrasonic Pocket Doppler, a device intended for detecting fetal heartbeats from the 10th week of gestation. While the document outlines performance data and its substantial equivalence to predicate devices, it does not detail specific acceptance criteria for performance metrics like sensitivity, specificity, or predictive values that would typically be associated with AI/ML diagnostic devices. The acceptance criteria mentioned primarily relate to regulatory compliance, electrical safety, electromagnetic compatibility, and general performance standards for ultrasonic equipment.

Therefore, I cannot provide an acceptance criteria table or information related to AI/ML specific aspects such as sample size for test sets/training sets, expert adjudication methods, MRMC studies, or standalone algorithm performance, as these details are not present in the provided document.

However, I can extract the information relevant to the performance evaluation that was conducted:

Here's a summary of the available information:

1. A table of acceptance criteria and the reported device performance

Based on the document, specific, quantitative clinical performance acceptance criteria (e.g., minimum sensitivity/specificity thresholds) and their corresponding reported values are not explicitly stated for the SD1 Ultrasonic Pocket Doppler in the context of fetal heart rate detection accuracy. The document focuses on demonstrating substantial equivalence to predicate devices by ensuring the SD1 performs comparably and meets relevant safety and performance standards.

The closest to "acceptance criteria" for clinical performance is the conclusion that:
"The results showed that it did not take more time to find the fetal heart rate in pregnant patients, from 10 weeks of gestation onward, using the SD1 Pocket Doppler in comparison to the predicate SD3 Ultrasonic Pocket Doppler." This implies an acceptance criterion related to the time taken to detect FHR, with the performance meeting this criterion by being comparable to the predicate.

General performance characteristics (like FHR Accuracy) are listed in the predicate comparison table, and the SD1 matches the predicate for these:

Other acceptance criteria are regulatory and non-clinical in nature:

2. Sample sized used for the test set and the data provenance

• Sample Size for Test Set: Not explicitly stated. The document mentions "clinical testing was conducted at a Chinese hospital" with "pregnant patients, from 10 weeks of gestation onward." The exact number of patients or cases is not provided.
• Data Provenance: Prospective, from a "Chinese hospital."

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

Not applicable. The clinical study focused on comparing the time taken to detect fetal heart rate between the subject device (SD1) and a predicate device (SD3). The "ground truth" here would likely be the confirmed presence of a fetal heartbeat, assessed by medical professionals, but the number and qualifications of experts involved in this specific assessment are not detailed.

4. Adjudication method for the test set

Not applicable. The study design described does not involve a multi-reader adjudication process for establishing ground truth, as it's a comparative performance study of two Doppler devices in detecting FHR.

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

Not applicable. This device is a fetal Doppler, not an AI-assisted diagnostic tool for image interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed.

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

Not applicable. The device is a hardware-based fetal Doppler, not an AI algorithm. Its performance inherently involves a human operator to locate the fetal heartbeat.

7. The type of ground truth used

The clinical study compared the SD1 to a legally marketed predicate device (SD3 Ultrasonic Pocket Doppler). The "ground truth" for the clinical performance aspect would be the successful detection of the fetal heart rate by a medical professional during the clinical test, effectively using the predicate device as a reference for comparison of detection time. There is no mention of pathology or other advanced outcomes data for ground truth in this context.

8. The sample size for the training set

Not applicable. This device is not an AI/ML device that requires a training set.

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

Not applicable. This device is not an AI/ML device that requires a training set.

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The SD3 Series Ultrasonic Pocket Dopplers (hereinafter called "the Doppler") are intended to be used by health care professionals including registered 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 waterproof probes are indicated for the detection of fetal heart rate from early gestation thru delivery and as a general indication of fetal well being. The 3 MHz waterproof probe is used for more than 9-week gestation and the 2 MHz is used for 12-week gestation. They can also be used to verify fetal heart viability.

The 4 MHz, 5 MHz and/or 8 MHz waterproof vascular probes are indicated for the detection of blood flow in veins and arteries for assisting in the detection of peripheral vascular disease.

The SD3 series Ultrasonic Pocket Doppler is a hand-held device for non-invasive measurement and display of fetal heart rate and blood flow velocity utilizing the principle of Doppler shift of an ultrasound. The ultrasound is transmitted from the probe to patient body (maternal abdominal wall), and moves through biophysical objects. The acoustic ultrasound is reflected by blood and moving objects such as the fetal heart. 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 processing on OLED Display, operation keys. The audio signal is taken off for the routing to the speaker to generate the analogue signals before digital processing. The following probes are supplied with the SD3 series Ultrasonic Pocket Doppler: 1. 2 MHz for fetal heart rate. 2. 3 MHz for fetal heart rate 3. 4 MHz for detections of arterial and venous blood flow velocity. 4. 5 MHz for detections of arterial and venous blood flow velocity. 5. 8 MHz for detections of arterial and venous blood flow velocity.

The provided document describes the Edan Instruments, Inc. SD3 Series Ultrasonic Pocket Doppler (K140579). Here's an analysis of the acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes Used for the Test Set and Data Provenance

• FHR Accuracy and Repeatability: The document doesn't specify a sample size for the FHR simulator testing (non-clinical). It only states that a simulator was used.
• Clinical Detection Rate:
  • 2 MHz probe: 162 tests for 11-week to 13-week pregnant women.
  • 3 MHz probe: 99 tests for 9-week to 10(+)-week pregnant women.
• Data Provenance: The document does not explicitly state the country of origin for the clinical data. It mentions "Physicians at 6 hospitals," but the location of these hospitals is not specified. However, the submitter Edan Instruments, Inc. is based in Shenzhen, P.R. China, suggesting the data may be from China, but this is not confirmed. The studies are prospective in nature, as they involve actively taking measurements.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• FHR Accuracy and Repeatability (Non-clinical): For the FHR simulator testing, the "ground truth" was established by the FHR simulator itself, which provides a known, controlled FHR. No human experts were involved in establishing this ground truth.
• Clinical Detection Rate: The "ground truth" for the clinical tests was likely the presence of a fetal heart rate (FHR) that could be detected. The determination of a "pass" or "fail" (whether FHR could be detected by the device) was made by "physicians at 6 hospitals." Their specific qualifications beyond "physicians" are not detailed, but the intended users are described as "health care professionals including registered nurses, practical nurses, midwives, ultrasound technicians, and physician assistants, by prescription from licensed physicians." It's implied that these professionals are the ones making the assessment during the clinical tests.

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method (like 2+1 or 3+1 consensus) for the clinical tests. The "pass" or "fail" determination for FHR detection appears to be a direct result of whether the device could detect an FHR and was likely determined by the operating healthcare professional.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not conducted. This device is an ultrasonic pocket doppler, not an AI-powered diagnostic tool requiring human-in-the-loop performance measurement. The evaluation focuses on the device's ability to detect FHR and blood flow.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone performance evaluation was done for the device's core functionality.

• FHR Accuracy and Repeatability: These were tested using an FHR simulator, which is an assessment of the device's performance in a controlled environment without human interpretation influencing the measurement itself.
• Clinical Detection Rate: While humans (healthcare professionals) operated the device, the "pass" or "fail" criterion was whether the device itself could detect the FHR. This is a measure of the device's standalone capability in a clinical setting.

7. The Type of Ground Truth Used

• FHR Accuracy and Repeatability: Instrumental ground truth (established by an FHR simulator providing known values).
• Clinical Detection Rate: Clinical observation/detection by healthcare professionals, confirming the presence or absence of a detectable fetal heart rate. It's not explicitly stated if this was confirmed by another gold standard (e.g., a full ultrasound), but the primary goal was to show the Doppler's ability to detect.

8. The Sample Size for the Training Set

The document does not mention any training set. This is a typical regulatory submission for a hardware medical device with embedded algorithms, not a machine learning or AI algorithm that requires a separate training phase with a distinct training dataset. The device operates based on physics principles (Doppler shift) and signal processing, not on learned patterns from a training set in the AI sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set for a machine learning algorithm was mentioned or used.

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The PD-100 series Ultrasonic Pocket Doppler are intended for use by health care professionals including registered nurses, practical nurses, midwives, ultrasound technicians, and physicians' assistants, by prescription from licensed physicians in hospitals, clinics and private offices. The 2 MHz and 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.

Not Found

This is most likely a 510(k) premarket notification letter for the PD-100 Series Ultrasonic Doppler. This type of document generally does not contain acceptance criteria or study results in the detail you are requesting.

Instead, 510(k) submissions demonstrate substantial equivalence to a legally marketed predicate device, often relying on existing validated technology and established performance characteristics rather than novel clinical studies with specific acceptance criteria as you've outlined.

Therefore, many of your questions cannot be answered from the provided text.

Here is what can be inferred or stated about the provided document:

1. A table of acceptance criteria and the reported device performance

• Cannot be provided. This document is a clearance letter, not a detailed technical report or study submission. It does not list specific acceptance criteria or reported device performance metrics in the format requested. The FDA's determination is based on the submission demonstrating substantial equivalence to a predicate device, which inherently means performance is considered "equivalent" to the predicate, but specific performance values are not typically part of the clearance letter itself.

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

• Cannot be provided. This information is not present in the clearance letter.

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)

• Cannot be provided. This information is not present in the clearance letter.

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

• Cannot be provided. This information is not present in the clearance letter.

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

• Cannot be provided. This device is an ultrasonic Doppler, not an AI-assisted diagnostic tool for interpretation by human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and would not have been performed.

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

• N/A. This device is a hardware device (ultrasonic Doppler) that produces signals (fetal heart rate, blood flow). It is not an algorithm that performs standalone diagnoses. Its performance is related to its ability to detect these physiological signals, which is then interpreted by a healthcare professional.

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

• Cannot be provided. This information is not present in the clearance letter. For Doppler devices, ground truth often involves comparison to established clinical methods or other validated Doppler devices, but the specific details are not here.

8. The sample size for the training set

• Cannot be provided. This information is not present in the clearance letter and is typically more relevant for machine learning/AI models.

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

• Cannot be provided. Same as above.

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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:

1. 2MHz for fetal heart rate.

2. 3MHz for fetal heart rate

3. SIMIZ for fetal neart face taxe

4. 4MHz for detections of arterial and venous blood flow velocity.

5. 4MHz for detections of arterial and venous blood flow velocity.

6. 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

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.

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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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