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The Fetal Doppler is used to detect the fetal heart rate. The device should be used by health care professionals including nurses, midwives, and specialized technicians in hospital, clinic, community and home. The device is intended for use at or after 16 weeks gestation.

The Fetal Doppler, model TK-T802CR, is a hand-held, battery powered audio Doppler device used for detecting fetal heart beats and sounds. The Fetal Doppler is used for non-invasive detection and display of the fetal heart rate (FHR) utilizing Doppler ultrasound. It has two hand-held components, a main unit and a probe. The main unit consists of the main board, power module, battery, speaker, and LCD screen. The probe consists of the ultrasonic transducers for transmission and for signal reception. The ultrasonic signal is continuously transmitted at a frequency of 2.0, 2.5, or 3.0 MHz, depending on the probe settings selected.

This document describes the premarket notification (510(k)) for the Shenzhen Taikang Medical Equipment Co., Ltd. Fetal Doppler. The FDA has determined the device is substantially equivalent to legally marketed predicate devices.

Acceptance Criteria and Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Vcomin Technology Limited Company Fetal Doppler, Model: FD-200D). The performance data provided is largely in the form of testing against applicable standards and showing similarity/equivalence to the predicate device, rather than explicit acceptance criteria and reported performance in a quantitative table for each functional aspect of the device in a clinical study.

However, based on the provided text, we can infer some key performance aspects and their reported outcomes:

Study Details:

The provided text from the 510(k) summary does not describe a clinical study with human subjects, a test set, expert readers, or ground truth establishment in the manner typically associated with AI/ML device evaluations. This submission is for a traditional medical device (Fetal Doppler) where substantial equivalence is demonstrated through engineering and performance testing against standards, and comparison to a predicate device.

Therefore, the following points are not applicable or not detailed in this specific 510(k) summary, as it's not a submission for an AI/ML-based device:

2. Sample size used for the test set and the data provenance: Not applicable in the context of a clinical test set for AI/ML. The performance testing was likely conducted in a lab environment using appropriate phantoms, simulators, or controlled setups as per the referenced standards (e.g., IEC 60601-2-37 for ultrasonic medical diagnostic equipment).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a Fetal Doppler's accuracy would be established through calibrated instruments or reference measurements, not expert consensus on images.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is not an MRMC study. The device is a diagnostic tool, not an AI assistance system for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a "standalone" hardware device, not an algorithm. Its performance is evaluated intrinsically.
7. The type of ground truth used: For FHR accuracy, the ground truth would be precise, known heart rate simulations from equipment or calibrated reference measurements. For biocompatibility, it's lab test results comparing to established biological responses. For electrical safety, it's compliance with specified measurement limits.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

In summary, for this Fetal Doppler (K211940), substantial equivalence was demonstrated primarily through:

• Comparison to a predicate device (K182526) showing sameness in intended use, design, mode of action, and core FHR specifications.
• Non-clinical performance testing against recognized international and national standards for biocompatibility (ISO 10993), electrical safety and electromagnetic compatibility (IEC 60601 series), battery safety (IEC 62133), software verification (FDA guidance), use-life, FHR accuracy (IEC 60601-2-37), and acoustic output (NEMA UD 2 and FDA guidance).

The documentation asserts that any differences in technological characteristics (like acoustic output) do not raise new questions of safety and effectiveness, thus supporting the substantial equivalence determination.

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Fetal Doppler is intended to detect fetal heart rate, and play the fetal heart sound. Fetal Doppler is indicated for use by health care professionals in hospital, clinic, community and home for singleton pregnancies after 12 weeks gestation.

Fetal Doppler is intended to detect fetal heart beats, display fetal heart rate, and play the fetal heart sound. Fetal Doppler is indicated for use by used by health care professionals in hospital, clinic, community and home for singleton pregnancies after 12 weeks gestation. It is comprised of an ultrasonic signal transmitter and receiver, analog signal processing unit, FHR calculating unit, and LCD/TFT display control unit. It has audio output and can be connected with headphones or to a recorder with audio input. The Fetal Doppler is powered by a standard 1.5 V DC alkaline battery.

This document seems to be a 510(k) summary for a Fetal Doppler device, not a study evaluating a device's performance against specific acceptance criteria in the way a clinical trial or algorithm validation study would. Therefore, much of the requested information regarding acceptance criteria for an AI/ML algorithm or a comparative effectiveness study is not available in the provided text.

The document instead focuses on demonstrating substantial equivalence to a predicate device through conformity with standards and basic performance tests.

Here's a breakdown of what is available and what is not:

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

The document does not provide a table with "acceptance criteria" and "reported device performance" in the context of an AI/ML algorithm's effectiveness. Instead, it outlines performance data provided to support substantial equivalence, primarily focusing on safety and basic operational characteristics.

Here's a summary of the performance testing conducted, which might be interpreted as meeting certain "acceptance criteria" for basic functionality:

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

This information is not provided in the document. The performance tests mentioned (biocompatibility, software V&V, electrical safety, use/battery life, acoustic output) are engineering tests, not typically clinical studies involving patient data or test sets in the context of an AI/ML algorithm.

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 applicable/not provided. The document describes testing of a medical device's physical and software components, not an AI/ML algorithm requiring expert ground truth for a test set.

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

This information is not applicable/not provided. As above, this document does not describe an AI/ML algorithm validation study that would involve expert adjudication of a test set.

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 applicable/not provided. This document is for a Fetal Doppler, which is not an AI-assisted diagnostic device. Therefore, no MRMC study or AI assistance evaluation was conducted or reported.

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

This information is not applicable/not provided. The Fetal Doppler is a standalone device; the question about "algorithm only" performance applies to AI/ML devices, which this is not. The device itself performs the function of detecting and displaying FHR.

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

This information is not applicable/not provided. The "ground truth" for a Fetal Doppler would be the actual fetal heart rate, which is derived directly from its acoustic processing, not from expert consensus or pathology in a diagnostic sense. The accuracy of the FHR measurement is stated as ±2BPM.

8. The sample size for the training set

This information is not applicable/not provided. This device is not an AI/ML algorithm that requires a "training set."

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

This information is not applicable/not provided. This device is not an AI/ML algorithm that requires a "training set" with ground truth.

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The device is used to detect the fetal heart rate. The device should be used by health care professionals including nurses, midwives, and specialized technicians in hospital, clinic, community and home.

The 510(k) covers four series of Fetal Doppler devices, including FD-200, FD-231, FD-591, and FD-640. Each series contains two models, and four series consists of a total of eight individual models (FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D). The subject devices are used for non-invasive measurement and display of the fetal heart rate (FHR) utilizing Doppler ultrasound. All models have two hand-held components, a main unit and a probe. The main unit consists of the main board, power module, battery, speaker, and LED screen. The probe consists of the ultrasonic transducers for transmission and one for signal reception. The ultrasonic signal is continuously transmitted at a frequency of 2.0. 2.5, or 3.0 MHz, depending on the probe selected. The reflected continuous signal is received, and detected Doppler shift is presented to the user. These devices are intended for use at or after 12 weeks' gestation.

The provided text is a 510(k) summary for a Fetal Doppler device. It describes the device, its intended use, and substantial equivalence to a predicate device, but it does not contain a detailed study proving the device meets specific acceptance criteria based on clinical performance with a test set, ground truth, or expert involvement.

The summary focuses on non-clinical performance testing and substantial equivalence.

Here's a breakdown of the requested information based on the provided document, highlighting what is not available:

1. Table of acceptance criteria and the reported device performance

Note: The document states that the FHR measuring range of the subject device is 50-210 bpm, while the predicate device is 50-230 bpm. This is a difference, but the document concludes it "does not raise different questions of safety and effectiveness."

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

• Not available. The document describes non-clinical performance testing, not a clinical study involving a test set of patient data to evaluate algorithmic performance. The "Use-life testing" involved evaluating "pressing-key performance and FHR measurement accuracy" under "simulated repeated use conditions," but this is not a clinical test set.

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)

• Not available. No clinical test set with expert-established ground truth is mentioned.

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

• Not available. No clinical test set with adjudication is mentioned.

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 / Not available. This device is a Fetal Doppler, which directly measures FHR. It is not an AI-assisted diagnostic tool that would typically involve human readers interpreting AI output.

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

• Not applicable / Not available. This is a hardware device for FHR detection. The "Performance" section lists device specifications for FHR measuring range, resolution, and accuracy, which are standalone device performance metrics. However, these are not the result of an "algorithm only" study in the context of AI/ML, but rather the intrinsic performance of the sensing and processing hardware.

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

• For the FHR accuracy claim (±2 bpm), the ground truth would typically be established by a highly accurate reference standard for heart rate measurement. The document implies this was evaluated during "Use-life testing" under "simulated repeated use conditions," but does not explicitly state the ground truth methodology. It would likely involve a calibrated signal generator or a highly precise alternative FHR measurement system. It does not involve expert consensus, pathology, or outcomes data.

8. The sample size for the training set

• Not applicable. This device is a Fetal Doppler, not an AI/ML device that requires a "training set" for an algorithm.

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

• Not applicable. As above, there is no mention of a training set as this is not an AI/ML device.

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The Fetal Doppler is intended to detect fetal heart beats, display fetal heart rate, and play the fetal heart sound from early gestation. The device should only be used by a trained medical professional in a clinical setting and is not intended for operated by the patient at home.

The subject device (model FD88) is a hand-held device for non-invasive measurement and display of the fetal heart rate (FHR) utilizing Dopler ultrasound. It includes two major components: main unit and probe. The main unit consists of the main board, power module, battery, speaker, and LCD screen. The main unit is supplied by a rechargeable 3.7V/500mAh Li-ion battery. The wired probe contains two angled semi-circle ultrasonic crystals, one for transmission and the other for reception. The ultrasonic signal is continuously transmitted (at a frequency of 2.5 MHz), received and presented to the user as numerical display. This device is intended to be used after 12 weeks gestation for singleton by a trained health professional in a clinical setting.

The provided text describes the acceptance criteria and the study conducted for the Fetal Doppler, Model FD88 (K182710).

Here's the information broken down as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state "acceptance criteria" for the Fetal Doppler's performance. Instead, it states that the device's "Performance is Same as the predicate device," and then lists the predicate device's performance specifications. Therefore, the predicate device's performance can be inferred as the "acceptance criteria" for substantial equivalence.

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

The document does not specify a separate "test set" for performance evaluation in terms of patient data or clinical trials. The performance data is derived from non-clinical performance testing. The document lists several types of non-clinical tests conducted, such as biocompatibility, cleaning/disinfection validation, software verification/validation, electrical safety, EMC, battery performance, ultrasound testing, acoustic output testing, and use-life testing. These tests evaluate the device's technical specifications and safety rather than its diagnostic accuracy on a patient population.

Therefore:

• Sample size for the test set: Not applicable in the context of patient data for diagnostic accuracy. The "test set" consists of the physical device units undergoing various engineering and safety tests.
• Data provenance: Not explicitly stated as being from a specific country or retrospective/prospective clinical data for a "test set." The studies are non-clinical performance testing conducted in a laboratory setting.

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

Not applicable. The provided document details non-clinical performance and safety testing, not diagnostic accuracy requiring expert panel review or ground truth establishment from patient data. The "ground truth" for these engineering tests would be established by reference standards, regulatory requirements (e.g., ISO, IEC), and established engineering principles.

4. Adjudication Method for the Test Set

Not applicable, as this was not a clinical study involving human readers or interpretation of diagnostic output that would require adjudication. The testing involved objective measurements against established standards and design specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. The document describes non-clinical performance testing, not a comparative effectiveness study involving human readers.

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

Yes, in the sense that the device's technical performance (e.g., FHR measurement range, resolution, accuracy, acoustic output) was evaluated in isolation, independent of a human operator, to ensure it met its specifications and safety standards. This is inherent in the "non-clinical performance testing" described. The device's ability to detect and display FHR is presumed to be the "algorithm's" core function.

7. The Type of Ground Truth Used

The ground truth for the non-clinical performance testing was based on:

• Reference standards and regulatory guidelines: e.g., ISO, IEC, FDA guidance documents for biocompatibility, electrical safety, EMC, ultrasound testing, and acoustic output.
• Design specifications: The device's internal design specifications for FHR measurement range, resolution, and accuracy, which were stated as being "Same as the predicate device."
• Functionality validation: Demonstrating that features like battery life, operation time, recharging, and status indicator functions met "all design specifications."

8. The Sample Size for the Training Set

Not applicable. This is not a study involving machine learning or artificial intelligence where a "training set" would be used to develop an algorithm’s performance. The Fetal Doppler is a medical device based on established Doppler ultrasound technology, not a learning-based system.

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

Not applicable, as there is no training set for this device.

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The Fetal Doppler is intended to detect fetal heart beats, display fetal heart rate and play the fetal heart sound from early gestation thru delivery for singleton pregnancies. The Fetal Doppler is intended for use by trained healthcare professionals only in a clinical setting.

The Fetal Doppler is a hand-held device for non-invasive measurement and display of the fetal heart beat utilizing the principle of Doppler shift of an ultrasound. The device consists of two main components, the main unit and probe. The main unit consists of the main board, power module, battery, speaker, and organic light-emitting diode screen. The wired probe consists of the transducer and includes two angled semi-circle ultrasonic crystals, one for transmission and one for reception. The ultrasonic signal is continuously transmitted at a frequency of 2 MHz. The reflected continuous wave signal is received by one of the crystals and then any detected Doppler shift is presented to the user.

The provided document is a 510(k) summary for a Fetal Doppler device (Models AOJ-50A and AOJ-50B). It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence.

Here's the information about acceptance criteria and the supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The core performance acceptance criteria for the Fetal Doppler relate to its ability to measure Fetal Heart Rate (FHR) accurately. The performance reported is in comparison to the predicate device, which inherently sets the acceptance criteria through substantial equivalence.

Note: The document states that the "subject and predicate device have similar technological characteristics" and that the "differences in technological characteristics between the subject and predicate device do not raise different questions of safety or effectiveness." This implies that the acceptance criteria for the subject device are met if its performance matches or falls within acceptable limits established by the predicate device for these parameters.

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

The document does not explicitly mention specific sample sizes for clinical test sets or data provenance (country of origin, retrospective/prospective clinical studies). The submission relies on non-clinical performance testing and comparison to a legally marketed predicate device.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

The document does not mention the use of human experts to establish ground truth for a test set. This type of device (Fetal Doppler) typically relies on direct measurement accuracy against established standards or instruments rather than expert interpretation of complex medical imagery or data requiring consensus.

4. Adjudication Method for the Test Set

Since no expert panel or clinical test set requiring subjective interpretation is described, an adjudication method is not applicable and therefore not mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not performed or reported as this device is a diagnostic tool primarily for objective measurement (FHR detection and display) and not one that relies on human interpretation of complex data that could be augmented by AI. The document does not describe AI assistance for human readers.

6. Standalone Performance Study (Algorithm Only)

The document focuses on the performance of the device as a whole system. It does not detail a standalone algorithm-only performance study in the context of AI or advanced algorithms. The core function is based on established Doppler ultrasound principles.

7. Type of Ground Truth Used

The ground truth for the performance parameters (like FHR measurement) would typically be established by:

• Bench testing against calibrated instruments: For accuracy, range, resolution, and acoustic output parameters, precise measurements from calibrated test equipment serve as the ground truth.
• Compliance with recognized standards: Adherence to standards like IEC 60601-1, IEC 60601-2-37, and NEMA UD2 ensures performance meets established safety and effectiveness benchmarks.

The document implicitly refers to these as the methods for establishing ground truth through "Non-Clinical Performance Testing" which includes "Ultrasound and Acoustic Testing."

8. Sample Size for the Training Set

The document does not describe or refer to a training set in the context of machine learning or AI models. This device is an ultrasonic monitor that relies on physical principles of Doppler shift, not on data-driven learning models with training sets.

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

As there is no mention of a training set for machine learning, the question of how its ground truth was established is not applicable.

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The iCareNewlife Fetal Doppler is indicated for monitoring fetal heart rate during the antepartum period as a general indication of fetal well-being. The device is for heart sounds through the speaker only. The device is 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 device is a hand-held ultrasonic fetal heart beat detector, which can detect the Fetal Heart Rate (FHR). The built-in speaker of the device allows for listening of the fetal heartbeat. The device is generally applied to above 16 weeks gestation.

Ultrasonic wave is transmitted from one piezoelectric ceramic at the front of the uterus of the pregnant women. Echo is received by the other piezoelectric ceramic at the front of the probe when ultrasonic wave reaches the fetal heart. Then it is converted into voltage. This Doppler signal is detected and demodulated from the received signal. And the Doppler frequency is consistent with the rhythm of the fetal systole and diastole. Once cardiac valves vibrate and a Doppler frequency excursion is formed. lt is transmitted an output signal of cardiac valves vibrating, and it is sent to the loudspeaker for getting a rhythmical sound with the fetal heartbeat.

The device is powered by a 9V alkaline battery.

Here's an analysis of the provided text regarding the iCareNewlife Fetal Doppler, focusing on the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Fetal Doppler JPD-100S, K110124) rather than explicit acceptance criteria defined by the manufacturer for this specific device. However, by comparing the subject device to the predicate, we can infer some performance benchmarks that were considered acceptable for market clearance.

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

The document does not provide details on a specific clinical test set sample size or its provenance (country of origin, retrospective/prospective). The "Performance Data" section primarily describes bench testing, biocompatibility testing, electrical safety, and EMC testing. The comparison to the predicate device is a theoretical assessment based on specifications.

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

This information is not provided in the document. Since there is no described clinical test set, there's no mention of experts establishing ground truth for such a set.

4. Adjudication Method for the Test Set

This information is not provided in the document, as a clinical test set with an adjudication method is not described.

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 document describes a Fetal Doppler, which is a device for detecting fetal heart rate through sound. It is not an AI-assisted diagnostic imaging system that would involve human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance is not applicable and was not done.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The iCareNewlife Fetal Doppler is a standalone device in the sense that it directly outputs fetal heart sounds via a speaker, and heart rate measurements (if displayed). It doesn't appear to be an "algorithm only" device that relies on a separate human interpretive step for its primary function of detecting the FHR. The "Performance Data" section details the device's technical specifications and compliance with safety and performance standards for its direct operation.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the technical performance characteristics (e.g., FHR measuring range, accuracy, acoustic output), the "ground truth" would have been established through calibrated measurement instruments and standardized testing procedures during bench testing. For biocompatibility, electrical safety, and EMC, compliance was determined against recognized international standards (ISO 10993, IEC 60601 series). There is no mention of clinical ground truth (e.g., expert consensus on observed fetal heart rates, pathology, or outcomes data) for a clinical performance study.

8. The Sample Size for the Training Set

This information is not provided in the document. The device does not appear to involve machine learning or AI algorithms that would require a "training set" in the conventional sense. The "Performance Data" describes traditional engineering and safety testing.

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

Since there is no "training set" for an AI algorithm mentioned, information on how its ground truth was established is not applicable and therefore not provided.

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The Fetal Doppler is a hand-held, battery powered audio Doppler device used for detecting fetal heart beats.

The Fetal Doppler is a hand-held, battery powered audio Doppler device integrated with 2MHz probe for detecting fetal heart beat. The device is normally applied to pregnancy as early as 12 weeks through the principle of ultrasound shift in hospital or homecare environment. The Fetal Doppler includes the following components: Power supply module, User interface, Signal collection and process module and Control module

The provided text describes a 510(k) submission for a Fetal Doppler device (K112911). However, the information regarding acceptance criteria and the study that proves the device meets the acceptance criteria is extremely limited. The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench tests and compliance with recognized standards.

Here's an analysis based on the provided text, highlighting what is present and what is missing based on your questions:

1. Table of acceptance criteria and reported device performance

Missing Information:

• Specific quantitative performance metrics: The document mentions compliance with standards but doesn't provide specific numerical thresholds or the device's measured performance against those thresholds (e.g., specific accuracy levels for heart rate detection, signal-to-noise ratios, etc.). It only states that the device "met all design specifications" and "complies with the following standards."

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

• Sample Size: Not explicitly stated. The submission refers to "Bench tests," which implies testing of devices in a lab setting, but doesn't quantify the number of devices or measurements taken.
• Data Provenance: The tests are described as "Bench tests," which means they were conducted in a controlled environment, likely by the manufacturer (Beijing Choice Electronic Technology Co., Ltd.) given the context of a 510(k) submission. No information on country of origin for specific test data is provided beyond the manufacturer's location (Beijing, China), and the tests are inherently "retrospective" as they are performed on the manufactured device models for regulatory submission.

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

• Not applicable. This submission focuses on non-clinical engineering and biocompatibility tests. There is no mention of a clinical study, human observers, or experts establishing ground truth for fetal heartbeat detection in a direct patient setting for this 510(k). The "ground truth" for these non-clinical tests would be the established scientific and engineering principles outlined in the referenced standards.

4. Adjudication method for the test set

• Not applicable. As there's no mention of a human-involved "test set" and ground truth establishment, there is no adjudication method described.

5. 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

• No. An MRMC study or AI assistance is not mentioned or relevant for this submission of a basic Fetal Doppler device. This device is a direct measurement tool, not an AI-assisted diagnostic system requiring human interpretation comparison.

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

• Not explicitly stated in these terms, but conceptually, yes in its most basic form. The device itself is "standalone" in that it detects fetal heartbeats directly. There is no "algorithm only" performance reported in the context of advanced signal processing or AI. The performance of the device in detecting heartbeats without human interpretation of raw signals is what the IEC 61266 standard compliance would address.

7. The type of ground truth used

• For the non-clinical tests, the "ground truth" is defined by:
  • Engineering specifications and recognized international standards: IEC 60601-1, IEC 60601-1-2, IEC 61266, ISO 10993-5, ISO 10993-10. These standards establish the acceptable performance thresholds and methodologies.
  • Comparison to a predicate device: The submission states that the proposed device was verified to be "Substantially Equivalent (SE) to the predicate device" through bench tests, implying the predicate device's performance (which was already cleared by the FDA) served as a benchmark for equivalence.

8. The sample size for the training set

• Not applicable. This device is not an AI/machine learning product and therefore does not have a "training set" in the conventional sense. The "training" for such a device would be its design and manufacturing process according to engineering principles.

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

• Not applicable. As there is no training set, there is no ground truth establishment for it.

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The Fetal Doppler JPD-100S is a hand-held, battery powered audio Doppler device used for detecting fetal heart beats.

JPD-100S Fetal Doppler is a prescription from licensed physician in hospitals, clinics and private offices. It is a hand-held, battery powered audio Doppler device integrated with 3MHz probe, used for detecting fetal heart beats. And the device is normally applied to pregnancy for more than twelve weeks.

The provided document describes the acceptance criteria and a study for the Fetal Doppler JPD-100S. However, the study conducted is primarily for substantive equivalence to a predicate device, focusing on electrical safety, EMC, and biological compatibility, rather than a clinical performance study with defined performance metrics like sensitivity or specificity.

Here's an analysis based on the information provided, highlighting what is present and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a table of specific clinical acceptance criteria (e.g., minimum sensitivity, specificity, accuracy for detecting fetal heartbeats). Instead, the "acceptance criteria" are implied by the standards the device was tested against and found compliant.

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

This information is not provided in the document. The "Test Conclusion" section mentions "Laboratory testing" but does not detail a clinical test set, sample size of patients, or data provenance. The assessment focuses on hardware compliance with standards.

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

This information is not provided. As no clinical test set for detecting fetal heartbeats is described, there's no mention of experts or their qualifications for establishing ground truth.

4. Adjudication Method for the Test Set

This information is not provided. No adjudication method is mentioned as a clinical test set is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The study described is a submission for substantial equivalence based on technical specifications and compliance with standards, not a clinical trial comparing human readers with and without AI assistance, or comparing this device to others clinically.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device is a "hand-held, battery powered audio Doppler device used for detecting fetal heart beats." This implies human-in-the-loop operation, and the documentation does not describe an "algorithm only" standalone performance evaluation. The "detection" is performed by the device, and the output (audio) is interpreted by a human user. The study focuses on the device's technical specifications and safety, not its standalone diagnostic accuracy as an autonomous algorithm.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically understood in AI/clinical performance studies (e.g., pathology, outcomes data) is not applicable to the data presented. The "ground truth" for the tests performed was compliance with engineering and safety standards (e.g., electrical safety tests, EMC tests, acoustic output measurements, biocompatibility tests). For the function of detecting fetal heartbeats, the "performance requirements" of IEC 61266 (1994) would define what constitutes "detection," but the document doesn't detail how this was clinically verified beyond stating compliance with the standard.

8. The Sample Size for the Training Set

This information is not provided. There is no mention of a "training set," as the device described is a hardware medical device (fetal Doppler) and not an AI/machine learning algorithm requiring a training phase for its core function.

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

This information is not provided and is not applicable as there is no mention of a training set for an AI/ML algorithm.

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