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The Ultrasonic Fetal Doppler (Model M520, M521, M523) is intended to detect and display fetal heart rate, and used by health care professionals in a hospital, clinic, community, and home setting for singleton pregnancies after 16 weeks gestation.

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The provided text is a 510(k) clearance letter from the FDA for an "Ultrasonic Fetal Doppler." This document primarily focuses on regulatory approval and does not contain specific information about the acceptance criteria, study details, or performance metrics of the device as typically found in clinical validation studies.

Therefore, I cannot extract the requested information regarding:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and data provenance
• Number of experts used to establish ground truth and their qualifications
• Adjudication method
• Multi-reader multi-case (MRMC) comparative effectiveness study results or effect size
• Standalone performance details
• Type of ground truth used
• Sample size for the training set
• How the ground truth for the training set was established

The document states the device's intended use: "to detect and display fetal heart rate, and used by health care professionals in a hospital, clinic, community, and home setting for singleton pregnancies after 16 weeks gestation." However, it does not provide the technical validation data that would be used to establish equivalence and meet performance criteria.

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The Pocket Fetal Doppler (Models CONTEC 10D, CONTEC 10E and CONTEC10F) is used to detect the fetal heart rate. The device should be used by health care professionals including nurses, midwives, and specialized technicians in the hospital, clinic, community and home. The device is intended for use at or after 12 weeks gestation.

The Pocket Fetal Doppler is a hand-held fetal Doppler used for non-invasive measurement and numerical display of the fetal heart rate (FHR) utilizing pulsed-wave Doppler ultrasound. The Pocket Fetal Doppler includes three models: CONTEC10E and CONTEC10E and CONTEC10F. All models have four components: upper shell, display and probe. The material for probe cap and shell is ABS. The device contains an ultrasonic signal transmitter and receiver, analog signals processing unit, FHR calculating unit, and LCD display control unit. 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. This device can detect a fetal heart rate value at or after twelve weeks gestation.

The CONTEC10D is powered by a 3.7V lithium battery, the ultrasonic signal is continuously transmitted at a frequency of 2.5MHz.

The CONTEC10E and CONTEC10F is powered by two 1.5V batteries (AA LR6), the ultrasonic signal is continuously transmitted at a frequency of 2.5MHz.

The FDA 510(k) summary for the Pocket Fetal Doppler (CONTEC 10D, 10E, 10F) does not contain the level of detail typically found in a clinical study report for device acceptance criteria and performance, especially for AI/ML-based devices. This is a traditional medical device (fetal Doppler) and not an AI/ML device, hence some of the requested information (like number of experts for ground truth, adjudication methods, MRMC studies, or training set details) is not applicable or provided in this document.

However, based on the provided text, here's an attempt to extract the relevant information regarding performance and acceptance, and clarify what is not applicable or available:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are primarily based on its ability to accurately measure fetal heart rate (FHR) within specified ranges and its compliance with relevant electrical safety, EMC, and performance standards.

1. Table of Acceptance Criteria and Reported Device Performance:

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The Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) is used to detect the fetal heart rate. The device should be used by health care professionals including nurses, midwives, and specialized technicians in the hospital, clinic, community and home. The device is intended for use at or after 12 weeks gestation.

The Pocket Fetal Doppler is a hand-held FHR detection device, it is used for non-invasive measurement and display of the fetal heart rate (FHR) utilizing Doppler ultrasound. The Pocket Fetal Doppler consists of two models (CONTEC10C, CONTEC10CL). Both models have two hand-held components, a main unit and a probe. The device contains components of ultrasonic signal transmitter and receiver, analog signals processing unit, FHR calculating unit, and LCD display control unit.

The provided text is a 510(k) Premarket Notification for a Pocket Fetal Doppler. It details the device's characteristics, indications for use, comparison to a predicate device, and results of non-clinical testing. However, it does not include information about acceptance criteria for performance metrics (beyond resolution and accuracy values), NOR does it describe a study involving human readers or experts to prove the device meets these criteria.

Therefore, many of the requested points cannot be extracted from the provided text.

Based on the information available:

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

The document provides performance specifications for the device and a predicate, but doesn't explicitly state "acceptance criteria" in a pass/fail sense in this section. It lists the device's performance characteristics.

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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:

• Battery Life Testing
• Battery Indicator Testing
• Testing per IEC 60601-2-37 Edition 2.1 2015 (ultrasonic medical diagnostic and monitoring)
• Acoustic output measurement as per FDA guidance "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" (June 27, 2019) for Track 1 devices. |
  | FHR Measuring Range | 50 – 240 BPM (Matches predicate) |
  | FHR Accuracy | ±2BPM (Matches predicate) |
  | FHR Resolution | 1BPM (Matches predicate) |
  | Iob |

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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

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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.

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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.

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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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