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The Doppler FHR Detector (Model BF-500D+ and BF-560) is intended to detect fetal heart beats, display fetal heart rate, and play the fetal heart sound in patients with singleton pregnancies after 12 weeks of gestation. The device is intended to be used by health care professionals in a hospital, clinic, community, and home setting.

The Fetal Doppler is a hand-held device for non-invasive measurement and display of the fetal heart beat utilizing Doppler 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 liquid crystal display(LCD) 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 one frequency.

The difference between BF-500D+ and BF-560 are shown as below:

• BF-500D+ is powered by a 9V rechargeable Ni-MH battery, and adapter is packaged with the unit; BF-560 is powered by three pieces of 1.5V AA alkaline disposable batteries.
• BF-500D+ will display Fetal heart rate, sound volume, and battery indicator; BF-560 will also display the selected working frequency besides in addition to the features of the BF-500D+.
• the two models have different probe shapes.

This 510(k) clearance letter pertains to a Doppler FHR Detector, a device intended to detect fetal heartbeats, display fetal heart rate, and play the fetal heart sound. The document describes non-clinical performance testing conducted to demonstrate substantial equivalence to a predicate device.

It's important to note that this document does not describe a study involving human subjects or AI-assisted diagnostic read-outs. Therefore, sections related to multi-reader multi-case studies, expert adjudication for ground truth for test sets, and the impact of AI assistance on human readers are not applicable.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a structured, quantitative table for all performance aspects. Instead, it demonstrates compliance with recognized standards and successful completion of various tests. The tables in the original document ("Table 6-1: Comparison between the predicate device BF-500B and the subject device BF-500D+" and "Table 6-2: Comparison between the predicate device BF-500B and the subject device BF-560") provide a comparison of technical characteristics and indicate "Same" or "Different" for each item, implying that similarity or acceptable differences were the internal criteria for many parameters.

For the performance tests explicitly mentioned in section 7, the reported device performance is that the device "complied with requirements" or "successfully passed all aspects of the testing." I will create a table summarizing the performance parameters that have a quantifiable criterion or a clear pass/fail outcome from the provided text.

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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.

Not Found

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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HeraBEAT™ US is intended to detect fetal heart beats, display fetal heart rate, and play the fetal heart sound. HeraBEAT™ US is indicated for use by medical professionals in clinical or home care settings for singleton pregnancies from 12 weeks gestation.

HeraBEAT™ US is a hand-held, battery powered audio Doppler device integrated with 2MHz probe, used for detecting and displaying the fetal heart rate (FHR) and FHR sound. The device uses an optical sensor to distinguish between the FHR and the maternal heart rate (MHR) to eliminate "crosstalk" in the FHR display.

HeraBEAT™ US includes the following components:

• The handheld HeraBEAT™ US device that incorporates an ultrasound transducer, rechargeable battery, and internal microcontroller and Bluetooth Low Energy (BLE) chip for wireless data transfer from the HeraBEAT™ US device to the user's smartphone.
• The HeraBEAT™ application, which is downloaded from an app store to the user's smartphone. The HeraBEAT™ application is used to communicate with the HeraBEAT™ US device using wireless BLE. It controls the operation of the device and receives the FHR values for numerical display to the user. It plays the FHR sound and stores the FHR values in a history log.

HeraBEAT™US is supplied with a battery charger (power supply), two tubes of commercially available Aquasonic 100 Ultrasound Transmission Gel (cleared under K802146), carry case and User Manual.

The HeraBEAT™ US fetal ultrasonic monitor is intended to detect fetal heart beats, display fetal heart rate, and play the fetal heart sound. It is indicated for use by medical professionals in clinical or home care settings for singleton pregnancies from 12 weeks gestation.

Here's an analysis of its acceptance criteria and the supporting study information:

1. Acceptance Criteria and Reported Device Performance

The document implicitly defines acceptance criteria through its comparison to the predicate device, MD800. The key performance metric is Fetal Heart Rate (FHR) measurement accuracy.

Note: The HeraBEAT™ US has a wider FHR measuring range (240 bpm) compared to the predicate (210 bpm), which suggests an improvement or at least equivalent capability. The accuracy and resolution are identical to the predicate.

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

The provided document does not specify a sample size for a clinical test set for FHR measurement accuracy. It mentions "Bench Performance Testing" where "Clinical measurement accuracy was conducted per the acoustic output measurement methodology as recommended in the FDA guidance document." This suggests the accuracy was validated using simulated signals or known standards in a lab environment, not necessarily a study with a test set of actual patients.

Therefore, details on data provenance (country of origin, retrospective/prospective) and the type of ground truth are not applicable as there is no described clinical test set for FHR accuracy.

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

This information is not provided in the document as there is no described clinical test set with human-established ground truth for FHR measurement. The accuracy was assessed against acoustic output measurement methodologies, not expert interpretation of fetal heart sounds/rates from patients.

4. Adjudication Method

This information is not provided in the document. As there is no described clinical test set involving human interpretation and ground truth establishment, adjudication methods are not applicable.

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

There is no mention of an MRMC comparative effectiveness study in the provided document. The submission focuses on substantial equivalence based on technical characteristics and bench testing.

6. Standalone Performance Study

The document describes "Bench Performance Testing" where "Clinical measurement accuracy was conducted per the acoustic output measurement methodology as recommended in the FDA guidance document 'Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers,' dated September 9, 2008." This indicates that the device's accuracy in measuring FHR was assessed using a controlled, standalone method, likely with calibrated equipment or simulated signals, to verify its technical specifications. However, this is distinct from a clinical standalone study involving human patients.

7. Type of Ground Truth Used

For the "Bench Performance Testing" of FHR measurement accuracy, the ground truth was established by:

• Acoustic output measurement methodology per FDA guidance: This implies the use of validated standards and equipment to measure the acoustic output and resulting FHR determination, rather than expert consensus, pathology, or outcomes data from patients.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set for the HeraBEAT™ US device. Given that it's a fixed-function fetal doppler, it's unlikely to rely on typical machine learning training sets in the same way an AI-powered diagnostic image analysis tool would. Its performance is based on established signal processing and measurement principles inherent in the hardware and software design.

9. How Ground Truth for the Training Set Was Established

This information is not applicable as no training set is mentioned for the device.

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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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