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Fetal Pillow is intended to elevate the fetal head and facilitate delivery of the fetus in women requiring a Caesarean Section at full dilation or those requiring a Caesarean Section after a failed instrumental vaginal delivery. Fetal Pillow is indicated for use at a gestational age ≥37 weeks.

The Fetal Pillow is an inflatable balloon device which consists of the following components:

• Silicone Balloon: Dome shaped balloon attached to base plate, inflated to elevate fetal head.
• Base plate: Oval shaped silicone base plate (9.3cm x 5.0cm) with internal connecting channel to allow attachment to silicone tube.
• Silicone Tube: 4mm tube attaches to connecting channel of base plate for inflation
• Two-way tap: Two-way stopcock at distal end of silicone tube, allows for inflation/deflation of balloon.
• Syringe: 60cc polypropylene syringe attached to distal end of silicon tube, used to inflate balloon with saline solution.

The Fetal Pillow is a single use, disposable, sterile device.

The subject device is a dome shaped, balloon, cephalic evaluation device that enables the elevation of the fetal head to facilitate delivery of the fetus. The inflation and application of the device only occurs under direct control of the user.

This FDA 510(k) clearance letter for the "Fetal Pillow" does not describe performance acceptance criteria or a study that proves the device meets those criteria. Instead, it states that the purpose of this 510(k) submission is to update clinical references in the Instructions for Use based on current literature, implying no new performance testing was conducted for this specific submission.

The letter explicitly mentions:

• "There were no design changes between the subject and predicate device, therefore, no additional performance data was presented as part of this 510(k) submission."
• "The information provided demonstrates that the Fetal Pillow is as safe and effective as the predicate device and supports a determination of substantial equivalence."

Therefore, based solely on the provided text, it's impossible to answer your questions about acceptance criteria and a study proving its performance, as no such study was conducted for this particular 510(k) submission. The clearance is based on the substantial equivalence to a predicate device (DEN150053), which would have had performance testing for its initial De Novo classification.

However, I can extract information related to the predicate device (DEN150053) as hinted by the included references, and explain why a detailed answer to your request isn't possible from this document.

Analysis based on the provided document (and limitations for your detailed request):

The document is a 510(k) clearance for a device called "Fetal Pillow." The key takeaway is that this specific submission (K243799) is not about proving new performance through new studies because the device's design is identical to its predicate (DEN150053). The purpose of this 510(k) was to update clinical references in the Instructions for Use. Therefore, the detailed questions about performance studies (sample size, ground truth, expert adjudication, MRMC studies, standalone performance) cannot be answered from this document because such studies were not performed for K243799.

The reference to "United States Food and Drug Administration. De Novo Classification Request For Fetal Pillow. De Novo Summary (DEN150053). 2015;1-14" strongly suggests that the original performance data would be found in the De Novo Summary for the predicate device, DEN150053.

Attempted Answer (highlighting what can't be answered from the provided text):

Since new performance data was not presented for K243799 due to substantial equivalence, the following sections cannot be populated with information from this document. Any information would be speculative or would require accessing the original DEN150053 De Novo summary.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance:

• Test Set Sample Size: Not applicable/Not provided in this 510(k). No new test set data was generated for K243799.
• Data Provenance: Not applicable/Not provided. The clinical references cited (Lassey et al., Hanley et al.) are external literature reviews/studies, not a primary study conducted for this 510(k). The original De Novo submission (DEN150053) for the predicate device would contain this information.

3. Number of Experts and Qualifications for Ground Truth:

• Not applicable/Not provided in this 510(k). No new ground truth establishment was described as no new performance study was conducted.

4. Adjudication Method:

• Not applicable/Not provided in this 510(k). No new performance study required adjudication.

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

• Not applicable/Not provided in this 510(k). No MRMC study was conducted or referenced as part of this submission for K243799. The device is a physical, interventional device, not an AI or imaging device, so conventional MRMC studies (as typically seen for diagnostic AI) would be less relevant.

6. Standalone Performance (Algorithm Only):

• Not applicable. The "Fetal Pillow" is a physical medical device, not a software algorithm. Its performance is tied to its physical characteristics and user interaction, not an algorithm's output.

7. Type of Ground Truth Used:

• Not applicable/Not provided in this 510(k). Any ground truth used would have been for the predicate device's original clearance, likely clinical outcomes from trials.

8. Training Set Sample Size:

• Not applicable. This is a physical device, not an AI/ML algorithm requiring a training set in the conventional sense.

9. How Ground Truth for Training Set was Established:

• Not applicable. Same as above.

Summary regarding the provided document:

The provided 510(k) clearance letter for the "Fetal Pillow" (K243799) is a substantial equivalence determination. This means the FDA found the device to be as safe and effective as a legally marketed predicate device (DEN150053) without requiring new clinical performance data for this specific submission. The stated purpose of K243799 was to update clinical references in the Instructions for Use, not to present new performance studies. Therefore, the detailed questions about sample sizes, expert adjudication, ground truth, and AI/MRMC studies are not addressed within this document, as these types of studies were not conducted for K243799. The information you seek would typically be found in the original De Novo classification summary (DEN150053) for the predicate device.

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Fetal & Maternal Monitor (Model: F15A, F15A Air) is intended for providing Non-Stress testing or fetal monitoring for pregnant women from the 28th week of gestation. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms.

Fetal & Maternal Monitor (Model: F15A, F15A Air) is intended for real time monitoring of fetal and maternal physiological parameters, including non-invasive monitoring and invasive monitoring:

Non-invasive physiological parameters:

• Maternal heart rates (MHR)
• Maternal ECG (MECG)
• Maternal temperature (TEMP)
• Maternal oxygen saturation (SpO2) and pulse rates (PR)
• Fetal heart rates (FHR)
• Fetal movements (FM)
• FTS-3

Note: SpO2 and PR are not available in F15A Air.

Invasive physiological parameters:

• Uterine activity
• Direct ECG (DECG)

The F15A series fetal and maternal monitor can monitor multiple physiological parameters of the fetus/mother in real time. F15A series can display, store, and print patient information and parameters, provide alarms of fetal and maternal parameters, and transmit patient data and parameters to Central Monitoring System.

F15A series fetal and maternal monitors mainly provide following primary feature:

Non-invasive physiological parameters:

• Maternal heart rates (MHR)
• Maternal ECG (MECG)
• Maternal temperature (TEMP)
• Maternal oxygen saturation (SpO2) and pulse rates (PR)
• Fetal heart rates (FHR)
• Fetal movements (FM)
• FTS-3

Note: SpO2 and PR are not available in F15A Air.

Invasive physiological parameters:

• Uterine activity
• Direct ECG (DECG)

The provided FDA 510(k) clearance letter and summary for the Fetal & Maternal Monitor (F15A, F15A Air) do not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the study that proves the device meets them.

The document focuses primarily on demonstrating substantial equivalence to a predicate device (Edan Instruments, Inc., F9 Express Fetal & Maternal Monitor, K173042) through comparison of intended use, technological characteristics, and conformance to various safety and performance standards. It mentions "functional and system level testing to validate the performance of the devices" and "results of the bench testing show that the subject device meets relevant consensus standards," but it does not specify quantitative acceptance criteria for each individual physiological parameter (e.g., FHR accuracy, SpO2 accuracy) nor the specific results of those tests beyond stating that they comply with standards.

Specifically, the document does not include information on:

• A table of acceptance criteria with specific quantitative targets for each parameter and the reported device performance values against those targets. It only states compliance with standards.
• Sample sizes used for a "test set" in the context of clinical performance evaluation (it mentions "bench testing," but this is typically laboratory-based and doesn't involve patient data in a "test set" sense for AI/algorithm performance validation).
• Data provenance for such a test set (e.g., country of origin, retrospective/prospective).
• Number or qualifications of experts used to establish ground truth.
• Adjudication methods.
• Multi-Reader Multi-Case (MRMC) studies or human reader improvement data with AI assistance.
• Standalone (algorithm-only) performance, as this is a monitoring device, not a diagnostic AI algorithm.
• Type of ground truth (beyond "bench testing" which implies engineered signals or controlled environments).
• Sample size for a training set or how ground truth for a training set was established. This device is a traditional medical device, not an AI/ML-driven diagnostic or interpretative algorithm in the way your request implies.

Therefore, based solely on the provided text, I can only address what is present or infer what is missing.

Here's a breakdown based on the available information:

Analysis of Acceptance Criteria and Performance Testing based on Provided Document

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (F9 Express Fetal & Maternal Monitor, K173042) by showing that the new device (F15A, F15A Air) has the same intended use and fundamentally similar technological characteristics, with any differences not raising new safety or effectiveness concerns.

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

The document does not provide a specific table with quantitative acceptance criteria for each physiological parameter (e.g., FHR accuracy, SpO2 accuracy) and the corresponding reported performance values obtained in testing. Instead, it states that the device was assessed for conformity with relevant consensus standards. For example, it lists:

• IEC 60601-2-37:2015: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment (relevant for FHR).
• ISO 80601-2-61:2017+A1:2018: Particular requirements for basic safety and essential performance of pulse oximeter equipment (relevant for SpO2).
• ISO 80601-2-56:2017+A1:2018: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (relevant for TEMP).
• IEC 60601-2-27:2011: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment (relevant for MECG/DECG).

Acceptance Criteria (Inferred from standards compliance): The acceptance criteria are implicitly the performance requirements specified within these listed consensus standards. These standards set limits for accuracy, precision, response time, and other performance metrics for each type of measurement.

Reported Device Performance: The document states: "The results of the bench testing show that the subject device meets relevant consensus standards." This implies that the measured performance statistics (e.g., accuracy, bias, precision) for each parameter fell within the acceptable limits defined by the respective standards. However, the specific measured values are not provided in this summary.

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

The document mentions "Bench Testing" which implies laboratory-based testing using simulators, controlled signals, or phantoms, rather than a "test set" involving patient data. There is no information provided regarding:

• Sample size (e.g., number of recordings, duration of recordings, number of simulated cases) for the bench tests for each parameter.
• Data provenance (e.g., country of origin, retrospective or prospective) as this is not a study involving patient data collection for performance validation.

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 is not applicable and not provided. For a traditional physiological monitor, ground truth for bench testing is typically established using:

• Calibrated reference equipment/simulators: e.g., ECG simulators to generate known heart rates, SpO2 simulators to generate known oxygen saturation levels.
• Physical standards/phantoms: e.g., temperature baths at known temperatures.
• Known physical properties: e.g., precise weights for pressure transducers.

Clinical experts are not involved in establishing ground truth for bench performance of these types of physiological measurements.

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

This is not applicable and not provided. Adjudication methods are relevant for human expert review of complex clinical data (e.g., medical images for AI validation) to establish a consensus ground truth. For bench testing of physiological monitors, ground truth is objectively determined by calibrated instruments or defined physical parameters.

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 is not applicable and not provided. An MRMC study is typically performed to evaluate the diagnostic accuracy of AI-assisted human interpretations versus unassisted human interpretations for AI-driven diagnostic devices. The Fetal & Maternal Monitor is a physiological monitoring device, not an AI-assisted diagnostic imaging or interpretation system. It measures and displays physiological parameters; it does not provide AI-driven assistance for human "readers" to interpret complex clinical information.

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

The device is a monitor that directly measures physiological parameters. It is not an "algorithm only" device in the sense of an AI model providing a diagnostic output. Its performance (e.g., FHR accuracy) is its standalone performance, as it directly measures these parameters. The document states "functional and system level testing to validate the performance of the devices," which would represent this type of standalone performance for the measurement functionalities. However, specific quantitative results are not given, only compliance with standards.

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

As explained in point 3, the ground truth for bench testing of physiological monitors is established using calibrated reference equipment/simulators and physical standards.

8. The sample size for the training set

This is not applicable and not provided. This device is a traditional physiological monitor, not a machine learning model that requires a "training set." Its algorithms for parameter measurement are based on established physiological principles and signal processing techniques, not on statistical learning from large datasets.

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

This is not applicable and not provided for the same reasons as point 8.

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Fetal EchoScan is a machine learning-based computer-assisted diagnosis (CADx) software device indicated as an adjunct to fetal heart ultrasound examination in pregnant women aged 18 or older undergoing second-trimester anatomic ultrasound exams.

When utilized by an interpreting physician, Fetal EchoScan provides information regarding the presence of any of the following suspicious radiographic findings:

• overriding artery
• septal defect at the cardiac crux
• abnormal relationship of the outflow tracts
• enlarged cardiothoracic ratio
• right ventricular to left ventricular size discrepancy
• tricuspid valve to mitral valve annular size discrepancy
• pulmonary valve to aortic valve annular size discrepancy
• cardiac axis deviation

Fetal EchoScan is to be used with cardiac fetal ultrasound video clips containing interpretable 4-chamber, left ventricular outflow tract, right ventricular outflow tract standard views.

Fetal EchoScan is intended for use as a concurrent reading aid for interpreting physicians (OB-GYN, MFM). It does not replace the role of the physician or of other diagnostic testing in the standard of care. When utilized by an interpreting physician, this device provides information that may be useful in rendering an accurate diagnosis regarding the potential presence of morphological abnormalities that might be suggestive of fetal congenital heart defects that may be useful in determining the need for additional exams.

Fetal EchoScan is not intended for use in multiple pregnancies, cases of heterotaxy and postnatal ultrasound exams.

Fetal EchoScan is a cloud-based software-only device which uses neural networks to detect suspicious cardiac radiographic findings for further review by trained and qualified physicians. Fetal EchoScan is intended to be used as an adjunct to the interpretation of the second-trimester fetal anatomic ultrasound exam performed between 18 and 24 weeks of gestation, for pregnant women aged 18 or more.

Here's a detailed breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) Clearance Letter for Fetal EchoScan v1.1:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" but rather presents the performance metrics achieved by the device in both standalone and reader studies. The implication is that these performance levels were deemed acceptable for clearance.

Table 1. Standalone Performance of Fetal EchoScan v1.1 for all suspicious radiographic findings Combined

Table 2. Reader Study Performance of Fetal EchoScan v1.1 for all suspicious radiographic findings Combined

Note: The numerical acceptance criteria for "high sensitivity" and "high specificity" are not explicitly defined in the provided document, but the reported performance values surpassed what was considered acceptable by the FDA for substantial equivalence.

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

• Test Set Sample Size (Standalone Testing): 877 clinically acquired fetal ultrasound exams.
• Test Set Sample Size (Reader Study): 200 exams.
• Data Provenance:
  • Country of Origin: U.S.A. and France.
  • Retrospective or Prospective: The document doesn't explicitly state whether the data was retrospective or prospective, but it mentions "clinically acquired" exams, which often implies retrospective use of existing data.

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

• Number of Experts: Three (3) pediatric cardiologists.
• Qualifications of Experts: Pediatric cardiologists. No further details on years of experience or board certification are provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Majority voting among the three pediatric cardiologists.

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

• Was an MRMC study done? Yes.
• Effect Size of Human Readers' Improvement with AI vs. without AI assistance:
  • ROC AUC: Humans improved by +14.9% (from 0.825 unaided to 0.974 aided), with a p-value of 0.002.
  • Mean Sensitivity: Humans improved by +15.3% (from 0.782 unaided to 0.935 aided).
  • Mean Specificity: Humans improved by +21.1% (from 0.759 unaided to 0.970 aided).

6. Standalone Performance Study

• Was a standalone study done? Yes.
• Performance Metrics: Refer to Table 1 above. The AI system had a conclusive output rate of 98.8%. Sensitivity ranged from 0.977 to 0.987, and Specificity ranged from 0.963 to 0.977 for the detection of any suspicious findings, depending on how inconclusive outputs were treated.

7. Type of Ground Truth Used

• Ground Truth Type: Expert consensus. Specifically, it was derived from a "truthing process in which three pediatric cardiologists assessed the presence or absence of each of the eight findings, and majority voting was used." This constitutes expert consensus.

8. Sample Size for the Training Set

• The document states: "The ultrasound examinations used for training and validation are entirely distinct from the examinations used in standalone testing." However, the specific sample size for the training set is not provided in the clearance letter. It only mentions that the data used for standalone testing (877 exams) and the reader study (200 exams) were distinct from the training and validation data.

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

• The document states: "The ultrasound examinations used for training and validation are entirely distinct from the examinations used in standalone testing." However, the methodology for establishing ground truth for the training set is not explicitly detailed in the provided text. It can be inferred that a similar expert review process would have been used, but no specific details are given.

Ask a specific question about this device

Fetal EchoScan is a machine learning-based computer-assisted diagnosis (CADx) software device indicated as an adjunct to fetal heart ultrasound examination in pregnant women aged 18 or older undergoing second-trimester anatomic ultrasound exams.

When utilized by an interpreting physician, Fetal EchoScan provides information regarding the presence of any of the following suspicious radiographic findings:

• overriding artery
• septal defect at the cardiac crux
• abnormal relationship of the outflow tracts
• enlarged cardiothoracic ratio
• right ventricular to left ventricular size discrepancy
• tricuspid valve to mitral valve annular size discrepancy
• pulmonary valve to aortic valve annular size discrepancy
• cardiac axis deviation

Fetal EchoScan is to be used with cardiac fetal ultrasound video clips containing interpretable 4-chamber, left ventricular outflow tract, right ventricular outflow tract standard views.

Fetal EchoScan is intended for use as a concurrent reading aid for interpreting physicians (OB-GYN, MFM). It does not replace the role of the physician or of other diagnostic testing in the standard of care. When utilized by an interpreting physician, this device provides information that may be useful in rendering an accurate diagnosis regarding the potential presence of morphological abnormalities that might be suggestive of fetal congenital heart defects that may be useful in determining the need for additional exams.

Fetal EchoScan is not intended for use in multiple pregnancies, cases of heterotaxy, and postnatal ultrasound exams.

Fetal EchoScan is a cloud-based software-only device which uses neural networks to detect suspicious cardiac radiographic findings for further review by trained and qualified physicians. Fetal EchoScan is intended to be used as an adjunct to the interpretation of the second-trimester fetal anatomic ultrasound exam performed between 18 and 24 weeks of gestation, for pregnant women aged 18 or more.

Here's a breakdown of the acceptance criteria and study details for the Fetal EchoScan device, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as a set of predefined thresholds. Instead, it presents the performance of the device in various metrics and then concludes that these results demonstrate substantial equivalence. For the purpose of this request, I will infer the implied acceptance criteria from the reported performance and the conclusion of substantial equivalence.

Inferred Acceptance Criteria & Reported Device Performance

2. Sample Size and Data Provenance for the Test Set

• Sample Size for Standalone Test Set: 877 clinically acquired fetal ultrasound exams.
• Sample Size for MRMC Test Set: 200 exams.
• Data Provenance: The data was collected from 11 centers in the U.S.A. and France. It was retrospectively collected as it refers to "clinically acquired fetal ultrasound exams".

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Three (3) pediatric cardiologists.
• Qualifications of Experts: The document specifies "pediatric cardiologists" but does not provide details on their years of experience or other specific qualifications beyond their specialty.

4. Adjudication Method for the Test Set

• Adjudication Method: Majority voting. This means that if at least two out of the three pediatric cardiologists agreed on the presence or absence of a finding, that was established as the ground truth.

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

• Was an MRMC study done? Yes.
• Effect size of human readers improvement with AI vs. without AI assistance:
  • ROC AUC for any suspicious finding: +14.9% increase (from 0.825 unaided to 0.974 aided, p=0.002).
  • Mean Sensitivity for any suspicious finding: +15.3% increase (from 0.782 unaided to 0.935 aided).
  • Mean Specificity for any suspicious finding: +21.1% increase (from 0.759 unaided to 0.970 aided).

6. Standalone (Algorithm Only) Performance Study

• Was a standalone study done? Yes.
• The results are presented in Table 1, showing sensitivity and specificity for "Any suspicious findings" and each individual finding, calculated under two scenarios for inconclusive outputs.

7. Type of Ground Truth Used

• Type of Ground Truth: Expert consensus. Specifically, it was derived from a truthing process by three pediatric cardiologists using majority voting.

8. Sample Size for the Training Set

• The document states that "The ultrasound examinations used for training and validation are entirely distinct from the examinations used in standalone testing," but it does not explicitly provide the sample size for the training set.

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

• The document states that the "ultrasound examinations used for training and validation are entirely distinct from the examinations used in standalone testing." However, similar to the training set sample size, it does not explicitly describe how the ground truth for the training set was established. It only details the ground truth establishment for the test sets (standalone and MRMC).

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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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F6/F9 Fetal & Maternal Monitor is intended for non-invasive monitoring of fetus during antepartum examination, labor and delivery. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms.

F6/F9 Fetal & Maternal Monitor provides Non-Stress testing for pregnant women from the 28th week of gestation. It can externally monitor the FHRs using ultrasound and uterine activity via a TOCO transducer. Alternatively, it can internally monitor one of the FHRs with DECG and uterine activity with an IUPC.

F6 Express/F9 Express Fetal & Maternal Monitor is intended for monitoring physiological parameters of pregnant women during antepartum examination, labor and delivery. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms.

F6 Express/F9 Express Fetal & Maternal Monitor is intended for providing Non-Stress testing or fetal monitoring for pregnant women from the 28th week of gestation. In addition, it provides a solution for maternal vital signs monitoring.

F3/F2 Fetal Monitor is intended for non-invasive monitoring of fetus during antepartum examination, labor and delivery. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms.

The monitor provides non-stress testing for pregnant women from the 28th week of gestation. It can externally monitor the FHRs using ultrasound and uterine activity via a TOCO transducer. Alternatively, it can internally monitor one of the FHRs with DECG and uterine activity with an IUPC.

The subject devices are bedside fetal and maternal monitors, which are used to monitor the physiological parameters of pregnant women including the fetus from 28 weeks gestation. The devices may be used antepartum as well as during labor and delivery. The submission seeks clearance for several devices and their accessories, which were modified since their last 510(k) clearance.

The subject devices of the present submission include the F2/F3 and F6/F9 fetal monitors as well as the F6/F9 Express, which provide both fetal and maternal monitoring capabilities.

The fetal and maternal physiological parameters that are supported by the EDAN bedside monitors are as follows:

• Fetal heart rate (FHR)
• Tocodynamometry (TOCO) for external monitoring of uterine contractions .
• Fetal Movement (FM) ●
• Automated Fetal Movement (AFM) ●
• Direct ECG (DECG) for internal monitoring of fetal heart rate
• . Intrauterine pressure catheter (IUP) for internal monitoring of uterine contractions
• . Maternal ECG (MECG)
• . Noninvasive blood pressure (NIBP) was added to F6/F9 Express in this submission
• Maternal Sp02 (MSp02) for monitoring pulse rate (PR) .
• . Temperature (TEMP) for monitoring maternal temperature

This document describes the regulatory submission for Fetal & Maternal Monitors (Models F6, F6 Express, F9, F9 Express) and Fetal Monitors (Models F2, F3) by Edan Instruments, Inc. It is a 510(k) premarket notification, aiming to demonstrate substantial equivalence to previously marketed predicate devices.

The document does not contain information about a study that proves the device meets specific acceptance criteria in the context of an AI/algorithm-driven medical device. Instead, it focuses on demonstrating substantial equivalence to existing predicate devices based on technical specifications and regulatory safety/performance testing. The performance data provided are related to general device functionality, electrical safety, electromagnetic compatibility, and sensor evaluations, rather than demonstrating performance against an AI algorithm's specific performance targets (like sensitivity, specificity, or accuracy) on a clinical test set.

Therefore, many of the requested elements pertaining to an AI/algorithm study (such as ground truth establishment, sample sizes for training/test sets in an AI context, expert qualifications, or MRMC studies) are not present in this document.

However, I can extract information related to the device's technical specifications and the types of performance data submitted for its clearance, which could be interpreted as acceptance criteria for a traditional medical device, rather than an AI.

Here's a breakdown of the available information:

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

The document doesn't provide a formal "acceptance criteria table" with specific numerical targets and results in the way an AI performance study would. However, it lists technical specifications for the new devices and compares them to predicate devices, indicating that "Same" values or minor acceptable "Different" values (with justification) serve as the "acceptance criteria" for substantial equivalence for these non-AI features.

Here's an attempt to structure relevant technical specifications from the comparison tables (pages 7 and 12-15), which imply the "acceptance criteria" through their "Comparison" column:

Note: Differences are highlighted. The document states that "The differences in technological characteristics do not raise different questions for safety or effectiveness."

For Fetal Monitors F2 & F3 vs. Predicate F3:

Note: Differences are highlighted. The document states that "The differences in technological characteristics do not raise different questions for safety or effectiveness."

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

• Test Set Sample Size: Not specified for any AI/algorithm performance testing as none was conducted in this context. The performance data listed (software validation, electrical safety, EMC, NIBP sensor evaluation, ultrasound transducer evaluation) are typical for medical device regulatory clearance, which usually involves a defined set of tests on the device itself, rather than a clinical dataset for AI performance.
• Data Provenance: Not applicable for an AI test set. The nature of these tests is laboratory or bench testing on the device prototypes. No mention of country of origin of data or retrospective/prospective studies in the context of clinical data for performance evaluation.

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

• Not applicable. No AI/algorithm performance study requiring expert adjudication was conducted or reported.

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

• Not applicable. No AI/algorithm performance study requiring adjudication was conducted or reported.

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:

• No MRMC study was done or reported. This device is a monitoring system and not an AI-assisted diagnostic tool for which such a study would be relevant.

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

• Not applicable. This is a monitoring device, not an AI algorithm.

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

• Not applicable. The performance data provided relate to device function and safety parameters (e.g., electrical safety, NIBP accuracy against reference measurements, etc.). "Ground truth" in this context would be defined by standard test methodologies and calibrated reference equipment.

8. The sample size for the training set:

• Not applicable. This document is not describing an AI/machine learning device.

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

• Not applicable. This document is not describing an AI/machine learning device.

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