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The Baby Dopplex® 4000 is a fetal monitor, which produces CTG's and gives indication of uterine activity by processing received ultrasound/electrical signals.

In basic format, the device performs antepartum fetal monitoring and uterine activity functions.

Connecting separate modules to the Baby Dopplex® 4000 main unit allows it to perform Intrapartum monitoring operations.

In instances of twin presentations, two basic Baby Dopplex® 4000 units can be linked together so that both fetuses can be monitored simultaneously.

The BD4000 is a fetal monitor, which produces cardiotocographs (CTG) and gives indication of uterine activity by processing received ultrasound/electrical signals. In basic format, the device performs antepartum fetal monitoring and uterine activity functions. Connecting separate modules to the BD4000 main unit allows it to perform Intrapartum monitoring operations.

In instances of twin presentations, two Baby Dopplex® 4000 units can be linked together so that both fetuses can be monitored simultaneously.

The complete BD4000 system has been tested to ensure compliance with internationally recognised medical electrical equipment standards. Tests have been performed in accordance with the requirements of IEC601-1. BS EN60601-1. UL2601-1. BS EN 60601-1-2. BS EN55011 & DIN VDE 0750-1. A checklist of Essential Requirements tests has been compiled in accordance with the direction of the Medical Devices Directive 93/42/EEC. Biocompatability has been assessed in line with the principles contained within BS EN30993-1 & ISO10993-1.

The provided document (510(k) summary for the Baby Dopplex® 4000) focuses on establishing substantial equivalence to predicate devices and detailing the device's intended use and compliance with general medical device standards. It does not contain information about specific clinical studies with acceptance criteria, sample sizes, expert ground truth, or comparative effectiveness studies that are typically associated with performance evaluation of new medical devices.

Therefore, most of the requested information cannot be extracted from this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Not Available: The document does not specify quantitative acceptance criteria or detailed performance metrics from a study demonstrating the device meets those criteria. It focuses on functional equivalence to predicate devices and compliance with safety standards (IEC601-1, BS EN60601-1, UL2601-1, etc.).

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

• Not Available: No clinical or performance study details are provided, so no information on sample size or data provenance is available.

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: Since no specific test set or clinical study is described, there's no mention of experts establishing ground truth.

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

• Not Available: No test set or related adjudication method 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: The Baby Dopplex® 4000 is a fetal monitor that processes ultrasound/electrical signals for cardiotocographs (CTG) and uterine activity. It is not an AI-assisted diagnostic tool that involves human readers interpreting images, so an MRMC comparative effectiveness study in the context of "human readers improve with AI" is not relevant to this device. No such study is mentioned.

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

• Not Available: The document describes the device's functionality and its equivalence to predicate devices but does not detail any standalone algorithm performance studies. The device itself is a standalone monitor, but the request refers to performance studies of an algorithm.

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

• Not Available: No specific ground truth methodology for performance evaluation is described.

8. The sample size for the training set

• Not Applicable/Not Available: This device is not described as an AI/ML device that requires a training set in the conventional sense. The "training set" concept is typically associated with AI model development, which is not discussed for this fetal monitor.

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

• Not Applicable/Not Available: As with point 8, this is not relevant to the described device.

Information provided in the document related to "acceptance criteria" and "study":

The document primarily focuses on compliance with international safety and electrical standards as its "acceptance criteria" for market clearance:

• Acceptance Criteria (as implied by compliance testing):

  • Compliance with IEC601-1 (medical electrical equipment general requirements)
  • Compliance with BS EN60601-1
  • Compliance with UL2601-1
  • Compliance with BS EN 60601-1-2 (electromagnetic compatibility)
  • Compliance with BS EN55011 (industrial, scientific and medical (ISM) radio-frequency equipment)
  • Compliance with DIN VDE 0750-1
  • Compliance with Medical Devices Directive 93/42/EEC (Essential Requirements checklist)
  • Biocompatibility assessed in line with BS EN30993-1 & ISO10993-1.

• "Study" (as implied by the document): The document states:

  • "The complete BD4000 system has been tested to ensure compliance with internationally recognised medical electrical equipment standards."
  • "Tests have been performed in accordance with the requirements of IEC601-1. BS EN60601-1. UL2601-1. BS EN 60601-1-2. BS EN55011 & DIN VDE 0750-1."
  • "A checklist of Essential Requirements tests has been compiled in accordance with the direction of the Medical Devices Directive 93/42/EEC."
  • "Biocompatability has been assessed in line with the principles contained within BS EN30993-1 & ISO10993-1."

In summary, the provided 510(k) document is a regulatory submission for substantial equivalence based on technical specifications and compliance with general safety standards, not a detailed clinical performance study with specific acceptance criteria as you've outlined for AI/diagnostic devices.

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The Baby Dopplex® 3000 is intended for use as a fetal monitor to perform cardiotocographs ("CTG"), i.e., fetal monitoring. The Baby Dopplex® 3000 is indicated for use in all areas of fetal monitoring except where internal scalp clip monitoring and/or intrauterine pressure measurement is required.

The Baby Dopplex® 3000 is supplied complete with the following components: the main unit, a single crystal transducer, a contractions or uterine activity transducer, a patient event marker, an integral thermal printer, paper, belts, gel, a detachable power cord, and a user manual. The Baby Dopplex® 3000 includes all the basic functions and features that are internationally recognized as essential requirements for fetal monitors. With the exception of the power switch, all user controls and displays on the Baby Dopplex® 3000 main unit are arranged on a control panel which is located on the top face of the unit. Controls take the form of membrane type push buttons with tactile feedback. The Baby Dopplex® 3000 utilizes ultrasound energy at 2 MHz to detect the fetus. The power level, frequency, pulse duration and repetition rate are all preset at the manufacturing stage and there are no user controls or adjustments affecting any of these parameters.

The provided document is a 510(k) summary for the Huntleigh Healthcare's Baby Dopplex® 3000 fetal monitor, dated August 16, 1996. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance metrics for the Baby Dopplex® 3000 itself.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria or detailed device performance metrics (e.g., sensitivity, specificity, accuracy) for the Baby Dopplex® 3000. It instead provides a comparison of its technological characteristics with a predicate device.

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

The document does not describe a clinical study with a "test set" in the context of performance evaluation (e.g., diagnostic accuracy). The submission is a 510(k) premarket notification, which often relies on comparison to a legally marketed predicate device rather than de novo clinical trials unless significant technological differences or new safety/effectiveness questions arise.

• Sample Size: Not applicable/not reported for a performance test set.
• Data Provenance: Not applicable/not reported for a performance test set. The document originates from Huntleigh Healthcare in Manalapan, NJ, USA, and was reviewed by the FDA in Rockville, MD, USA.

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

Since no specific "test set" for performance evaluation is described, this information is not available.

4. Adjudication Method for the Test Set

Not applicable, as no specific performance test set is described.

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

No, an MRMC comparative effectiveness study is not mentioned or described in this 510(k) summary. The document focuses on demonstrating substantial equivalence based on technological characteristics and intended use.

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

The Baby Dopplex® 3000 is a fetal monitor that measures and displays fetal heart rate and uterine activity. While it uses ultrasound technology and processing, it is not an AI algorithm in the modern sense that would typically have a "standalone" performance evaluation for diagnostic purposes. Its use inherently involves a human (healthcare professional) interpreting its output (cardiotocographs). Therefore, a standalone algorithm-only evaluation, as often understood for AI devices, is not applicable to this type of device and not reported.

7. The Type of Ground Truth Used

No explicit "ground truth" (e.g., pathology, outcomes data) for performance evaluation is mentioned, as a formal performance study is not described. The basis for the 510(k) is substantial equivalence to a predicate device (Hewlett Packard GmbH Model 1351A Fetal Monitor), which implies that the predicate device's established safety and effectiveness serve as the benchmark.

8. The Sample Size for the Training Set

Not applicable. The Baby Dopplex® 3000 is a hardware device utilizing established ultrasonic principles, not a machine learning or AI model that requires a "training set" of data.

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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