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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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