(181 days)
Contect Pocket Fetal Doppler (SONOLINE A, SONOLINE B, Baby Sound A and Baby Sound B) are hand-held, battery powered audio Doppler devices used for detecting fetal heart beats. They are all available for user replaceable batteries. The user interface includes power button, mode button, volume control, single speaker, headphone jack and LCD display for heart rate, battery and working mode, probe type.
SONOLINE A and SONOLINE B includes four interchangeable probes (2MHz normal probe,2MHz water proof probe,3MHz normal probe,3MHz water proof probe), while Baby Sound A and Baby Sound B are integrated with 2MHz probe.
Contect Pocket Fetal Doppler includes four models, SONOLINE A. SONOLINE B, Baby Sound A and Baby Sound B. They are handheld, battery powered audio Doppler devices used for detecting fetal heart beats. They are all available for user replaceable batteries.
SONOLINE A and SONOLINE B include four interchangeable probes (2MHz normal probe, 2MHz water proof probe, 3MHz normal probe and 3MHz proof resistance probe), while Baby Sound A and Baby Sound B are integrated with 2MHz probe.
The provided text does not contain detailed information about specific acceptance criteria or a dedicated study proving the device meets them. Instead, it focuses on the device's substantial equivalence to a predicate device, intended use, and general compliance with standards.
Here's an analysis based on the available information, noting the missing elements:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided text. The document states that "Laboratory testing was conducted to validate and verify that Contec Pocket Fetal Doppler met all design specifications, including electrical safety, EMC, specification," and that "Results of these tests demonstrate compliance to the requirements of all consensus standards." However, it does not specify what those "design specifications" or "consensus standards" are, nor does it provide performance metrics.
2. Sample Size Used for the Test Set and Data Provenance
Not available in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not available in the provided text.
4. Adjudication Method for the Test Set
Not available in the provided text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not conducted or mentioned in this document. The device in question is a fetal Doppler and does not involve AI for interpretation or assistance with human readers.
6. If a Standalone Study Was Done
A standalone performance study in the clinical sense (e.g., measuring diagnostic accuracy against a gold standard) is not explicitly detailed with specific metrics. The document mentions "Laboratory testing was conducted to validate and verify that Contec Pocket Fetal Doppler met all design specifications, including electrical safety, EMC, specification." This implies engineering and safety testing were performed standalone for the device, but not a clinical performance study as typically understood in the context of device accuracy.
7. The Type of Ground Truth Used
Based on the nature of the device (a fetal Doppler for detecting heartbeats) and the general regulatory context described, the "ground truth" for the device's primary function would likely be the actual presence or absence of a fetal heartbeat, potentially confirmed by other clinical methods or simultaneous observations. However, the document does not explicitly state how ground truth was established for any performance testing. For electrical safety and EMC, the ground truth would be compliance with established international standards.
8. The Sample Size for the Training Set
Not applicable. The device described is a hardware medical device (fetal Doppler) that detects fetal heartbeats. There is no indication that it utilizes a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned for this device.
Summary of what is available:
The provided documents primarily constitute a 510(k) summary for the Contec Pocket Fetal Doppler, aiming to demonstrate its substantial equivalence to an existing legally marketed predicate device (LifeDop Doppler Ultrasound System K-number: K024197). The primary evidence for meeting regulatory requirements lies in:
- Comparison to a predicate device: The device shares similar intended use, technology, and operating principles with the LifeDop Doppler Ultrasound System.
- Compliance with consensus standards: The manufacturer states that laboratory testing was conducted to ensure compliance with electrical safety, EMC, and other specifications, adhering to recognized consensus standards. However, the specific standards and test results are not detailed in this summary.
The document is a regulatory submission focused on proving equivalence and safety based on engineering tests and comparison to a predicate, rather than a detailed clinical performance study with specific acceptance criteria and ground truth derived from expert consensus or pathology.
§ 884.2660 Fetal ultrasonic monitor and accessories.
(a)
Identification. A fetal ultrasonic monitor is a device designed to transmit and receive ultrasonic energy into and from the pregnant woman, usually by means of continuous wave (doppler) echoscopy. The device is used to represent some physiological condition or characteristic in a measured value over a period of time (e.g., perinatal monitoring during labor) or in an immediately perceptible form (e.g., use of the ultrasonic stethoscope). This generic type of device may include the following accessories: signal analysis and display equipment, electronic interfaces for other equipment, patient and equipment supports, and component parts. This generic type of device does not include devices used to image some relatively unchanging physiological structure or interpret a physiological condition, but does include devices which may be set to alarm automatically at a predetermined threshold value.(b)
Classification. Class II (performance standards).