(14 days)
Obstetric (2.1 and 3.2 MHz Probes) This product will be used to detect fetal heart beats as an aid for determining fetal viability.
Vascular (4.0 and 8.0 MHz Probes) This product will be used to detect blood flow in veins and arteries for assisting in the detection of peripheral vascular disease.
Diagnostic ultrasound Imaging or fluid flow analysis of the human body as follows: Fetal (Mode of Operation: CWD); Peripheral Vascular (Mode of Operation: CWD)
The LifeDop is a hand-held, battery powered, audio Doppler device used for detecting fetal heart beats and for blood flow detection in veins and arteries. The product includes four interchangeable probes (OB Late Term, OB Early Term, Vascular pencil probe, Vascular flat face probe) and user replaceable batteries. The user interface includes an on/off button, play/record button, volume control, single 2-1/4" speaker, headphone jack and LCD display for heart rate, battery and waveform information.
The provided document is a 510(k) premarket notification for the Summit Doppler Systems LifeDop Doppler Ultrasound System. It asserts substantial equivalence to predicate devices and does NOT contain information about acceptance criteria or a study proving that the device meets those criteria.
Instead, the document focuses on:
- Device Description and Intended Use: The LifeDop is a handheld, battery-powered audio Doppler device for detecting fetal heartbeats (obstetric) and blood flow in veins and arteries (peripheral vascular).
- Predicate Devices: Huntleigh Technologies Manalapan, New Jersey Dopplex II Pocket Doppler (K930200) and Medasonics Incorporated Newark, California Cadance Doppler Ultrasound System (K991441).
- Technology Summary: The core Doppler ultrasound technology is stated to be the same as the substantially equivalent predicate devices. The new technology in the LifeDop is an optional built-in audio recorder.
- Clinical Testing: The document explicitly states "None provided."
- Conclusion: The device is substantially equivalent based on comparisons of device features, materials, intended use, and performance.
Therefore, based on the provided text, there is no information regarding a study demonstrating the device meets specific acceptance criteria.
The request asks for various details related to acceptance criteria and performance studies. Since the document states "Clinical Testing: None provided" and relies on substantial equivalence to predicate devices rather than direct performance metrics against acceptance criteria, most of the requested information cannot be extracted.
Here's a breakdown of why specific points cannot be answered:
- A table of acceptance criteria and the reported device performance: Not provided. The submission relies on substantial equivalence.
- Sample sizes used for the test set and the data provenance: Not applicable, as no clinical testing was performed for this 510(k) submission.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- 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. This device is a basic audio Doppler, not an AI system.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable. This device does not use a training set in the context of an AI/machine learning model.
- How the ground truth for the training set was established: Not applicable.
§ 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).