(212 days)
HandyDop™ is a device designed to transmit and receive ultrasonic energy into and from the pregnant woman, by means of continuous wave (doppler) echoscopy. The device is indicated for use to detect the flow of blood within the body.
When using it with the 2 MHz probe, HandyDop™ is indicated for use for the early detection of fetal life, detection of multiple pregnancies, fetal screening from early gestation through delivery, and general indication of fetal well being.
When using it with the 4 MHz or 8 MHz probes, HandyDop™ is indicated for use for detection of blood flow in the peripheral vascular system for assisting in the detection of peripheral vascular disease.
The Handydop is a handheld, unidirectional, continuous wave (CW) Doppler with three changeable probes. 2MHz CW probe for foetal heartbeat detection, 4MHz CW probe and 8 MHz CW probe for peripheral vascular applications. You can hear the blood flow from a vein as a modulated noise on the speaker of the handydop. The Handydop works cordless with two 9V Battery's or Accumulators. The housings of the Handydop and the probes are made of ABS-plastics. The quartz crystals where encapsulated with Araldit-D (a Duroplastic). As control panel there are only the ON/OFF switch and the loudness wheel.
The provided document is a 510(k) summary for the HANDYDOP, a continuous wave (CW) Doppler device. It primarily focuses on demonstrating substantial equivalence to a predicate device and discussing its intended use and classification.
Critically, the document does not contain information about acceptance criteria, the study design, or device performance against specific metrics. It is a regulatory submission for market clearance, not a clinical study report. Therefore, I cannot extract the detailed information requested in your prompt regarding acceptance criteria and performance data.
Specifically, the following information is missing from the provided text:
- A table of acceptance criteria and the reported device performance: This document only describes the device and its intended uses. It does not provide any performance metrics or acceptance criteria that would typically be found in a study report (e.g., sensitivity, specificity, accuracy, signal-to-noise ratio, etc.).
- Sample size used for the test set and the data provenance: There is no mention of a test set, sample size, or data provenance (country, retrospective/prospective).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: There is no discussion of ground truth establishment or expert involvement.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: No adjudication method is described.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: This device is a standalone Doppler, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance would not be applicable or present.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The device is a human-operated Doppler; it doesn't have an "algorithm only" performance that would be separated from human interaction in this context. Its function is to transmit and receive ultrasonic energy, with interpretation done by the user.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): As no study details are provided, there is no mention of the type of ground truth.
- The sample size for the training set: This device does not appear to involve machine learning or AI, so there would be no "training set."
- How the ground truth for the training set was established: Not applicable, as there is no training set.
Summary of what is available: The device's intended use.
The document primarily focuses on the intended use of the HANDYDOP device for which substantial equivalence is being claimed:
- When using it with the 2 MHz probe: Early detection of fetal life, detection of multiple pregnancies, fetal screening from early gestation through delivery, and general indication of fetal well-being.
- When using it with the 4 MHz or 8 MHz probes: Detection of blood flow in the peripheral vascular system for assisting in the detection of peripheral vascular disease.
The FDA's letter (pages 2-3) indicates that the device has been found substantially equivalent to the predicate device (Medasonics' Cadence Doppler Ultrasound System, 510k #K991441). This "substantial equivalence" is the primary "proof" for market clearance, rather than a detailed performance study against explicit acceptance criteria in the vein of a novel AI device. The FDA also requests specific post-clearance information regarding acoustic output measurements based on production line devices, which suggests that safety and technical specifications, rather than diagnostic accuracy metrics, were the focus of evaluation for this type of device.
§ 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).