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The iCareNewlife Fetal Doppler is indicated for monitoring fetal heart rate during the antepartum period as a general indication of fetal well-being. The device is for heart sounds through the speaker only. The device is intended to be used by health care professionals including registered nurses, midwives, ultrasound technicians, and physician assistants, by prescription from licensed physicians in hospitals, clinics and private offices.

The device is a hand-held ultrasonic fetal heart beat detector, which can detect the Fetal Heart Rate (FHR). The built-in speaker of the device allows for listening of the fetal heartbeat. The device is generally applied to above 16 weeks gestation.

Ultrasonic wave is transmitted from one piezoelectric ceramic at the front of the uterus of the pregnant women. Echo is received by the other piezoelectric ceramic at the front of the probe when ultrasonic wave reaches the fetal heart. Then it is converted into voltage. This Doppler signal is detected and demodulated from the received signal. And the Doppler frequency is consistent with the rhythm of the fetal systole and diastole. Once cardiac valves vibrate and a Doppler frequency excursion is formed. lt is transmitted an output signal of cardiac valves vibrating, and it is sent to the loudspeaker for getting a rhythmical sound with the fetal heartbeat.

The device is powered by a 9V alkaline battery.

Here's an analysis of the provided text regarding the iCareNewlife Fetal Doppler, focusing on the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Fetal Doppler JPD-100S, K110124) rather than explicit acceptance criteria defined by the manufacturer for this specific device. However, by comparing the subject device to the predicate, we can infer some performance benchmarks that were considered acceptable for market clearance.

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

The document does not provide details on a specific clinical test set sample size or its provenance (country of origin, retrospective/prospective). The "Performance Data" section primarily describes bench testing, biocompatibility testing, electrical safety, and EMC testing. The comparison to the predicate device is a theoretical assessment based on specifications.

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

This information is not provided in the document. Since there is no described clinical test set, there's no mention of experts establishing ground truth for such a set.

4. Adjudication Method for the Test Set

This information is not provided in the document, as a clinical test set with an adjudication method is not described.

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

This document describes a Fetal Doppler, which is a device for detecting fetal heart rate through sound. It is not an AI-assisted diagnostic imaging system that would involve human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance is not applicable and was not done.

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

The iCareNewlife Fetal Doppler is a standalone device in the sense that it directly outputs fetal heart sounds via a speaker, and heart rate measurements (if displayed). It doesn't appear to be an "algorithm only" device that relies on a separate human interpretive step for its primary function of detecting the FHR. The "Performance Data" section details the device's technical specifications and compliance with safety and performance standards for its direct operation.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the technical performance characteristics (e.g., FHR measuring range, accuracy, acoustic output), the "ground truth" would have been established through calibrated measurement instruments and standardized testing procedures during bench testing. For biocompatibility, electrical safety, and EMC, compliance was determined against recognized international standards (ISO 10993, IEC 60601 series). There is no mention of clinical ground truth (e.g., expert consensus on observed fetal heart rates, pathology, or outcomes data) for a clinical performance study.

8. The Sample Size for the Training Set

This information is not provided in the document. The device does not appear to involve machine learning or AI algorithms that would require a "training set" in the conventional sense. The "Performance Data" describes traditional engineering and safety testing.

9. How the Ground Truth for the Training Set Was Established

Since there is no "training set" for an AI algorithm mentioned, information on how its ground truth was established is not applicable and therefore not provided.

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This product will be used to detect fetal heart tones transvaginally as an aid for determining fetal viability.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Transvaginal (N= new indication)

The EchoHeart Transvaginal Doppler is an interchangeable transvaginal Doppler probe used with the handheld LifeDop Doppler System. It is designed for more consistent determination of fetal viability in difficult examinations when a standard transabdominal probe is insufficient - such as early gestations. obese patients and retroverted uterine positions.

The provided text is a 510(k) premarket notification for the Summit Doppler Systems, Inc. EchoHeart Transvaginal Doppler. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a detailed study with acceptance criteria and device performance metrics.

Therefore, many of the requested sections (Table of acceptance criteria, sample sizes for test/training sets, number and qualifications of experts, adjudication method, MRMC study, standalone performance, ground truth types, and how ground truth was established) cannot be fully populated as they are not explicitly present in the provided document.

However, I can extract information related to the device's intended use and the basis for its clearance.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for substantial equivalence, formal acceptance criteria in terms of specific performance metrics (like sensitivity, specificity, accuracy) are not provided in the document. The "acceptance criteria" here is implicitly assumed to be "substantial equivalence" to predicate devices, meaning it performs as well as or better than the predicate for its intended use without raising new questions of safety or effectiveness.

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

The provided document does not describe a specific clinical test set (i.e., a study involving human subjects or data collected specifically to test the performance of the EchoHeart Transvaginal Doppler against a defined ground truth). The clearance is based on substantial equivalence, which primarily relies on comparing the new device's features and technological principles to existing, legally marketed devices.

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

Not applicable, as no specific test set requiring expert ground truth establishment is described in the document for the EchoHeart Transvaginal Doppler.

4. Adjudication Method for the Test Set

Not applicable, as no specific test set requiring adjudication is described.

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. The device is a transvaginal Doppler probe, not an AI-powered diagnostic system. No MRMC study is mentioned.

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

Not applicable. The device is a hardware probe used by a human practitioner. It is not an algorithm evaluated for standalone performance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the purpose of this 510(k) submission, the "ground truth" for demonstrating the device's functionality and safety is implicitly tied to the established safety and effectiveness of the predicate devices it is compared against. There is no specific, independent ground truth described as being used for a novel study of the EchoHeart probe itself.

8. The Sample Size for the Training Set

Not applicable, as this is a hardware device (Doppler probe) and not an AI/machine learning algorithm that would require a "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable for the same reason as above.

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