(53 days)
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.
| Criteria Category | Acceptance Criteria (Implied for 510(k) Clearance) | Reported Device Performance |
|---|---|---|
| Intended Use | Detect fetal heart tones transvaginally as an aid for determining fetal viability. | Designed for more consistent determination of fetal viability in difficult examinations when a standard transabdominal probe is insufficient (early gestations, obese patients, retroverted uteri). |
| Technology | Utilize Doppler ultrasound technology similar to predicate devices. | Uses Doppler ultrasound technology. |
| Safety & Effectiveness | Substantially equivalent to predicate devices (no new safety/effectiveness concerns). | Concluded to be substantially equivalent based on device features, materials, intended use, and performance to the predicate devices. |
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.
§ 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).