(24 days)
The Fetal Doppler is a hand-held, battery powered audio Doppler device used for detecting fetal heart beats.
The Fetal Doppler is a hand-held, battery powered audio Doppler device integrated with 2MHz probe for detecting fetal heart beat. The device is normally applied to pregnancy as early as 12 weeks through the principle of ultrasound shift in hospital or homecare environment. The Fetal Doppler includes the following components: Power supply module, User interface, Signal collection and process module and Control module
The provided text describes a 510(k) submission for a Fetal Doppler device (K112911). However, the information regarding acceptance criteria and the study that proves the device meets the acceptance criteria is extremely limited. The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench tests and compliance with recognized standards.
Here's an analysis based on the provided text, highlighting what is present and what is missing based on your questions:
1. Table of acceptance criteria and reported device performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Safety & Electrical Performance | Compliance with IEC 60601-1 (General Requirements for Safety) | Bench tests demonstrated compliance. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 (Collateral standard: Electromagnetic Compatibility) | Bench tests demonstrated compliance. |
| Doppler Performance | Compliance with IEC 61266 (Ultrasonic Hand-held probe Doppler fetal heartbeat detectors - Performance requirements and methods of measurement and reporting) | Bench tests demonstrated compliance. |
| Biocompatibility (Cytotoxicity) | Compliance with ISO 10993-5 (Tests for Vitro cytotoxicity) | Bench tests demonstrated compliance. |
| Biocompatibility (Irritation & Delayed Hypersensitivity) | Compliance with ISO 10993-10 (Test for irritation and delay-type hypersensitivity) | Bench tests demonstrated compliance. |
| Intended Use Achievement | "detecting fetal heart beats" (as per the intended use statement) | The non-clinical tests collectively aimed to verify the device's ability to perform its intended function safely and effectively, implying it can detect fetal heartbeats. |
Missing Information:
- Specific quantitative performance metrics: The document mentions compliance with standards but doesn't provide specific numerical thresholds or the device's measured performance against those thresholds (e.g., specific accuracy levels for heart rate detection, signal-to-noise ratios, etc.). It only states that the device "met all design specifications" and "complies with the following standards."
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated. The submission refers to "Bench tests," which implies testing of devices in a lab setting, but doesn't quantify the number of devices or measurements taken.
- Data Provenance: The tests are described as "Bench tests," which means they were conducted in a controlled environment, likely by the manufacturer (Beijing Choice Electronic Technology Co., Ltd.) given the context of a 510(k) submission. No information on country of origin for specific test data is provided beyond the manufacturer's location (Beijing, China), and the tests are inherently "retrospective" as they are performed on the manufactured device models for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This submission focuses on non-clinical engineering and biocompatibility tests. There is no mention of a clinical study, human observers, or experts establishing ground truth for fetal heartbeat detection in a direct patient setting for this 510(k). The "ground truth" for these non-clinical tests would be the established scientific and engineering principles outlined in the referenced standards.
4. Adjudication method for the test set
- Not applicable. As there's no mention of a human-involved "test set" and ground truth establishment, there is no adjudication method described.
5. 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
- No. An MRMC study or AI assistance is not mentioned or relevant for this submission of a basic Fetal Doppler device. This device is a direct measurement tool, not an AI-assisted diagnostic system requiring human interpretation comparison.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not explicitly stated in these terms, but conceptually, yes in its most basic form. The device itself is "standalone" in that it detects fetal heartbeats directly. There is no "algorithm only" performance reported in the context of advanced signal processing or AI. The performance of the device in detecting heartbeats without human interpretation of raw signals is what the IEC 61266 standard compliance would address.
7. The type of ground truth used
- For the non-clinical tests, the "ground truth" is defined by:
- Engineering specifications and recognized international standards: IEC 60601-1, IEC 60601-1-2, IEC 61266, ISO 10993-5, ISO 10993-10. These standards establish the acceptable performance thresholds and methodologies.
- Comparison to a predicate device: The submission states that the proposed device was verified to be "Substantially Equivalent (SE) to the predicate device" through bench tests, implying the predicate device's performance (which was already cleared by the FDA) served as a benchmark for equivalence.
8. The sample size for the training set
- Not applicable. This device is not an AI/machine learning product and therefore does not have a "training set" in the conventional sense. The "training" for such a device would be its design and manufacturing process according to engineering principles.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, there is no ground truth establishment for it.
§ 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).