(249 days)
The Fetal Doppler JPD-100B is a hand-held, battery powered audio Doppler device used for detecting fetal heart beats.
JPD-100B Fetal Doppler is device prescribed by a licensed physician for use in hospitals and the homecare environment. It is a hand-held, battery powered audio Doppler device integrated with 2.5 MHz probe, used for detecting fetal heart beats. And the device is for prescription use and is intended for use at or after 12 weeks gestation.
The provided text is a 510(k) summary for the Shenzhen Jumper Medical Equipment Co., Ltd. Fetal Doppler JPD-100B. It does not include detailed acceptance criteria or a study proving the device meets specific performance criteria through clinical testing. Instead, it demonstrates substantial equivalence to a predicate device (MD800 Fetal Doppler, K112911) by comparing technological characteristics and adherence to relevant standards.
Here's an analysis of the information that is and is not present, based on your requested categories:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific quantitative performance criteria and results from a clinical study for the JPD-100B. It states that the device "can detect the Fetal Heart Rate" and "can display values of fetal heart rate" but doesn't provide numerical targets or achievement of these targets.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The document explicitly states "Brief discussion of clinical tests: Not applicable." This indicates that a clinical test set, in the traditional sense, was not used for this 510(k) submission. The equivalence is based on non-clinical tests (standards adherence) and comparison of technical specifications to the predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided as there was no clinical test set mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as there was no clinical test set mentioned.
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 information is not applicable/provided. The device is a Fetal Doppler, a diagnostic instrument for detecting fetal heartbeats, not an AI-assisted diagnostic tool that would involve "human readers" in the context of image interpretation or complex analysis.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not explicitly provided in terms of formal standalone performance study results. The device itself is a standalone instrument (a Fetal Doppler) that provides direct output (audio and displayed FHR values). However, a formal "standalone" performance study demonstrating accuracy against a ground truth (e.g., comparing FHR readings to a gold standard over a large sample) is not detailed. The non-clinical tests listed focus on electrical safety, EMC, and biological compatibility with standards like IEC 61266, which covers performance requirements and methods of measurement and reporting for hand-held probe Doppler fetal heartbeat detectors. This standard would indirectly address the device's functional performance in a standalone capacity.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not explicitly provided as no clinical study or specific test set with a ground truth is described. For non-clinical tests, the "ground truth" would be the specifications and performance requirements outlined in the referenced standards (e.g., IEC 61266 for performance).
8. The sample size for the training set
This information is not applicable/provided as the device is a hardware Fetal Doppler and does not involve AI/machine learning models that require a training set.
9. How the ground truth for the training set was established
This information is not applicable/provided as the device does not involve AI/machine learning models and thus no training set.
§ 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).