(17 days)
The Fetal Doppler JPD-100S is a hand-held, battery powered audio Doppler device used for detecting fetal heart beats.
JPD-100S Fetal Doppler is a prescription from licensed physician in hospitals, clinics and private offices. It is a hand-held, battery powered audio Doppler device integrated with 3MHz probe, used for detecting fetal heart beats. And the device is normally applied to pregnancy for more than twelve weeks.
The provided document describes the acceptance criteria and a study for the Fetal Doppler JPD-100S. However, the study conducted is primarily for substantive equivalence to a predicate device, focusing on electrical safety, EMC, and biological compatibility, rather than a clinical performance study with defined performance metrics like sensitivity or specificity.
Here's an analysis based on the information provided, highlighting what is present and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a table of specific clinical acceptance criteria (e.g., minimum sensitivity, specificity, accuracy for detecting fetal heartbeats). Instead, the "acceptance criteria" are implied by the standards the device was tested against and found compliant.
| Acceptance Criterion (Standard Compliance) | Reported Device Performance (Compliance Status) |
|---|---|
| IEC60601-1 (1988; Amendment 1, 1991-11, Amendment 2, 1995): Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | Compliant |
| IEC60601-1-2 (2001): Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests | Compliant |
| IEC 61266 (1994): Ultrasonic - Hand-held probe Doppler fetal heartbeat detectors - Performance requirements and methods of measurement and reporting | Compliant |
| ISO 10993-5 (2009): Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity | Compliant |
| ISO 10993-10 (2002; Amd. 1:2006): Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity | Compliant |
| Transducer Acoustic Output (Isata and frequency) | Compliant with standard criteria |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The "Test Conclusion" section mentions "Laboratory testing" but does not detail a clinical test set, sample size of patients, or data provenance. The assessment focuses on hardware compliance with standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided. As no clinical test set for detecting fetal heartbeats is described, there's no mention of experts or their qualifications for establishing ground truth.
4. Adjudication Method for the Test Set
This information is not provided. No adjudication method is mentioned as a clinical test set is not described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The study described is a submission for substantial equivalence based on technical specifications and compliance with standards, not a clinical trial comparing human readers with and without AI assistance, or comparing this device to others clinically.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a "hand-held, battery powered audio Doppler device used for detecting fetal heart beats." This implies human-in-the-loop operation, and the documentation does not describe an "algorithm only" standalone performance evaluation. The "detection" is performed by the device, and the output (audio) is interpreted by a human user. The study focuses on the device's technical specifications and safety, not its standalone diagnostic accuracy as an autonomous algorithm.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically understood in AI/clinical performance studies (e.g., pathology, outcomes data) is not applicable to the data presented. The "ground truth" for the tests performed was compliance with engineering and safety standards (e.g., electrical safety tests, EMC tests, acoustic output measurements, biocompatibility tests). For the function of detecting fetal heartbeats, the "performance requirements" of IEC 61266 (1994) would define what constitutes "detection," but the document doesn't detail how this was clinically verified beyond stating compliance with the standard.
8. The Sample Size for the Training Set
This information is not provided. There is no mention of a "training set," as the device described is a hardware medical device (fetal Doppler) and not an AI/machine learning algorithm requiring a training phase for its core function.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable as there is no mention of a training set for an AI/ML algorithm.
§ 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).