(162 days)
The BT-350 is a Prenatal Monitoring System for non-invasively measuring and showing graphically maternal abdominal contractions and the fetal heart rate by means of display on a non-permanent graphical display and on a strip chart recorder. This data is intended to aid in assessing the well being of the fetus during the antepatum periods(Non-Stress Test.) Therefore the Bt-350 is not used in delivery room. ,This device is for use only by trained medical personnel located in hospitals, clinics, doctor's offices and in the patient's home.
BT-350 is the fetal monitor that measures the fetal heart rate(FHR) and uterine contraction. Using these parameters, the medical team can monitor fetal status and check uterine contraction degree. BT-350 irradiates ultrasound wave to the abdomen of a pregnant woman, and detects the Doppler frequency signal reflected from the heart of the fetus. BT-350 analyzes this signal and displays the heart rate by LCD or LED(7-Segment). Also, BT-350 provides the sound from the heart of fetus. BT-350 measures the uterine contraction of a pregnant woman by pressure sensors and displays the numerical values. And BT-350 prints the heart rate of the fetus and the values of uterine contraction. BT-350 records the heart rate of the fetus, the uterine contraction of a pregnant woman, and basic information of the equipment with a provided thermal printer. BT-350 is capable of Twin Monitoring with two pulsed Ultrasound Transducers. BT-350 has a free voltage(100 240VAC input) power adaptor.
The provided text describes the Bistos BT-350 Fetal Monitor and its 510(k) submission. However, it does not contain specific acceptance criteria or details of a study demonstrating the device meets such criteria.
The document outlines the device's function, its comparison to a predicate device, and compliance with general safety and EMC standards. It states, "Electrical, mechanical, environmental safety and performance testing according to standard EN/IEC 60601-1 was performed, and EMC testing was conducted in accordance with standard EN/IEC 60601-1-2(2001). All test results were satisfactory." This indicates that general safety and electromagnetic compatibility standards were met, but it doesn't provide specific performance acceptance criteria for the fetal heart rate measurement or uterine contraction measurement, nor does it detail a study proving such performance.
Therefore, I cannot populate the requested table or answer most of the questions as the information is not present in the provided text.
Here's what can be extracted based on the limitations:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | Not specified in document |
| Electrical, mechanical, environmental safety (EN/IEC 60601-1) | "All test results were satisfactory." |
| EMC compliance (EN/IEC 60601-1-2(2001)) | "All test results were satisfactory." |
No further detailed performance acceptance criteria (e.g., accuracy, precision for FHR or uterine contraction) or specific study results demonstrating those criteria were met are provided in the document.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not specified. The document mentions "performance testing" but does not detail any clinical or performance study with a test set.
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)
- Not applicable. No clinical study or ground truth establishment process is described beyond general safety and EMC testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical study or adjudication process 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
- No. This device is a fetal monitor, not an AI-powered diagnostic imaging device. No MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware device for monitoring, not an algorithm being tested in a standalone fashion. The general safety and performance testing would refer to the device's integrated operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not specified. For general safety and EMC testing, ground truth refers to compliance with the standards, verified by testing procedures outlined in those standards. No clinical "ground truth" for diagnostic accuracy is described.
8. The sample size for the training set
- Not applicable. This device is not described as utilizing machine learning or requiring a training set in the context of its performance validation.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
§ 884.2740 Perinatal monitoring system and accessories.
(a)
Identification. A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may include any of the devices subject to §§ 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts.(b)
Classification. Class II (performance standards).