(283 days)
BT-220L/220C is a pocket sized ultrasonic fetal monitor that measures heart rate, which is displayed on an LCD display, and outputs fetal heart sounds through a built in speaker. The fetal heart rate is measured using Doppler ultrasound.
Bistos' BT-220L, BT-220C is a pocket size Fetal Doppler that measures the fetal heart rate and out put the fetal sound through built-in speaker. By measuring fetal heart rate (FHR), they are able to predict fetal well-being. BT-220 irradiates ultrasound wave to the abdomen of a pregnant women to detect. The Doppler frequency signal and analyze, displays the heart rate in LCD screen. The device also provides the heart sound from the heart of fetus.
The provided document is a 510(k) summary for the Bistos Model BT-220L and BT-220C Ultrasonic Fetal Doppler. It primarily focuses on demonstrating substantial equivalence to a predicate device (BT-200T, K100885) rather than presenting a standalone study with detailed acceptance criteria and performance metrics for the new device itself.
Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, and expert involvement is not explicitly available in this document. The document refers to an "HR Accuracy Measuring Report (G)" which likely contains the performance data, but the report itself is not included in the provided text.
Based on the available information, here's what can be inferred and what is explicitly stated:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a quantitative format for the new device (BT-220L/220C). Instead, it relies on demonstrating substantial equivalence to the predicate device (BT-200T). It mentions an "HR Accuracy Measuring Report (G)," which implies that a study was conducted to measure heart rate (HR) accuracy. However, the specific metrics and acceptance thresholds from this report are not provided.
Inferred Acceptance Criterion (from substantial equivalence): The new device's HR accuracy is expected to be comparable to, or meet the performance of, the predicate device (BT-200T).
| Acceptance Criteria (Inferred from Substantial Equivalence Goal) | Reported Device Performance (as implied by "HR Accuracy Measuring Report") |
|---|---|
| Heart Rate Accuracy similar to predicate device (BT-200T) | Performance data exists in "HR Accuracy Measuring Report (G)" (details not provided) |
2. Sample Size for the Test Set and Data Provenance
This information is not provided in the document. The "HR Accuracy Measuring Report (G)" would presumably contain these details.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document. It's unclear if expert review was used or what their qualifications were.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC study comparing human readers with and without AI assistance is not applicable here as this device is a standalone fetal doppler, not an AI-assisted diagnostic tool for human interpretation.
6. Standalone Performance
Yes, a standalone performance assessment for the device (algorithm only, without human-in-the-loop performance) was performed. This is implied by the "HR Accuracy Measuring Report (G)" which assesses the device's ability to measure fetal heart rate. The device outputs a numerical heart rate on an LCD and audibly.
7. Type of Ground Truth Used
The document does not specify the exact type of ground truth used to establish HR accuracy. However, for a fetal heart rate monitor, the ground truth would typically be established by a reference standard measurement of fetal heart rate, possibly from a high-fidelity monitoring system or directly from a fetal electrocardiogram (ECG) if applicable, or by comparison to readings from a well-established and validated predicate device.
8. Sample Size for the Training Set
This information is not applicable/not provided. The BT-220L/220C is a traditional ultrasonic fetal doppler, not an AI/machine learning device that requires a training set in the conventional sense. Its performance is based on its hardware and signal processing algorithms, which are engineered rather than trained from data.
9. How Ground Truth for the Training Set Was Established
This information is not applicable/not provided due to the nature of the device (not an AI/ML system requiring a training set).
§ 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).