(633 days)
The Sonicaid® System 8002 is for use in pregnancies from 32 weeks gestation and greater. It can be used on women who are experiencing Braxton-Hicks contractions but is not suitable for use in established labour as the fetus is then exposed to additional factors such as labour contractions, pharmacological agents, epidural anaesthesia, and the possibility of fetal infection secondary to ruptured membranes. Typical indications for use include the following:
- previous questionable fetal heart rate recordings or poor obstetric history
- abnormal umbilical blood flow vekveity waveforms
- suspected fotal anomalies
- suspicion of maternal intoxication or assault
- intrauterine growth retardation
- antepartum haemorrhage
- -- uterine pain
- reduced fetal movements
- hypertension or pre-eclampsia
- reduced amniotic fluid volume
The Sonicaid® System 8002 is used as an adjunct to and is not intended to replace or substitute The Someation of ammiotic fluid amount, Doppler evaluations, and/or biophysical profile.
The Sonicaid® System 8002 is a software accessory for the computerized analysis of antepartum cardiotocograms (CTGs) in pregnancies from 32 weeks gestation onwards. It informs the clinician whether a CTG meets a number of criteria that are indicative of a normal CTG.
Here's an analysis of the provided text regarding the Sonicaid® System 8002, focusing on acceptance criteria and the study that proves its performance:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state numerical acceptance criteria in a table format. Instead, it describes the device's function: "The Sonicaid® System 8002 informs the clinician whether a CTG meets a number of criteria that are indicative of a normal CTG."
The "Performance Studies" section broadly states: "Software verification studies were performed in-house to ensure what are "indicative" of a "normal" CTG criteria, and clinical validation studies have been performed and documented supporting the use of these criteria in the determination of a normal CTG."
Without specific metrics or thresholds, a direct numerical comparison is not possible.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not provide information on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the clinical validation studies).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not specify the number of experts used to establish ground truth or their qualifications. It only refers to "clinical validation studies."
4. Adjudication Method for the Test Set:
The document does not describe any adjudication method (e.g., 2+1, 3+1) for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not mention an MRMC comparative effectiveness study, nor does it provide an effect size for human readers improving with or without AI assistance.
6. Standalone (Algorithm Only) Performance:
The document indicates that "Software verification studies were performed in-house" and "clinical validation studies have been performed and documented." This implies that the device's performance was evaluated, likely in a standalone capacity given that it's a "software accessory for the computerized analysis of antepartum cardiotocograms." However, the specific details of this standalone performance, such as metrics (accuracy, sensitivity, specificity), are not provided in this summary.
7. Type of Ground Truth Used:
The document states that the device "informs the clinician whether a CTG meets a number of criteria that are indicative of a normal CTG." It further mentions "clinical validation studies...supporting the use of these criteria in the determination of a normal CTG." This suggests that the ground truth for "normal CTG" was established through expert clinical consensus based on established criteria for interpreting cardiotocograms. It is not explicitly stated to be pathology or outcomes data.
8. Sample Size for the Training Set:
The document does not provide details on the sample size used for a training set. Given that this is a 510(k) summary, which often focuses on validation rather than development, this information might not be included.
9. How the Ground Truth for the Training Set Was Established:
The document does not explicitly describe how ground truth for a training set was established. It only refers to "software verification studies" and "clinical validation studies" which informed the "indicative" criteria for a normal CTG. Assuming a machine learning approach, the "criteria that are indicative of a normal CTG" would likely form the basis of the ground truth labels for any training data.
§ 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).