(29 days)
Avalon Fetal Monitor FM30: Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, ECG, oxygen saturation, non-invasive blood pressure, and pulse rate of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms and in antepartum testing areas.
Avalon Fetal Monitor FM20: Indicated for use by trained health care professionals whenever there is a need for monitoring of the physiological parameters uterine activity, heart rate, non-invasive blood pressure, pulse rate of pregnant women and the fetal heart rates of single fetuses, twins, and triplets in labor and delivery rooms and in antepartum testing areas.
The modified devices Philips Avalon Fetal Monitors FM20 and FM30 are intended for non-invasive and invasive monitoring of the physiological parameters of pregnant women during antepartum testing and labor and delivery. The Avalon FM20 and FM30 are intended for monitoring fetal and maternal heart rates, uterine activity, maternal non-invasive blood pressure (NIBP) and maternal oxygen saturation (SpO2). The Avalon FM20 and FM30 are intended for generating alarms, for displaying, storing and recording patient data and related waves.
The provided text describes a 510(k) summary for the Philips Avalon Fetal Monitors FM20 and FM30, specifically for a modification that introduces the capability of monitoring fetal heart rates of triplets. However, the text does not include detailed acceptance criteria or a specific study that quantitatively proves the device meets such criteria.
The information mainly focuses on establishing substantial equivalence to a predicate device, regulatory classifications, and the general scope of the device's intended use and functionality.
Here's a breakdown of what is and is not available in the provided text regarding your request:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not Available. The document states that "Pass/Fail criteria were based on the specifications cleared for the predicate devices" but does not provide details of these criteria nor specific reported performance metrics against them. It only states that "test results showed substantial equivalence" and "the results demonstrate that the Philips Avalon Fetal Monitors FM20 and FM30 meet all reliability requirements and performance claims." There are no quantitative performance numbers (e.g., sensitivity, specificity, accuracy, error rates) reported for the device, especially concerning the triplet monitoring capability.
2. Sample Size Used for the Test Set and Data Provenance:
- Not Available. The document mentions "performance tests, regression tests, and testing from hazard analysis" but does not specify the sample size (number of patients, records, or fetal heart rate traces) used for any of these tests. There is no information regarding the provenance of the data (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not Applicable/Not Available. Since no specific performance study with a 'ground truth' is described (such as for diagnostic accuracy), there's no mention of experts establishing ground truth or their qualifications. The device is a physiological monitor, not typically one that requires expert-established ground truth for its core function in the same way an AI diagnostic tool would.
4. Adjudication Method for the Test Set:
- Not Applicable/Not Available. As no detailed performance study requiring adjudication is described, this information is not present.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- Not Available. The document does not describe any MRMC comparative effectiveness study, nor does it mention any AI component or the effect size of AI assistance on human readers. The device is a monitor, not an AI-assisted diagnostic tool in the sense of image analysis.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
- Not Applicable/Not Available. This device is a monitor, not a standalone algorithm in the typical sense of AI/ML. Its function is to acquire and display physiological parameters. While it processes signals, the "algorithm only" performance metric as described for AI is not relevant here.
7. The Type of Ground Truth Used:
- Not Available. As no specific performance study requiring ground truth is described, this information is not present. For a physiological monitor, "ground truth" typically refers to the accuracy of the measurements against a gold standard instrument, but details of such testing are not provided beyond a general statement of meeting specifications.
8. The Sample Size for the Training Set:
- Not Applicable/Not Available. The document describes a traditional medical device (fetal monitor) and a modification for triplet monitoring. It does not indicate the use of machine learning or AI that would require a "training set."
9. How the Ground Truth for the Training Set was Established:
- Not Applicable/Not Available. Since no training set for an AI/ML algorithm is mentioned, the method for establishing its ground truth is not applicable.
In summary, the provided 510(k) summary focuses on regulatory compliance through substantial equivalence, indicating that the device's modification (triplet monitoring) was verified through "performance tests, regression tests, and testing from hazard analysis" against existing predicate specifications. However, it does not provide the detailed, quantitative performance data, sample sizes, or specifics of ground truth establishment that you requested for a comprehensive understanding of the device's acceptance criteria and the study proving it.
§ 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).