(131 days)
The Sense4Baby System Model B+ is indicated for conventional antepartum fetal monitoring applications in pregnancies greater than or equal to 24 weeks gestation. It may be used for antenatal monitoring (e.g., non-stress testing and/or uterine activity monitoring) in a health care setting or home.
It is to be used by health care professionals and patients on the order of a physician.
Before the Sense4Baby System Model B+ is prescribed for home use, the user (patient) must be instructed/trained in proper use of the equipment.
Home uterine activity monitoring has not been shown to prevent the onset of preterm labor nor will it prevent the occurrence of preterm birth.
The Sense4Baby System, Model B+ (MSA) is a non-invasive, wireless, external monitoring system used to measure fetal heart rate, maternal heart rate, and uterine contractions during antepartum (non-stress) testing. The system transmits the measured data to a gateway device, and then a HIPAA Compliant web based portal for storage and physician review.
The provided document is a 510(k) premarket notification for the Sense4Baby System Model B+ (MSA), a home uterine activity monitor. It focuses on demonstrating substantial equivalence to a predicate device (Huntliegh Healthcare Limited Fetal Assist, K020390) rather than presenting a detailed study proving the device meets specific acceptance criteria based on clinical performance metrics like sensitivity or specificity.
The document discusses various tests for safety, technical characteristics, and usability, but does not provide quantitative clinical performance data against specific acceptance criteria for fetal heart rate or uterine activity monitoring accuracy. Therefore, a table of acceptance criteria and reported device performance related to diagnostic accuracy cannot be created from this document.
Here's an analysis of the information provided, addressing the requested points where possible, and noting where information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not provide specific numerical acceptance criteria for clinical performance (e.g., accuracy, sensitivity, specificity for detecting fetal heart rate anomalies or uterine contractions) or the reported device performance against such metrics. The focus is on demonstrating substantial equivalence to a predicate device based on technical characteristics, safety standards, and usability.
The document states: "Verification and validation activities established the performance, functionality, and reliability characteristics of the device with respect to the predicate. Testing involved sub-system, as well as system level tests. Pass/Fail criteria were based on the specifications cleared for the predicate devices and test results demonstrated substantial equivalence." However, the specific "specifications cleared for the predicate devices" and the numerical outcomes for comparison are not detailed.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Performance (if any): Not explicitly stated for specific clinical performance studies in this document. The document mentions "two separate studies to determine the ability of the user to operate the device in the home environment" (usability studies), but does not provide sample sizes for these or any other clinical tests.
- Data Provenance: Not specified for clinical performance data. The device is intended for "antenatal monitoring... in a health care setting or home."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable based on the provided document. The document does not describe a clinical study where experts established ground truth for a test set to evaluate the device's diagnostic performance. The document focuses on technical safety, functional characteristics, and usability.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set requiring ground truth adjudication is described in the provided text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document does not describe an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The device itself is a monitoring system, not explicitly an AI-driven diagnostic interpretation tool in the context of reader study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a "monitoring system" that measures and transmits data for "physician review." It is not an algorithm designed for standalone diagnostic performance (i.e., making a diagnosis without human interpretation). Therefore, a standalone algorithm-only performance study as typically understood for AI/ML diagnostic devices is not applicable or described. The document states it is "to be used by health care professionals and patients on the order of a physician," implying human-in-the-loop operation.
7. The Type of Ground Truth Used
Not applicable. The document does not describe clinical studies that established ground truth for diagnostic accuracy (e.g., pathology, outcomes data, expert consensus). The "ground truth" implicitly referred to in the context of "predicate comparison testing" would be the performance characteristics of the predicate device. For usability studies, the "ground truth" would be successful operation of the device by users.
8. The Sample Size for the Training Set
Not applicable. This device is a physiological monitoring system, not an AI/ML device that requires a training set in the typical sense for developing a diagnostic algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set for an AI/ML algorithm.
Summary of Device Evaluation in the Document:
The 510(k) submission for the Sense4Baby System Model B+ (MSA) focuses on demonstrating substantial equivalence to a predicate device (Huntliegh Healthcare Limited Fetal Assist, K020390) by comparing:
- Indications for Use: Found to be largely similar, with minor differences in gestation age for monitoring (Sense4Baby >= 24 weeks vs. Fetal Assist approx. 26 weeks).
- Technological Characteristics: Both use Doppler Ultrasound for FHR and relative pressure sensors for uterine activity. Minor differences in ultrasound frequency (1 MHz vs 1.5 MHz) and burst rate (3125 Hz vs 3200 Hz) are discussed and deemed not to raise new safety/effectiveness concerns.
- Safety and Performance Standards Compliance: The device claims compliance with numerous international standards for electrical safety, EMC, biocompatibility, risk management, and environmental testing (e.g., IEC 60601 series, ISO 10993 series, ASTM D4169, ISO 14971, ISO 13485).
- Usability Studies: Two such studies (formative and summative) were conducted to ensure lay users could operate the device in a home environment with a "statistically equivalent" success rate to that in a healthcare provider environment. However, specific performance metrics or sample sizes for these usability studies are not detailed.
The document does not provide a traditional clinical performance study with defined acceptance criteria for diagnostic accuracy (e.g., sensitivity, specificity) against a clinical ground truth. Instead, it relies on demonstrating that the device's technical specifications and safety profile are comparable to a legally marketed predicate device.
§ 884.2730 Home uterine activity monitor.
(a)
Identification. A home uterine activity monitor (HUAM) is an electronic system for at home antepartum measurement of uterine contractions. The HUAM system comprises a tocotransducer and an at-home recorder. This device is intended for use in women with a previous preterm delivery to aid in the detection of preterm labor.(b)
Classification. Class II (special controls); guidance document (Class II Special Controls Guidance for Home Uterine Activity Monitors).