(139 days)
These devices are intended to be used as replacement accessories to Corometrics Monitors, to measure fetal heart rate in the gravid patient.
AIV's ultrasound (US) and tocodynamometer (TOCO) transducers are replacements for similar transducers manufactured by Corometrics and Hewlett Packard for their respective monitors. The AIV transducers are also a replacement for similar transducers manufactured by Epic for use on Corometrics and Hewlett Packard monitors. The US transducers are used to detect the fetal heart rate using Doppier shift technology. These transducers are intended to be a direct replacement for the Corometrics transducers.
The provided document is a 510(k) Summary for a medical device (Transducers for Ultrasound Fetal Monitoring) and does not contain detailed information about a clinical study or specific acceptance criteria for performance metrics beyond general functional equivalence.
However, I can extract the relevant information that is present and indicate where specific details you requested are not available in this document.
Here's an attempt to answer your request based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from comparison to predicate) | Reported Device Performance (from "Performance Data and Conclusions") |
|---|---|
| Acoustic Output ≤ 20mW/cm² average | Acoustic output testing shows power is less than 20mW/cm² average. |
| Assembly design equivalent to predicate device | AIV assembly design is equivalent to predicate device assembly design. |
| Biocompatibility (Conforms to consensus standards) | AIV plastics have conformed to consensus standards relating to Biocompatibility. |
| Perform as intended (measure fetal heart rate) | Alv assembly design is equivalent to producted by devices perform as intended and are equivalent to predicate device assemblies. |
| Does not raise new safety or effectiveness issues, nor alter fundamental technology of predicate devices | These devices do not raise new issues of safety and effectiveness, nor do they alter the fundamental technology of the predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document primarily focuses on demonstrating equivalence through design and testing of fundamental characteristics rather than a clinical trial with a defined test set of patients.
- Data Provenance: Not specified. Given the nature of the tests (acoustic output, biocompatibility, assembly design comparison), it's likely laboratory-based. No patient data or clinical study data is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for these types of engineering and material tests would be established through accredited laboratory methods and technical specifications, not expert clinical consensus.
4. Adjudication method for the test set
Not applicable. There's no indication of an adjudication method used. The "performance data" describes physical and material properties rather than clinical outcomes requiring expert review.
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 passive transducer for fetal monitoring, not an AI-powered diagnostic tool. Therefore, an MRMC study or AI-assistance evaluation is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This device is hardware (transducer) and does not involve an algorithm for standalone performance evaluation in the context of an AI device.
7. The type of ground truth used
- Acoustic Output: Likely established through standardized acoustic power measurement techniques and equipment.
- Assembly Design: Established by expert engineering comparison against the predicate device's design and specifications.
- Biocompatibility: Established by adherence to recognized consensus standards (e.g., ISO 10993 series) through laboratory testing.
- Performance as Intended: Inferred equivalence based on the above tests and similarity to the predicate.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable (no 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).