(310 days)
The IFM-500 is an Perinatal Fetal Monitor for measuring and recording maternal contraction and fetal heart rate. Data is displayed on a front panel 7-segment LED Display, recorded on a strip chart recorder and may be transmitted over telephone lines to a remote data receiver. Single or twin fetal heart rates may be measured by means of Pulsed Doppler Ultrasound. Uterine Activity is measured with an external TOCO transducer.
The IFM-500 is an Perinatal Fetal Monitor for measuring and recording maternal contraction and fetal heart rate. Data is displayed on a front panel 7-segment LED Display, recorded on a strip chart recorder and may be transmitted over telephone lines to a remote data receiver. Single or twin fetal heart rates may be measured by means of Pulsed Doppler Ultrasound. Uterine Contraction (UC) is measured with an external TOCO transducer.
The provided text does not contain a detailed study design with specific acceptance criteria and device performance metrics in the format requested. The document is a 510(k) summary for a Fetal Monitor, primarily focusing on demonstrating substantial equivalence to a predicate device and compliance with general safety standards.
However, based on the information provided, here's a breakdown of what can be extracted and what is missing relative to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for features like FHR range, UC range, or the specific performance metrics (e.g., accuracy, sensitivity, specificity) that would typically be found in an acceptance criteria table. Instead, it compares the IFM-500's specifications to those of a predicate device (Model 118).
| Feature | Acceptance Criteria (Implied) | Reported Device Performance (IFM-500) |
|---|---|---|
| FHR Range | Comparable to predicate device (50 - 210 BPM for Model 118) | 50 - 240 BPM |
| UC Range | Comparable to predicate device (0 - 100 relative units/mmHg) | 00 - 99 relative units / 00 - 99 mmHg |
| FHR Detection Method | Pulsed-wave Doppler (as per predicate) | Pulsed-wave Doppler |
| UC Detection Method | Strain gauge strength (as per predicate) | Strain gauge strength |
| Acoustic Output Display & FDA Limits | Less than Track 1 maximum acoustic values (as per predicate) | Less than Track 1 maximum acoustic values |
| Product Safety Certification | IEC 601-1 / UL 544 (as per predicate) | IEC 60601-1 |
| EMC Compliance | Implied compliance to relevant standards | IEC 60601-1-2 |
| Software Validation | Designed, developed, tested, and validated to written procedures | Certifies procedures for design, development, testing, validation, and field maintenance, with responsible individuals identified. |
| Hazard Analysis | Identification, control, and effect determination | Performed throughout development, no new hazards beyond predicate, "Minor" Level of Concern. |
2. Sample size used for the test set and the data provenance
The document does not provide information regarding a specific "test set" sample size or data provenance for performance evaluation. The submission relies on comparative data against a predicate device and compliance with international standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide information about experts used to establish ground truth. This type of detail is typically associated with clinical studies involving interpretation of results, which are not described here.
4. Adjudication method for the test set
The document does not describe an adjudication method as no specific test set or human reader evaluation criteria are mentioned.
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
The document does not describe a MRMC comparative effectiveness study. The device is a "monitor" measuring and recording physical parameters (FHR, UC), not an AI-assisted interpretation or diagnostic tool for which such a study would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The description of the device details its function of measuring and recording FHR and UC. While there's an implied "algorithm" in its measurement capabilities (e.g., Pulsed-wave Doppler for FHR detection), the document does not present a standalone performance study for this algorithm in isolation from the hardware. The "performance" described is about the device's adherence to specifications and safety standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document does not explicitly state the type of ground truth used for performance evaluation. For a device like a fetal monitor, the "ground truth" for FHR and UC measurements would typically be established against reference instruments or established physiological principles during testing and calibration, rather than expert consensus or pathology in the clinical diagnostic sense. The document refers to testing against European Standard EN / IEC 60601-1 and EMC requirement EN / IEC 60601-1-2, implying these standards define the criteria for acceptable measurement accuracy and safety.
8. The sample size for the training set
The document does not mention a training set sample size. As a physiological monitor, its core functionality isn't based on machine learning models that require training data sets in the typical sense.
9. How the ground truth for the training set was established
Since there is no mention of a training set, the document does not describe how ground truth for a training set was established.
§ 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).