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510(k) Data Aggregation
(374 days)
These devices are replacement accessories for the original manufacturer's fetal monitor transducers and are intended to monitor and chart Fetal Heart Rate and maternal uterine activity.
These devices are replacement accessories for the original manufacturer's fetal monitor transducers and are intended to obtain signals to monitor and chart Fetal Heart Rate and maternal uterine activity on a fetal monitor.
Cetro America, Inc. Transducers for Ultrasonic and Tocodynamometer fetal monitoring will be used as replacements for similar transducers manufactured by Corometrics (currently GE), Hewlett Packard Medical (currently Phillips Medical) and Advanced Medical Systems (currently Spacelabs Medical) and their respective fetal monitors. The ultrasound transducer is used to detect Fetal Heart Rate (FHR) using the ultrasound Doppler shift technology. Ultrasound transducers operate in a pulsed Doppler mode with around a 33% Duty Cycle. The Tocodynamometer transducer uses a strain gauge to detect uterine contraction frequency and duration during labor.
The provided text is a 510(k) summary for Cetro America, Inc.'s Transducers for Ultrasonic and Tocodynamometer fetal monitoring. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.
However, the document does not describe a study involving detailed acceptance criteria and reported device performance metrics in the way that would typically be associated with AI/ML device validation. This is a clearance for replacement medical transducers based on substantial equivalence to existing devices, not a study evaluating an AI algorithm's performance.
Therefore, many of the requested categories (sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of regulatory submission.
Here's a breakdown of what can be extracted and what is not present:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by demonstrating substantial equivalence to predicate devices and conformity to consensus performance standards. The "reported device performance" is not quantified with specific metrics like sensitivity, specificity, or AUC, but rather by stating that "Bench testing demonstrates that the devices perform as intended."
| Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Intended Use (Ultrasound) | To detect, measure and record fetal heart rate and the duration and frequency of uterine contractions during labor. | "Same" as predicate devices (Corometrics 174 & 145, HP 1356, AMS IM-76 & IM-77). Implicitly, the device successfully detects, measures, and records FHR and uterine contractions as intended. |
| Intended Use (Toco) | To detect, measure and record uterine pressure to determine timing of contractions. | "Same" as predicate devices. Implicitly, the device successfully detects, measures, and records uterine pressure as intended. |
| Target Patient Population | Gravid patients, particularly during labor. | "Same" as predicate devices. |
| Anatomical sites | Ultrasound on abdomen aimed at fetal heartbeat; Toco on abdomen at top of uterus. | "Same" as predicate devices. |
| FHR Range | As per monitor system specifications. | "Same" as predicate devices. Implicitly, it operates within the same FHR range as the monitors it's compatible with. |
| Uterine Activity Range | As per monitor system specifications. | "Same" as predicate devices. Implicitly, it operates within the same uterine activity range as the monitors it's compatible with. |
| Patient Use/Reuse | Reusable. | "Same" as predicate devices. |
| Sterility | Non-sterile. | "Same" as predicate devices. |
| Patient Attachment | Attaches with elastic belts strapped to the patient. | "Same" as predicate devices. |
| Cable Length | Eight feet. | "Same" as predicate devices. |
| Accessories | Transducer belts and Ultrasonic Gel. | "Same" as predicate devices. |
| Connector Design | Color-coded and designed to fit appropriate monitoring system. | "Same" as predicate devices. |
| Acoustic Output (Ultrasound) | <20mW/cm² average. | "Same" as predicate devices. Implicitly, the acoustic output is <20mW/cm² average. |
| Operational Characteristics | Pulsed Doppler for Ultrasonic transducers. | Cetro 8031010-02, 8031011-02, 8031012-02 are Pulsed Doppler. Compared to specific predicate models (HP 1356, AMS IM-76, AMS IM-77), "Same" where applicable. |
| U/S Center Frequency | Specific frequencies for each model: 1.536 MHz (8031010-02), 1.024 MHz (8031011-02), 0.9984 MHz (8031012-02). | Confirmed frequencies listed for each model. Compared to specific predicate models (HP 1356, AMS IM-76, AMS IM-77), "Same" where applicable. |
| General Performance | Conformity to consensus performance standards relating to Electrical/Mechanical/Thermal Safety and Biocompatibility. | "The company declares conformity to consensus performance standards relating to Electrical/Mechanical/Thermal Safety and Biocompatibility." "Bench testing demonstrates that the devices perform as intended." This implies successful demonstration of safety, electrical, mechanical, biocompatibility, and functional performance consistent with the intended use and predicate devices. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable (N/A). This document describes a 510(k) submission for medical device transducers. The "study" mentioned is bench testing for substantial equivalence, not a clinical trial with a defined test set of patient data, data provenance, or retrospective/prospective nature as one would find for an AI/ML diagnostic device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- N/A. Ground truth from experts is not a concept applied in this type of substantial equivalence submission for transducers. The performance is assessed against technical specifications and comparison to predicate devices, not expert human interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. No adjudication method is described because there are no human interpretations of a test set to adjudicate.
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
- N/A. This is not an AI/ML device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is not an AI/ML device. No standalone algorithm performance was evaluated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" in this context is the technical specifications and established performance characteristics of the predicate devices and relevant consensus performance standards (Electrical/Mechanical/Thermal Safety, Biocompatibility). The device's performance is deemed acceptable if it meets these technical specifications and shows equivalence.
8. The sample size for the training set
- N/A. This is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established
- N/A. Not an AI/ML device.
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