(212 days)
The Disco™ Uterine Contraction Transducer System is designed and intended for use in monitoring the progress of labor by measuring the duration, frequency and relative pressure of uterine contractions with a transducer strapped to the maternal abdomen.
The Disco™ Uterine Contraction Transducer System is a non-sterile, single patient use external uterine contraction transducer and accessories. The system consists of a disposable belt with the transducer, an adapter cable with sensitivity switch for use with either Corometrics or Hewlett Packard patient monitor, and the package with appropriate label copy. The Disco™ Uterine Contraction Transducer System uses a transducer that is placed in contact with the maternal abdomen and the output signal is displayed on a monitor and/or recording device. The transducer is composed of a mylar sheet with a pressure sensitive ink silk screened to its surface. This ink responds to changes in pressure from the foam pad by changing its electrical resistance. A series of conductive silver traces silk screened to a rigid ceramic substrate allow termination and measurement of this changing electrical resistance. A firm, yet flexible rounded elastomeric button is used to transfer the uterine contraction from the patient to the transducer. It is mounted in the center of the transducer and has an achesive bond to the foam pad at its base. A thin, flexible, stranded, insulated wire is used to connect the transducer to the adapter cable. A two wire RJ-11 male telephone type connector is used as the electrical interface for the transducer. Because the pressure sensitive ink produces a stronger signal than strain gauge type transducers, the Disco™ Uterine Contraction Transducer System has an output control switch to adjust the level of the output signal.
The provided document is a 510(k) summary for the Disco™ Uterine Contraction Transducer and Accessories. It outlines the device's intended use and technological characteristics, and claims substantial equivalence to predicate devices. However, it does not contain detailed acceptance criteria or specific study results that would allow for the completion of the requested table and robust answers to your questions.
The "Performance Data" section briefly mentions clinical and bench testing but lacks the specifics needed to fulfill your request. It states: "In the clinical tests conducted the Disco™ transducer was compared to an internal catheter, to an external HP transducer, and to an exterral Corometrics transducer. In the bench tests conducted, the Disco™ Transducer was tested against a standard gauge, and against and external Corometrics transducer. A linearity and a hysteresis test was also performed. Finally, an independent laboratory tested the Disco™ transducer for EMI and leakage current. In all instances the proposed device met or exceeded all functional requirements and had virtually identical performance to marketed products."
Here's why the information is insufficient for your request:
- No specific acceptance criteria: The document only states "met or exceeded all functional requirements" and "virtually identical performance to marketed products" without defining what those functional requirements or performance metrics are.
- No quantitative results: There are no numbers, percentages, or statistical analyses to populate a "reported device performance" column.
- Missing details on study design: While it mentions comparisons, it doesn't specify sample sizes (patients, contractions), ground truth methods, adjudication, or expert qualifications.
Therefore, I cannot generate the table or answer most of your questions based solely on the provided text.
Assuming the device met unspecified "functional requirements" and had "virtually identical performance" to predicate devices, here's what I can extract and what remains unknown:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Functional equivalence to predicate devices (Corometrics and HP uterine contraction transducers) | Virtually identical performance to marketed products. |
| Meeting all functional requirements | Met or exceeded all functional requirements. |
| Linearity (against standard gauge) | Performed (result not detailed, but implied acceptable) |
| Hysteresis (against standard gauge) | Performed (result not detailed, but implied acceptable) |
| Electrical Safety (EMI, leakage current) | Tested (result not detailed, but implied acceptable) |
| Clinical comparability to internal catheter | Clinical test conducted (result not detailed, but implied acceptable) |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The studies are referred to as "clinical tests" and "bench tests," suggesting prospective testing was performed for some aspects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not specified.
- Qualifications of experts: Not specified.
- Ground Truth: For clinical tests, the comparisons included an "internal catheter." This internal catheter measurement would likely serve as a more direct and accurate ground truth for uterine contraction strength/duration compared to external transducers. It's unclear if expert interpretation was part of establishing this ground truth or simply comparing device readings to the internal catheter.
4. Adjudication method for the test set
- Not specified.
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 MRC study was conducted. The device is an external transducer, not an AI-powered diagnostic tool requiring human reader interpretation in the context of improving outcomes. The studies focused on the performance of the transducer itself, comparing its measurements to predicate devices and an internal catheter.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, a standalone study was done. The "clinical tests" and "bench tests" directly assessed the performance of the Disco™ transducer itself in measuring uterine contractions, compared to other devices and a standard gauge. There is no "human-in-the-loop" component described for interpretation; it's about the device's accuracy in physical measurement.
7. The type of ground truth used
- Expert consensus: Not explicitly mentioned for the reported studies.
- Pathology: Not applicable for a uterine contraction transducer.
- Outcomes data: Not explicitly mentioned as a direct ground truth for device performance in this summary.
- Internal catheter: Used as a comparative reference in clinical tests, which would represent a more direct physiological measurement and could be considered a form of "ground truth" for contraction strength.
- Standard gauge: Used in bench tests to assess linearity and hysteresis, serving as a ground truth for physical measurements.
8. The sample size for the training set
- Not applicable. This device is a measurement transducer, not an AI/machine learning device that requires a "training set" in the conventional sense.
9. How the ground truth for the training set was established
- Not applicable. (See point 8)
§ 884.2720 External uterine contraction monitor and accessories.
(a)
Identification. An external uterine contraction monitor (i.e., the tokodynamometer) is a device used to monitor the progress of labor. It measures the duration, frequency, and relative pressure of uterine contractions with a transducer strapped to the maternal abdomen. This generic type of device may include an external pressure transducer, support straps, and other patient and equipment supports.(b)
Classification. Class II (performance standards).