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CALM Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is ≥ 35 weeks.

CALM Curve is a computerized method to assess progress during labor. Its algorithms calculate the patient's progress based on user-entered values for parity, dilatation, effacement, station, contraction frequency, and epidural use. Results of these calculations are displayed graphically and as percentile values derived from comparison to a database of women with similar characteristics who delivered vaginally. CALM Curve is intended for use as a data analysis system to assess labor progress in singleton, cephalic presentation pregnancies when the gestational age is > 35 weeks.

CALM Curve can function in a networked environment, as a standalone workstation, or as a web-based application. When connected to a fetal monitor, CALM Curve can use the monitor's uterine activity signal in lieu of user-entered values to calculate contraction counts.

The provided text describes the CALM Curve device but does not contain information about specific acceptance criteria or a study proving that the device meets those criteria. The document is a 510(k) summary focused on demonstrating substantial equivalence to a predicate device, not on presenting performance data against defined acceptance criteria.

Therefore, I cannot fulfill the request to provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method.
5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
6. Information on standalone performance.
7. Type of ground truth used for a test set.
8. Sample size for the training set.
9. How the ground truth for the training set was established.

The document primarily focuses on:

• Device Description: CALM Curve is a computerized method to assess labor progress based on user-entered values (parity, dilatation, effacement, station, contraction frequency, epidural use) and displays results graphically and as percentile values compared to a database.
• Intended Use: To assess labor progress in singleton, cephalic presentation pregnancies with a gestational age > 35 weeks.
• Comparison to Predicate Device (LPM module of CALM software): The differences are operational (standalone product, web-based, manual contraction data entry) rather than algorithmic or related to core performance. The algorithm is stated to be the same as the predicate.
• Justification for Substantial Equivalence: The changes are described as minor modifications to the user interface and data input methods, not fundamental changes to the underlying algorithm for assessing labor progress.

The document states that the algorithm is the same as the predicate device (K980719). This implies that if any studies were done to establish the effectiveness or performance of the algorithm, they would have been associated with the predicate device's clearance. This 510(k) focuses on showing that the modifications to the predicate do not raise new questions of safety or effectiveness.

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