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510(k) Data Aggregation
(316 days)
LMS MEDICAL SYSTEMS LTD.
CALM Patterns is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at ≥36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations.
WARNING: Evaluation of FHR during labor and patient management decisions should not be based solely on CALM Patterns annotations.
CALM Patterns is a computerized method to detect, label and measure features in the fetal monitor recording. CALM Patterns uses fetal monitor data imported through an interface with an external source as described in a previous submission (K980719) or with a third-party clinical information system. CALM Patterns can function in a networked environment or as a standalone workstation.
The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary for the CALM Patterns device, discussing its substantial equivalence to a predicate device (OB TraceVue).
Therefore, I cannot provide the requested information. The document focuses on comparing the features of CALM Patterns to OB TraceVue for substantial equivalence, rather than presenting a performance study with acceptance criteria.
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(157 days)
LMS MEDICAL SYSTEMS LTD.
The CALM system is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions.
CALM is an easy-to-use system consisting of personal computers, data acquisition modules, and a system server. Interfaced with standard fetal and maternal monitors, CALM helps an Obstetrics Labor and Delivery department with fetal surveillance, charting, and archiving of patient data.
Here's an analysis of the provided text regarding the CALM system's acceptance criteria and study information, formatted as requested:
Acceptance Criteria and Study Information for CALM System (K980719)
It's important to note that the provided 510(k) summary for the CALM system is a substantial equivalence determination rather than a report on a clinical study designed to meet specific performance acceptance criteria. The document's purpose is to demonstrate that the CALM system is as safe and effective as a legally marketed predicate device (Birthnet™ Perinatal Patient Data Management System), based on a comparison of features, intended use, and technical specifications. Therefore, direct "acceptance criteria" and "reported device performance" in the traditional sense of a performance study are not explicitly detailed in the provided text. Instead, substantial equivalence is established by comparing functionalities.
The table below reflects the comparison of features between the CALM system and its predicate device, which implicitly serve as the basis for the FDA's substantial equivalence determination.
1. Table of Acceptance Criteria and the Reported Device Performance
Given that this is a 510(k) summary for substantial equivalence, the "acceptance criteria" are implicitly defined by the functionalities and specifications of the predicate device. The "reported device performance" is a statement of the CALM system's ability to match or perform similarly to these functionalities.
| Feature (Implicit Acceptance Criteria based on Predicate) | Reported CALM Device Performance (as presented for Substantial Equivalence) |
|---|---|
| Intended Use | The CALM system's intended use description matches that of the predicate device, focusing on capturing, displaying, printing, and managing physiological obstetrical and fetal patient data, real-time monitoring of multiple patients, and correlating observations. CALM explicitly notes plotting recorded cervical dilatation versus time and comparing it with a sample population. |
| Data Collection | Collects FHR and UA data from maternal monitors and caregiver input, matching the predicate. |
| Sample Rate (FHR) | Samples FHR at a minimum of 4 samples per second, typical of FHR monitors, matching the predicate. |
| Central Display | Provides central display capability at any required workstation, including Chalkboard and All Tracings display, matching the predicate. |
| Viewing (selected observations) | Views selected observations for all patients and views FHR and UA data while charting, matching the predicate. |
| Additional Patient Viewing | With appropriate access privileges, views another patient's observations from any patient's room, matching the predicate. |
| Chalkboard | Any workstation can be configured to display "Ward Status" chalkboard, matching the predicate. |
| Communications (data via network) | Communications of data via network to workstations, matching the predicate. |
| Communications to other Hospital Info System | Uses the ANSI standard Health Level 7 (HL7) v2.3 protocol, matching the predicate (which uses HL7). |
| Labor Progress Curves | Displays the patient's curve of Cervical Dilatation compared to a reference population (Friedman's curve), matching the predicate's intent to compare with Friedman's curve. |
| Archiving | Optional - uses Dual optical disk as well as others, matching the predicate's use of Dual optical disk. |
| Annotation | Bedside annotation of caregiver (doctors and nurses) interventions, a slight expansion from the predicate's "nursing interventions" but still deemed substantially equivalent in scope. |
| Admission, Transfer & Discharge (ADT) | ADT capability provided for patient visits, matching the predicate. |
| Calculations | Calculates patient age, fetal gestational age, and estimated date of delivery, expanding slightly on the predicate's calculation of patient age and estimated date of delivery, but still within the scope of perinatal data management. |
| Reports | Several patient reports available, matching the predicate. |
| Remote Access | Via Modem, matching the predicate. |
Detailed Study Information:
The provided document is a 510(k) summary for the CALM system, and it primarily focuses on demonstrating substantial equivalence to a predicate device (Birthnet™ Perinatal Patient Data Management System, K965008). It does not describe a clinical performance study designed to establish new acceptance criteria or to show performance against such criteria. Instead, it compares the features and intended use of the CALM system to a previously cleared device. Therefore, many of the requested details about performance studies, such as sample sizes, expert qualifications, adjudication methods, MRMC studies, and standalone performance evaluations, are not applicable or not provided in this type of submission.
Here's an attempt to address your points based on the available information:
- Sample sizes used for the test set and the data provenance: Not applicable. The document describes a comparison of device features and intended use for substantial equivalence, not a performance test with a distinct test dataset.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring ground truth establishment by experts is described in this substantial equivalence summary.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set requiring expert adjudication is described.
- 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: Not applicable. This document predates widespread AI integration in medical devices and describes a data management system, not an AI-assisted diagnostic or interpretation tool. No MRMC study is mentioned.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The CALM system is a "Computer-based information management system" and a "central monitoring system with signal analysis and display functions." Its function is to interface with existing fetal and maternal monitors and process/display their data, along with caregiver input. It is not an "algorithm only" device in the sense of an AI performing diagnosis without human oversight. Its performance is intrinsically linked to the input from monitors and human interaction.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to this type of submission. The "ground truth" here is the established functionality and performance of the predicate device for comparison.
- The sample size for the training set: Not applicable. As this is a data management system being cleared via substantial equivalence, there is no mention of a "training set" in the context of machine learning or algorithm development.
- How the ground truth for the training set was established: Not applicable, for the reasons stated above.
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