Search Results

The Spacelabs élance Vital Signs Monitor and élance Central Station is indicated for use in patient populations for:

• Adult
• Pediatric

The Spacelabs élance Vital Signs Monitor and élance Central Station facilitates the monitoring of:

• ECG with arrhythmia detection
• Respiration
• Non-invasive blood pressures
• Invasive blood pressures
• Body temperature
• Functional arterial oxygen saturation, and
• End tidal CO2.

The Spacelabs élance Vital Signs Monitor and élance Central Station is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.

The Spacelabs Medical, Inc. (Spacelabs) élance Vital Signs Monitor is a family of portable patient monitors intended to be used by clinicians and medical qualified personnel for monitoring ECG, respiration, NIBP, temperature, SPO2, invasive blood pressure and EtCO2. Models within the Spacelabs élance family come in two different sized viewing areas (10.2" and 12.1"), two different housing colors (white and black) and offer selected monitoring features.

The Spacelabs Medical, Inc. élance Central Station software package is available for use with a customer acquired computer based on specifications provided by Spacelabs Medical. This package allows monitoring of the élance Vital Signs Monitor at a central workstation.

The provided text describes a 510(k) submission for the Spacelabs Medical élance Vital Signs Monitor and élance Central Station. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical trial data with specific acceptance criteria and performance metrics typically seen in studies for novel technologies.

Therefore, for many of your requested points, the information is not available in the provided document, as it is not a study report designed to evaluate the device's performance against specific clinical acceptance criteria. Instead, it highlights verification that modifications were implemented correctly and that the device complies with predetermined specifications.

Here's an analysis based on the available information:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the document. The document states that "Verification results indicated that the élance Vital Signs Monitor and élance Central Station complies with predetermined specifications," but it does not list those specifications or report numerical performance data against them.

2. Sample size used for the test set and the data provenance

This information is not provided. The submission refers to "verification results" but does not detail a specific test set, its size, or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. As it's a 510(k) for a monitoring device, ground truth for patient physiological parameters would typically involve highly accurate reference measurements from other medical devices, not expert human agreement in the same way it would for image interpretation. However, the document does not specify any details about how reference data was obtained or validated.

4. Adjudication method for the test set

This information is not provided.

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

There is no indication of an MRMC comparative effectiveness study in the provided text. This device is a physiological monitor, not an AI-assisted diagnostic tool for human readers, so such a study would not typically be applicable in this context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document states, "The élance Vital Signs Monitor and élance Central Station utilize the same technology for each parameter as utilized by the predicate device." While there's a "central station," the primary function is monitoring, and the "arrhythmia detection" is likely an algorithmic function. However, the document does not detail specific standalone algorithm performance metrics or any studies conducted on the algorithm alone without considering the human user. The focus is on the device as a whole and its substantial equivalence to a predicate.

7. The type of ground truth used

This information is not explicitly stated. For a vital signs monitor, the ground truth for parameters like ECG, respiration, blood pressure, temperature, SpO2, and EtCO2 would typically be established by highly accurate reference devices or invasive measurements (e.g., arterial line for invasive blood pressure, capnography for EtCO2). However, the document does not elaborate on how ground truth was established for the "predetermined specifications" against which the device was verified.

8. The sample size for the training set

This information is not provided. The submission is not for a device developed using machine learning that would typically involve a "training set" in the sense of AI model development. The verification is against "predetermined specifications," suggesting a more traditional engineering validation approach.

9. How the ground truth for the training set was established

This information is not provided, as the concept of a "training set" in the context of AI model development does not appear to apply to this submission.

Ask a specific question about this device