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

Device Description

The Spacelabs Healthcare Medical Equipment (Suzhou) Co., Ltd. (Spacelabs) élance Vital Signs Monitoring System (élance) 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. See the following Product Configuration List for the identified models and Spacelabs defined monitoring features.

AI/ML Overview

The provided document (K090556) is a 510(k) summary for the Spacelabs élance Vital Signs Monitoring System. This summary primarily focuses on establishing substantial equivalence to predicate devices and describes the general types of testing performed rather than detailed performance study results with specific acceptance criteria and outcome metrics.

Therefore, many of the requested details about acceptance criteria, specific performance results, and clinical study methodologies (like sample size, ground truth establishment, expert adjudication, MRMC studies) are not available in this document. The document explicitly states that "Clinical performance testing was not performed and is not necessary to demonstrate safety and effectiveness of the Spacelabs élance."

Here's a breakdown of the available information:

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

The document does not provide a table of explicit acceptance criteria or reported device performance metrics in terms of quantitative values. It states:

Software Testing: "Test results indicated that the Spacelabs élance complies with its predetermined specification."
Electrical Safety: "Test results indicated that the Spacelabs élance complies with its predetermined specification."
Electromagnetic Compatibility Testing: "Test results indicated that the Spacelabs élance complies with its predetermined specification."
Performance Testing – Bench: "Test results indicated that the device complies with the predetermined requirements. This testing includes performance and functional, environmental, and shipping and transportation testing."

These statements confirm that internal testing was conducted and passed "predetermined specifications" or "requirements," but the specific numerical acceptance criteria (e.g., accuracy, precision, sensitivity, specificity) and the measured performance are not disclosed in this summary.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size: Not specified for any of the performance tests mentioned (software, electrical safety, EMC, bench).
Data Provenance: Not specified.

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)

Not applicable as no clinical studies are mentioned. For bench and engineering tests, ground truth would typically be established by calibrated reference devices or known input signals. The document does not provide details on this.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable as no clinical studies with expert adjudication are mentioned.

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 MRMC study was done. The device described is a physiological monitor, not an AI-assisted diagnostic tool that would typically involve human "readers" or an MRMC study.

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

The device itself is a standalone monitor. Bench testing and engineering verification and validation (V&V) were performed to assess its performance against specifications. However, specific standalone performance metrics (e.g., accuracy of arrhythmia detection) are not detailed in this summary. The device's function involves inherent "algorithms" for processing physiological signals.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the technical and bench performance testing, the ground truth would have been established through known input signals, calibrated measurement equipment, and industry standards. For example, electrical safety tests would use international safety standards, and EMC tests would use electromagnetic compatibility standards. No clinical ground truth (like pathology or outcomes data) was used, as clinical testing was not performed or deemed necessary.

8. The sample size for the training set

Not applicable. This device is a physiological monitor, not a machine learning or AI algorithm that requires a "training set" in the typical sense. Its functionality is based on established signal processing and measurement principles.

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

Not applicable, as there is no "training set" for this type of device.

In summary, the 510(k) K090556 document for the Spacelabs élance Vital Signs Monitoring System indicates that the device underwent rigorous engineering and bench testing to ensure compliance with its predetermined specifications and applicable standards. However, it explicitly states that clinical performance testing was not performed or necessary for its clearance. Therefore, detailed information regarding clinical acceptance criteria, study sizes, expert involvement, or AI-specific performance metrics is not found in this summary. The basis for clearance was substantial equivalence to predicate devices and adherence to internal and external technical standards.

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