(268 days)
The Spacelabs élance Vital Signs Monitor and élance Central Station is indicated for use in patient populations for:
- Adult
- Pediatric (1 year old and above)
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 Healthcare (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 with arrhythmia detection, 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 élance Central Station software package is available for use with a customer acquired computer based on specifications provided by Spacelabs. This package allows monitoring of the élance Vital Signs Monitor at a central workstation.
The provided text is a 510(k) premarket notification summary for the Spacelabs Healthcare élance Vital Signs Monitor and élance Central Station. This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo clinical acceptance criteria and conducting a dedicated study to prove that the device meets those criteria.
Therefore, much of the requested information (e.g., number of experts, adjudication method, MRMC comparative effectiveness study, standalone performance metrics, sample sizes, and detailed ground truth establishment for a specific "study" demonstrating meeting acceptance criteria) is not present in this document because it describes a different type of regulatory submission. Clinical trial data with specific acceptance criteria and detailed performance studies are typically required for Novel Devices or those without a clear predicate.
However, based on the provided text, I can infer some aspects and present the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are implicitly alignment with recognized standards and successful completion of verification and validation testing, demonstrating that the device performs as intended and is as safe and effective as the predicate. Specific numerical performance metrics for individual parameters (e.g., accuracy for NIBP, sensitivity/specificity for arrhythmia detection) are referred to as being assessed against these standards but are not explicitly detailed in a table format with specific numerical targets.
| Performance Aspect | Acceptance Criteria (Implicitly from Standards) | Reported Device Performance |
|---|---|---|
| Software | Compliance with FDA guidance documents: "The content of premarket submissions for software contained in medical devices," "Off-the-shelf software use in medical devices," "General principles of software validation," and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices." Implies robust design, development, verification, and validation processes meeting predetermined specifications. | "Test results indicated that the élance VSM and élance CS software comply with predetermined specification." |
| Electrical Safety | Compliance with IEC 60601-1:1988, Am1: 1991, Am2: 1995 (Medical electrical equipment – Part 1: General requirements for basic safety and essential performance). | "Test results indicated that the élance VSM complies with the applicable standards." |
| EMC | Compliance with IEC 60601-1-2: 2007 (Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests). | "Test results indicated that the élance VSM complies with the applicable standards." |
| Parameter Performance (Bench) | Compliance with various standards including: |
- ANSI/AAMI EC57: 1998/(R) 2003 (Cardiac rhythm and ST-segment measurement algorithms)
- ANSI/AAMI SP10: 2002, Am1: 2003 (Sphygmomanometers)
- EN 12470-4: 2009 (Electrical thermometers)
- EN 60601-1-6: 2010 (Usability)
- EN 60601-1-8 2007, Am1: 2013, AC: 2014 (Alarm systems)
- EN 62366: 2008 (Usability engineering)
- IEC 60601-2-27: 2005 (ECG monitoring equipment)
- IEC 60601-2-30: 1999 (Non-invasive blood pressure monitoring)
- IEC 60601-2-34: 2000 (Invasive blood pressure monitoring)
- IEC 60601-2-49: 2011 (Multifunction patient monitoring equipment)
- ISO 80601-2-55: 2011 (Respiratory gas monitors)
- ISO 80601-2-61: 2011 (Pulse oximeter equipment)
- Internal requirements and procedures. | "Test results indicated that the élance VSM and élance CS comply with these Standards. Additionally, the élance VSM and élance CS were tested in accordance with internal requirements and procedures, and test results indicated that the devices comply with the predetermined requirements." |
| Overall Equivalence| The device is "as safe, as effective, and perform as well as or better than the predicate devices." | The conclusion states that "the élance VSM and élance CS are as safe, as effective, and perform as well as or better than the predicate devices. Therefore, the élance VSM and élance CS are considered substantially equivalent to the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
The document refers to "test results" for compliance with various standards but does not specify sample sizes for these tests for each parameter. The data provenance is not explicitly stated as originating from a specific country or being retrospective/prospective in a clinical trial context. It refers to a series of bench tests against recognized standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. For bench testing against standards, the "ground truth" often comes from reference equipment, simulated signals, or specified test conditions described within the standards themselves, rather than clinical expert consensus.
4. Adjudication Method for the Test Set
This information is not provided as it typically pertains to clinical trials requiring expert review of patient data, which is not described here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
A MRMC comparative effectiveness study is not mentioned or described in this document. The submission focuses on demonstrating substantial equivalence through technical characteristics and compliance with standards, not on assessing the improvement of human readers with AI assistance. The device is a monitor, not an AI diagnostic tool for human interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done
The document describes "parameter performance" testing for the élance VSM and élance CS against various standards. This testing would inherently involve evaluating the algorithms and hardware of the device itself (standalone performance) under controlled conditions to ensure they meet the criteria specified in those standards (e.g., accuracy of ECG measurement, NIBP, SpO2). However, specific metrics like sensitivity, specificity, or PPV/NPV for arrhythmia detection are not quantified in this summary, beyond stating compliance with the relevant standard (ANSI/AAMI EC57).
7. The Type of Ground Truth Used
For the performance testing mentioned, the ground truth would be based on:
- Reference Standards: The specifications and requirements outlined in the cited IEC, ANSI/AAMI, EN, and ISO standards define the acceptable performance.
- Controlled Bench Test Conditions: Specific inputs (e.g., simulated ECG waveforms, pressure cuffs with known pressures, temperature probes in calibrated environments) were used to test the device's accuracy and functionality against known values.
- Predetermined Specifications: Internal requirements and procedures of Spacelabs Healthcare.
8. The Sample Size for the Training Set
This document does not mention a training set in the context of machine learning or AI algorithm development because the device, as described, is a vital signs monitor leveraging established physiological monitoring techniques rather than a novel AI system requiring extensive machine learning training. The "software" referred to is for device operation and data processing, validated against traditional software development processes.
9. How the Ground Truth for the Training Set Was Established
As no training set for machine learning is mentioned, this information is not applicable/provided.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.