(147 days)
The Portrait VSM vital signs monitor is intended to monitor a single patient's vital signs at the site of care or during intra-hospital transport.
The noninvasive oscillometric blood pressure parameter is intended for measurement of systolic, and mean arterial blood pressure, as well as pulse rate, for adult, pediatric and neonatal patients.
The optional GE TruSignal pulse oximetry and accessories are indicated for the continuous nonitoring of functional Oxygen Saturation (SpO2) and pulse rate, including monitoring conditions of clinical patient motion or low perfusion, with adult, pediatric and neonatal patients.
The optional Masimo SET® pulse oximetry and accessories are indicated for the continuous nonitoring of functional Oxygen Saturation (SpO2) and pulse rate, during both no motion conditions, and for patients who are well or poorly perfused (low perfusion) for adult, pediatric and neonatal patients.
The optional Nellcor™ pulse oximetry and accessories are indicated for the continuous noninvasive monitoring of functional Oxygen Saturation (SpO2) and pulse rate of adult, pediatric, and neonatal patients during both motion and non-motion conditions, and for patients who are well or poorly perfused.
The optional Welch Allyn® SureTemp® Plus electronic thermometer is intended to measure one of oral, axillary, and rectal temperature of adult and pediatric patients.
The optional Exergen TemporalScanner thermometer is intermittent measurement of human body temperature of patients of all ages.
The optional HeTaiDa electronic infrared non-touch thermometer is intermittent measurement of human body temperature of patients of all ages.
A wireless network connection is provided to transmit clinical data into various hospital information systems. An optional remote alarm cable connection is intended to complement visual and audible alarms and not replace the need for the presence of a caregiver.
The portable device is designed for use in hospital-type facilities. The Portrait VSM vital signs monitor can also be used in satellite areas or alternate care settings.
The Portrait VSM vital signs monitor is intended for use under the direct supervision of a licensed health care practitioner.
The Portrait VSM vital signs monitor is not intended for use during MRI.
"Portable" refers to the ability of the Portrait VSM vital signs monitor to be easily moved by the caregiver, such as on a roll stand.
The proposed Portrait™ VSM is a vital signs monitor which is developed based on primary predicate vital signs monitor VC150(K133810) with integrated NIBP and SpO2 design from a secondary predicate monitor B105M (K213490) and provided additional non-contact infrared body temperature measurement option by supporting OEM thermometer (K171888) previously cleared by FDA.
In addition to the added non-contact infrared body thermometer, the proposed monitor Portrait™ VSM also offer several enhancements:
New hardware platform
Adopted equivalent NIBP design from B105M(K213490)
Adopted equivalent SpO2 design from B105M(K213490)
Compatible with Recorder B1X5-REC
Support Round Advisor in spot check mode
Support automatically screens brightness adjustment.
Improved Early Warning Score
Addtional alarm management enhancement.
Additional cybersecurity enhancement
The proposed monitor Portrait™ VSM adopts larger 10-inch LCD touch screen with improved Industrial Design (ID) to be more portable and more compact for clinicians than the primary predicate monitor VC150 (K133810) while maintaining the same primary function and operation.
As with the predicate Monitor VC150 (K133810), the proposed Portrait™ VSM is Vital Signs Monitor, utilizing an LCD display and can measure the most commonly used vital signs of patient: Non-invasive Blood Pressure (NIBP), Pulse Rate (PR), Temperature (Temp), and Pulse Oxygen Saturation (SpO2).
Same as the predicate monitor VC150 (K133810), the proposed monitor Portrait™ VSM also has three choices for SpO2 include GE TruSignal™; Nellcor™ or Masimo SET® and temperature measurement from Exergen® TemporalScanner™, and Welch Allyn® SureTemp®.
Both the predicate monitor VC150 (K133810) and the proposed monitor Portrait™ VSM can be configured to be used for Spotchecking or for continuous morning, the device can send measured patients' data to EMR (Electronic Medical Record) system by interfacing to Hospital Information Systems (HIS) over a wired or wireless network.
Moreover, same as the predicate monitor VC150 (K133810), the proposed monitor Portrait™ VSM can be powered by battery or AC, has a carrying handle and can be placed on a shelf or table or mounted in a variety of ways using a mounting plate located on the bottom of the monitor.
The provided document is a 510(k) Summary for the GE Medical Systems Information Technologies, Inc. Portrait VSM vital signs monitor. It describes the device, its intended use, and a comparison to predicate devices, along with summaries of non-clinical and clinical testing.
However, the document explicitly states that "the proposed monitor Portrait™ VSM did not require clinical studies to support substantial equivalence." This means there is no detailed clinical study described in this document that proves the device meets specific acceptance criteria based on human-in-the-loop performance or expert-adjudicated ground truth, as would be expected for a complex AI/ML-driven device.
The document primarily focuses on demonstrating substantial equivalence to existing predicate devices through bench testing, compliance with consensus standards, and verification of hardware/software functionality, electrical safety, usability, and environmental performance.
Therefore, I cannot fulfill all parts of your request as the provided text does not contain a study with the specific elements you've asked for related to clinical performance verification with AI/ML and human readers.
However, I can extract the acceptance criteria (in terms of standards compliance and functional equivalence) and the reported performance from the non-clinical testing described.
Here's what can be extracted and what cannot be provided given the document's content:
Acceptance Criteria and Device Performance (Based on Non-Clinical Testing and Equivalence Claim)
Since no clinical study was required, the "acceptance criteria" for this device's submission are primarily based on demonstrating:
- Functional Equivalence to legally marketed predicate devices.
- Compliance with relevant electrical safety, EMC, usability, and performance standards for vital signs monitors.
- Verification of hardware and software specifications through bench testing.
Therefore, the table below will reflect the claimed equivalence and standards compliance as the "performance" rather than specific accuracy metrics against a clinical ground truth from a reader study.
| Acceptance Criterion (Based on Equivalence/Standards) | Reported Device Performance (from Non-Clinical Testing) |
|---|---|
| Functional Equivalence to Predicate VC150 (K133810) and B105M (K213490) | The Portrait™ VSM is described as having "essentially same" features and parameters as the VC150. It incorporates NIBP and SpO2 design from the B105M, and supports an OEM thermometer previously cleared (K171888). Minor differences (e.g., larger screen, capacitive touch, wired network, specific Masimo/Nellcor OEM boards) are highlighted as either equivalent or improvements that do not affect safety/effectiveness. |
| Non-Invasive Blood Pressure (NIBP) Performance | Compliance with IEC 80601-2-30:2018 ("Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers"). The NIBP design is identical to predicate B105M (K213490) and uses the SuperSTAT algorithm (K022834). |
| Pulse Oximetry (SpO2) Performance | Compliance with ISO 80601-2-61:2017+C1:2018 ("Particular requirements for basic safety and essential performance of pulse oximeter equipment"). GE TruSignal SpO2 design is identical to predicate B105M (K213490). Different Masimo (MS-2011SB, K053269) and Nellcor (NELL1-SR OxiMax, K060576) OEM boards are used, which are noted to have been implemented in predicate B105M (K213490). |
| Temperature Measurement Performance | Compliance with ISO 80601-2-56:2017+AMD1:2018 ("Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement") and ASTM E1112-00 (2018) ("Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature"). Supports Welch Allyn SureTemp, Exergen TemporalScanner, and the added HeTaiDa Non-Contact Infrared Body Thermometer (K203332). |
| General Safety (Electrical, EMC) | Compliance with IEC 60601-1:2005+A1:2012+A2:2020 (Electrical safety) and IEC 60601-1-2:2014+A1:2020 (EMC). Also passed IEC TR 60601-4-2:2016. |
| Alarm System Performance | Compliance with IEC 60601-1-8:2006+A1:2012+A2:2020 (General requirements for alarm systems). Alarm volume ranges (e.g., Min >= 45dBA, Max |
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).