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.

Device Description

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.

AI/ML Overview

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 <= 85dBA) meet this standard.
Usability/Human Factors	Compliance with IEC 60601-1-6:2010+A1:2013+A2:2020 and IEC 62366-1:2015+A1:2020. Summative Usability testing was concluded with 15 US Clinical and 15 US Technical users.
Software Validation & Cybersecurity	Follows FDA software guidance on "Content of Premarket Submissions for Device Software Functions" (categorized as "Enhanced" documentation level), "General Principles of Software Validation," "Off-The-Shelf Software Use in Medical Devices," and relevant cybersecurity guidances. Software standards IEC 62304:2006+A1:2015 and ISO 14971:2019 were applied. Security Risk Assessment, Threat model, and Penetration testing were conducted.
Environmental Performance (Mechanical, Thermal, Humidity)	Verified to meet specifications for operating and storage conditions (e.g., Temp: 5-40°C operating, -20-60°C storage; Humidity: 15-90% non-condensing operating, 10-90% storage).
Reprocessing Efficacy	Follows FDA guidance "Reprocessing Medical Devices in Health Care Settings Validation Methods and Labeling." Efficacy validation met acceptance criteria.
Wireless Coexistence	EMC testing per IEC 60601-1-2:2020, adherence to FDA Guidance-Radio Frequency Wireless Technology in Medical Devices, and IEEE ANSI C63.27-2021.

Regarding the specific questions about clinical studies, AI/ML, and human reading components:

2. Sample sized used for the test set and the data provenance: Not applicable as no clinical study for device performance was conducted/required according to the document. The document describes non-clinical bench testing and usability testing (15 US clinical, 15 US technical users) which are not designed to establish "performance" against a clinical ground truth for vital signs measurements.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth established for performance validation from a clinical study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical study with adjudication.
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. This device is a vital signs monitor, not an AI-driven image analysis or diagnostic tool that assists human readers in interpreting complex medical data. The "AI" concept as you've framed it (human readers improving with AI assistance) does not apply to this device's function or the described testing.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device's core functions (NIBP, SpO2, Temp) are algorithm-driven, and their performance is proven through compliance with relevant IEC/ISO standards and comparison to predicate devices, as detailed in the non-clinical bench testing section. This validates the "standalone" performance of these measurement algorithms against established testing methodologies for vital signs monitors.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the NIBP, SpO2, and Temperature measurements, the "ground truth" for the non-clinical performance validation is derived from established testing protocols within the cited international standards (e.g., IEC 80601-2-30 for NIBP, ISO 80601-2-61 for SpO2, ISO 80601-2-56 for temperature). These standards define specific test setups, reference equipment, and acceptable deviation ranges for accuracy. It's not "expert consensus" or "pathology" in the diagnostic AI sense, but rather engineering-validated performance against known inputs and reference measurements.
8. The sample size for the training set: Not applicable. This document is for a vital signs monitor, not a new AI/ML algorithm that requires a "training set" in the context of deep learning or similar AI development.
9. How the ground truth for the training set was established: Not applicable. (See #8)

In summary, the provided document details a substantial equivalence submission for a vital signs monitor, where the acceptance criteria and proof are based on equivalence to existing devices and compliance with established performance and safety standards through extensive non-clinical bench testing and verification, rather than a clinical study involving AI/ML performance or human reader improvements.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 25, 2024

GE Medical Systems Information Technologies, Inc. Jung William Regulatory Affairs Director 9900 Innovation Drive Wauwatosa, Wisconsin 53226

Re: K233810

Trade/Device Name: Portrait VSM Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MWI, DXN, DQA, DPZ, FLL, MHX Dated: November 30, 2023 Received: November 30, 2023

Dear Jung William:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Robert T. Kazmierski -S

for

LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology Diagnostics and Monitoring Devices Office of Cardiovascular Devices

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Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K233810

Device Name

Portrait VSM

Indications for Use (Describe)