The DASH 3000/4000 Patient Monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. The Dash is designed as a bedside, portable, and transport monitor that can operate in all professional medical facilities and medical transport modes including but not limited to: emergency department, operating room, post anesthesia recovery, critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care areas located in hospitals, outpatient clinics, freestanding surgical centers, and other alternate care facilities, intra-hospital patient transport, inter-hospital patient transport via ground vehicles (i.e., ambulance, etc.) and fixed and rotary winged aircraft, and prehospital emergency response.

Physiologic data includes but is not restricted to: electrocardiogram, invasive blood pressure, noninvasive blood pressure, pulse, temperature, cardiac output, respiration, pulse oximetry, carbon dioxide, oxygen, and anesthetic agents as summarized in the operator's manual.

The DASH 3000/4000 Patient Monitor is also intended to provide physiologic data over the Unity network to clinical information systems and allow the user to access hospital data at the point-of-care.

This information can be displayed, trended, stored, and printed.

The DASH 3000/4000 Patient Monitor was developed to interface with non-proprietary third party peripheral devices that support serial data outputs.

Device Description

The DASH 3000/4000 Patient Monitor is a device that is designed to be used to monitor, display, and print a patient's basic physiological parameters including: electrocardiography (ECG), invasive blood pressure, non-invasive blood pressure, oxygen saturation, temperature, impedance respiration, end-tidal carbon dioxide, oxygen, nitrous oxide and anesthetic agents. Other features include arrhythmia, cardiac output, cardiac and pulmonary calculations, dose calculations, PA wedge, ST analysis, and interpretive 12 lead ECG analysis (12SL). Additionally, the network interface allows for the display and transfer of network available patient data.

AI/ML Overview

The provided text is a 510(k) summary for the GE DASH 3000/4000 Patient Monitor. It does not contain specific acceptance criteria or a detailed study section with reported device performance metrics against those criteria.

Instead, it outlines the device's intended use, technological equivalence to predicate devices, and a high-level summary of tests and standards it complies with. It concludes with a general statement about safety and effectiveness.

Therefore, I cannot populate the requested table or provide detailed information for many of the questions based on the provided text.

Here is what can be inferred or stated based on the text, with limitations noted:

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

Acceptance Criteria (Inferred from regulatory standard compliance and general claims)	Reported Device Performance (as stated in the document)
Compliance with ANSVAAMI EC13 (ECG)	Device "complies with" standard.
Compliance with ANSVAAMI SP10:1992 (BP Sphygmomanometer)	Device "complies with" standard.
Compliance with IEC 60601-1 (General medical electrical equipment safety)	Device "complies with" standard.
Compliance with IEC 60601-1-1 (Safety requirements for medical electrical systems)	Device "complies with" standard.
Compliance with IEC 60601-1-2 (Electromagnetic compatibility)	Device "complies with" standard.
Compliance with IEC 60601-2-27 (ECG safety)	Device "complies with" standard.
Compliance with IEC 601-2-30 (Automated noninvasive sphygmomanometers)	Device "complies with" standard.
Compliance with IEC 601-2-34 (Invasive blood pressure monitoring)	Device "complies with" standard.
Compliance with UL 2601 (Medical electrical equipment safety)	Device "complies with" standard.
Safety equivalent to predicate devices	"is as safe as the predicate devices."
Effectiveness equivalent to predicate devices	"is as effective as the predicate devices."
Performance equivalent to predicate devices	"performs as well as the predicate devices."

Limitations: The document only states compliance with these standards and general equivalence. It does not provide specific numerical performance metrics (e.g., accuracy, precision, sensitivity, specificity, or specific error ranges) for each physiological parameter that would typically define "acceptance criteria" in a detailed study.

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

Not provided. The document mentions "Software and hardware testing," "Safety testing," "Environmental testing," and "Final validation" but gives no details on sample sizes, types of data (e.g., clinical, simulated), or provenance.

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/Not provided. This device is a patient monitor, not an AI/imaging device requiring expert interpretation for ground truth. The "ground truth" for a patient monitor would typically be established by comparing its measurements to established reference standards or other calibrated devices. The document does not detail this process.

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

Not applicable/Not provided. Adjudication methods are typically used in studies involving human interpretation (e.g., radiologists) where there might be disagreement in assessments. For a patient monitor, performance is usually assessed against objective, measurable standards.

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 is a patient monitor, not an AI-assisted diagnostic tool that would typically involve a multi-reader multi-case study comparing human performance with and without AI.

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

Not applicable/Not provided in the context of an "algorithm only" AI device. The device is a physiological monitor; its performance is inherently standalone in terms of measuring vital signs. The summary describes general testing and compliance with standards, implying the device's functions work as intended, but doesn't detail standalone algorithmic performance in the way it would for an AI-driven image analysis tool.

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

Not specified, but inferred to be reference standards or calibrated measurement devices. For physiological monitors, ground truth for parameters like ECG, blood pressure, temperature, etc., is typically established by using highly accurate and calibrated reference instruments or simulated physiological signals that mimic real-world conditions. The document does not describe the specific ground truth methods.

8. The sample size for the training set

Not applicable. This device precedes the era where "training sets" for deep learning models were a standard part of medical device submissions. It appears to be a traditional hardware and software medical device, not an AI/machine learning product. Therefore, there is no "training set" in the modern sense.

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

Not applicable. As a traditional device, there is no "training set" (as understood in machine learning) or associated ground truth establishment for such a set.

Summary

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JUN 0 3 2004

K040458

510(k) Summary of Safety and Effectiveness

May 7, 2004 Date: GE Medical Systems Information Technologies Submitter: 8200 West Tower Avenue USA Milwaukee, WI 53223 Melissa Robinson Contact Person: Phone: 813-887-2133 Fax: 813-887-2545 DASH 3000/4000 Patient Monitor Trade Name: Device: Physiological Patient Monitor Common/Usual Name: Classification Names: 21 CFR 868.1400 Analyzer, Gas, Carbon Dioxide, Gaseous-Phase 21 CFR 868.2375 Breathing Frequency Monitor 21 CFR 870.1025 Detector and Alarm, Arrhythmia 21 CFR 870.1100 Monitor, Blood Pressure, Indwelling 21 CFR 870.1130 Noninvasive Blood Pressure Measurement System 21 CFR 870.1100 Blood Pressure Alarm 21 CFR 870.1425 Programmable Diagnostic Computer 21 CFR 870.2340 Electrocardiograph 21 CFR 870.1435 Monitor, Cardiac Output, Thermal (Balloon Type Catheter) 21 CFR 880.2910 Monitor, Temperature (with probe) 21 CFR 870.2300 Monitor, Cardiac (Incl. Cardiotachometer & rate alarm) 21 CFR 870.2700 Oximeter, Pulse 21 CFR 870.1025 Monitor, Physiological, Patient (With Arrhythmia Detection Or

Alarms)

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21 CFR 870.2770 Plethysmograph, Impedance

K033304 DASH 3000/4000 Patient Monitor Predicate Device:

The DASH 3000/4000 Patient Monitor is a device that is Device Description: designed to be used to monitor, display, and print a patient's basic physiological parameters including: electrocardiography (ECG), invasive blood pressure, non-invasive blood pressure, oxygen saturation, temperature, impedance respiration, end-tidal carbon dioxide, oxygen, nitrous oxide and anesthetic agents. Other features include arrhythmia, cardiac output, cardiac and pulmonary calculations, dose calculations, PA wedge, ST analysis, and interpretive 12 lead ECG analysis (12SL). Additionally, the network interface allows for the display and transfer of network available patient data.

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Intended Use:

data includes but is is not restricted to: Physiologic electrocardiogram, invasive blood pressure, noninvasive blood pressure, pulse, temperature, cardiac output, respiration, pulse oximetry, carbon dioxide, oxygen, and anesthetic agents as summarized in the operator's manual.

The DASH 3000/4000 Patient Monitor is also intended to provide physiologic data over the Unity network to clinical information systems and allow the user to access hospital data at the point-ofcare.

This information can be displayed, trended, stored, and printed.

The DASH 3000/4000 Patient Monitor was developed to interface with non-proprietary third party peripheral devices that support serial data outputs.

The DASH 3000/4000 Patient Monitor employs the same Technology: functional technology as the predicate devices.

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Test Summary: The DASH 3000/4000 Patient Monitor complies with the following voluntary standards: ANSVAAMI EC13, ANSVAAMI SP10:1992; IEC 60601-1, 60601-1-am1, 60601-1-am2; IEC 60601-1-1, 60601-1-1-am1; IEC 60601-1-2; IEC 60601-2-27; IEC 601-2-30; IEC 601-2-34; UL 2601. The following quality assurance measures were applied to the development of the system:

. Requirements specification review
Software and hardware testing .
Safety testing .
Environmental testing .
. Final validation

Conclusion:

The results of these measurements demonstrated that the DASH 3000/4000 Patient Monitor is as safe, as effective, and performs as well as the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "HUMAN SERVICES - USA" are arranged in a circular pattern around the top of the symbol, and the word "DEPARTMENT" is at the bottom.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 0 3 2004

Ms. Melissa Robinson Regulatory Affairs Specialist GE Medical Systems Information Technologies 8200 West Tower Ave. Milwaukee, WI 53223

Re: K040458

Trade/Device Name: GE Dash 3000/4000 Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Regulatory Class: Class II Product Code: MHX Dated: May 7, 2004 Received: May 11, 2004

Dear Ms. Robinson:

We have reviewed your Section 510(k) premarket notification of intent to market the device wf have roviowed your becamed the device is substantially equivalent (for the indications ferenced above and have ure to legally marketed predicate devices marketed in interstate for use stated in the encreative in the enactment date of the Medical Device Amendments, or to conninered prior to rits) 2011-12-11 in accordance with the provisions of the Federal Food, DDVA de vices that have been receasined in quire approval of a premarket approval application (PMA). and Cosmotion (110) that the device, subject to the general controls provisions of the Act. The I va may, merelore, manel of the Act include requirements for annual registration, listing of goneral volt. on the virus wing, and prohibitions against misbranding and adulteration.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I hat FDA has made a determination that your device complies with other requirements of the Act that 1 DX has made a Lotto made in administered by other Federal agencies. You must or uny I oderal statues and seguirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 – Ms. Melissa Robinson

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFF 100-1050.
product radiation control provisions (Sections 531-542 of the Actived in your Section 2 product radiation control provisions (Sections 55 in the simple in your Section 510(k)
This letter will allow you to begin marketing your device of your device to a legal This letter will anow you to ocgin hanceing your aveness of your device of your device to a legally premarket nothication. The PDA miding of ouosantal experies and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your do 1,601, 594-4646. Also, please note the regulation entitled, Contact the Office of Complaned at (301) 37 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - - 1 - - 1 - - 1 - - 1 - - 1 - - 1 - - 1 - - - - - - - - " Misbranding by reference to premanse nothead.incernedations of Small other general information on your responsibilities and its toll-free mumber (800) 638-2041 or 1 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Ques

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: DASH 3000/4000 Patient Monitor

Indications For Use:

The Dash 3000/4000 Patient Monitor is intended for use under the direct supervision of a The Dash 3000/4000 Patient Molition in the intended use of the system is to monitor physiologic
licensed healthcare practitioner. The intended use of the Dash is designed as licensed healthcare practitioner. The lifent son and patients. The Dash is designed as a
parameter data on adult, pediatio and necessor and necessional medical parameter data on adult, pediatic and nechanter in all professional medical bedside, portable, and transport modes including but not limited to: emergency
facilities and medical transport modes including but not limited to: surgical intensive facilities and medical transport intodes into recovery, critical care, surgical intensive department, operating from, post anestileste recovery, tensive care, pediatric intensive
care, respiratory intensive care, coronary care, medical intensive care, pediations f care, respiratory Intensive care, colonal y care, incultals, outpatient clinics, freestanding
care, or neonatal intensive care areas located in hospital catient transport, in care, or neonatal intensive care areas located in nospital patient transport, intersurgical centers, and other alternate care facilities, intro noopical particles and rotary nospital patient transpe-hospital emergency response.

Wingsa are includes but is not restricted to: electrocardiogram, invasive blood Physiologic data Includes but is not resure, pulse, temperature, cardiac output, respiration,
pressure, noninvasive blood pressure, pulse, temperations summarized in the pressure, noninvasive blood pressure, pulse, temporaters, we summarized in the operator's manual.

oper the on
The Dash 3000/4000 Patient Monitor is also intended to provide physiologic data at The Dash 3000/4000 Patient Monitor is also intended to provide provides
Unity network to clinical information systems and allow the user to access hospital data at the point-of-care.

This information can be displayed, trended, stored, and printed.

The Dash 3000/4000 Patient Monitor was developed to interface with non-proprietary third party peripheral devices that support serial data outputs.

Prescription Use X (Part 21 CFR 801 Subpart D) And/OR

Over-The-Counter Use_ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Dexice

Division Sian-Off n of Anesthesiology, General Hospital,

510(k) Number: K040438

Regulation Number and Section

§ 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.