The vital signs monitor is a portable device indicated for use in non-invasively measuring and displaying functional oxygen saturation of arterial haemoglobin (SpO2), pulse rate(PR), Non-invasive measurement of blood pressure(NIBP) of adult and pediatric patients in hospitals, medical facilities, and sub-acute environments. The vital signs monitor is intended for spot-checking and/or continuous monitoring of patients.

Device Description

The proposed device, MD2000B Vital Signs Monitor, is a portable device, which is intended for measuring and/or cont pulse oxygen saturation (SpO2), pulse rate (PR), systolic pressure (SYS), diastolic pressure (DIA) and mean arterial pressure (MAP) on adult and pediatric.

AI/ML Overview

The provided text describes specific details about a 510(k) submission for the MD 2000B Vital Signs Monitor. However, it does not contain the detailed acceptance criteria for performance, the study that proves the device meets those criteria, or most of the specific study design elements you requested.

The submission states that "Performance testing including clinical and laboratory testing was conducted to validate and verify that the proposed device, MD2000B Vital Signs Monitor met all design specifications and was substantially equivalent to the predicate device." However, the results, acceptance criteria, and methodology of these tests are not present in the provided text.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or information regarding sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance. This information would typically be found in the detailed test reports attached to the 510(k) submission, not in the summary or cover letters.

Here's what I can extract based on the limited information available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Not available in the provided text. The document states that "Performance testing... was conducted to validate and verify that the proposed device... met all design specifications..." but does not list those specifications or the quantitative results.

2. Sample size used for the test set and the data provenance:

Not available in the provided text. The document mentions "clinical and laboratory testing" but does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not available in the provided text.

4. Adjudication method for the test set:

Not available in the provided text.

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:

Not applicable/available. This device is a vital signs monitor, not an AI-assisted diagnostic imaging device that typically involves human "readers." The text does not mention any MRMC studies or AI involvement.

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

The device itself is a standalone monitor for vital signs. Performance testing would assess its accuracy in measuring SpO2, PR, and NIBP without human "in-the-loop" interpretation in the way one might consider for an AI CAD system. However, specific performance metrics are not provided.

7. The type of ground truth used:

Not explicitly stated for the "clinical testing." For vital signs monitors, ground truth for parameters like SpO2, PR, and NIBP is typically established using a reference standard device (e.g., arterial blood gas analysis for SpO2, ECG for PR, invasive arterial line for NIBP, or a highly accurate clinical reference monitor). The document only generally refers to "performance testing including clinical and laboratory testing."

8. The sample size for the training set:

Not applicable/available. This is a hardware vital signs monitor, not typically a machine learning or AI device that requires a "training set" in the sense of an algorithm being trained on data. Its performance is based on its sensor technology and signal processing, not a trained dataset.

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

Not applicable/available. (See point 8)

Summary

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Section 4 510(k) Summary

JUL - 9 2010

This 510(k) Summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is:

Sponsor:	Beijing Choice Electronic Technology Co., LtdBailangyuan Bldg B 1127-1128, Fuxing road, A36Beijing, 100039, ChinaEstablishment Registration Number: 3005569927
	Contact Person: Mr. Chen Lei
Correspondent:	Ms. Diana HongMr. Tarzan. WangShanghai Mid-Link Business Consulting Co., LtdSuite 5D, No. 19, Lane 999, Zhongshan No.2Road(S)Shanghai, 200030, ChinaTel: +86-21-64264467Fax: (240)238-7587Email: Diana.hong@mid-link.net
Proposed Device Information
Trade Name	Vital Signs Monitor;
Model:	MD2000B;
Classification Name:	monitor, physiological, patient;
Product Code:	MWI;
Subsequent Product Codes:	DQA,DXN
Regulation Number:	870.2300;
Device Class:	II
Intended Use:	The vital signs monitor is a portable device indicatedfor use in non-invasively measuring and displayingfunctional oxygen saturation of arterial haemoglobin(SpO2), pulse rate(PR), Non-invasive measurementof blood pressure(NIBP) of adult and pediatric

patients in hospitals, medical facilities, and sub-acute environments. The vital signs monitor is intended for spot-checking and/or continuous monitoring

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Report SN: SHA00920090508FDA patients. Predicate Device: VS-800 Vital Signs Monitor K Number: K063055 The proposed device, MD2000B Vital Signs Monitor, Device Description: is a portable device, which is intended for measuring and/or cont pulse oxygen saturation (SpO2), pulse rate (PR), systolic pressure (SYS), diastolic pressure (DIA) and mean arterial pressure (MAP) on adult and pediatric. Performance testing including clinical and laboratory Testing Conclusion: testing was conducted to validate and verify that the proposed device, MD2000B Vital Signs Monitor met all design specifications and was substantially equivalent to the predicate device. The proposed device, MD2000B Vital Signs Monitor SE Conclusion:

is substantially equivalent (SE) to the predicate device, VS-800 Vital Signs Monitor.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human services, with three wave-like lines emanating from a central point.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUL - 9 2010

Beijing Choice Electronic Technology Co., Ltd. c/o Ms. Diana Hong General Manager Shanghai Mid-Link Business Consulting Co., Ltd. Suite 8D, No. 19, Lane 999, Zhongshan No. 2 Road(S) CHINA 200030

Re: K100740

Trade/Device Name: MD 2000B Vital Signs Monitor 1 Regulatory Number: 21 CFR 870.2300 Regulation Name: Physiological Patient Monitor (without arrhythmia detection or alarms) Regulatory Class: II (two) Product Code: 74 MWI Dated: June 2, 2010 Received: June 3, 2010

Dear Ms. Hong:

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, Or ve and Cosmetic Act (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. 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.

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.

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Page 2 - Ms. Diana Hong

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indication For Use

510(k) Number (if known): Pending

Device Name: MD 2000B Vital Sign Monitor

Indications for Use:

Prescription Use √ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

W.W.

(Division Sign-Off)
Division of Cardiovascular Devices

Page 1 of

510(k) Number

Regulation Number and Section

§ 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).