This monitor is intended to be used for monitoring, storing, reviewing, recording, and generating alarms for multiple physiological parameters including ECG, respiration (RESP), temperature (TEMP), functional arterial oxygen saturation (Sp02), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), expired C02, cardiac output (C.O.) and anesthetic gas (AG)of adults, pediatrics and neonates in hospital environments. The monitor is equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both.

This monitor is suitable for use in hospital environments including but not limited to OR, PACU, ICU and neonate intensive care room.

Device Description

The PM-2000M Patient Monitor can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormities happen.

The PM-2000M realizes the monitoring of physiological parameters by configuration with different parameter modules which include Sp02 (pulse oxygen saturation, pulse rate and Sp02 plethysmogram) with EDAN Sp02 module or Nellcor SP02 module, NIBP (systolic pressure, diastolic pressure, mean pressure and pulse rate), TEMP, ECG, RESP, C02, IBP, C.O. and AG.

The above is the maximum configuration for elite VB, the user may select different monitoring parameters in according with the requirement.

The PM-2000M is configured with a 17-inch touch screen and build-in Lithium-ion battery, Besides, and supports software upgrade online and networking

AI/ML Overview

This document is a 510(k) summary for the PM-2000M Patient Monitor. It focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study report as typically seen for novel devices that require extensive performance validation against a defined set of criteria.

Therefore, the requested information, particularly regarding specific acceptance criteria, detailed study designs (sample size, data provenance, expert ground truth, adjudication, MRMC, or standalone performance), and ground truth establishment for novel algorithms, is not explicitly available in the provided text.

Here's an analysis based on the information provided and what can be inferred:

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

The document does not provide a table of
specific, quantitative acceptance criteria for each physiological parameter (ECG, SpO2, NIBP, etc.) or a corresponding reported performance from a study. The "Test Summary" lists general categories of testing:

Software testing
Hardware testing
Safety testing
Environment testing
Risk analysis
Final validation

This implies that the device underwent validation to ensure it meets general performance and safety standards for patient monitors, likely including accuracy and reliability benchmarks commonly applied to such devices (e.g., ISO or AAMI standards for specific physiological measurements). However, the specific metrics and thresholds are not detailed.

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

This information is not provided in the document. The general nature of the "Test Summary" does not include details about specific test sets, their size, or the provenance of any data used for validation.

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)

This information is not provided. The document does not describe studies that would require expert-established ground truth in the way a diagnostic AI device would (e.g., for image interpretation). Patient monitors typically rely on physical measurement standards or highly accurate reference devices for ground truth during testing.

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

This information is not provided. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which are not detailed here for this patient monitor.

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, an MRMC comparative effectiveness study was not done or at least not reported in this document. This type of study is usually conducted for AI-powered diagnostic aids where human readers interact with the AI. The PM-2000M is a patient monitor, and its primary function is direct physiological measurement, not aiding human readers in interpretation tasks in the same way an AI diagnostic tool would.

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

The document implies that standalone testing of the device's functions (measurements, alarms) was performed as part of "Software testing," "Hardware testing," and "Final validation." However, explicit details of these standalone performance metrics (e.g., accuracy of ECG measurement compared to a reference, alarm detection rates) are not provided. The focus is on substantial equivalence to a predicate device, suggesting performance was assessed against established standards for patient monitors rather than novel algorithm-specific benchmarks.

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

The document does not explicitly state the type of ground truth used. For patient monitors, ground truth typically involves:

Reference devices: Highly accurate, calibrated medical devices (e.g., a reference ECG machine, a calibrated blood pressure simulator, a SpO2 simulator) that provide the true physiological values.
Physical standards: For environmental and safety testing, compliance with relevant industry standards (e.g., for electromagnetic compatibility, temperature ranges).

8. The sample size for the training set

This information is not applicable / not provided. Patient monitors like the PM-2000M typically rely on established physics-based algorithms and signal processing techniques for physiological parameter measurement, rather than machine learning algorithms that require a "training set" of data in the common sense of AI/ML devices. Therefore, the concept of a training set of data for a "novel" algorithm is not relevant here based on the device description.

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

This information is not applicable / not provided for the same reason as point 8.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

April 23, 2014

Advanced Instrumentations, Inc. Jorge Millan 601 West 20th Street Hialeah, FL 33010 US

Re:	K132077
Trade/Device Name:	PM-2000M Patient monitor
Regulation Number:	21 CFR 870.1025
Regulation Name:	Patient Physiological Monitor (With Arrhythmia Detection orAlarms)
Regulatory Class:	Class II
Product Code:	MHX, DRT, DXN, DSK, FLL, DQA, CCK, CBQ, CBS, CBR,CCL, DSA, DRT, DSI, MLD
Dated:	March 26, 2014
Received:	March 28, 2014

Dear Jorge Millan,

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 (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. 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.

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

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mitchell Stein

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

Enclosure

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Indications for Use

510(k) Number (if known): K132077

Device Name:

PM-2000M Patient Monitor

Indications for Use:

This monitor is suitable for use in hospital environments including but not limited to OR, PACU, ICU and neonate intensive care room.

Prescription Use X (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Date: 2014.04.23
08:55:00 -04'00'

Page 1 of

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510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

The assigned 510(k) number is: K132077

Submitter

Advanced Instrumentations, Inc. 6800 N.W. 77th Court Miami, Fl 33166 Telephone: 305-477-6331 Fax: 305-477-5351

Registration # 1066270

Official correspondent :

Jorge Millan, PhD Email: jmillan@hiatec.org 601 West 20 St Hialeah, FL 33010 Phone : (305) 925-1260

Date Prepared:

March 26, 2014

Device name and classification:

Device Name: PM-2000M Patient Monitor ●
Common Name: Patient Monitor Arrhythmia detector and alarm ●

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. Classification

Description	Classification	ProductCode
21 CFR 870.1025 monitor, physiological, patient (witharrhythmia detection or alarms)	II	MHX
21 CR 870.2300 Cardiac monitor (including cardiotachomentand rate alarm)	II	DRT
21 CFR 870.1130 Non-Invasive blood pressure measurement	II	DXN
21 CFR 870.1110 Blood pressure computer	II	DSK
21 CFR 880.2910 Clinical Electronic Thermometers-Temperature Monitor with Probe	II	FLL
21 CFR 870.2700 Oximeter, Pulse	II	DQA
21 CFR 868.1400 Carbon Dioxide Gas Analyzer	II	CCK
21 CFR 868.1500 Enflurane gas analyzer	II	CBQ
21 CFR 868.1620 Halothane gas analyzer	II	CBS
21 CFR 868.1700 Nitrous Oxide gas analyzer	II	CBR
21 CFR 868.1720 Oxygen gas analyzer	II	CCL
21 CFR 870.2900 cable, transducer and electrode,patient, (including connector)	II	DSA
21 CFR 870.2300 monitor, cardiac (incl. cardiotachometer &rate alarm)	II	DRT
21 CFR 870.1025 Detector and Alarm, Arrhythmia	II	DSI
21 CFR 870.1025 Monitor, ST Segment with Alarm	II	MLD

Regulatory Class: Class II .

Predicate Device:

V8 Patient Monitor, K120173 Manufacturer: EDAN Instruments

Device Description:

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The above is the maximum configuration for elite VB, the user may select different monitoring parameters in according with the requirement.

The PM-2000M is configured with a 17-inch touch screen and build-in Lithium-ion battery, Besides, and supports software upgrade online and networking

Comparison to the predicate device:

The subject device has same technology characteristics, materials, design, manufacturing processes, operating principle, performance specifications and has the same indications for use as the predicate device.

Intended Use:

This monitor is suitable for use in hospital environments including but not limited to OR, PACU, ICU and neonate intensive care room.

Contraindications

It is not intended for use in patient's home or residence, or when it has not been ordered by a physician.

Effectiveness and Safety Contraindications:

Test Summary

The following quality assurance measures were applied to the development of the Patient Monitor

Software testing Hardware testing Safety testing

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Environment testing Risk analysis Final validation

Substantially Equivalent Determination:

This premarket notification submission demonstrates that PM-2000M Patient Monitor is substantially equivalent to the predicate device.

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.