The MTS Option for the ESCORT II Monitor is a portable patient monitor intended to be used for monitoring vital signs of critically ill adult and pediatric patients in the hospital environment.

Device Description

The MTS Option for the ESCORT® II Monitor is a modular patient monitor capable of monitoring two parameters simultaneously, including dual-vector ECG and SpO2. The MTS Module is equipped with an alphanumeric LCD display that is capable of displaying vital signs providing the detail needed to aid clinical decisions.

AI/ML Overview

The provided text describes a 510(k) summary for the MTS Option for the ESCORT® II Monitor. However, it does not contain the specific details required to complete your request for acceptance criteria, device performance, or study specifics as if it were a modern AI device submission.

The document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria with detailed studies. It references general standards and guidance documents, but doesn't present the results of specific performance tests in the format you've requested.

Here's why the requested information cannot be fully extracted from the provided text and what general inferences can be made:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: The document states that the device is "designed to meet established standards" such as "ANSI/AAMI EC-13: 1992, Cardiac monitors, heart rate meters, and alarms" and "ASTM F 1415 - 92, Standard Specification for Pulse Oximeters." However, it does not explicitly list specific numerical acceptance criteria (e.g., heart rate accuracy within X bpm, SpO2 accuracy within Y%).
Reported Device Performance: The document generally states, "The MTS Option for the ESCORT® II Monitor is shown by performance testing to be a safe, effective portable patient monitor." It does not provide specific performance metrics (e.g., sensitivity, specificity, accuracy, precision for ECG or SpO2 measurements) or a comparison of these against the (unspecified) acceptance criteria.

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

Not provided. The document states "comprehensive bench testing and product verification and validation studies" were conducted but does not give any details on sample sizes, types of data (e.g., patient data, simulated data), or where the data came from (country, retrospective/prospective). This was common for 510(k) submissions of this era, which often relied on meeting established standards and substantial equivalence rather than extensive clinical efficacy studies.

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

Not applicable/Not provided. For a device like a patient monitor measuring ECG and SpO2, ground truth is typically established by reference measurement equipment (e.g., a calibrated ECG simulator, co-oximeter for SpO2) rather than expert consensus on diagnostic images or interpretations. The document does not describe any studies involving human experts establishing ground truth.

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

Not applicable/Not provided. As ground truth for these types of vital sign measurements is typically objective reference measurements, an adjudication method for expert consensus would not be relevant or described in this document.

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. This document describes a patient monitor (hardware device for measuring vital signs), not an AI-powered diagnostic or decision support system that would involve human "readers" or an "AI assistance" component to evaluate. Therefore, an MRMC study is not relevant here.

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

Not applicable/Not explicitly stated in relevant terms. While the device itself operates "standalone" in terms of its algorithms for processing ECG and SpO2 signals, the term "standalone performance" is often used in the context of AI algorithms analyzing data to provide a diagnostic or predictive output. This document is about the physical monitor and its basic measurement capabilities. Its "performance testing" would be against reference standards, implying an "algorithm only" type of evaluation in that sense, but not in the context of complex AI interpretation.

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

Inferred: Reference Measurement Equipment/Standards. For vital signs monitoring, ground truth is typically established by highly accurate and calibrated reference devices or simulators that generate known physiological signals or concentrations. The mention of specific standards (ANSI/AAMI EC-13, ASTM F 1415) implies testing against established methods and reference values defined within those standards.

8. The sample size for the training set:

Not applicable/Not provided. This is a hardware device for vital sign monitoring, not an AI model that requires a "training set" in the context of machine learning.

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

Not applicable. As above, no training set for an AI model is described.

In summary of what can be extracted:

Device Type: Portable Patient Monitor (ECG, SpO2).
Intended Use: Monitoring vital signs of critically ill adult and pediatric patients in the hospital environment.
Key "Study" Reference: "conformance to product development procedures and plans is assured by application of comprehensive bench testing and product verification and validation studies."
Standards Met (Implicit Acceptance Criteria):
- Reviewer Guidance for Premarket Notification Submissions, Anesthesiology and Respiratory Devices Branch; Division of Cardiovascular, Respiratory and Neurological Devices; November, 1993
- Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review; Office of Device Evaluation, August, 1991
- ANSI/AAMI EC-13: 1992, Cardiac monitors, heart rate meters, and alarms, 2nd edition
- ASTM F 1415 - 92, Standard Specification for Pulse Oximeters
Conclusion: "The MTS Option for the ESCORT® II Monitor is shown by performance testing to be a safe, effective portable patient monitor. The MTS Monitor is substantially equivalent to the MDE ESCORT® II 300 Series and the MDE ESCORT® II+ 400 Series Monitors."

This document reflects a 510(k) submission from 1997, which had different requirements and expectations for demonstrating device safety and effectiveness, particularly for non-AI hardware devices. The level of detail you're requesting is more aligned with modern AI/ML device submissions.

Summary

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K970763

JUL | 4 1997

MEDICAL DATA ELECTRONICS ESCORT® II MODULAR TELEMETRY SYSTEM 510(k) SUBMISSION 510(K) SUMMARY

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K970763

510(k) Summary

MTS Option for the ESCORT® II Monitor

Submitter:

Medical Data Electronics 12720 Wentworth Street Arleta, California 91331

Telephone:	818.768.6411
Telefacsimile:	818.768.4197

February 28, 1997 2. Date of Preparation:
1. Device Name:

Trade Name:	MTS Option for the ESCORT® II Monitor
Common Name:	Portable Patient Monitor
Classification Name:	Portable Patient Monitor, consisting of:

Cardiac Monitor ●
Pulse Oximetry .
Radiofrequency Physiological . Signal Transmitter & Receiver
1. Substantial Equivalence:

The MTS Patient Monitor is substantially equivalent to the MDE ESCORT® II+ 400 Series Monitor and to the MDE ESCORT® II Series 300 Monitor.

Description of the Device:

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The MTS Patient Monitor can monitor adult and pediatric patients. The appropriate monitoring mode for each patient, ADULT or PED, is selectable. Changing from one mode to another automatically changes all appropriate algorithms, alarm limits and any applicable parameter defaults.

The MTS Module functions through fixed function keys labeled on the front panel.

Factory defaults have been established and installed for all system and physiological monitoring issues (i.e., default ECG lead, initial inflation pressure, etc.). These values may be configured for specific needs.

Indications for use of the Device:

The MTS Option for the ESCORT® II Monitor is a portable patient monitor intended to be used for monitoring vital signs of critically ill adult and pediatric patients in the hospital environment.

Summary of the Technological Characteristics of the New Device Compared to the Predicate Device.

The MTS Option for the ESCORT® II Monitor is substantially equivalent to the MDE ESCORT® II Series 300 Monitor and the ESCORT® II+ 400 Series Monitor. The main difference between the ESCORT® with MTS Option Monitor and the current ESCORT® Series Monitors is the addition of a new multiparameter module (MPM) that can be communicate via hardwired or wireless connection. The wireless option will be configured to monitor ECG and oxygen saturation via pulse oximetry.

Device Testing:

The MTS Monitor is designed to meet established standards as follows:

. Reviewer Guidance for Premarket Notification Submissions, Anesthesiology and Respiratory Devices Branch; Division of Cardiovascular, Respiratory and Neurological Devices; November, 1993:
Reviewer Guidance for Computer Controlled Medical Devices ● Undergoing 510(k) Review; Office of Device Evaluation, August, 1991.
. ANSI/AAMI EC-13: 1992, Cardiac monitors, heart rate meters, and alarms, 2nd edition
ASTM F 1415 - 92, Standard Specification for Pulse Oximeters

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Tests demonstrating consideration of and mitigation of hazards identified as having potentially arisen as the result of the modifications described were developed. Conformance to product development procedures and plans is assured by application of comprehensive bench testing and product verification and validation studies.

9. Test Conclusions:

The MTS Option for the ESCORT® II Monitor is shown by performance testing to be a safe, effective portable patient monitor. The MTS Monitor is substantially equivalent to the MDE ESCORT® II 300 Series and the MDE ESCORT® II+ 400 Series Monitors.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 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 a stylized image of an eagle or bird-like figure with three distinct head profiles, suggesting a sense of community or collaboration.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. David M. Trueblood Medical Data Electronics, Inc. 12720 Wentworth Street Arleta, California 91331-4329

JUL | 4 1997

Re: K970763 Modular Telemetry System (MTS) Option for the MDE ESCORT® II Monitor Requlatory Class: II (two) Product Code: 74 DQA Dated: June 2, 1997 Received: June 3, 1997

Dear Mr. Trueblood:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. David M. Trueblood

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. -

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

MTS Option for the ESCORT II Monitor Device Name:

The MTS Option for the ESCORT II Monitor is a portable Indications for Use: monitor intended to be used for monitoring vital signs ( of critically-ill-adult and pediatric patients in the " hospital environment.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Richard N. Phillips

(Division Sign-C Division of Cardiovas and Neurological De 510(k) Number

Prescription Use
(Per 2.1 CFR 801.109)

Over-the-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 870.2700 Oximeter.

(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).