The MedStar System is intended to transfer patient physiological data from a range of patient monitors to a remote station, such as a Disease Management Center, for subsequent transfer by a Hospital Information System for review by a healthcare professional. The MedStar System is intended for use with any patient requiring Out-of-Hospital monitoring. The MedStar System is not used directly with a patient.

The MedStar Unit is intended for Out-of-Hospital Use. The associated Collection Server is intended for use in a Disease Management Center, Hospital or Hospital-Type facility, Medical Clinic or Physician's Office. The MedStar System is intended for sale by or on the order of a physician only.

The MedStar System is indicated for Out-of-Hospital Use with any patient requiring Out-of-Hospital monitoring The associated Collection Server is intended for use in a Disease Management Center, Hospital or Hospital -Type facility, Medical Clinic or Physician's Office.

Device Description

The MedStar Monitoring System comprises the MedStar Unit and the associated Collection Server. The MedStar Unit is a portable, battery-operated unit for controlling the transmission of data from a range of compatible patient monitors or measurement devices to a remote monitoring center. Data is transmitted via telephone lines to the associated data collection server at the remote site. The MedStar Unit is contained in a small plastic enclosure with an LCD screen mounted into the top of the case. A User push button control is located adjacent to the display. Four serial communication ports are located at the side of the unit for connection to the serial data ports of specific patient monitors. Two standard phone jacks are also located at the side of the unit for connection to standard phone outlets. Two recessed programming buttons are included on the opposite side of the enclosure to the phone jacks. The Collection Server comprises a Personal Computer-type Processor Unit incorporating an additional electronics board to control phone line transmission to and from the MedStar Unit. The MedStar System accepts serial data from Blood/Glucose Monitors, Weight Scales, and NIBP Monitors. Monitored/measured data is transferred from a patient monitor/measurement device via that unit's serial data port under the control of a serial port protocol. The data is then stored in the MedStar Unit prior to undergoing Dual Tone Multiple Frequency, DTMF, encoding to facilitate phone line transmission to a remote site. A Collection Server receives and decodes the transmitted data and stores the data locally for subsequent transfer by a Hospital Information System for review by a healthcare professional. In addition to transferring encoded data from the three measurement devices described above, EKG data may also be transferred directly from an EKG Monitor to the Collection Server, via phone line, using an EKG Monitor's standard audio data output.

AI/ML Overview

The provided text does not contain detailed information about the acceptance criteria or a study proving the device meets specific acceptance criteria in the format requested. The document is a 510(k) summary and FDA clearance letter for the MedStar System, a "Telephone Electrocardiograph transmitter and receiver."

Here's a breakdown of what can be extracted and what is missing:

The document primarily focuses on establishing substantial equivalence to predicate devices and describing the device's function and intended use. While it mentions "bench testing was conducted to establish the MedStar System's accuracy and performance to specification," it does not provide the specifics of these tests, acceptance criteria, or their results in a quantifiable manner.

Here's a breakdown based on your request, highlighting what's missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (What was measured?)	Reported Device Performance (How did it perform?)
Not specified in detail. The document generally states "bench testing was conducted to establish the MedStar System's accuracy and performance to specification."	Not specified in detail. The document does not provide quantitative results for accuracy, latency, data integrity, or specific benchmarks.
Potential criteria based on device function (analogous to predicate devices):
- Data transmission integrity (e.g., error rate)	- Not reported.
- Accuracy of transmitted physiological data	- Not reported.
- Compatibility with listed patient monitors	- Compatibility is stated, but performance metrics not provided.
- Reliability of telephone line transmission	- Not reported.

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

Sample Size for Test Set: Not specified. The document mentions "bench testing," which implies laboratory-based testing, but does not provide details of the sample size (e.g., number of transmission cycles, number of data points, number of connected devices, length of tests).
Data Provenance (country of origin, retrospective/prospective): Not specified. Bench testing is typically performed in a controlled laboratory environment.

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):

Number of Experts: Not applicable or not specified. This type of device (data transmission system) would likely rely on technical specifications and objective measurements rather than expert human interpretation for "ground truth" in the way a diagnostic imaging AI would. The "ground truth" for its performance would be whether the transmitted data accurately reflects the input data from the patient monitors.
Qualifications of Experts: Not applicable or not specified.

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

Adjudication Method: Not applicable or not specified. Adjudication methods are typically used in studies involving human interpretation (e.g., radiological reads) where there might be disagreement among experts. For a technical data transmission device, performance is typically assessed against a predefined technical standard or the known input data, not through expert consensus 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:

MRMC Study: No. The MedStar System is a data transmission device, not a diagnostic AI or an AI intended to directly assist human readers in interpretation. It facilitates the transfer of physiological data for subsequent review by healthcare professionals, but it does not perform analysis or interpretation itself. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device.
Effect Size of Improvement: Not applicable.

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

Standalone Performance: Yes, in a sense. The "bench testing" mentioned would assess the device's technical performance (e.g., data transmission accuracy, reliability, compliance with communication protocols) in a standalone capacity. However, the details of these tests are not provided. The device's primary function is to transmit data without human intervention in the transmission process itself.

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

Type of Ground Truth: The ground truth for this device would be the original, untransmitted physiological data as measured by the connected patient monitors (Blood/Glucose Monitor, Weight Scale, NIBP Monitor, EKG Monitor). The "accuracy" and "performance to specification" would be demonstrated by comparing the data received by the Collection Server to the data originally sent by the patient monitors.

8. The sample size for the training set:

Training Set Sample Size: Not applicable. The MedStar System is described as a hardware device with embedded software for data handling and transmission. It is not an AI/Machine Learning algorithm that typically requires a "training set" in the context of learning patterns or making predictions. Its functionality is based on established communication protocols and hardware design.

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

Ground Truth for Training Set: Not applicable, as there is no "training set" in the AI/ML sense for this device. Its "performance to specification" would be verified through engineering and bench testing against known, controlled inputs according to its design.

In summary, the provided document is a regulatory submission focused on demonstrating substantial equivalence and describing the device. It lacks the detailed study information, acceptance criteria, and performance metrics typically found in a clinical or analytical validation study report for a diagnostic or AI-driven device.

Summary

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Section 16. SECTION 16. 510(k) SUMMARY.

Section 16.a Date Summary Prepared February 15, 2002

Section 16.b Company Information

Establishment:

Official Correspondent:

FEB 1 1 2003

Cybernet Medical. 727 Airport Blvd. Ann Arbor MI 48108

David A. C. Green Regulatory Affairs Consultant for Cybernet Medical. 1460 Golfcrest Place Vista, CA 92083 (760) 599 9661 (760) 599-9661 (fax)

Section 16.c Name of Device

Proprietary:

Common/Usual:

Classification:

MedStar System

MedStar

Telephone Electrocardiograph transmitter and receiver (§870.2920/74DXH)

Section 16.d Equivalent Devices

Substantial equivalence to the following legally marketed predicate devices with the same or similar indications for use has been demonstrated by a comparison of product features as described in the labeling and promotional literature for predicate devices and for the MedStar System, as well as testing to accepted industry standards. In addition. bench testing was conducted to establish the MedStar System's accuracy and performance to specification. The predicate devices are as follows:

Home Care Monitoring System, AvidCare Corp., K010029 ●
Model EHC 400 Desktop Patient Station, Cybercare Technologies Inc., K003257 ●
PaceArt Central Station CPTS 86-12, PaceArt Inc., K915632 ●

Section 16.e Device Description & Technological Characteristics

Data is transmitted via telephone lines to the associated data collection server at the remote site.

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Data is transmitted via telephone lines to the associated data collection server at the remote site.

The MedStar Unit is contained in a small plastic enclosure with an LCD screen mounted into the top of the case. The case is made of a strong impact resistant plastic material. A User push button control is located adjacent to the display.

Four serial communication ports are located at the side of the unit for connection to the serial data ports of specific patient monitors.

Two standard phone jacks are also located at the side of the unit for connection to standard phone outlets.

Two recessed programming buttons are included on the opposite side of the enclosure to the phone jacks.

Collection Server comprises a Personal Computer-type Processor Unit The incorporating an additional electronics board to control phone line transmission to and from the MedStar Unit.

The MedStar System accepts serial data from the following patient monitors or measurement devices:

Device	Communication Protocol
Blood/Glucose MonitorLifescan SureStep	Available
Weight Scale - A&D Medical UC-300	Available
Weight Scale - A&D Medical UC-321	Available
NIBP Monitor -A&D Medical UA-767PC	Available

Monitored/measured data is transferred from a patient monitor/measurement device, e.g. a Blood/Glucose Monitor or Weight Scale, via that unit's serial data port under the control of a serial port protocol. The data is then stored in the MedStar Unit prior to undergoing Dual Tone Multiple Frequency, DTMF, encoding to facilitate phone line transmission to a remote site, such as a Disease Management Center.

A Collection Server comprising a Personal Computer with an additional communications board, receives and decodes the transmitted data and stores the data locally for subsequent transfer by a Hospital Information System for review by a healthcare professional.

In addition to transferring encoded data from the three measurement devices described above, EKG data may also be transferred directly from an EKG Monitor to the Collection Server, via phone line, using an EKG Monitor's standard audio data output.

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Section 16.f Intended Use

The intended use, patient population and environment of use are the same or similar to the predicate devices, the Avid Care Corporation Home Care Monitoring System, K010029, the Cybercare Technologies Model EHC 400 Desktop Patient Station, K003257 and the PaceArt Central Station CPTS 86-12, K915632.

Section 16.g Certification Statement

In accordance with the requirements of 21 CFR 807.87(j), the following certification is provided:

Cybernet Medical believes that all data and information submitted in this premarket notification are truthful and accurate and no material fact has been omitted.

Eric D. Lichtenstein Product Development Manager Cybernet Medical.

David A. C. Queen

David A. C. Green Regulatory Affairs Consultant for Cybernet Medical.

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Public Health Service

Image /page/3/Picture/2 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" around the perimeter. Inside the circle is a stylized image of a human figure, represented by three curved lines forming a profile of a head and shoulders.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 1 2003

Cybernet Medical c/o Mr. David A.C. Green Regulatory Consultant BBP Consultants Inc. 1460 Golfcrest Place Vista, CA 92083

Re: K020534

Trade Name: MedStar System Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter and Receiver Regulatory Class: Class II (two) Product Code: DXH Dated: November 29, 2002 Received: December 2, 2002

Dear Mr. Green:

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.

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 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 – Mr. David A.C. Green

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); 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. This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

K. Bruce D. Zuckerman, M.D.

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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INDICATIONS FOR USE STATEMENT 2.g

Applicant:	Cybernet Medical.
510(k) Number:	K020534
Device Name:	MedStar System
Indications for Use:	The MedStar System is indicated for Out-of-Hospital Use with any patientrequiring Out-of-Hospital monitoringThe associated Collection Server is intended for use in a DiseaseManagement Center, Hospital or Hospital -Type facility, Medical Clinic orPhysician's Office.

Yes (Per 21 CFR 801.109). Prescription Use:

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 CFR 801.109) (Optional Format 1-2-96)

NCATTM

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K020534

Prescription Use _____________________________________________________________________________________________________________________________________________________________

OTC Use ______________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 870.2920 Telephone electrocardiograph transmitter and receiver.

(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).