This device is intended to acquire and condition the ECG signal from a patient so that it can be transmitted via radio frequency to a workstation in a hospital or clinical setting where the ECG is displayed and analyzed. This device is for use with ambulatory adult patients, which need monitoring while undergoing cardiac or pulmonary rehabilitation, or other monitoring. The data output from the telemetry remains of the patients' progress through rehabilitation or other monitoring. Patients demographies, exercise protocor hire wireless input devices or automatically a variety of connifereially available weeks. A database can be created for use with an Outcomes program.

Device Description

ScottCare TeleKellaborm 2004 Cardiopannonial (outpatient) environment). It is used device intended for non-diagnostic use in a remote or in-hospital (outpation) of coursely t device intended for non-thaghosic use in a remote transmitted via radio frequency to a to acquire and condition the ECG signal so that it can be seriest, of the heat, of workstation. The telemetry capable system measures the electrical activity of the heart of workstation. The telement capable system inteasedial or pumonary rehabilitation, or other ambulatory adults undergoning presentous monitoring such as Congestive Heart Failure (CHF) patients.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text for the ScottCare TeleRehab™ 2004 Cardiopulmonary Rehabilitation System:

The provided document is a 510(k) summary for a medical device seeking substantial equivalence to predicate devices, not a study report detailing performance against specific acceptance criteria for a novel algorithm or AI. As such, the information you've requested regarding AI improvement, standalone algorithm performance, and training/test set specifics for AI will not be present. The focus of this document is demonstrating the device's adherence to general safety and performance standards for a medical device, and its similarity to existing, legally marketed devices.

However, I can extract the information that is available:

Acceptance Criteria and Reported Device Performance

Note: The "acceptance criteria" in this context refer to compliance with recognized medical device standards rather than specific statistical performance metrics against a defined ground truth for a diagnostic task. The "reported device performance" indicates that the device meets these standards.

Acceptance Criteria (Standard)	Reported Device Performance
IEC 60601-1 Safety of Medical Electrical Equipment Part 1: General Requirements	Meets requirements
IEC 60601-1-2:2004/EN61000-4 Generic Emissions Standard	Meets requirements
EN 55011 Class B Product Specific Emissions	Meets requirements
EN61000-4-2 Electrostatic Discharge	Meets requirements
EN61000-4-3 Radiated Susceptibility	Meets requirements
EN61000-4-4 Electrical Fast Transient Burst	Meets requirements
EN61000-4-5 Surge	Meets requirements
EN61000-4-6 Conducted Susceptibility	Meets requirements
EN61000-4-8 Magnetics	Meets requirements
EN61000-3-2 Harmonic Current	Meets requirements
EN61000-3-3 Voltage Fluctuations and Flicker	Meets requirements
EN61000-3-5 Voltage Fluctuations and Flicker (likely a repeat or typo in original)	Meets requirements
EN61000-3-5 Uniteness and alarms (applicable parts only)	Meets requirements

Study Details

Sample size used for the test set and the data provenance:
- The document does not specify a "test set" in the context of diagnostic performance involving patient data and ground truth. The testing performed was for compliance with electrical and safety standards.
- There is no mention of patient data provenance (e.g., country of origin, retrospective/prospective) for performance evaluation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no diagnostic "test set" requiring expert ground truth was described in this document.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as no diagnostic "test set" was described.
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 MRMC comparative effectiveness study was mentioned.
- This device is a hardware system for acquiring and displaying ECG signals, not an AI diagnostic algorithm. Therefore, there is no discussion of human reader improvement with or without AI assistance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware system, not a standalone algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. The "ground truth" for the tests performed was defined by the parameters and requirements of the cited industry standards (e.g., voltage limits, emission levels).
The sample size for the training set:
- Not applicable. This document describes a medical device, not a machine learning model that would have a "training set."
How the ground truth for the training set was established:
- Not applicable. As above, no training set for a machine learning model is involved.

Summary of Device and its Evaluation:

The ScottCare TeleRehab™ 2004 is a Cardiopulmonary Rehabilitation System intended to acquire and condition ECG signals from patients for display and analysis in a hospital or clinical setting. It is designed for non-diagnostic use with ambulatory adult patients undergoing cardiac or pulmonary rehabilitation.

The "study" described in the 510(k) summary is primarily focused on demonstrating the device's compliance with established safety and electromagnetic compatibility (EMC) standards (e.g., IEC 60601-1, various EN/IEC 61000 series standards). The document asserts that the device meets the requirements of these standards. The purpose of this 510(k) submission is to show substantial equivalence to previously cleared predicate devices, specifically "ScottCare TeleRehab™ System of Cardiac Rehabilitation" and the "Quinton Q-Tel RMS release." The argument for equivalence is based on similar intended use, technological characteristics, operational principles, performance characteristics, and environment of use, along with compliance to shared safety and performance standards. No advanced diagnostic algorithms or AI-driven performance metrics are discussed.

Summary

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APR 1 3 2005

510(k) SUMMARY

510(k) Premarket Notification for ScottCare TeleRehab™ 2004 Cardiopulmonary Rehabilitation System (TeleRehab™ 2004)

Submitter's Name, Address, Telephone Number:

ScottCare Corporation 4791 West 150th Street Cleveland, Ohio 44135 Phone: (216) 362-0550 Facsimile: (216) 267-6129

Contact Person:

Wayne Stripe Manager of Quality Assurance ScottCare Corporation

Date Prepared: February 8, 2005

Name of Device:

Name of Device:
ScottCare TeleRehab™ 2004 Cardiopulmonary Rehabilitation System (TeleRehab™ 2004)

Name/Address of Sponsor:

ScottCare Corporation 4791 West 150th Street Cleveland, Ohio 44135 Phone: (216) 362-0550 Facsimile: (216) 267-6129

Common or Usual Name:

Common of 'Usual Prailion Telemetry Monitoring System

Classification Name:

Classification Names

Predicate Devices:

Predicate Devices:
ScottCare Corporation's "ScottCare TeleRehab™ System of Cardiac Rehabilitation." Scoulcare Corporation's - Beotesare - release - releasement System." (K041607)

Intended Use:

Intended Use:
This device is intended to acquire and condition the ECG signal from a patient to a veryeration to a veryeration to a veryeration This device is intended to acquire and condition the 2000 telements transmitter to a workstation in a hospital or clinical setting where the ECG is displayed and analyzed. This device is for use in a hospital of cimical setting which need monitoring while undergoing cardiac or pulmonary with ambulatory adult patients, which need monitoring is viewed and stored on a workstation for

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tracking of the patients' progress through rehabilitation. Patient demographics, excited insult tracking of the patients "progress unough remoment" a variety of caranters input and medical information can be cifered Tha a Valloy of Section of the face. A database can be created for use with an Outcomes program.

Technological Characteristics:

Technological Characteristics.
Both the TeleRehabTM 2004 and its' TeleRehab predicate are electrically powered, porchional devices with the same intended function and use. Both incorporation a olinion or pornition principles; have the same basic performance characteristics, are used in a clinical or hospital principles, have the same basic PC technology on the same ambulatory adult population. Both devices display ECG waveforms of the transmitted signals and include a central monitoring Both devices display ECO waveromis of the transmitter and a receiver. Both devices station, one of multiple receivers and connection to a local area network. Additionally, both devices can be used to develop, edit and produce reports of patient data acquired during them rehabilitation process. Both devices do not require sterilization. Mechanical safety, aside from rehability, is not applicable for either device. Stability, electromechanical compatibility, electrical stability, is not applicable for the proposed device was performed in accordance with safety and themal salely testing of the proposed as reading Equipment - Part 1: General applicable sections of ILC 00001 Fulle 110 or applicable for either device. Both devices are Requirements For Salety. Chininear salety is not op both devices are similar and generated data used in identical allatomical sites. Thanks actives. The primary difference between the is identical. 10th2lig energy is not cinner of on the TeleRehab™ 2004 includes a new digital I elekendom. 2004 and 113 predicate to the differences between the TeleRehab™ 2004 and the receiver for signal lectpublic "None of mact on the safety and efficacy of the proposed device. predicate TeleKenab device have an impact on the sames which are beyond the TeleRehalt™ While the Quinton device has additional marcasions when viewed as a Radiofrequency Physiological 2004, they share the same multanons for use as with Now of the TeleRehab™ 2004 Signal Transmitter and Receiver pursually powered, prescription devices with the same intended and Q-Tel RMS predicate are electrically porters) data and conditioning the ECG signal so that it can be transmitted by radio waves to a workstation. They incorporate the same basic operational principles, have the same basic performance characteristics, are used in a clinical or hospital environment, and utilize the same basic PC technology on the same and include and include a hospital environment, and unize the same base i & ansmitted signals and include a central monitoring station, one or several workstation computers, a signal transmitter and a central monitoring station, one of multiple receivers and connection to a local area newving and riguing Optional workstations may be comected to both systems via network for entering and viewing Optional workstations may be comiceled to both devices can be used to develop. patient demographic and renab sessori data. 770 developilitation process. Both devices edit and produce reports of patient data acquired arade electrode and patient lead.
do not require sterilization, and utilize a biocompatible medical is not opticable do not require stermization, and united a broompanse and from stability, is not applicable that come into contact with the patient. "Menhamed safety and themal safety and themal safety and themalicable for either device. Stability, electionicelians was performed in accordance with applicable testing of the proposed and predically of the may be new le part it General Requirements sections of IEC 60001-1 and IEC 00001-1 a measure in the property. Both devices are used in

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identical anatomical sites. Human factors for both devices are similar and generated data is identical analy and emit ionizing energy.

The primary difference between the TeleRehab™ 2004 and the Quinton Q-Tel RMS device is I he primary difference between the Telefonal and optional ECG features for other than the intended that the Quinton device includes auditional and options 2004 and the TeleRehab™ 2004 and the use for TeleKenab™ 2004. None of the Gifterences connects of the device when used as the TeleRehab™ 2004 is intended.

Device Description:

Device Description: ScottCare TeleKellaborm 2004 Cardiopannonial (outpatient) environment). It is used
device intended for non-diagnostic use in a remote or in-hospital (outpation) of coursely t device intended for non-thaghosic use in a remote transmitted via radio frequency to a
to acquire and condition the ECG signal so that it can be seriest, of the heat, of workstation. The telemetry capable system measures the electrical activity of the heart of workstation. The telement capable system inteasedial or pumonary rehabilitation, or other ambulatory adults undergoning presentous monitoring such as Congestive Heart Failure (CHF) patients.

Performance Data:

Performance Data:
The ScottCare TeleRehab™ 2004 Cardiopulmonary Monitoring System was tested to and meets the requirements of the following standards.

IEC 60601-1 Safety of Medical Electrical Equipment Part 1: General Requirements
IEC 60601-1-2:2004/EN61000-4 Generic Emissions Standard
EN 55011 Class B Product Specific Emissions
EN61000-4-2 Electrostatic Discharge
EN61000-4-3 Radiated Susceptibility
EN61000-4-4 Electrical Fast Transient Burst
EN61000-4-5 Surge
EN61000-4-6 Conducted Susceptibility
EN61000-4-8 Magnetics
EN61000-3-2 Harmonic Current
EN61000-3-3 Voltage Fluctuations and Flicker
EN61000-3-5 Voltage Fidetuations and I neness and alarms (applicable parts only)

Substantial Equivalence:

Substantial Equivalence:
The performance data shows that ScottCare TeleRehabTM Cordios Poblioging The performance data shows that ScottCare TeleRehab System for Cardiac Relabilitation System is substantially equivalent to the Bootecare a provent system (K041607) and is safe for intended use.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wing segments, symbolizing care and protection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

Public Health Service

APR 1 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ScottCare Corporation c/o Mr. Ned Devine Entela, Inc. 3033 Madison Avenue SE Grand Rapids, MI 49458

Re: K050778 KU50778
Trade Name: ScottCare TeleRehab™ 2004 Cardiopulmonary Rehabilitation System (TeleRehab™ 2004) Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter and Receiver Regulatory Class: II (two) Product Code: DRG Dated: Undated Received: March 28, 2005

Dear Mr. Devine:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bocation in (a) the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conniner of rial to rial) 2011-07-12 in accordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). and Cosmeter Free (110) that as device, subject to the general controls provisions of the Act. The I ou may, mererere, mains of the Act include requirements for annual registration, listing of general controls provisions or ractice, 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 If your device is elassified (soo as rols. Existing major regulations affecting your device can may be subject to bach additions, 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. Ned Devine

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that 1271 3 issuates or a case ice complies with other requirements of the Act that I Dri has made a acternations administered by other Federal agencies. You must of ally reactal statutes and regarations and limited to: registration and listing (21 Comply with an the Fice orequirements, as a manufacturing practice requirements as set CFK Fart 807), labeling (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Section ) our device as described in your Section 510(k) This letter will anow you to ough manieang your antial equivalence of your device to a legally premarket notheadon: "The PDF Intelling of casion 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 If you desire spochie at (240) 276-0120. Also, please note the regulation entitled, Colliati the Office of Compilance wa (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Other general information on your responsional 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,

Blyminma for

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

510(k) Number (if known): TBD

Cardiopulmonary TeleRehab™ 2004 ScottCare Name: Device Rehabilitation System (TeleRehab™ 2004)

Indications For Use: This device is intended to acquire and condition the Indications For 'Ose. This device is include transmitted via radio frequency
ECG signal from a patient so that it can be transmitted via a hospital ECG signal from a patient so the it var it var setter to a workstation in a hospital (WMTF) while a Stickman telomen's and analyzed. This device is a or clinical selling where the ECC is as a sees monitoring while for use with anibulatory addit pattersting the data output from the undergoing cardiac or pullionary renarmany remains of the patients' progress through rehabilitation or other monitoring. Patients patients - progress - through - remaintain- - 1 information can be entered via demographies, exercise protocor hire wireless input devices or automatically a variety of connifereially available weeks. A database can be created for use with an Outcomes program.

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

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)

Blummen

(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number KI) 50777

Page 1 of 1

Regulation Number and Section

§ 870.2910 Radiofrequency physiological signal transmitter and receiver.

(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).