The 3100 Series device is single-channel looping cardiac event recorder for transmitting multiple ECG recordings via land-line or GSM telephony networks to a compatible ECG receiving system, such as "sensor mobile" REMOS ECG Receiving Software (510(k) K050670) or compatible standard acoustic ECG receivers. The 3100 series device is intended for auto-triggered and patient activated event recordings (Bradycardia, Tachycardia and Atrial Fibrillation). It is battery driven and utilizes a loop-memory to capture ECG data with an adjustable pre- and post-event time.

AI/ML Overview

This 510(k) submission for the TMS Telemedizinische Systeme GmbH Loop-Recorder vitaphone 3100 Series does not appear to contain a study specifically demonstrating the device meets acceptance criteria in the manner typically seen for complex AI/ML-based diagnostic devices. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices, which is common for hardware devices with established product codes.

Based on the provided documents, here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated in the provided 510(k) summary. For devices like the vitaphone 3100 Series (a cardiac event recorder), acceptance criteria would typically revolve around:

ECG Signal Quality: Ability to accurately capture and store ECG signals.
Event Detection Accuracy: For auto-triggered events (Bradycardia, Tachycardia, Atrial Fibrillation), the accuracy of the device in identifying and logging these events.
Loop Memory Functionality: Correct operation of the pre- and post-event loop recording.
Data Transmission Reliability: Successful and accurate transmission of ECG data via land-line or GSM.
Battery Life: Meeting specified operational hours.
Safety Standards: Compliance with electrical safety and EMC standards.

The 510(k) summary only states: "The technical specification comparison reveals no substantial differerence between the 3100 Series device and the predicate devices and no differences which affect safety or efficacy." This implies that the device is expected to perform comparably to the predicate devices, which are already on the market and presumably meet established performance standards for cardiac event recorders.

To provide a placeholder, a potential table might look like this (hypothetical, as actual criteria are not given):

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
ECG Signal Acquisition	ECG recording quality meets specified standards (e.g., bandwidth, noise).	Not explicitly stated, implied to be equivalent to predicates.
Event Detection	Auto-trigger sensitivity and specificity for specified arrhythmias (Bradycardia, Tachycardia, Atrial Fibrillation).	Not explicitly stated, implied to be equivalent to predicates.
Data Transmission	Reliable transmission of ECG data to compatible receiving systems.	Not explicitly stated, implied to be equivalent to predicates.
Safety	Compliance with relevant electrical safety and EMC standards.	Not explicitly stated, but fundamental for 510(k) clearance.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the given 510(k) summary. For a hardware device, "test set" might refer to device-level testing (e.g., bench testing, electrical tests, performance verification) rather than a clinical dataset in the way it's used for AI/ML devices. There is no mention of patient data (retrospective or prospective) being used to prove specific performance metrics.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable and not provided. The device is a "single-channel looping cardiac event recorder" which captures raw ECG data. The interpretation of this data would typically be done by clinicians (cardiologists, electrophysiologists) after the data is transmitted, not by the device itself establishing "ground truth" for diagnostic purposes. The 510(k) emphasizes the device's role in transmitting recordings for diagnostic evaluation, not performing the diagnosis itself.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. As there's no mention of a human-adjudicated test set, there's no adjudication method described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done and is not mentioned. Such studies are typically performed for AI/ML diagnostic tools to assess how the AI impacts human reader performance. This device is a hardware recorder, not an AI diagnostic tool.

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

No, a standalone study in the context of an algorithm's diagnostic performance was not done. The device itself has internal algorithms for auto-triggering based on detected heart rate deviations or fibrillation patterns, but the 510(k) focuses on the device's equivalence to predicates for its core function as a recorder and transmitter. Standalone performance for a diagnostic algorithm is not the focus here.

7. The Type of Ground Truth Used

This is largely not applicable in the context of clinical ground truth (e.g., pathology, outcomes data) for diagnosis provided by the device. The "ground truth" for this device's functionality would be based on engineering specifications, electrical performance tests, and comparison to the known operational characteristics of predicate devices. For its event detection capabilities, the ground truth would inherently be based on expert cardiology interpretation of the ECGs it records. However, the 510(k) does not describe a study where the device's event detection was compared against expert consensus or pathology.

8. The Sample Size for the Training Set

This is not applicable and not provided. This device is a hardware medical device with embedded firmware/algorithms, but there is no indication of it being an AI/ML device that underwent a "training" process with a large dataset in the modern sense. Its event detection logic would be based on established physiological thresholds and patterns, manually programmed, not learned via machine learning from a training set.

9. How the Ground Truth for the Training Set Was Established

This is not applicable and not provided for the reasons stated above (not an AI/ML device in the context of a training set).

Summary

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FEB 2 3 2006

K053378

TMS Telemedizinische Systeme GmbH 510(K) Submission 3100 Series Document: Sec. 5, 510(k) Summary

Image /page/0/Picture/3 description: The image shows a logo with the words "TELEMEDIZINISCHE SYSTEME" stacked on top of each other. Above the text is a graphic of a person standing inside of a circle. The image is black and white and appears to be of low resolution.

510(k) Summary Loop-Recorder vitaphone 3100 Series

Submitter:	TMS Telemedizinische Systeme GmbHStadlerstraße 14D-09126 Chemnitz
	Phone: +49 371 40081 0
	Fax: +49 371 40081 22

Contact Person: Tilo Borchardt, Director Engineering Phone: +49 371 40081 122 Fax: +49 371 40081 22 Email: tb@telemedsys.de

EstablishmentRegistration Number:	3005191294
Trade Name:	Vitaphone 3100 Series
Common Name:	Tele ECG System, Cardiac Event Recorder, Loop-Recorder
Classification Name:	Telephone electrocardiograph transmitter and receiver(per 21 CFR Section 870.2920, Product Code: DXH)

1. Predicate Devices

Device Type	ER800	King of HeartsExpress AF	SM100	PMP4 SelfCheckECG
Manufacturer	Braemar Inc.	Instromedix	TMS Tele-medizinischeSysteme GmbH	Card Guard Ltd.
510(K) Number	K042469	K020825	K050670	K042254

The subject device shares operating characteristics and features with the predicate devices.

The technical specification comparison reveals no substantial differerence between the 3100 Series device and the predicate devices and no differences which affect safety or efficacy.

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Image /page/1/Picture/1 description: The image shows a logo with the words "TELEMEDIZINISCHE SYSTEME" written in bold, sans-serif font. Above the text is a circular graphic that appears to depict a human figure or a stylized representation of a person. The logo is simple and likely represents a company or organization involved in telemedicine systems.

2.Intended Use

The 3100 series device is intended for auto-triggered and patient activated event recordings (Bradycardia, Tachycardia and Atrial Fibrillation). It is battery driven and utilizes a loop-memory to capture ECG data with an adjustable pre- and post-event time.

3. Device Classification

The system is classified as Class II medical device (21 CFR 870.2920).

4. Substantial Equivalence

Through the data and information presented in this 510(k) submission TMS Telemedizinische System GmbH considers the 3100 Series device as substantially equivalent to the previously discussed predicate devices.

TMS Telemedizinische Systeme GmbH Tilo Borchardt Director Engineering

Signature: B_de

Date: 2005-10-14

K053378
page 2 of 2

Page 5-2

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 3 2006

TMS Telemedizinische Systeme GmbH c/o Mr. Jeffrey Rongero Underwriters Laboratories, Inc. 12 Laboratory Drive P.O. Box 13995 Research Triangle Park, NC 27709-3995

Re: K053378 Trade Name: TMS Loop Recorder Vitaphone 3100 Series Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter And Receiver Regulatory Class: Class II (two) Product Code: DXH Dated: February 8, 2006 Received: February 10, 2006

Dear Mr. Rongero:

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 - Ms. Rebecca Kitchens

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r has be advised that i Dri onstan that your device complies with other requirements of the Act that I Dri has made a associations administered by other Federal agencies. You must or any I each statutes and regairements, including, but not limited to: registration and listing (21 comply with an the Not 8 requirements, while and manufacturing practice requirements as set CI It Far 807); adomig (21 OFF CFR Raveton (21 CFR Part 820); and if applicable, the electronic forth in the quant) bystems (Sections 531-542 of the Act); 21 CFR 1000-1050. product taxiation control pro here as a seting your device as described in your Section 510(k) This letter will and w you to cognifinding of substantial equivalence of your device to a legally prematicate 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 if you don't office of Compliance at (240) 276-0120. Also, please note the regulation entitled, Contact the Office of Course to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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/industry/support/index.html.

Sincerely yours,

Brimmer 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): ____________________________________________________________________________________________________________________________________________________

Device Name: Loop Recorder vitaphone 3100 series

Indications for Use:

Diagnostic evaluation of patients with asymptomatic and symptomatic disturbances of the cardiac rhythm such as:

Dizziness
Heart race
Palpitations
Syncopes of unknown cause

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)

Blumimon

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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).