PACEART TX3 CARDIAC EVENT RECORDER by PACEART, INC.

The TX3 Cardiac Event Recorder, called the TX3, is intended to be worn by the patient and to record a short period of electrocardiogram when the patient detects symptoms indicated to him by his physician. It is indicated when such recordings are required for diagnosis, prognosis, and management of transient symptoms such as dizziness, syncope, palpitations, and arrhythmias.

Device Description

The TX3 Cardiac Event Recorder is intended to record samples of a patient's electrocardiograph (ECG) when indicated by the patient, store the ECGs in a temporary storage, and then to be transmitted to a central station by the patient, by telephone. The unit has two modes: Post-event and Arrhythmia, or "Looping.". In post-event mode, the unit records a period of ECG following the pressing of a button by the patient. The unit can also determine the pulse duration of implanted pacemakers in Post-Event mode. In arthythmia mode, the unit is a so-called "looping recorder." it is always active, and thus records a sample of ECG both before and after the "patient event."

The unit records a 3-lead ECG, using four electrodes. Normally, the unit records the limb leads.

The Central Station unit is the Paceart WINCPTS 86-12 system (K915632).

The physician can program the unit and set the number of recordings and the duration of the recording that can be made before they must be transmitted to the central station.

AI/ML Overview

The provided text does not contain specific acceptance criteria or a study demonstrating that the TX3 Cardiac Event Recorder meets such criteria.

Instead, it's a 510(k) Summary and an FDA clearance letter, which focus on demonstrating substantial equivalence to a predicate device rather than presenting performance metrics against predefined acceptance criteria.

Therefore, I cannot provide the requested table or detailed information about a study proving the device meets acceptance criteria. However, I can infer some points based on the provided text:

Based on the provided document, the following information can be extracted:

A table of acceptance criteria and the reported device performance
The document does not specify quantifiable acceptance criteria for device performance. It states that the device and/or its predicate "met the requirements of AAMI standard EC38" and that "software has had extensive validation testing." However, no specific performance metrics (e.g., sensitivity, specificity for arrhythmia detection, or accuracy of pacemaker pulse duration measurement) or corresponding target values are provided.

Acceptance Criteria	Reported Device Performance
Not specified (See Note 1)	Met requirements of AAMI standard EC38
Not specified	Software had extensive validation testing

*Note 1: While AAMI EC38 is a standard for ambulatory electrocardiographs, the document does not break down which specific requirements were met or provide quantitative results from meeting those requirements.*

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: Not specified.
* Data Provenance: Not specified. The document explicitly states "Clinical tests: Not required." This implies that the validation relied on non-clinical testing and equivalence arguments, not on clinical data collected from patients.

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)
Not applicable, as no clinical tests or human expert ground truth establishment for a test set are mentioned. The testing focused on engineering standards and software validation.
Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no clinical tests were performed requiring adjudication of results against a ground truth.
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 study was mentioned or implied. The device is an event recorder, not an AI-assisted diagnostic tool that aids human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The document describes the TX3 as a "Cardiac Event recorder" that records ECGs and transmits them to a central station (Paceart WINCPTS 86-12 system). The "unit can also determine the pulse duration of implanted pacemakers in Post-Event mode." This suggests standalone algorithmic functions for pacemaker pulse duration, but no specific performance study for this standalone algorithm is detailed beyond the general statement about meeting AAMI EC38 and extensive software validation. The overall device is a recorder; its performance is related to its ability to accurately capture and store ECGs, not to interpret them in an AI context.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests mentioned (AAMI standard EC38 and software validation), the ground truth would likely be established by:
- AAMI EC38: Reference standards for electrical performance, accuracy of recording, signal integrity, and safety parameters as defined by the standard.
- Software Validation: Requirements specifications, expected outputs for given inputs, and absence of bugs, verified through testing. No biological or clinical ground truth is implied for these tests.
The sample size for the training set
Not applicable. The device is a hardware cardiac event recorder with associated software, not a machine learning or AI model that requires a distinct "training set."
How the ground truth for the training set was established
Not applicable (no training set for an AI model).

Summary

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PaceArt Division of Data Critical Corporation Special 510(k) TX3 Cardiac Event Recorder

510(k) Summary

(1) Submitter Information

Name: PaceArt Division of Data Critical Corporation

Address: 81 Two Bridges Road Fairfield. NJ 07004

Telephone Number: 973-439-9393

Contact Person: Dr. George Myers (Official Correspondent) Medsys Inc. 377 Rt. 17 S Hasbrouck Heights, NJ 07604 201-727-1703 fax 201-727-1708 Date Prepared: July 23, 2001

(2) Name of Device:

Trade Name: TX3 Cardiac Event recorder Common Name: Cardiac Event Recorder Classification Name: Transmitters and Receivers, Electrocardiograph, Telephone (74DXH)

(3) Equivalent legally-marketed device: Paceart Heart Access Plus Event Recorder K973141

(4) Description

The unit records a 3-lead ECG, using four electrodes. Normally, the unit records the limb leads.

The Central Station unit is the Paceart WINCPTS 86-12 system (K915632).

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The physician can program the unit and set the number of recordings and the duration of the recording that can be made before they must be transmitted to the central station.

(5) Intended Use

(b) Performance data

(1) Non-clinical tests

The TX3 and/or its predicate device have met the requirements of AAMI standard EC38. The software has had extensive validition testing.

(2) Clinical tests

Not required.

(3) Conclusions

The TX3 Cardiac Event Recorder is equivalent in safety and efficacy to the legally-marketed predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 4 2001

Paceart, Inc. c/o Dr. George Myers Medsys, Inc. 377 Route 17 South Hasbrouck Heights, NJ 07604

Re: K012407

Trade Name: TX3 Cardiac Event Recorder Regulation Number: 21 CFR 870.2929 Regulatory Class: II (two) Product Code: 74 DXH Dated: July 27, 2001 Received: July 30, 2001

Dear Dr. Myers:

We have reviewed your Section 510(k) notification of intent to market the device referenced we nave reviewed your becaon - Fronty nevers substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce stated in the enclosure) to legally manote of the Medical Device Amendments, or to devices that prior to May 26, 1970, the chaomical date of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosment Act (Act. The general controls provisions of the Act include requirements for annual provisions of the Act. "The general controls practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (see above) anto such additional controls. Existing major regulations (1 charkst Approval), it they of our cases of Federal Regulations, Title 21, Parts 800 to 895. allecting Jour at riov lent determination assumes compliance with the Current Good A suostantany equirements, 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 inspotions, the Food and may result in regulatory action. In addition, FDA may publish comply with the GMT regararing your device in the Federal Register. Please note: this

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Page 2 - Dr. George Myers

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.

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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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 regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mormation on your some 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. D. K. Tulle
James E. Dillard III

Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 __ of _________________________________________________________________________________________________________________________________________________________________ ﻠﺴﺮ

K012407 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Indications for Use Form

Device Name: TX3 Cardiac Event Recorder

Indications for Use:

The TX3 Cardiac Event Recorder, called the TX3, is intended to be worn by the patient and to record a short The TX3 Cardiac Event Recorder, called the 1723, is minuse systems indicated to him by his period of electrocardiogram when the patient depts are required for disensis, gop in thended patient population is
physician. It is indicated when such recordings are require physician. It is indicated which such recordings are request and arrhythmias.

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

NEWS – CONTINUE – VEEDED) NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 810.109) OR

Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Division of Cardiovascular & Respiratory Devices
510(k) Number
510(k) Number
K012407

TX3

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).