BIOSENSOR HOLTER MONITOR SYSTEM SOFTWARE, MODEL 1005 by BIOSENSOR CORP.

Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.
Evaluation of Symptoms suggesting army announce of the works or groups of patients.
Evaluation of patients for ST segment changes.
Evaluation of a patient's response after resuming occupational or recreational activities (e.g., after M.I. or cardiac surgery.)
Clinical and epidemiological research studies.
Evaluation of patients with pacemakers
Reporting of time and frequency domain heart rate variability
Reporting of QT Interval.

Device Description

Holter analysis systems contain software, which must perform effectively, accurately, and reliably.

AI/ML Overview

I understand you're asking for information about a device's acceptance criteria and a study proving it meets those criteria. However, the provided text does not contain the acceptance criteria or a study that rigorously proves the device meets specific performance metrics.

The text is a 510(k) submission and FDA clearance letter for a Holter Monitor System Software from 1999. It discusses general principles of safety and effectiveness for Holter systems but does not provide specific quantitative acceptance criteria or a study design to meet them for this particular device.

Here's what the provided text does say, and why it doesn't fulfill your request:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria: The document mentions "Recommended standards and test methods for the performance of these systems are also compiled in detail in the Association for the Advancement of Medical Instrumentation draft standard for Holter systems." It also lists areas for effectiveness like "Diagnostic Accuracy (In Holter systems that measure heart rate, arrhythmia content, ST values and other ECG parameters, the algorithms used to make such measurements and report trends to the physician influence the quality of information provided to the physician. Testing of the diagnostic accuracy of the ST measurements, QRS detector and VE detector are necessary to evaluate the value of the measurements and trends supplied to the physician for review."
Reported Device Performance: The document does not report any specific performance metrics for the Biosensor CMS Holter Analysis System. It's a regulatory clearance document, not a clinical study report.

Therefore, a table cannot be constructed from the provided text.

Regarding the other points you requested:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided in the text.
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): Not provided in the text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided in the text.
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 provided in the text. (This document predates modern AI as defined by such studies).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not provided in the text.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): The text generally refers to "diagnostic accuracy" of measurements (ST, QRS, VE detection), implying comparison to a "true" or established value, but does not specify how this ground truth was established.
8. The sample size for the training set: Not provided in the text.
9. How the ground truth for the training set was established: Not provided in the text.

In summary: The provided document is a 510(k) FDA clearance letter for a Holter monitor system from 1999. It outlines general safety and effectiveness considerations and refers to external standards (like AAMI draft standards) for performance testing. However, it does not include the actual acceptance criteria or any study results demonstrating the device's performance against specific metrics. To obtain this information, one would typically need to review the full 510(k) submission, clinical study reports, or performance testing documentation submitted to the FDA for this device, which are not present in the given text.

Summary

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Image /page/0/Picture/0 description: The image shows a sequence of handwritten alphanumeric characters. The sequence starts with the letter 'K', followed by the numbers '990956'. The characters are written in a simple, clear style, with each digit and letter easily distinguishable.

JUN 1 4 1999

Section 2 - Safety and Effectiveness Summary and Certifications

Safety

For safe use of Holter systems, labeling and documentation must be complete. Standards for these are also covered in ANSI/AAMI EC11-1982.

Effectiveness

Holter analysis systems contain software, which must perform effectively, accurately, and reliably. Recommended standards and test methods for the performance of these systems are also compiled in detail in the Association for the Advancement of Medical Instrumentation draft standard for Holter systems.

In addition to these, because of lack of proper user training, problems may arise regarding the following:

(a) Lead placement (Correct positions for electrodes are explained in ECG textbooks such as "Harrison's Principles of Internal Medicine", Eds. R.G. Petersdorf, R.D. Adams, E. Braunwald, K.J. Isselbacher, J.B. Martin and J.D. Wilson, 10th edition, pp: 1320-21. McGraw Hill, 1983).

(b) Line Interference (A comprehensive reference list for causes and reduction methods for line interference is given in "A new technique for line interference monitoring and reduction in biopotential amplifiers", Y.Z. Ider and H. Koymen, IEEE Trans. Biomedical Engineering, Vol. 37, pp. 624-31, 1990.) Patient recorder hardware with 05-40 Hz bandpass filters can reduce partially or substantially an problems with line interference.

(c) EMG (myopotential) interference (A low pass filter may be provided as an option as too much muscle interference may be encountered during an Holter recording. Users should be notified continuously when this filter is in use, since low pass filters may affect the diagnostic value of the ECG recording information. The CMS Holter Analysis System provides such notification on screen.)

(d) Baseline wander (High pass correction filters may be provided as an option as baseline wander may occur during Holter recording. Users should be notified continuously when this filter is used, since baseline wander filters may affect the diagnostic value of the recording. The CMS Holter Analysis System provides such notification on screen.)

(e) Averaging (In Holter systems, ST level changes must be accurately measured for each lead). Due to myopotential, baseline wander and other noise interference, such measurements cannot be reliably made using a single beat. Therefore, beats are averaged and measurements are made from average beats to minimize errors.

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(f) Diagnostic Accuracy (In Holter systems that measure heart rate, arrhythmia content, ST values and other ECG parameters, the algorithms used to make such measurements and report trends to the physician influence the quality of information provided to the physician. Testing of the diagnostic accuracy of the ST measurements, QRS detector and VE detector are necessary to evaluate the value of the measurements and trends supplied to the physician for review.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is a stylized image of a caduceus, a symbol of medicine and health, with a staff entwined by two snakes.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 4 1999

Mr. Steve Springrose Vice President Biosensor Corporation 11481 Rupp Drive Burnsville, MN 55337

Re: K990956 Biosensor Holter Monitor System Software, Model 1005 Requlatory Class: II (two) Product Code: DQK Dated: March 17, 1999 Received: March 22, 1999

Dear Mr. Springrose:

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 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). 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 Regulations, 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 Requlation (QS) for Medical Devices: General requlation (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 regulatory action. In addition, FDA may publish further announcements

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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.

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) 594-4648. 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 regulation entitled, ² Misbranding by reference to premarket notification? (21CFR 807.97). Other qeneral 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/dsma/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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Page 1 of 1

510(k) Number (if known):	K990956
Device Name:	Ambulatory (Holter) ECG

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Indications For Use:

Ambulatory (Holter) ECG intended use:

The Biosensor CMS Holter Analysis system is intended for patients requiring anbulatory The Biosensor Citis Hotel Analysis 35 oven 10 monitoring is most frequently used for the indications below.

Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.
Evaluation of Symptoms suggesting army announce of the works or groups of patients.
Evaluation of patients for ST segment changes.
Evaluation of a patient's response after resuming occupational or recreational activities (e.g., after M.I. or cardiac surgery.)
Clinical and epidemiological research studies.
Evaluation of patients with pacemakers
Reporting of time and frequency domain heart rate variability
Reporting of QT Interval.

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

Concurrence of CDRH Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devic 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

. OR

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 870.1425 Programmable diagnostic computer.

(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).