It is indicated for use in the analysis, display, editing and report generation of ambulatory ECG data as part of the assessment of cardiac rhythm disturbance and myocardial ischaemia. Typically it is intended for patients requiring analysis of 24 hour ambulatory ECG recordings as determined by a medical practitioner.

Device Description

Medilog Darwin Holter Analysis is designed to acquire, analyse and store data recorded on Medilog series ambulatory ECG recorders. Editing facilities are offered to allow some of the information to be modified. The processed data can be printed in the form of an analysis report. The device is not a life supporting, implanted or otherwise critical device, and it is does not provide on-line warnings or alarms.

Medilog Darwin Holter Analysis is designed to operate on an industry standard PC. Customers purchase the device as a software kit for installation on their own compatible PC.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the Medilog Darwin Holter Analysis device, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state numerical acceptance criteria (e.g., "accuracy must be >90%"). Instead, the primary acceptance criterion appears to be demonstrating substantial equivalence to the predicate device, specifically by performing as well as or better than the predicate device, and compliance with relevant ANSI/AAMI standards.

Acceptance Criterion (Inferred from 510(k))	Reported Device Performance
Compliance with ANSI/AAMI EC38:1998 (Ambulatory electrocardiographs)	Exceeds predicate device performance on AHA, MIT, ESC, and NST databases.
Compliance with ANSI/AAMI EC57:1998 (Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms)	Exceeds predicate device performance on AHA, MIT, ESC, and NST databases.
Performance in identifying isolated VEBs, couplets, bigeminy, pauses, bradycardia, tachycardia in non-paced recordings.	Closer to manual count in more cases than the predicate device.
Performance in identifying abnormalities in paced recordings.	Closer to manual count in more cases than the predicate device.
Overall safety and effectiveness compared to predicate device.	As safe and effective, and performs as well as or better than the predicate device.

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

Sample Size: Not explicitly stated as a single number.
- For the standard databases: The document mentions "AHA, MIT, ESC and NST databases." These are well-established public databases commonly used for Holter analysis algorithm testing. The exact number of recordings within these databases is not provided in this summary, but they typically contain numerous subjects/recordings.
- For parallel tests: "non-paced three-channel Holter recordings from different customers" and "paced three-channel Holter recordings from different customers." The specific number of customers or recordings is not provided.
Data Provenance:
- AHA, MIT, ESC, NST databases: These are international, publicly available and widely recognized databases for ECG analysis. Their original provenance (e.g., country of origin, retrospective/prospective collection) is inherent to the specific database (e.g., MIT-BIH Arrhythmia Database, European ST-T Database). The 510(k) does not specify the exact records used, but they are generally retrospective.
- Customer data for parallel tests: "from different customers." The country of origin is not specified, nor whether it was retrospective or prospective, though general "customer recordings" often imply retrospective collected data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The ground truth for the "manual counts" is established by human review, but the expertise of those performing the manual counts is not detailed. For the standard databases (AHA, MIT, etc.), the ground truth is typically meticulously annotated by multiple cardiologists or experts, but this document does not provide details on the specific qualification of those experts.

4. Adjudication Method for the Test Set

For the "manual counts" used in the parallel tests against customer data, the adjudication method is not specified.
For the standard databases (AHA, MIT, ESC, NST), the ground truth labels are typically established through a rigorous consensus process by multiple experts, but the specific adjudication method (e.g., 2+1, 3+1) for these databases, nor for the manual counts in this study, is detailed in the 510(k).

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

No, an MRMC comparative effectiveness study was not explicitly done in the sense of comparing human readers with AI assistance versus without AI assistance.
The study focuses on the standalone performance of the algorithm and its comparison to the predicate device and manual counts. The device's role is described as providing "additional information" to a qualified physician who "reviews and interprets" the reports. This suggests an assistance tool, but not a study designed to quantify human performance improvement with the tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone algorithm-only performance evaluation was conducted.
The summary explicitly states: "The performance of the candidate device was tested on the AHA, MIT, ESC and NST databases..." and "The unedited analysis results generated by each device were then compared against manual counts..." This indicates that the algorithm's raw output, without human intervention or editing, was directly evaluated against established ground truth.

7. The Type of Ground Truth Used

Expert Consensus / Reference Databases: For the AHA, MIT, ESC, and NST databases, the ground truth is established through expert-annotated reference labels.
Manual Counts: For the parallel tests on customer data (both paced and non-paced), the ground truth was established by "manual counts of isolated VEBs, couplets, bigeminy, pauses, bradycardia, tachycardia, etc." This implies human expert review and counting to establish the true presence and number of these events.

8. The Sample Size for the Training Set

Not specified. The 510(k) summary only describes the testing of the device and its algorithm, not the development or training phase.

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

Not specified. Similar to the training set size, the 510(k) does not provide details on how the training data was curated or how its ground truth was established. This information is typically part of the development documentation but not always included in the 510(k) summary focused on validation.

Summary

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Section H Medilog Darwin Holter Analysis 510(k)

K053369

DEC 2 2 2005

510(K) SUMMARY

[As required by 21 CFR 807.92]

1. Submitter's name, address, telephone number, and fax number

Huntleigh Healthcare Cardiology Products Division Lion House Oriental Road Woking Surrey GU22 8AP United Kingdom.

Tel: +44 1483 746421 Fax: +44 1483 746426

2. Contact person

Dr J Pardey Research and Development Manager Huntleigh Healthcare - Cardiology Products Division.

3. Date this summary was prepared

23/11/05.

4. Name of the candidate device

Medilog Darwin Holter Analysis.

6. Classification name and number

Device Classification:	Class II.
Regulation Number :	21 CFR 870.1425 Programmable Diagnostic Computer.
Classification Panel:	74-Cardiovascular.
Product Code:	DQK.

Predicate device(s) to which substantial equivalence is claimed 5.

Device Name:	Medilog Excel 3 Holter Management System.
510(k) Number:	K002544, approved by FDA on 13th September 2000.
Device Classification:	Class II.
Regulation Number :	21 CFR 870.1425 Programmable Diagnostic Computer.
Product Code:	DQK.

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Description of the candidate device ల్

Medilog Darwin Holter Analysis is designed to operate on an industry standard PC. Customers purchase the device as a software kit for installation on their own compatible PC.

7. Intended use of the candidate device

The intended use of Medilog Darwin Holter Analysis is for the replay and analysis of data pre-recorded on Medilog series ambulatory ECG recorders.

Medilog Darwin Holter Analysis is indicated for use in the analysis, display, editing and report generation of ambulatory ECG data as part of the assessment of cardiac rhythm disturbance and myocardial ischaemia. Typically it is indicated for patients requiring analysis of 24-hour ambulatory ECG recordings as determined by a medical practioner.

It is intended that the PC on which the Medilog Darwin Holter Analysis is installed be located in a clinical environment - typically in a hospital cardiology department ~ and be operated by a suitably trained technician. Reports generated by the Medilog Darwin Holter Analysis are to be reviewed and interpreted by a qualified physician providing additional information in the diagnosis of the patient's condition and the determination of suitable treatment.

8. Technological characteristics

The candidate device uses a new three-channel ECG analysis algorithm, developed by the manufacturer, to analyse ECG data from Mediloq series ambulatory ECG recorders.

ல் Non-clinical tests performed to demonstrate substantial equivalence

The performance of the candidate device was tested on the AHA, MIT, ESC and NST databases in compliance with ANSI/AAMI EC38:1998 Ambulatory electrocardiographs, and ANSIIAAMI EC57:1998 Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms. The results obtained for the candidate device were compared against available results for the predicate device. This comparison confirmed that the performance of the candidate device exceeds that of the predicate device.

In addition, parallel tests were performed in which non-paced three-channel Holter recordings from different customers were analysed using both the candidate and predicate devices. The unedited analysis results generated by each device were then

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Section H Medilog Darwin Holter Analysis 510(k)

compared against manual counts of isolated VEBs, couplets, bigeminy, pauses, bradycardia, tachycardia, etc. The results demonstrated that the candidate device is closer to the manual count in more cases than the predicate device.

Parallel tests were also performed on paced three-channel Holter recordings from different customers, and again the results demonstrated that the candidate device is closer to the manual count in more cases than the predicate device.

The conclusion drawn from the results of the tests described above is that the candidate device is as safe and effective, and performs as well as or better than, the predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 2 2005

Huntleigh Healthcare c/o Mr. Olaf Teichert TUV America, Inc. Tuv Product Service 1775 Old Highway 8 New Brighton, MN 55112-1891

Re: K053369

Trade/Device Name: Medilog Darwin Holter Analysis Regulation Number: 21 CFR 870.1425 Regulation Name: Computer, Diagnostic, Programmable Regulatory Class: II (performance standards) Product Code: DQK Dated: December 1, 2005 Received: December 5, 2005

Dear Mr. Teichert:

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. Olaf Teichert

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 (240) 276-0120. 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 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/cdrb/industry/support/index.html.

Sincerely vours,

B.Zimmerman 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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Section C Medilog Darwin Holter Analysis 510(k)

INDICATIONS FOR USE

K053369

510(k) Number (if known):

Device Name:

Medilog Darwin Holter Analysis.

Indications for Use:

Medilog Darwin Holter Analysis is indicated for the replay and analysis of ECG data prerecorded on Medilog series ambulatory recorders.

Prescription Use V (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Blymmmo
(Division Sign-Off)
Division of Cardiovascular Devices

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).