The SEER MC Ambulatory Digital Analysis Recorder is intended to provide ambulatory ECG signal and automated analysis of the recorded ECG data. Results of the automated analysis, when used in conjunction with an ECG review system, are intended to assist the physician in the interpretation of the recorded data. This information is not intended to serve as a substitute for the physician overread of the recorded ECG data. The SEER MC can collect and store up to 48 hours of continuous 2 or 3 channels of ambulatory ECC data. In addition, the SEER MC can record and analyze 12-lead ambulatory ECG data for definition of morphology shape and measurements, heart rate, rhythm, and ST segment trending. The SEER MC is intended for use on adult and pediatric (greater than 10Kg) patients in a clinical setting by qualified medical personnel.

The SEER MC in its 2 or 3 channel mode of operation detects the following: normal beats, ventricular beats, supraventricular beats, paced beats and artifact. This information with an ECG review system, documents the following: fastest and slowest heart rate, runs of ventricular beats, runs of supraventricular beats, pauses, ST segment changes, areas of atrial fibrillation, percentage of paced beats, prolonged QT, T-Wave Alternans, Heart Rate Turbulence, Heart Rate Variability and ECG strips associated with patient events and/or symptoms.

The SEER MC in its 12-lead mode of operation, in conjunction with a ECG Review system, documents the afforementioned information and also measures and trends the following 12 lead parameters: PR interval, QT interval, QRS diration, ST measurements at J point plus 40, 60 and 80 mseconds for all 12 leads and displays the Ventricular rate, and P, R and T axis for each 12-lead segment.

The SEER MC is not intended to be used as a substitute for a standard, diagnostic-quality 12-lead electrocardiograph.

Device Description

SEER MC is a Holter Recorder designed to be used in conjunction with an ambulatory ECG system to assist in the diagnosis and assessment of patients. The SEER MC acquires, digitizes, stores and analyzes data for scanning and review by an ambulatory ECG review system. SEER MC can collect and store up to 48 hours of continuous 2 or 3 channels of ambulatory ECG data. In addition, the SEER MC can record and analyze 12 lead ambulatory ECG data periodically or on demand. This analysis performs waveform measurements. These measurements are performed during recording for use in analysis and review within the ambulatory ECG review system.

AI/ML Overview

The provided text is a 510(k) summary for the GE Medical Systems Information Technologies SEER MC Holter Recorder. It describes the device's intended use and claims substantial equivalence to predicate devices, but it does not contain acceptance criteria or a detailed study proving the device meets specific performance metrics beyond general safety and effectiveness.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document. The document states that the SEER MC "complies with the voluntary standards as detailed in Section 9 Test Summary: of this submission," but Section 9 is not included.

Here's an analysis of what can and cannot be extracted from the provided text based on your request:

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

Cannot be provided. The document states, "The SEER MC complies with the voluntary standards as detailed in Section 9 Test Summary: of this submission." However, Section 9 (the Test Summary) is not provided in the input text. Thus, the specific acceptance criteria and detailed performance against those criteria are not available. The overall conclusion is that the device "is as safe, as effective, and performs as well as the predicate devices."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided. The document mentions "Performance testing" and "Clinical use evaluation," but it does not specify any sample sizes, data provenance (e.g., country of origin), or whether the studies were retrospective or prospective.

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)

Cannot be provided. The document does not describe the methodology for establishing ground truth for any testing performed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Cannot be provided. The document does not describe any adjudication methods.

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

While the device includes an "automated analysis algorithm" and its results are "intended to assist the physician in the interpretation," the document does not describe an MRMC comparative effectiveness study directly comparing human readers with and without AI assistance, nor does it provide an effect size.

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

The device performs "automated analysis of the recorded data," and the analysis performs "waveform measurements." However, the text explicitly states the automated analysis is "intended to assist the physician" and "is not intended to serve as a substitute for the physician overread." While the algorithm performs analysis, the document does not detail a standalone performance study of the algorithm in isolation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Cannot be provided. The document does not specify how ground truth was established for any testing.

8. The sample size for the training set

Cannot be provided. The document does not mention a training set or its sample size.

9. How the ground truth for the training set was established

Cannot be provided. The document does not mention a training set or how its ground truth was established.

Summary of what is available regarding "study" information (limited):

The document mentions that the following quality assurance measures were applied to the development of the device:

Requirements specification review
Risk analysis
Software and hardware testing
Performance testing
Safety testing
Environmental testing
Clinical use evaluation
Final validation

The conclusion drawn from these measures is that "The results of these measurements demonstrated that the SEER MC is as safe, as effective, and performs as well as the predicate devices." This implies a comparative study or testing against predicate devices, but the details of such a study are not provided in the given text.

Summary

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SEP 0 2 2005

Section 2 Summary

510(k) Summary of Safety and Effectiveness

Date:	October 4, 2004
Submitter:	GE Medical Systems Information Technologies8200 West Tower AvenueMilwaukee, WI 53223 USA
Contact Person:	Grace LeMieuxRegulatory Affairs ManagerGE Medical Systems Information TechnologiesPhone: (262) 293-1609Fax: (262) 293-1460
Device:
Trade Name:	SEER MC
Common/Usual Name:	Holter Recorder
Classification Names:	21 CFR 870.2800 Electrocardiograph, ambulatory, with analysis algorithm
Predicate Devices:	SEER® (K882818)Mortara H12+ Holter Recorder (K021373)
Device Description:	SEER MC is a Holter Recorder designed to be used in conjunction with anambulatory ECG system to assist in the diagnosis and assessment of patients.The SEER MC acquires, digitizes, stores and analyzes data for scanning andreview by an ambulatory ECG review system. SEER MC can collect and storeup to 48 hours of continuous 2 or 3 channels of ambulatory ECG data. Inaddition, the SEER MC can record and analyze 12 lead ambulatory ECG dataperiodically or on demand. This analysis performs waveform measurements.These measurements are performed during recording for use in analysis andreview within the ambulatory ECG review system.

The SEER MC recorder is intended to provide ambulatory ECG signal and Intended Use: automated analysis of the recorded data. Results of the automated analysis when used in conjunction with an ECG review system are intended to assist the physician in the interpretation of the recorded data. This information is not intended to serve as a substitute for the physician overread of the recorded ECG data. SEER MC can collect and store up to 48 hours of continuous 2 or 3 channels of ambulatory ECG data. In addition, the SEER MC can record and analyze12-lead ambulatory ECG data periodically or on demand. This analysis performs waveform measurements. The SEER MC is intended for use on adult and pediatric (greater than 10Kg) human patients in a clinical setting by qualified medical personnel. Ambulatory ECG monitoring is useful for the following indications:

Evaluation of symptoms that may be caused by cardiac arrhythmia . and/or conduction disturbances
Evaluation of symptoms that may be due to myocardial ischemia .
Detection of ECG events that alter prognosis in certain forms of heart ● disease
Detection and analysis of pacemaker function and failure .
Determination of cardiac response to lifestyle .
Evaluation of therapeutic interventions .

Investigations in epidemiology and clinical trials

SEER MC is not intended to be used as a substitute for a standard, diagnostic-

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quality 12-lead electrocardiograph.

Technology: The proposed SEER MC employs the same functional scientific technology as the predicate devices SEER (K882818) and Mortara H12+ (K021373).
The SEER MC complies with the voluntary standards as detailed in Section 9 Test Summary: of this submission. The following quality assurance measures were applied to the development of the device:
- . Requirements specification review
- Risk analysis .
- . Software and hardware testing
- . Performance testing
- . Safety testing
- Environmental testing .
- Clinical use evaluation .
- Final validation
- Conclusion: The results of these measurements demonstrated that the SEER MC is as safe, as effective, and performs as well as the predicate devices.

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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract eagle design with three stylized lines representing the eagle's head and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 0 2 2005

General Electric Medical Systems Information Technologies c/o Ms. Lisa M. Baumhardt Regulatory Affairs Specialist 8200 West Tower Avenue Milwaukee, WI 53223

Re: K042782

Trade Name: SEER MC Ambulatory Digital Analysis Recorder Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II (two) Product Code: MLO Dated: July 6, 2005 Received: July 8, 2005

Dear Ms. Baumhardt:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection 310(x) pressure 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 encrosule) to regally to regally the Medical Device Amendments, or to commerce provided in accordance with the provisions of the Federal Food, Drug, devices mat have been reculise in quire approval of a premarket approval application (PMA). alle Cosment Act (Act) that do not require appent a fre
You may, therefore, market the device, subject to the general controls provisions of the Act. The f ou may, merciole, manot the Act include requirements for annual registration, listing of general controls provisions of the tice, 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 crassified (see abor of als. Existing major regulations affecting your device can may be subject to suen additional controliations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous acements concerning your device in the Federal Register.

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Page 2 – Ms. Lisa M. Baumhardt

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA's issuance of a substanted other requirements of the Act
that FDA has made a determination that your device with other requirements of the Act that FDA has made a determination that your device on the Federal agencies. You must
or any Federal statutes and regulations administed to: registration and listin or any Federal statutes and regulations administed or rotlimited to : egistration and listing
comply with all the Act's requirements, including arectice requirements a comply with all the Act's requirements, metuding, out mor macuring practice requirements as set
(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice req (21 CFR Part 807); labeling (21 CFR Pati 801); good manatotanas pamicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Patter at); 21 CFR 1000-1050 forth in the quality systems (QS) regulation (21 -512 of the Act); 21 CFF 1000-1050.
product radiation control provisions (Sections 531-542 of the Action Section 5 product radiation control provisions (Scctions 31 device as described in your Section 5 10(k)
This letter will allow you to begin marketing your device of your device to a le This letter will allow you to begin marketing your article quisales of your device to a legally
premarket notification. The FDA finding of substantial equivalence of your de premarket notification. The FDA inding of substantial equive 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
rs and the many of the may or and 0005 - Alge masses note the regulation en If you desire specific advice for your uevice on our lacemite the regulation entitled,
contact the Office of Compliance at (240) 276-0295. Also, please note the regulation o contact the Office of Compliance at (240) 270 - 270 - 270 - 1207.97). You may obtain
"Misbranding by reference to premarket notification of Small "Misbranding by reterence to prematicallities under the Act from the Division of Small
other general information on your responsibilities under the Act from world 1800) 638-2 other general information on your responsibilities under (800) -free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-fremamain html Manufacturers, International and Consumer Absteaner and world driver and main.html

Sincerely yours,

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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510(k) Number (if known):

Page 1 of 1

Device Name: SEER MC Ambulatory Digital Analysis Recorder

Indications For Use:

The SEER MC is not intended to be used as a substitute for a standard, diagnostic-quality 12-lead electrocardiograph.

Prescription Use _ X (Per 21 CFR 801.109 Subpart D) 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)

vices
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K042787

Regulation Number and Section

§ 870.2800 Medical magnetic tape recorder.

(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).