(11 days)
The EK-Pro Arrhythmia Detection Algorithm is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the EK-Pro Algorithm is to monitor ECG parameter data on adult, pediatric and neonatal patients. The EK-Pro Algorithm is designed to monitor ECG parameter data in bedside, portable, and transport monitors that can operate in all professional medical facilities and medical transport modes.
The EK-Pro Arrhythmia Detection Algorithm is a software algorithm that runs in GE Medical Systems Information Technologies patient monitors. When used in a patient monitor, the EK-Pro Algorithm processes the ECG data acquired by the patient monitor to detect various ECG arrhythmia events, and to compute and trend measurements that include heart rate, ventricular ectopic beats per minute, and ST segment deviations.
Here's an analysis of the provided text regarding the EK-Pro Arrhythmia Detection Algorithm, focusing on the requested information:
Unfortunately, the provided text does not contain details about specific acceptance criteria or the numerical results of a study demonstrating the device meets those criteria. The document is a 510(k) summary and approval letter, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed validation study results with performance metrics.
However, based on the available information, I can address some of your points:
1. A table of acceptance criteria and the reported device performance
This information is not present in the provided text. The document states:
- "The results of these measurements demonstrated that the EK-Pro Conclusion: Arrhythmia Detection Algorithm is as safe, as effective, and performs as well as the predicate device in monitoring ECG parameter data."
This is a qualitative statement about the device's performance relative to its predicate, but it does not provide specific acceptance criteria (e.g., sensitivity, specificity thresholds) or numerical performance results (e.g., 95% sensitivity, 98% specificity).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not present in the provided text. The document mentions "Clinical Acceptance Testing (Validation)" but does not specify the sample size, data provenance, or whether the study was 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)
This information is not present in the provided text. There is no mention of experts or how ground truth was established for any testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not present in the provided 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
This information is not present in the provided text. The device is referred to as an "Arrhythmia Detection Algorithm," implying it operates either standalone or as an aid, but there's no mention of an MRMC study or its effect size. The context is that the algorithm processes ECG data, suggesting it's either an automated detection system or provides outputs that human readers would then interpret.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The text describes the device as a "software algorithm that runs in GE Medical Systems Information Technologies patient monitors" and "processes the ECG data acquired by the patient monitor to detect various ECG arrhythmia events, and to compute and trend measurements." This strongly suggests a standalone algorithm without a human-in-the-loop performance study for its primary claims of arrhythmia detection and measurement. While intended for "use under the direct supervision of a licensed healthcare practitioner," this supervision refers to the overall use of the monitor and the information it presents, not necessarily that the algorithm's performance was evaluated in an AI-assisted mode.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not present in the provided text.
8. The sample size for the training set
This information is not present in the provided text.
9. How the ground truth for the training set was established
This information is not present in the provided text.
Summary of what is present and relevant:
- Device Type: Software algorithm for arrhythmia detection and ECG parameter measurement.
- Intended Use: Monitoring ECG parameter data on adult, pediatric, and neonatal patients in various medical settings.
- Compliance: Complies with voluntary standards (as detailed in Section 9, which is not provided).
- Validation: "Clinical Acceptance Testing (Validation)" was performed, leading to the conclusion that the device is "as safe, as effective, and performs as well as the predicate device."
- Comparison: Substantial equivalence to predicate device K020290 Dash 3000/4000 Patient Monitor.
- Development Measures: Risk Analysis, Requirements Specification Review, Code Inspections, Software Verification Testing.
In conclusion, for a comprehensive understanding of acceptance criteria and detailed study results, more specific documentation beyond this 510(k) summary would be required. The provided text focuses on the regulatory submission process and the determination of substantial equivalence, rather than a detailed technical report of the device's validation.
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MAY 0 6 2003
Section 2 Summary of Safety and Effectiveness
| Date: | April 21, 2003 |
|---|---|
| Submitter: | GE Medical Systems Information Technologies8200 West Tower AvenueMilwaukee, WI 53223 USA |
| Contact Person: | Karen M. LundeSr. Regulatory Affairs SpecialistGE Medical Systems Information TechnologiesPhone: 414-362-3329Fax: 414-918-8114 |
| Device:Trade Name: | EK-Pro Arrhythmia Detection Algorithm |
| Common/Usual Name: | Arrhythmia Detection Algorithm |
| Classification Names: | 21 CFR 870.1025 Detector and Alarm, Arrhythmia |
| Predicate Device: | K020290 Dash 3000/4000 Patient Monitor |
| Device Description: | The EK-Pro Arrhythmia Detection Algorithm is a software algorithm thatruns in GE Medical Systems Information Technologies patient monitors.When used in a patient monitor, the EK-Pro Algorithm processes theECG data acquired by the patient monitor to detect various ECGarrhythmia events, and to compute and trend measurements thatinclude heart rate, ventricular ectopic beats per minute, and STsegment deviations. |
| Intended Use: | The EK-Pro Arrhythmia Detection Algorithm is intended for use underthe direct supervision of a licensed healthcare practitioner. Theintended use of the EK-Pro Algorithm is to monitor ECG parameter dataon adult, pediatric and neonatal patients. The EK-Pro Algorithm isdesigned to monitor ECG parameter data in bedside, portable, andtransport monitors that can operate in all professional medical facilities |
- Technology: The EK-Pro Arrhythmia Detection Algorithm employs the same functional technology as the predicate device in the monitoring of ECG parameter data.
- Test Summary: The EK-Pro Arrhythmia Detection Algorithm and its host patient monitor complies with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the EK-Pro Arrhythmia Detection Algorithm:
- Risk Analysis
- Requirements Specification Review .
- . Code Inspections
- . Software Verification Testing
and medical transport modes.
- Clinical Acceptance Testing (Validation) ●
- The results of these measurements demonstrated that the EK-Pro Conclusion: Arrhythmia Detection Algorithm is as safe, as effective, and performs as well as the predicate device in monitoring ECG parameter data.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 0 6 2003
GE Medical Systems Information Tech c/o Ms. Karen M. Lunde Senior Regulatory Affairs Specialist 8200 West Tower Avenue Milwaukee, WI 53223
Re: K031320
Trade Name: EK-Pro Arrhythmia Detection Algorithm Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm Regulatory Class: Class III (three) Product Code: MHX Dated: April 21, 2003 Received: April 25, 2003
Dear Ms. Lunde:
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.
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
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Page 2 - Ms. Karen M. Lunde
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 (301) 594-4646. 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/cdrh/dsma/dsmamain.html
Sincerely yours,
K. DeWitt
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):
510(k) filed on April 21, 2003
EK-Pro Arrhythmia Detection Algorithm Device Name:
Indications For Use:
The EK-Pro Arrhythmia Detection Algorithm is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the EK-Pro Algorithm is to monitor ECG parameter data on adult, pediatric and neonatal patients. The EK-Pro Algorithm is designed to monitor ECG parameter data in bedside, portable, and transport monitors that can operate in all professional medical facilities and medical transport modes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
VDeleTu
ardiovascular Dev
510(k) Number K031320
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.