(331 days)
The MedSet Cardiolight system is intended to be used by trained ECG technicians with analysis and interpretation by cardiologists for the measurement and analysis of electrocardiogram signals on ambulatory patients as an aid to the diagnosis of heart disease.
The MedSet Cardiolight System is a real time ambulatory ECG recording and analysis system for a recording period of up to 24 hours. The stored data is transferred to a PC for graphical display of the results as an aid to the medical diagnosis of heart disease by a trained cardiologist.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Sensitivity (Normal) | N/A (Compared to AHA) | 99% |
| Specificity (Normal) | N/A (Compared to AHA) | 99% |
| Pos. Predictive Acc. (Normal) | N/A (Compared to AHA) | 92% |
| Sensitivity (VES) | N/A (Compared to AHA) | 91% |
| Specificity (VES) | N/A (Compared to AHA) | 95% |
| Pos. Predictive Acc. (VES) | N/A (Compared to AHA) | 99% |
| Overall Quality | Comparable to other commercial long-term ECG devices | "the quality of the automatic analysis of the Cardiolight system corresponds to those of other commercial long term ECG devices." |
Note on Acceptance Criteria: The document does not explicitly state numerical acceptance criteria for Sensitivity, Specificity, and Positive Predictive Accuracy. Instead, it reports the device's performance against "standard data of the American Hearts Association (AHA)" as a benchmark. The overall qualitative acceptance criterion appears to be that its performance is equivalent to, or better than, other commercial long-term ECG devices, as stated in the conclusion of the validation study.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set: "150 000 events" for the automatic ECG analysis (derived from "many recorded and manually edited ECG data sets," including the AHA standard data).
- Clinical Validation (Patients): 150 patients.
- Data Provenance:
- Automatic ECG Analysis: "standard data of the American Hearts Association (AHA)" and "many recorded and manually edited ECG data sets." The nationality of the "many recorded and manually edited ECG data sets" is not specified but given the company location (Germany) and the use of AHA data, it's likely a mix. This appears to be retrospective data.
- Clinical Validation: Performed at the University of Ulm Medical Clinic, which is in Germany. This was likely a prospective study on 150 patients.
- Commercial Use: "in commercial use in Europe for several years" implies retrospective real-world data collection.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Automatic ECG Analysis: The ground truth for the "150 000 events" was established using "AHA-annotations" and "manually edited ECG data sets."
- For the AHA data, the ground truth would have been established by experts associated with the American Heart Association. Their specific number and qualifications are not detailed in this document but are generally understood to be highly qualified cardiologists/electrophysiologists.
- For the "manually edited ECG data sets," the number and specific qualifications of the experts who performed the manual editing are not specified, but the context implies trained professionals.
- Clinical Validation: The analysis and interpretation are intended "by cardiologists." For the clinical validation protocol, it's implied that cardiologists assessed the results to make the comparison, but the exact number or qualifications of those involved in establishing the ground truth for this specific study are not given.
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1). For the "manually edited ECG data sets" and "AHA-annotations," it's generally understood that a consensus or expert review process would have been used to establish the ground truth, but the specifics are not provided.
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, a multi-reader multi-case (MRMC) comparative effectiveness study evaluating human readers with and without AI assistance was not reported. The study focused on the performance of the algorithm itself (standalone) and then a clinical validation where the system served as an "aid to the medical diagnosis," implying a human-in-the-loop, but not a direct comparative effectiveness study on reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance evaluation of the algorithm was done. The "Test Results" section directly compares the "automatic analysis" results (Sensitivity, Specificity, Positive Predictive Accuracy for Normal and VES events) to "AHA-annotations" and manually edited data.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used was:
- Expert Consensus/Annotation: "AHA-annotations" and "manually edited ECG data sets." This implies a form of expert consensus or highly trained expert review of ECG waveforms.
8. The Sample Size for the Training Set
The document does not specify the sample size for the training set. The provided performance metrics (Sensitivity, Specificity, PPP) relate to the test results of the algorithm.
9. How the Ground Truth for the Training Set was Established
The document does not specify how the ground truth for the training set was established, as it doesn't describe the training process or data.
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JUN 1 1 1999
Image /page/0/Picture/2 description: The image shows the logo for CAPINTEC, INC. The logo consists of the letters "CII" stacked on top of each other inside of a box. Below the logo is the text "CAPINTEC, INC." in a sans-serif font. Underneath the company name is the number "K982448" in a handwritten style.
510(k) SUMMARY
Submission Date: July 13, 1998
Pursuant to the requirements of Section 510(k) of the Food, Drug, and Cosmetic Act, notification is made by Capintec, Inc. on behalf of MedSet to manufacture and market an ambulatory electrocardiogram with analysis algorithm.
Medset is located at the following site:
| Medset Medizintechnik GmbHPostfach 800 103D-21001Hamburg, Germany | Tel: 49-40-725-822-0FAX: 49-40-725-822-11 |
|---|---|
| 510(k) Contact:Mary Anne Dell | |
| Capintec, Inc.540 Alpha DrivePittsburgh, PA 15238 | Tel: 412-963-1988FAX: 412-963-0610 |
| Classification Name: | Holter |
|---|---|
| Classification Number: | 74MLO (870.2800) a DSH |
| Common or Usual Name: | Electrocardiograph, Ambulatory, with analysisalgorithm |
| Proprietary Name: | Cardiolight Ambulatory Cardiac Monitor |
| Establishment Registration Number: | N/A |
| Regulatory Class: | II |
Description: The MedSet Cardiolight System is a real time ambulatory ECG recording and analysis system for a recording period of up to 24 hours. The stored data is
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transferred to a PC for graphical display of the results as an aid to the medical diagnosis of heart disease by a trained cardiologist.
Substantial equivalence: The Medset Cardiolight ambulatory ECG recording and analysis system is substantially equivalent to the Medicomp EpiCardia System which was found to be substantially equivalent under 510(k) number K830013A.
Intended Use: The MedSet Cardiolight system is intended to be used by trained ECG technicians with analysis and interpretation by cardiologists for the measurement and analysis of electrocardiogram signals on ambulatory patients as an aid to the diagnosis of heart disease.
Test Results: The accuracy of the automatic ECG analysis was tested using many recorded and manually edited ECG data sets. Among these were the standard data of the American Hearts Association (AHA). Comparing the AHA-annotations to the results of the automatic analysis gives the following results from 150 000 events:
| Sensitivity | Specificity | Pos.predictiveaccuracy | |
|---|---|---|---|
| Normal | 99% | 99% | 92% |
| VES | 91% | 95% | 99% |
Clinical validation protocol was performed at the University of Ulm Medical Clinic on 150 patients. In addition, the Cariolight ECG System has been in commercial use in Europe for several years and has log term data for clinical use. The conclusion of the validation testing was that "the quality of the automatic analysis of the Cardiolight system corresponds to those of other commercial long term ECG devices."
Conclusion: The MedSet Cariolight Ambulatory ECG System functions as intended and is substantially equivalent in performance and intended use to the EpiCardia Ambulatory ECG System. The MedSet system provides improved performance specifications and better data manipulation compared to its predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest wings and a body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 11 1999
Ms. Mary Anne Dell Capintec, Inc. 540 Alpha Drive Pittsburgh, PA 15238
Re: K982448 Cardiolight ECG Monitor, including FMC Recorder, PC Interface Card, and Associated Software Requlatory Class: II (two) Product Code: 74 DSH Dated: Undated Received: April 30, 1999
Dear Ms. Dell:
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, Druq, 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 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 comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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.
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Page 2 - Ms. Mary Anne Dell
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 requlation (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, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general 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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K982448
INTENDED USE STATEMENT
The MedSet Cardiolight system is intended to be used by trained ECG technicians with analysis and interpretation by cardiologists for the measurement and analysis of electrocardiogram signals on ambulatory patients as an aid to the diagnosis of heart disease.
Prescription Use $\checkmark$
Wolf Sapinlen MD ta
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number
§ 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).