(89 days)
Ambu General Purpose Disposable ECG Electrodes are intended for use in all Standard ECG Applications. Electrodes are made for single patient use only.
Not Found
This is a 510(k) premarket notification for a medical device (Ambu Disposable ECG Electrode) and as such, it does not typically contain detailed studies with acceptance criteria and performance metrics in the same way a clinical trial report would for a novel device. The primary purpose of a 510(k) is to demonstrate substantial equivalence to a legally marketed predicate device.
Therefore, many of the requested fields cannot be directly answered from the provided text. However, I can extract the information that is present and explain why other information is not available.
Here's a breakdown based on the provided document:
1. A table of acceptance criteria and the reported device performance
This document (510(k) summary) does not include a direct table of acceptance criteria and reported device performance for a study. The 510(k) process primarily relies on demonstrating substantial equivalence to a predicate device, which usually involves comparing design, materials, indications for use, and performance characteristics. The performance is typically demonstrated through bench testing and often, but not always, limited clinical testing, which are then compared to the predicate device's known performance. The specific performance data and criteria would be in the full submission, not usually in the publicly available summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not available in the provided document. A 510(k) summary typically doesn't detail the sample size or provenance of specific test data unless it's a critical part of demonstrating substantial equivalence for a novel aspect. It's likely that a variety of bench tests were performed on a sample of electrodes, but specifics are not mentioned.
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 applicable/available. For an ECG electrode, ground truth for performance is established through objective electrical and biocompatibility testing (e.g., impedance, adhesion, irritation) against established standards or predicate device performance, not typically by expert review of "truth" in the same way an imaging AI algorithm would be.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/available. Adjudication methods are typically used in studies where human interpretation of medical data is being evaluated, such as in imaging or clinical diagnoses. For an ECG electrode, objective test results are generally compared to pre-defined thresholds or predicate device results.
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 applicable. MRMC studies, especially those involving AI assistance, are relevant for diagnostic devices that interpret complex data, such as imaging. An ECG electrode is a passive measurement device; it doesn't "interpret" data in a way that would involve human readers or AI assistance in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. There is no algorithm in the "Ambu Disposable ECG Electrode" to perform standalone analysis. It is a physical device used to acquire physiological signals.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for an ECG electrode would generally refer to specific performance metrics established through validated testing methods, such as:
- Electrical Performance: Impedance, DC offset, combined offset instability, defibrillation overload recovery (as per ANSI/AAMI EC12:2000 standard).
- Adhesion: Adhesion strength over time.
- Biocompatibility: Absence of cytotoxicity, irritation, sensitization (as per ISO 10993 standards).
These "ground truths" are verified through standardized bench tests and potentially limited human use studies for skin irritation, but not through expert consensus on diagnostic interpretation or pathology, as the device doesn't make a diagnosis. The document does not specify which of these were used or the details of the testing.
8. The sample size for the training set
Not applicable. This device does not use an algorithm that requires a "training set" in the machine learning sense.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an algorithm, there is no ground truth established for it.
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Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 2 2004
Ambu, Inc. c/o Mr. Sanjay Parikh Technical and Regulatory Affairs 611 North Hammonds Ferry Road Linthicum, MD 21090-1356
Re: K041734
Trade Name: Ambu Disposable ECG Electrode Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph Electrode Regulatory Class: II (two) Product Code: DRX Dated: June 22, 2004 Received: June 25, 2004
Dear Mr. Parikh:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications felerenced above and nave acterings ally marketed predicate devices marketed in interstate 101 use stated in the encrosaly to togally to the Medical Device Amendments, or to connineres provision to May 20, 1978, the excordance with the provisions of the Federal Food. Drug. devices mat have boon results in a were approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The 1 ou may, mercetore, market the act include requirements for annual registration, listing of general controls proficions of aactice, 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 elassified (600 about of ols. Existing major regulations affecting your device can may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Our acements concerning your device in the Federal Register.
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Page 2 -- Mr. Sanjay Parikh
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease oc advised that I Dris brissantes vour device complies with other requirements of the Act that I DA has made a decemments ons administered by other Federal agencies. You must or any I cacial stututios and regeranents, including, but not limited to: registration and listing (21 Comply with an the fict brequirements)01); good manufacturing practice requirements as set CFR Part 6077, adoning (21 CFR Part 820); and if applicable, the electronic forth in the qualis (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation of to begin marketing your device as described in your Section 510(k) This letter will anow yourse ough finding of substantial equivalence of your device to a legally premarket notication: "The Prix mailing sification 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 If you desire specific as no and (301) 594-4646. Also, please note the regulation entitled, eonador the Ories of Come to premarket notification" (21CFR Part 807.97) you may obtain. IMisoranding of reference to prescent to promotibilities under the Act may be obtained from the Other general miormation on Journational 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,
B. Simmerman for
Dr. D. Z. Isserman, MD
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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Indications for Use
510(k) Number (if known): K04/734
Device Name: Ambu Disposable ECG Electrode
Indications For Use:
Ambu General Purpose Disposable ECG Electrodes are intended for use in all Standard ECG Applications. Electrodes are made for single patient use only.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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510(k) Number K041734
§ 870.2360 Electrocardiograph electrode.
(a)
Identification. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents.