(192 days)
Single Use Only - Disposable
The NEONATAL PEDIATRIC ECG ELECRODE is intended for use whenever cardiac monitoring of neonatal or pediatric patients is deemed or desirable by trained medical or emergency personnel. This electrode is for use on the surface of the body,
NEONATAL PEDIATRIC ECG ELECTRODE
The provided document, K050443, is a 510(k) summary for a Neonatal Pediatric ECG Electrode manufactured by Kentec Medical, Inc. This submission is for a medical device cleared via the regulatory pathway of substantial equivalence to a previously cleared predicate device, rather than an AI/ML-driven diagnostic or therapeutic device. As such, many of the requested fields related to AI/ML device performance studies (e.g., ground truth, MRMC studies, training set details) are not applicable to this type of traditional medical device submission.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly met by demonstrating "Common Technological Characteristics" and passing "NON-CLINICAL TEST" standards, primarily related to device safety and performance as an ECG electrode. The submission claims substantial equivalence to the predicate device K011564, "Neolead" by Neotech Products.
| Acceptance Criteria (Standard / Characteristic) | Reported Device Performance (Compliance / Characteristic) |
|---|---|
| Common Technological Characteristics: | |
| Silver Silverchloride Sensing Eyelet | Present |
| DIN Standard Socket Safety Lead Wire | Present |
| Hydrogel | Present |
| Nonwoven Backing | Present |
| Non-Clinical Performance Data: | |
| ANSI/AAMI EC12-1991 (ECG electrodes) | Met (implicitly, by claiming substantial equivalence to a device that met this standard) |
| ANSI/AAMI EC53:1995/(R)2001 (General safety of medical electrical equipment) | Met (implicitly, by claiming substantial equivalence to a device that met this standard) |
2. Sample size used for the test set and the data provenance
Not applicable in the context of an AI/ML performance study. This submission refers to non-clinical testing against standards. Test sets for patient data or clinical performance are not described in this 510(k) summary. The "test set" in this context refers to the physical electrode devices tested against the ANSI/AAMI standards. The document does not specify the number of electrodes tested.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth in the context of expert consensus is not relevant for this type of device. The "ground truth" for an ECG electrode is its ability to maintain electrical contact and provide a clear signal according to established standards. This is assessed through physical and electrical testing, not expert interpretation of outputs in the same way an AI diagnostic would be.
4. Adjudication method for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert review of data/images in AI/ML performance studies. Testing against ANSI/AAMI standards for an ECG electrode primarily involves objective measurements conducted in a laboratory setting.
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. This is not an AI/ML device, so an MRMC comparative effectiveness study is not applicable. The device is a physical electrode, not a tool to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware medical device (an ECG electrode), not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance is compliance with recognized industry standards for ECG electrodes (ANSI/AAMI EC12-1991) and general safety of medical electrical equipment (ANSI/AAMI EC53:1995/(R)2001). This is established through laboratory and bench testing, not expert consensus, pathology, or outcomes data in the sense of a diagnostic claim.
8. The sample size for the training set
Not applicable. This is a hardware medical device; there is no "training set" for an algorithm.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no corresponding ground truth to be established.
§ 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.