(370 days)
Ambu® White Sensor electrode is for multipurpose ECG monitoring. The ECG electrode 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. The electrode is for single patient use only.
Ambu® White Sensor CFM/CFL are non-sterile, self adhesive, multifunction ECG electrodes. Ambu® White Sensor CFM/CFL should only be used by or on the order of a physician. Ambu® White Sensor CFM/CFL are single patient use disposable devices. Ambu® White Sensor CFM/CFL are multi-layer constructions containing a metal stud, a plastic eyelet sensor, hydrogel, foam with medical adhesive and a polymer topfilm.
The provided 510(k) summary (K052944) for the Ambu® White Sensor CFM/CFL describes the device's technical characteristics and performance testing. However, it does not describe a study that involves typical "acceptance criteria" and "device performance" in the way one would for an AI/ML medical device, which is implied by several of your questions (e.g., number of experts, ground truth, MRMC study).
This document pertains to a disposable ECG electrode, which is a physical medical device, not a software algorithm. Therefore, many of your questions related to AI/ML device testing methodologies are not applicable to this submission.
Here's a breakdown of the available information adapted to your request, with an explanation of why certain questions cannot be answered from this specific submission:
Acceptance Criteria and Study for Ambu® White Sensor CFM/CFL
The Ambu® White Sensor CFM/CFL is a disposable ECG electrode. The "study" described is a series of non-clinical laboratory tests and biocompatibility assessments to ensure the device meets established performance standards for ECG electrodes.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from ANSI/AAMI EC12:2000 - Disposable ECG Electrodes) | Reported Device Performance |
|---|---|
| Electrical functionality (as per standard) | Meet the mandatory performance standard requirements under ANSI/AAMI EC12:2000. Equivalent electrical functionality as predicate devices. |
| Mechanical functionality (as per standard) | Meet the mandatory performance standard requirements under ANSI/AAMI EC12:2000. Equivalent mechanical functionality as predicate devices. |
| Biocompatibility (as per ISO 10993-1) | Biological safety assured through material selection. Biocompatibility established. |
| Aging test performance | Passed aging test. |
| Comparison to predicate devices | Equivalent electrical and mechanical functionality as predicate devices. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a "test set" in the context of data or images. Instead, it refers to laboratory tests performed on the physical ECG electrode devices themselves. Therefore, details regarding sample size for a "test set" for data and data provenance (country of origin, retrospective/prospective) are not applicable and not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable. For a physical ECG electrode, "ground truth" would relate to its physical and electrical properties, evaluated by standard laboratory methods and equipment, not by interpretation from human experts.
4. Adjudication Method for the Test Set
This information is not applicable, as there is no "test set" of data requiring expert adjudication.
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. An MRMC comparative effectiveness study is designed for evaluating AI/ML algorithms that assist human readers in tasks like image interpretation. This submission is for a physical ECG electrode and does not involve AI or human readers in that capacity.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No. This submission is for a physical medical device, not a software algorithm.
7. The Type of Ground Truth Used
For the physical electrode:
- Electrical and Mechanical Functionality: Ground truth is established by objective measurements against the performance standards defined in ANSI/AAMI EC12:2000.
- Biocompatibility: Ground truth is established by material selection and testing based on ISO 10993-1.
8. The Sample Size for the Training Set
This information is not applicable. This device is not an AI/ML algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set was Established
This information is not applicable, as there is no training set for this type of device.
In summary: The K052944 submission details the non-clinical testing and biocompatibility assessment of a disposable ECG electrode to demonstrate its equivalence to predicate devices and adherence to relevant performance standards. It does not involve any AI/ML components or clinical data-based studies typically associated with "acceptance criteria" for software or interpretation devices.
§ 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.