(25 days)
The Mactrode® 3 is intended for use on adult patients during an ECG electrocardiogram test. The Mactrode® 3 is applied to the patient's skin. The Mactrode® 3 is intended to be used for less than one hour. The Mactrode® 3 is for single patient use.
The Mactrode® 3 is intended to be used under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The Mactrode® 3 is intended for use in a professional medical facility, such as a hospital, clinic or doctor's office.
The Mactrode® 3 is an electrocardiograph electrode. The Mactrode® 3 is triangular in shape providing multiple alternate connection areas. The Mactrode® 3 is a pre-gelled electrode that is disposable and is not sterile.
The provided text is for a 510(k) summary for a medical device called Mactrode® 3, an electrocardiograph electrode. It describes the device, its intended use, and states that it performs as well as the predicate device. However, the document does not contain details about specific acceptance criteria, a detailed study proving performance against those criteria, or the specific quantitative metrics requested in your prompt (e.g., performance values, sample sizes for test/training sets, expert methods for ground truth, MRMC studies, or standalone performance).
The "Test Summary" section in the 510(k) Summary states: "The Mactrode® 3 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 system: Risk Analysis, Technical Reviews, Design Reviews, Unit level Testing, Performance Testing, Safety Testing."
This indicates that a study was performed (referred to as "Performance Testing" and "Safety Testing"), but it does not provide the results or the methodology for these tests. The conclusion only states that the device is "as safe, as effective, and performs as well as the predicate device."
Therefore, I cannot populate the table or answer the specific questions about the study design, sample sizes, ground truth, or expert involvement as this information is not present in the provided document. The document primarily focuses on regulatory approval based on demonstrating substantial equivalence to a predicate device (K902176 Silver Mactrode®), rather than providing a detailed clinical or performance study report with specific quantitative outcomes.
§ 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.