(78 days)
The 12 lead glove is designed to configure ECG electrodes in a single unit using a conventional ECG electrode configuration for the purpose of conducting an electrocardiogram. It is for use in patients with a chest girth of 97 - 104 cm.
The 12 lead glove is designed to configure ECG electrodes in a single unit using a conventional ECG electrode configuration for the purpose of conducting an electrocardiogram.
I am sorry, but the provided text from the FDA 510(k) letter does not contain the specific information required to answer your questions regarding the acceptance criteria, study details, and performance of the "12 Lead Glove" device.
The document is a clearance letter indicating that the device has been found substantially equivalent to a predicate device, allowing it to be legally marketed. It specifies the trade/device name, regulatory number, regulation name, regulatory class, product code, and the date of the 510(k) submission and review. It also includes the "Indications for Use" for the device, which states:
"The 12 lead glove is designed to configure ECG electrodes in a single unit using a conventional ECG electrode configuration for the purpose of conducting an electrocardiogram. It is for use in patients with a chest girth of 97 - 104 cm."
However, it does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test sets or data provenance.
- Number of experts, their qualifications, or adjudication methods for ground truth.
- Information on multi-reader multi-case (MRMC) comparative effectiveness studies.
- Details on standalone algorithm performance.
- The type of ground truth used in studies.
- Sample size or ground truth establishment for the training set.
To obtain this information, you would typically need to refer to the full 510(k) submission document, which would contain the clinical or non-clinical testing data that the FDA reviewed to make its substantial equivalence determination. This letter is merely the outcome of that review.
§ 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.