(50 days)
The disposable Light Handle Cover is a single use sterile product. Its intended use is as a cover for surgical light handles. It is to be placed over the light handle prior to the start of a surgical procedure to provide the nurse or surgeon with a sterile protective cover to enable them to move the light during the procedure without compromising the sterility of their hands. This product does not come in contact with the patient.
The disposable Light Guard Light Handle Cover is made from a plastic material and is a single use item used to cover the handle of a surgical light. This device fits over the handle of a surgical light to provide a sterile barrier between sterile personnel and the non-sterile light handle.
The provided text does not contain information regarding acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for a medical device (Light Guard Light Handle Cover) which focuses on demonstrating substantial equivalence to a predicate device.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide information for the specific points you've listed (sample size, experts, adjudication, MRMC, standalone, ground truth, training set size).
The document states: "Xodus Medical Inc.'s Light Guard Light Handle Cover has the same physical characteristics, material and design as the predicate device. They are both designed to slide over a surgical light handle. Both the predicate device and Xodus Medical's device are used to provide a sterile barrier between the sterile personnel and the non-sterile light handle." This indicates that the regulatory approval was based on substantial equivalence, implying that the new device performs similarly to the already approved predicate device, rather than requiring a new clinical study to establish performance against specific acceptance criteria.
§ 878.4580 Surgical lamp.
(a)
Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.(b)
Classification. Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.