(64 days)
The ORS-2000LD is designed to warm and maintain the temperature of surgical solutions prior to their use.
Not Found
The provided text is related to a 510(k) clearance letter for the "Warmer 2000LD" device, which is a "Powered Heating Unit" designed to warm and maintain the temperature of surgical solutions.
However, the document does not contain any information regarding acceptance criteria, device performance metrics, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or how ground truth was established.
The letter is a regulatory document stating that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It refers to general controls and regulations but does not delve into the specific performance studies that would be required to establish acceptance criteria and device performance.
Therefore, I cannot provide the requested table and study details based on the given input.
§ 890.5950 Powered heating unit.
(a)
Identification. A powered heating unit is a device intended for medical purposes that consists of an encased cabinet containing hot water and that is intended to heat and maintain hot packs at an elevated temperature.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.