(58 days)
The intended use of the MED-TEC, INC. Carbon Fiber Conformal Couch Top is to support and aid in positioning a patient during radiologic and other medical procedures.
MED-TEC, INC. has a Table, Radiographic, Stationary Top System to be manufactured by MED-TEC, INC. The MED-TEC, INC. Carbon Fiber Conformal Couch Top operates in the same manner as an ordinary couch.
This document is a 510(k) premarket notification for a "Carbon Fiber Conformal Couch Top." It is a regulatory approval letter from the FDA, and as such, it does not contain the detailed technical study information requested. The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can proceed to market.
Therefore, most of the requested information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not available in the provided text.
Here's what can be inferred from the document:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as this is a regulatory approval letter rather than a technical report. However, the FDA's acceptance of substantial equivalence implies that the device met certain safety and effectiveness benchmarks comparable to predicate devices.
- Reported Device Performance: Not explicitly stated with specific metrics. The letter implies that the device operates "in the same manner as an ordinary couch" and is intended "to support and aid in positioning a patient during radiologic and other medical procedures."
Remaining information (2-9) is not available within the provided FDA letter. The letter is a formal notification of approval based on a submission, not the submission itself or a summary of its technical data.
To provide the requested details, a different type of document, such as the actual 510(k) submission summary or a scientific study report, would be necessary.
§ 892.1980 Radiologic table.
(a)
Identification. A radiologic table is a device intended for medical purposes to support a patient during radiologic procedures. The table may be fixed or tilting and may be electrically powered.(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 § 892.9.