(43 days)
Devices are intended to attach boot stirrups to operating revm table rail or cysto table rail during surgical or diagnostic procedures requiring positioning and support of the patient's legs.
Not Found
The provided document is a 510(k) clearance letter from the FDA for the "Allen®, Ultra™ and SMART Sockets" devices. This document does not contain information about specific acceptance criteria or a study proving the device meets them.
The letter explicitly states:
"We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."
This indicates that the clearance was based on substantial equivalence to a predicate device, rather than a new study demonstrating performance against a set of acceptance criteria. For devices cleared through the 510(k) pathway via substantial equivalence, the rigorous performance studies you've requested are often not submitted to the FDA in the same way they would be for a Pre-Market Approval (PMA) pathway or a de novo classification.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment based on the provided text. This information would typically be found in the 510(k) summary or the full submission, which is not included here.
§ 878.4960 Operating tables and accessories and operating chairs and accessories.
(a)
Identification. Operating tables and accessories and operating chairs and accessories are AC-powered or air-powered devices, usually with movable components, intended for use during diagnostic examinations or surgical procedures to support and position a patient.(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 § 878.9.