(57 days)
The MicroFlow Spacer (Frontal) is indicated for use as a postoperative spacer to maintain an opening to the frontal sinuses within the first 14 days following surgery. The MicroFlow Spacer also helps to prevent obstruction.
The Frontal Sinus Spacer is a device that maintains an opening at the frontal sinus for up to 14 days postoperatively. The subject device can be manually removed during an office follow-up visit at any time.
The provided document is a 510(k) summary for the Acclarent Relieva Stratus MicroFlow Spacer. However, it does not contain the detailed performance data or study information required to answer your specific questions about acceptance criteria and study design.
The document states:
- "The Frontal Sinus Spacer met all performance acceptance criteria."
- "The Frontal Sinus Spacer is substantially equivalent to the predicate device as confirmed through relevant performance tests."
This indicates that internal performance testing was conducted, and the device met the pre-defined criteria. However, the summary does not provide the actual acceptance criteria, the reported device performance metrics, or any details about the study design (e.g., sample size, ground truth, expert qualifications, adjudication methods, or a multi-reader multi-case comparative effectiveness study).
Therefore, I cannot populate the table or provide specific answers to questions 2 through 9 based solely on the provided text. To get that information, you would typically need to consult a more detailed document, such as the full 510(k) submission or a dedicated performance study report, which are not included here.
§ 878.4800 Manual surgical instrument for general use.
(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(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 § 878.9.