(51 days)
The Smith & Nephew, Inc., Endoscopy Division Limited Reuse Endoscopic Surgery Blades as indicated for use during endoscopic resection of soft and osseous tissue in various large and small articular cavities. These blades are for limited reuse. The actual number of reuses will be dependant on proper care and use of the blade by healthcare facilities.
Limited reuse instrument consisting of several concentric tubes and various tip designs. The blades are used to resect and remove tissue endoscopically. The inner blade is driven by a motor. Tissue is removed by suction through the inner diameter of the inner blade.
The provided text is a 510(k) summary for Limited Reuse Endoscopic Surgery Blades and the FDA's response letter. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, or expert qualifications.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size
- If a standalone performance (algorithm only) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
The document focuses on regulatory approval based on substantial equivalence to a previously approved device (K955914) and highlights a "validated sterilization method and inclusion of test data showing that burr devices will meet all performance and safety standards when run at 8000 rpm" as the modification. While this implies performance and safety tests were conducted, the specific acceptance criteria and results are not detailed in this summary.
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.