(33 days)
The mi-eye 3 needlescope™ with cannula, mi-eye tablet 3™ is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination of an interior cavity of the body through either a natural or surgical opening.
The mi-eye 3 needlescope™ with cannula, mi-tablet 3™ is a portable visualization device that uses a probe with integrated camera and separate LCD monitor attached via a cable. The sterile, single-use needlescope probe includes the camera and image capture features with LED light source. The mi-eye 3 probe connects to, and is powered by, the reusable mi-tablet 3. The mi-tablet 3 includes an internal battery and power supply, along with a cable for external charging. The mi-tablet 3 LCD Monitor displays a real-time image from the probe. The Monitor is also capable of connecting to separate ultrasound transducer, linear and convex, imaging probes and displaying their visual output. The mi-eye 3 needlescope™ with cannula has a rigid shaft that extends from the handle. The distal tip of the probe contains the camera, illumination, and imaging optics. Irrigation may be provided through the distal end of the probe from user supplied solution attached to the handle.
The mi-eye 3 needlescope™ with cannula is available in 75 and 95mm lengths with 0 and 25 degree viewing angles, relative to the axis of the probe is packaged with a scalpel, cannula, obturator and switching stick for use in creating and maintaining the channel for the probe. The monitor has a 12" (diagonal) screen. The probe weight is under 300 grams.
This document is a 510(k) summary for a medical device (mi-eye 3 needlescope™ with cannula, mi-tablet 3™). It asserts substantial equivalence to a predicate device and provides a table of performance data showing various tests passed. However, it does not contain the specific information required to answer your detailed questions about acceptance criteria for AI/ML device performance, the study design for proving it meets those criteria, sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance.
The provided text describes a traditional medical device (an arthroscope and its associated monitor) and focuses on engineering and safety performance testing (e.g., biocompatibility, electrical safety, sterilization, mechanical strength). It is not an AI/ML powered device submission.
Therefore, based solely on the provided text, I cannot answer the questions about acceptance criteria and studies proving the device meets those criteria, as these pertain to AI/ML device performance, which is not discussed in this document.
The document details performance data related to manufacturing, safety, and physical properties (as seen in the "Performance Data" table), but these are not the type of performance criteria (e.g., sensitivity, specificity, AUC) you would expect for an AI/ML-powered diagnostic device.
If you have a different document or there's a misunderstanding of what "acceptance criteria" you are referring to based on the provided text, please clarify.
§ 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.