(79 days)
The VisionScope High Definition Endoscopy Camera System is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination, visualization and capture of still and motion pictures of an interior cavity of the body through a natural or surgical opening. Examples of generic surgical use include imaging of articular cavities, body cavities, hollow organs and canals.
Additionally, when used in conjunction with an appropriately indicated and FDA 510(k)cleared endoscope and light source, the VisionScope High Definition Endoscopy Camera Control Unit and Camera Handpiece are indicated for use in arthroscopic and endoscopic surgical procedures to provide illumination, visualization and capture of still and motion pictures of articular cavities, body cavities, hollow organs and canals.
The VisionScope High Definition Endoscopy Camera System is made up of the following components:
- · Integrated Camera Control Unit containing the camera control electronics, light source and image capture electronics
- Camera Handpiece .
- . VisionScope line of four Endoscopes of identical design except for the lengths
- . VisionScope Disposable Sterile Procedure Kits in four matched lengths as the endoscopes
The provided K101734 document is a 510(k) summary for the VisionScope High Definition Endoscopy Camera System. It primarily focuses on demonstrating substantial equivalence to predicate devices under FDA regulations. However, it does not contain specific information about detailed clinical studies with acceptance criteria, sample sizes, expert ground truth establishment, or multi-reader multi-case studies as requested.
The document states:
"VisionScope conducted the verification and validation testing with the VisionScope High Definition Endoscopy Camera System to demonstrate safety and effectiveness and substantial equivalence to the predicate devices listed above. All verification and validation data demonstrate that the device is safe and effective and performs as intended."
This is a general statement and does not provide the granular detail required to answer your specific questions about performance metrics, study design, and ground truth. The submission mainly relies on demonstrating the technological similarities and adherence to voluntary safety standards.
Therefore, I cannot populate the requested table and information based on the provided text. The document does not describe a study involving specific acceptance criteria for performance metrics (like sensitivity, specificity, accuracy, etc.) or a comparison with human readers.
If such a study was performed, the details are not present in this 510(k) 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.