(133 days)
The Karl Storz Imaging (KSI) Direct Coupled Interface (DCI 5) Camera System combines a color, television camera head with an integrated light source cable and camera control unit (CCU). These units are designed for attachment to any Karl Storz Tuttlingen (KST) DCI compatible rigid or flexible endoscope, including, but not limited to sinoscopes, colonoscopes, sigmoidoscopes, bronchoscopes, gastroscopes, laparoscopes, choledochoscopes, ureteroscopes, hysteroscopes and arthroscopes. The DCI 5 camera head is coupled to the endoscope by directly pressing the endoscope onto the front of the camera head until it locks into place. An optional adapter allows DCI 5 camera head attachment to non-DCI rigid and flexible endoscopes. The endoscopic image can be displayed on any standard operating room video monitor. All commonly available endoscopic light sources may be used with the DCI 5 System.
The KSI DCI 5 incorporates two programmable function buttons (to select an accessory port(s) and to control the port output), a focus knob and a zoom in/zoom out control bar. The camera head also has an integrated light cable. The camera is designed to allow the user to axially rotate the camera head while maintaining proper image orientation on the monitor.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary for the Karl Storz Imaging Direct Coupled Interface Camera Head and primarily focuses on:
- Device Description and Intended Use: Explaining what the DCI 5 Camera System is and how it's used with various endoscopes.
- Substantial Equivalence: Demonstrating that the DCI 5 is substantially equivalent to previously cleared Karl Storz Imaging devices by combining features from them.
- FDA Clearance Letter: Official notification from the FDA granting clearance for the device to be marketed.
The text does not contain:
- A table of acceptance criteria and reported device performance.
- Details about sample sizes or data provenance for a test set.
- Information on expert ground truth establishment for a test set.
- Adjudication methods.
- Any multi-reader multi-case (MRMC) comparative effectiveness study.
- Details about standalone algorithm performance if an AI component were present.
- The type of ground truth used.
- Training set sample size or how its ground truth was established.
This is a predicate device submission, meaning it compares the new device to existing, legally marketed devices to demonstrate that it is largely similar in terms of technology, safety, and effectiveness, without necessarily providing comprehensive new performance studies against predefined acceptance criteria in the way a novel AI device might.
§ 878.4160 Surgical camera and accessories.
(a)
Identification. A surgical camera and accessories is a device intended to be used to record operative procedures.(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.