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The Karl Storz Imaging (KSI) Autoclavable camera head is a color, television camera. suitable for use with any rigid or flexible endoscope, including, but not limited to sinoscopes, colonoscopes, sigmoidoscopes, bronchoscopes, gastroscopes, laparoscopes, choledochoscopes, ureteroscopes, hysteroscopes and arthroscopes. The camera head is coupled to the endoscope. The camera head may be used with any current, compatible KSI camera control unit (CCU). The endoscopic image can then be displayed on any standard operating room video monitor.

The new autoclavable camera heads are identical to previous single chip and three chip models with the exception that these units are hermetically sealed and use a magnetic switch for operating the integral hand-held camera controls.

The provided text is a 510(k) summary for the Karl Storz Autoclavable Camera Head. It outlines the device's intended use, description, and claims of substantial equivalence to previously reviewed devices. However, it does not contain any information regarding specific acceptance criteria, performance data, or details of a study that proves the device meets such criteria.

The submission focuses primarily on demonstrating substantial equivalence based on the device's design (hermetically sealed, magnetic switch) and sterilization capability, rather than presenting a performance study with detailed metrics.

Therefore, most of the requested information cannot be extracted from this document.

Here's what can be stated based on the provided text:

• Acceptance Criteria and Reported Device Performance: Not provided in the document. The submission focuses on substantial equivalence to predicate devices rather than meeting specific performance metrics.
• Sample size used for the test set and data provenance: Not mentioned. No specific test set or clinical study data is presented.
• Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as no test set or ground truth establishment is described.
• Adjudication method for the test set: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: No, an MRMC study is not mentioned.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a camera head, not an AI algorithm.
• The type of ground truth used: Not applicable, as no ground truth is described.
• The sample size for the training set: Not applicable, as no training set for an algorithm is described.
• How the ground truth for the training set was established: Not applicable.

Summary of available information:

The 510(k) summary addresses the regulatory requirements for showing substantial equivalence. It highlights:

• Device Name: Karl Storz Autoclavable Camera Head
• Intended Use: A color, television camera suitable for use with various rigid or flexible endoscopes, coupled to the endoscope, and used with compatible KSI camera control units (CCUs) to display endoscopic images on standard operating room video monitors.
• Device Description: Identical to previous single-chip and three-chip models, but hermetically sealed and uses a magnetic switch for integral handheld camera controls.
• Substantial Equivalence: Claimed to be substantially equivalent to previously reviewed KSI single CCD (K883943) and triple CCD (K950862) camera heads, and in pressurized steam sterilization capability, to M.P. Video's "Autoclaveable Medicam 900 Digicon Camera" (K942358).

The document's purpose is to demonstrate that the new autoclavable camera head is safe and effective because its technological characteristics and intended use are comparable to legally marketed predicate devices, not through a detailed performance study with specific acceptance criteria and outcome data.

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