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The KSEA Laparocam is designed to be used by qualified surgeons and physicians for general endoscopic and laparoscopic surgical procedures. This instrument is indicated for use during general endoscopic and laparcascopic surgical procedures, and, using additional accessories, to perform various diagnostic and therapeutic procedures.

The KSEA Laparocam is comprised of a rigid telescope with an integral CCD chip. The body contact portions of the KSEA Laparocam are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.

This 510(k) summary for the Karl Storz Laparocam is a premarket notification for a medical device seeking substantial equivalence to existing devices. It does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The document primarily focuses on establishing the device's substantial equivalence to predicate devices based on "basic features, design and intended uses." It states that "The minor differences between the KSEA Laparocam and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no affect on the performance, function or intended use of the devices."

Therefore, I cannot provide the requested information from the provided text. The document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for a test set or data provenance.
3. Number of experts used or their qualifications.
4. Adjudication method for a test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Information about a standalone (algorithm only) performance study.
7. The type of ground truth used.
8. Sample size for a training set.
9. How ground truth for a training set was established.

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