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The Schoelly Laparoscope is indicated for examination of body cavities, hollow organs, and using additional accessories, to perform various diagnostic and therapeutic procedures.

The Schoelly Laparoscope is a rigid reusable endoscope for visualization of body cavities used in conjunction with a commercially available and approved light guide, light source, video camera, monitor, and printer. Light guide, light source, video camera, monitor, and printer are not included in the scope of delivery and are further not within the scope of this application.

Light that is created by an external light source is transmitted from the laparoscope light guide connector through the laparoscope itself to the tip via a fiber optic system. Images are transferred the other way back through a rigid rod lens system.

Schoelly Laparoscopes are manufactured in multiple configurations that differ in insertion tube outer diameter and working length and with respect to optical parameters (direction of view, field of view).

Like other currently marketed laparoscopes, the proposed device has outer surfaces mainly made from metal (304 stainless steel) and further comprise fiber optics for light transmission and rigid rod-lenses for image transmission.

The Schoelly Laparoscope is delivered in a non-sterile condition and is already CE marked.

This document does not contain the information required to populate the fields of the request. The document describes a 510(k) premarket notification for a medical device (Schoelly Laparoscope) and focuses on demonstrating substantial equivalence to a predicate device.

The provided text details:

• The device's intended use and design.
• That changes were limited to material and dimensional configurations.
• That performance testing involved biocompatibility in accordance with ISO 10993-1.
• A conclusion that the modified device met predetermined acceptance criteria and does not introduce new risks, therefore being substantially equivalent.

However, the document does not provide:

1. A table of acceptance criteria and reported device performance for clinical effectiveness studies. The "acceptance criteria" mentioned refer to engineering and biocompatibility tests, not clinical performance metrics like sensitivity, specificity, accuracy, or AUC.
2. Details about a study that assesses clinical performance against specific acceptance criteria. The document focuses on regulatory equivalence based on design and biocompatibility, not on a clinical performance study with human subjects or a large dataset.
3. Information about sample sizes for test sets, training sets, or data provenance in the context of clinical AI/ML model evaluation.
4. Details about ground truth establishment, expert involvement, or adjudication methods.
5. Information regarding multi-reader multi-case (MRMC) studies or standalone algorithm performance.

Therefore, I cannot fulfill the request as the necessary information is not present in the provided text.

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