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UROLOGY
DirectView™ Endoscopes may be used by qualified physicians for imaging of a surgical site for diagnostic and surgical urology procedures.

GENERAL SURGERY
DirectView™ endoscopes may be used for general diagnostic and laparoscopic surgical procedures by a qualified physician for visualization of body cavities, organs, and canals to perform various diagnostic and surgical procedures.

A laparoscope is a device used for minimally invasive surgery for specific indications of use. The device consists of two separate and distinct optical paths. The illumination usually takes the form of fiber optics connected to a light cable which brings light from an external light source to the instrument.

The second path is an optical telescope that captures an image from inside the body cavity with an optical objective lens system. This image is then transmitted through a series of optical relay lenses and/or rods to convey the image to a eyepiece for viewing by the human eye. Over the years, human viewing using the eyepiece has given way to electronic cameras which projects the image from the telescope on to a video monitor. Recent designs using what is called a chip-ona-stick technology has replaced the optical relay with an electronic camera embedded in the distal end of the device at the expense of bringing wiring into the body cavity.

The basic optical design as well as physical design of the laparoscope has remained constant with the exception of the reduction of its diameter. The device has remained essentially the same since the original Hopkin's design over forty years ago. Major developments have occurred, however, in the application of solid state camera systems and high definition video monitors creating a revolution in minimally invasive surgerv. MITI seeks to make major revisions in the basic design of the device itself to address problems which have largely been unaddressed for decades. MITI defines functionality of its technology in terms of flexibility, sterility, visibility, interchangeability, availability, safety, and affordability.

The provided text describes the Micro Invasive Technology Inc. (MITI) DirectView™ Laparoscope and Disposable LightGuide device and its substantial equivalence to a predicate device, the Wolf Lumina Model 8934.40. The evaluation focuses on optical performance to demonstrate equivalence.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the device are not explicitly stated in numerical or statistical terms, but rather implied through the comparison with the predicate device. The general acceptance criterion is "substantial equivalence" in optical performance.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated as a number of devices or cases. The evaluation appears to involve a comparison of two devices (the DirectView™ and the Lumina) using multiple test targets and human skin tissue.
• Data Provenance: The nature of the test (photographing standard resolution targets and skin tissue) suggests laboratory testing rather than clinical data from a specific country or patient population. It is a prospective test in the sense that the testing was conducted specifically to support the 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. The ground truth for the optical performance comparison was established by using standard resolution targets and direct visual/photographic comparison by presumably qualified personnel involved in the device testing, but not explicitly by "experts" in the sense of clinicians establishing a "ground truth" for a medical condition. The conclusion section states "For purposes of this document, the instruments are substantially equivalent," which implies an internal assessment by the manufacturer.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of an adjudication method as the comparison was based on direct observation and photographic documentation of test targets.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The submission focuses on the standalone optical performance and equivalence to a predicate device, not on assessing human reader performance with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone performance evaluation was conducted. The study primarily assessed the optical performance of the device itself (DirectView™ Laparoscope) in comparison to the predicate device (Wolf Lumina) using test targets and skin tissue photography. The performance being evaluated is the image generation capability of the laparoscopes, independent of a human interpreter's diagnostic accuracy.

7. Type of Ground Truth Used

The ground truth used for the comparison was:

• Standard resolution targets (AF standard resolution targets): These provide an objective measure of optical resolution.
• Empirical test of skin tissue: This represents a real-world, albeit simplified, biological target for visual comparison.

8. Sample Size for the Training Set

Not applicable. This device is a medical instrument (laparoscope), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI algorithm.

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