(217 days)
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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalent optical image quality to predicate device | The MITI DirectView™ and Lumina both have an optical system for transmitting images. The MITI design uses modern optical design software for a more efficient system with fewer lens components. |
| Equivalent resolution | Photographs of the DirectView™ and Lumina under identical test configurations with identical AF standard resolution targets show comparable performance. |
| Equivalent field of view | The MITI DirectView™ has a "slightly greater field of view" than the Wolf Lumina, resulting in a "slightly larger image of the test targets at the same distance." |
| Equivalent performance on real tissue | "An empirical test of skin tissue is shown in photos 1 & 2 that demonstrate the equivalency results on human tissue." |
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.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.