(163 days)
The InfraVision™ Bougie is intended to aid in the identification of the esophagus, rectum, rectosigmoid, other structures, and surgically produced cavities using infrared transillumination during laparoscopy, thoracoscopy, or open procedures. The indications for use are detailed below:
a. Infrared transillumination of the esophagus to assist in the identification and location of the esophagus and its surrounding tissues during laparoscopic, thoracoscopic, and open procedures;
b. Infrared transillumination of the rectum and rectosigmoid to assist in the identification and location of these structures and surrounding tissues during gynecological and colorectal laparoscopic and open procedures; and
C. Infrared transillumination of other organs or provide transillumination or illumination to other natural or surgically produced cavities.
The InfraVision™ Bougie is intended to aid in the identification of the esophagus, rectum, rectosigmoid, other structures, and surgically produced cavities using infrared transillumination during laparoscopy, thoracoscopy, or open procedures. The InfraVision™ Bougie is a disposable device ranging in diameters from 13 Fr to 60 Fr, all having bougie sheath lengths of 80 cm. The overall length of the Infra Vision™ Bougies is 250 cm. The Infra Vision™ Bougie has a translucent tip that is either tapered or rounded in shape and varies in length.
This document describes the K960173 InfraVision™ Bougie, a medical device designed to aid in the identification of internal structures using infrared transillumination.
Based on the provided text, there is no detailed information about acceptance criteria or a specific study proving the device meets them in the format typically seen for modern AI/ML medical devices. The document is from 1996 and pertains to a physical medical device (an illuminated bougie), not an AI/ML diagnostic or predictive tool, hence the requested metrics like sample size for test/training sets, ground truth establishment methods, expert qualifications, and MRMC studies are not applicable or detailed in the provided text.
However, I can extract the information related to the "testing" section provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Tissue heating | Significantly less tissue heating observed using the InfraVision™ System dual fiber emitters compared to the EndoLumina predicate device (energized with a Cabot Medical System 3000 Xenon Videolap Light set to full power). |
Note: The document implies "less tissue heating" is a desirable outcome and thus serves as an implicit acceptance criterion. No specific numerical thresholds are provided.
2. Sample Size Used for the Test Set and Data Provenance
The testing was performed using "simulated test tissue."
- Sample Size (Test Set): Not specified.
- Data Provenance: Simulated tissue.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The testing described focuses on a physical characteristic (tissue heating) using simulated tissue, not on diagnostic accuracy requiring expert consensus.
4. Adjudication Method for the Test Set
Not applicable, as the testing was on a physical characteristic using simulated tissue.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for evaluating the performance of diagnostic tools (often AI-assisted) where human interpretation is involved. The InfraVision™ Bougie is a physical device used for illumination.
6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study
Not applicable, as this is a physical medical device, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" implicitly used was the actual temperature measurements or observation of tissue heating in simulated tissue. The comparison was against a predicate device's heating profile.
8. Sample Size for the Training Set
Not applicable. This is a physical device, and the concept of a "training set" is not relevant to the described testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 876.5365 Esophageal dilator.
(a)
Identification. An esophageal dilator is a device that consists of a cylindrical instrument that may be hollow and weighted with mercury or a metal olive-shaped weight that slides on a guide, such as a string or wire and is used to dilate a stricture of the esophagus. This generic type of device includes esophageal or gastrointestinal bougies and the esophageal dilator (metal olive).(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.