(30 days)
The flexible trans-nasal video esophagoscope with digital video processor and disposable sheath system is intended for use in endoscopic access and examination of the larynx, esophagus and gastro-esophageal junction. The system can also be used to aid in intubation.
The digital video processor is intended for use with the VSI flexible video scope.
The VSI flexible endoscope is a flexible endoscope with connections to a video processor and display monitor. The EndoSheath® Systems are sterile, single-use protective sheath systems, with or without a working channel, that are intended to cover the entire insertion tube of the videoscope. The digital video processors are used with the flexible videoscope for image visualization and capture.
The provided text describes a Special 510(k) Premarket Notification for a modified medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device through certification of compliance to design control requirements and a description of risk analysis procedures, rather than extensive new clinical or performance studies.
Therefore, the supplied text does not contain detailed information regarding:
- A table of specific acceptance criteria and reported device performance metrics.
- Sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, or standalone performance data.
- Specific types of ground truth used or sample sizes for training sets (as this is a modification of an existing device, not a de novo AI device).
Summary of available information:
1. Acceptance Criteria and Reported Device Performance:
The submission states that "V & V activities, including scope/sheath/processor system functional and performance testing, and software validation was addressed through comprehensive Design Validation and Verification planning." It concludes that "Based on the indications for use, technological characteristics, performance testing and comparison to predicate devices, the VSI flexible video TNE endoscope with digital video processors and disposable EndoSheath® Systems have been shown to be safe and effective for their intended use."
However, specific quantitative acceptance criteria (e.g., in terms of sensitivity, specificity, accuracy, or other performance metrics) and the numerical results against these criteria are not provided in the document. The general acceptance criteria would be that the modified device performs as intended and is as safe and effective as the predicate device.
2. Sample size used for the test set and the data provenance:
Not explicitly stated. The submission focuses on design control compliance and functional/performance testing of the device system, rather than a clinical study evaluating diagnostic accuracy on a specific patient test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable or not provided. This type of information is typically relevant for studies validating diagnostic algorithms, which is not the primary focus of this Special 510(k) for a hardware modification.
4. Adjudication method for the test set:
Not applicable or not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a modified endoscope system, not an AI-powered diagnostic algorithm designed to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a hardware device (endoscope, video processor, and sheaths), not a standalone algorithm.
7. The type of ground truth used:
Not explicitly stated, but for a physical device, "ground truth" would likely relate to objective measurements of device function (e.g., image quality, illumination, navigational capabilities, integrity of sheaths, software functionality) rather than clinical diagnostic outcomes requiring expert consensus or pathology.
8. The sample size for the training set:
Not applicable or not provided, as this is a device modification submission for hardware, not an AI algorithm.
9. How the ground truth for the training set was established:
Not applicable or not provided.
§ 874.4710 Esophagoscope (flexible or rigid) and accessories.
(a)
Identification. An esophagoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the esophagoscope and is intended to examine or treat esophageal malfunction symptoms, esophageal or mediastinal disease, or to remove foreign bodies from the esophagus. When inserted, the device extends from the area of the hypopharynx to the stomach. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.