(56 days)
The Vision-Sciences Trans-Nasal Esophagoscope with EndoSheath® System is indicated for use in endoscopic access and examination of the larynx, esophagus and gastro-esophageal junction. The System may also be used to assist in intubation.
The device system described in this 510(k) consists of a flexible, fiberoptic esophagoscope and sterile, single use protective sheath.
The provided text is a 510(k) Premarket Notification for a medical device (Trans-Nasal Esophagoscope with EndoSheath® System). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study in the way an AI/ML device would.
Therefore, the requested information elements related to AI model evaluation (acceptance criteria, test set, ground truth, MRMC study, training set) are not applicable to this document.
The document discusses "Safety and Performance" which states: "Substantial equivalence for the new device was based on design characteristics, comparison to legally marketed predicate devices, and performance testing. Performance testing included sheath burst/leak testing, sheath tensile/elongation testing, sheathed scope articulation testing, sheathed scope image quality evaluation and scope cycle testing." However, specific acceptance criteria values and the reported device performance for these tests are not detailed within the provided text. The table in Section {1} compares design characteristics and indications for use between the proposed device and various predicate devices, but it does not present performance data against acceptance criteria.
In summary:
- Table of acceptance criteria and reported device performance: Not provided in the document. The document lists types of performance tests conducted (e.g., sheath burst/leak, tensile/elongation, articulation, image quality, scope cycle testing) but does not present the specific acceptance criteria for these tests nor the detailed results obtained.
- Sample size used for the test set and data provenance: Not applicable as no clinical study for an AI/ML device is described. This device is an endoscope system.
- Number of experts used to establish the ground truth for the test set and qualifications of those experts: Not applicable.
- Adjudication method: Not applicable.
- Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable. This is not an AI/ML device requiring such a study.
- Standalone performance (algorithm only without human-in-the loop performance): Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 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.