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E.G. Scan™ II Esophagoscope System Is Intended for use in endoscopic access and examination of the larynx, esophagus and gastroesophageal junction.

E.G. Scan™ II Esophagoscope System and its accessories are used for diagnosis of patients. E.G. Scan™ II Probe takes pictures of the esophagus of human and sends image data to E.G. Scan™ II Controller. E.G. Scan™ II Controller processes and converts image data and upload. E.G. View™ image displaying software displays the image for diagnosis. The E.G Scan™ II Esophagoscope Probe is disposable. E.G. Scan™ II Esophagoscope system is a transnasal esophagoscope designed to capture images of the esophagus. Captured images are viewed via the E.G. View™ Software for diagnosis of diseases related to the esophagus.

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for the E.G. Scan™ II Esophagoscope System, primarily focusing on its substantial equivalence to a predicate device.

It lists:

• Device Name: E.G. Scan™ II Esophagoscope System
• Indication for Use: Endoscopic access and examination of the larynx, esophagus, and gastroesophageal junction.
• Predicate Device: E.G. Scan™ Esophagoscope System (K120702) from IntroMedic Co., Ltd.
• Safety, EMC, and Performance Data: States that the device has the same device characteristics as the predicate device (intended use, material, design, use concept). It also mentions biocompatibility testing (cytotoxicity, sensitization, irritation by ISO 10993-1) and conformity to electrical safety (IEC 60601-1, IEC 60601-2-18) and EMC standards (IEC 60601-1-2).

However, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about a study to prove performance, including sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods for either test or training sets.
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size of AI improvement.
• Details of a standalone (algorithm only) performance study.

The submission focuses on establishing substantial equivalence based on similar design, intended use, technological characteristics, and conformance to general medical device safety standards, rather than a clinical performance study with specific acceptance criteria.

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