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This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment is indicated for use within the nasal lumens and airway anatomy (including nasopharynx and trachea). This instrument is intended for use in a clinical or ambulatory medical environment.

This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment. This instrument is indicated for use within the nasal lumens and airway anatomy (including nasopharynx and trachea).

It is mainly consisted of four functional parts:

• video connection section including video connector and video cable that connect the endoscope to the video system center for displaying images on compatible video monitors
• light guide connector section that links the endoscope with a light source and transmits light to the distal end of the endoscope
• control section that operates the endoscope such as controlling angulation to guide insertion and observation, activating suction by single-use suction valve and performing treatment by means of allowing EndoTherapy accessories to enter into the instrument channel.
• insertion section that goes through and contacts with the nasal lumens and airway anatomy (including nasopharynx and trachea) under the light guide.

The provided document is a 510(k) summary for the Olympus Rhino-Laryngo Videoscope ENF-VT3. It describes the device, its indications for use, and a comparison to a predicate device. However, it explicitly states that no clinical study was performed to demonstrate substantial equivalence and that no animal study was performed. This means there is no data presented in this document about acceptance criteria for device performance with respect to clinical or functional outcomes, nor a study proving those criteria were met by the device.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
• If a standalone (algorithm only) performance study was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

The document primarily focuses on demonstrating substantial equivalence through non-clinical testing, such as:

• Reprocessing validation testing: Conducted according to FDA guidance.
• Biocompatibility testing: Conducted in accordance with ISO 10993-1, including Cytotoxicity, Intracutaneous, Guinea Pig Maximization Sensitization, and Systemic Toxicity Studies.
• Software verification and validation testing: Conducted according to FDA guidance for software and cybersecurity.
• Electrical safety and electromagnetic compatibility (EMC) testing: Complied with ANSI/AAMI ES 60601-1:2005/(R)2012, A1:2012, IEC 60601-2-18:2009, and IEC 60601-1-2:2014 standards.
• Performance testing - Bench: Included Thermal safety, Mechanical durability, Resolution, and Phototoxicity tests.
• Risk analysis: Conducted in accordance with ISO 14971:2007, with human factors validation according to FDA guidance.

The document indicates that design verification tests and their acceptance criteria were identified and performed as a result of the risk analysis assessment. However, the specific acceptance criteria for these bench tests (e.g., specific resolution values, durability cycles, temperature ranges) are not detailed in this summary. The general statement is that these tests "ensure that the subject device performs as intended and meet design specifications."

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