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This instrument has been designed to be used with an OLYMPUS compact i nici intrasound center, video system center, light source, documentation endoscopic uitraoound ochter, wtterrapy accessories and other ancillary equipment equipment, video mornior, Endo trony .
for endoscopic real time ultrasonic imaging, ultrasound guided needle aspiration and for ondoscopic rour and and within the airway and trancheobronchial tree and the gastrointestinal tract and surrounding organs.

The subject device has been designed to be used with the OLYMPUS EU-C60 EUS EXERA Compact Endoscopic ultrasound center, OLYMPUS video system center, light source, documentation equipment, display monitor, Endo-therapy accessories such as an aspiration biopsy needle.

The subject device is designed for endoscopic real-time ultrasonic imaging, for performing endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) within the airways and trancheobronchial tree and the gastrointestinal tract.

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a 510(k) summary for a medical device (EVIS EXERA Ultrasonic Bronchofibervideoscope OLYMPUS BF type UC160F-OL8 and OLYMPUS EU-C60 EUS EXERA Compact Endoscopic Ultrasound Center) seeking substantial equivalence to predicate devices.

Here's what the document does contain:

• Device Description: It describes the device, its intended use, design compliance with standards (IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-18, CISPR11), and materials (biocompatibility testing for a new patient-contacting material).
• Comparison to Predicate Devices: It states that the subject device operates identically to a predicate device (K010591) and is basically identical in its imaging capabilities to another (K021024, K033225), except for the addition of a CCD in the control section for video signals.
• Conclusion: It concludes that because there are no significant changes in intended use, method of operation, or design that could affect safety and effectiveness compared to predicate devices, clinical data is not necessary for evaluation of safety and efficacy.

Since clinical data was deemed "not necessary," there is no mention of:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, or expert ground truthing.
• Adjudication methods.
• MRMC comparative effectiveness studies.
• Standalone algorithm performance.
• Training set details.

The 510(k) process often relies on demonstrating substantial equivalence to a legally marketed predicate device rather than requiring new clinical studies to prove effectiveness, especially if the new device does not introduce significant changes in technological characteristics or indications for use.

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