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B5-2C Balloon Catheter (Color of Branch - Blue) The B5-2C Balloon Catheter is designed to be used as an accessory to Olympus endoscopes with the minimum channel size of 2.0 mm.

B7-2C Balloon Catheter (Color of Branch - Yellow) The B7-2C Balloon Catheter is designed to be used as an accessory to Olympus endoscopes with the minimum channel size of 2.8 mm.

Indications for Use:

B5-2C/B7-2C Balloon Catheters (Two Models)

Olympus B5-2C/B7-2C Balloon Catheters are to be used for selective endoscopic bronchography, medicine injection to bronchi, saline injection associated with bronchoalveoler lavage, foreign body removal from bronchi, and bronchial hemostasis (tamponade).

The subject balloon catheters are designed to be used as an accessory to Olympus endoscopes. It is introduced to the desired anatomical site through the instrument channel of the endoscope.

The subject device is constructed of the inflatable balloon, catheter, bifucation, irrigation port, air feed cap, and stopcock. The B5 series balloon catheter is 5 French in diameter and designed to be used with minimum 2.0 mm channel endoscopes, while the B7 series balloon catheter is 7 French in diameter and should be used with minimum 2.8 mm channel size endoscopes. They are identified them by a color code. For example, B5 series have been identified with the blue color branch and B7 series catheters have the yellow color branch. The length of both catheters is 1050 mm.

The provided document is a 510(k) summary for the Olympus B5-2C/B7-2C Balloon Catheter. It outlines the device description, intended use, and a comparison to a predicate device for regulatory clearance. It does not contain information about acceptance criteria or a study proving that the device meets those criteria, as typically found in clinical validation studies for diagnostic or AI-powered devices.

The document states: "In conclusion, when compared with the predicate biliary balloon (K904669), the subject Olympus B5-2C/B7-2C Balloon Catheter does not incorporate any significant change in the design, specifications, or method of operation that could affect the safety or efficacy of the subject devices." This indicates that the regulatory clearance is based on substantial equivalence to a predicate device, rather than a de novo clinical validation study with specific acceptance criteria and performance metrics.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample size used, data provenance, number of experts, adjudication method, MRMC study details, standalone performance, type of ground truth, training set sample size, or how ground truth for the training set was established.

This document is concerned with the regulatory clearance of a medical device based on its similarity to an already approved device, not a performance study for a diagnostic algorithm or AI.

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