Search Results

The BF Type 240 Bronchovideoscopes have been designed to be used with an Olympus EVIS CV- 200 video system center, light source, documentation equipment, video monitor, Endo-Therapy accessories, electrocautery devices, electrosurgical unit, and other ancillary equipment for endoscopic diagnosis and treatment within the airways and tracheobronchial tree.

The BF Type 240 Bronchovideoscopes have been specifically designed to be used with the recommended electrocautery devices for endoscopic diagnosis and treatment within the airways and tracheobronchial tree.

Olympus offers three models: BF-240, BF-P240, and BF-1T240 of Bronchovideoscopes. They are specifically designed to be used in conjunction with the EVIS 200 Video System which was cleared in 510(k) # K931154 and recommended electrocautery devices.

All other characteristics such as optical, product specifications, material, intended use, and indications for use of the BF-240 Bronchovideoscopes remains unchanged except the modifications identified earlier in this section.

Olympus currently markets EVIS BF Type 200Bronchvideoscopes, its associated accessories and ancillary equipment, which were cleared for marketing in 510(k) # K931154. The BF Type 240 Bronchoviseoscopes are substantially equivalent to the BF Type 200 Bronchvideoscopes in design, specifications, materials, intended use, and method of use except the BF-240 allows the user to use the electrocautery devices such as electrosurgical snares and coagulation electrodes during the endoscopic procedure.

Acceptance Criteria and Study for Olympus BF Type 240 Bronchovideoscopes

This document describes the acceptance criteria and the study that demonstrates the Olympus BF Type 240 Bronchovideoscopes meet these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided summary does not contain information regarding a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective or prospective) for demonstrating the device's performance against clinical endpoints. The submission primarily focuses on substantial equivalence to a predicate device and compliance with safety standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This information is not provided in the submitted summary. The summary does not describe a study involving expert-established ground truth for clinical performance.

4. Adjudication Method for the Test Set

This information is not applicable/not provided as there is no mention of a clinical test set requiring adjudication in this summary.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

A Multi Reader Multi Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not mentioned in the provided summary. This device is an endoscope, not an AI-powered diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

A standalone performance study for an algorithm was not performed, nor is it applicable, as the device is a medical instrument (bronchovideoscope), not an algorithm or AI system.

7. The Type of Ground Truth Used

The primary "ground truth" used for this submission is the predicate device's established safety and effectiveness and the Voluntary Safety Standards IEC 601-1 and IEC 601-2-18. The submission asserts that the new device meets these safety standards and is substantially equivalent to the predicate, implying that the predicate's performance serves as a benchmark for the new device's expected function. There is no mention of a separate clinical ground truth (e.g., pathology, outcomes data) for the BF Type 240.

8. Sample Size for the Training Set

This information is not applicable/not provided. Bronchovideoscopes are medical devices, not AI models that require training sets.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not provided, as the device is not an AI model requiring a training set with established ground truth.

Ask a specific question about this device