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510(k) Data Aggregation
(30 days)
GlideScope® BFlex™ Single-Use Bronchoscopes are intended to work with the video monitor, in conjunction with nonpowered endoscopic accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.
The GlideScope® BFlex™ 3.8 Single-Use Bronchoscope is one component of the GlideScope® BFlex™ Single-Use Bronchoscope System. The system consists of a single-use flexible bronchoscope, a reusable monitor, and a reusable cable. The GlideScope® BFlex™ Single-Use Bronchoscope System is intended to provide real time viewing and recording for a wide range of airway procedures. Similar to the predicate GlideScope® BFlex™ 5.0 and 5.8 Single-Use Bronchoscopes, the GlideScope® BFlex™ 3.8 Single-Use Bronchoscope is distributed sterile and is for single use only. The GlideScope® BFlex™ bronchoscopes operate with a portable reusable GlideScope video monitor (GVM or Core monitor) for purposes of image display.
The provided text is a 510(k) Summary for the GlideScope® BFlex™ 3.8 Single-Use Bronchoscope. This document focuses on demonstrating substantial equivalence to predicate devices and describes the results of performance testing.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The text states, "Results: All testing resulted in acceptance criteria passed." However, specific quantitative acceptance criteria or detailed device performance metrics are not explicitly provided in the summary. The "Technological Characteristic" table compares the proposed device to predicates, indicating "Same" or specific values for certain features, but these are characteristics, not performance metrics against acceptance criteria.
| Type of Testing / Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Full System Requirements Testing | Meets established requirements | Passed |
| Electrical Safety (AAMI/ANSI ES60601-1, IEC 60601-2-18) | Complies with standards | Passed |
| Electromagnetic Compatibility (ANSI AAMI IEC 60601-1-2) | Complies with standards | Passed |
| Optical testing (ISO 8600-1, ISO 8600-3, ISO 8600-4) | Complies with standards | Passed |
| Biocompatibility (ANSI AAMI ISO 10993-1) | Complies with standards | Passed |
| Aging Performance Testing | Meets established requirements | Passed |
| Sterile Packaging Integrity Testing | Meets established requirements | Passed |
| Cleaning Testing | Meets established requirements | Passed |
| Design Validation | Meets established requirements | Passed |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for the performance tests conducted. It details types of tests performed (e.g., electrical safety, optical testing) but not the number of units tested. The data provenance is not explicitly stated as country of origin, retrospective or prospective for these engineering and performance tests, but it is implied to be internal testing by the manufacturer (Verathon Medical (Canada) ULC).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. The performance testing described appears to be engineering and design verification/validation against established standards and internal specifications, rather than clinical studies requiring expert ground truth for a test set.
4. Adjudication Method for the Test Set
This information is not applicable and hence not provided. The testing described does not involve expert adjudication as it is not a clinical study or a study comparing interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No MRMC comparative effectiveness study was conducted or mentioned in the document. The device is a bronchoscope, not an AI-powered diagnostic tool for interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No standalone algorithm performance study was conducted or mentioned. The device is a physical medical instrument (bronchoscope), not an algorithm.
7. The Type of Ground Truth Used
For the engineering and performance testing described, the "ground truth" would be the acceptance criteria defined by the relevant international standards (e.g., ISO, AAMI, IEC) and the manufacturer's own design specifications. It is not expert consensus, pathology, or outcomes data in a clinical sense.
8. The Sample Size for the Training Set
No training set is mentioned or applicable, as this device is a physical bronchoscope, not an AI/machine learning system that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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