(79 days)
Broncoflex Agile and Vortex: This video-bronchoscope is intended to provide an optical display of the pulmonary tract using a monitor (Screeni®) and to be used with endotherapy accessories and instruments. This video-bronchoscope is designed for use exclusively in a hospital environment.
Screeni: This device is designed for use exclusively in a hospital environment, in combination with an Axess Vision Broncoflex @ video-bronchoscope.
Broncoflex® Agile and Broncoflex Vortex are a single-use video-bronchoscope which is part of a system made up of the endoscope (Broncoflex) and its reusable display monitor (Screeni). The applied part of the medical device is the whole of the flexible tubing containing the insertion tube, the articulated section and the distal tip (BF type applied part: BF). Broncoflex is sterile and supplied ready to use in its sealed packaging (sterilization method ethylene oxide). The Screeni is a reusable non-sterile medical device and is a video processor with interface touch interface designed to display live imaging data captured by Broncoflex Agile and Broncoflex Vortex.
The provided text does not contain detailed acceptance criteria or a study that proves the device meets the acceptance criteria in the format requested. The document is a 510(k) summary for a medical device (Broncoflex Agile, Broncoflex Vortex, and Screeni) and primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical performance data.
Here's an breakdown of the available information and what is missing:
The document states:
- "The Flexible Bronchoscope System passed all the testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device"
- "Image quality comparison image quality was assessed same or better compared to predicate devices"
- "Cleaning of display monitor – met performance requirements"
- "Functionality tests (conditions in use) and climatic tests (transport and storage conditions) -. image present and number of deflections up/down specified during 5 defined cycles"
However, it does not provide:
- A table of specific acceptance criteria.
- Reported device performance against those specific criteria (beyond general statements like "met performance requirements" or "same or better").
- Details about the study design, such as sample sizes for test sets, data provenance, number or qualifications of experts, or adjudication methods for any image quality comparison.
- Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies, effect sizes with or without AI assistance, or standalone algorithm performance.
- The type of ground truth used (e.g., pathology, expert consensus, outcomes data) for any comparative studies.
- Sample size for training sets or how ground truth for training sets was established, as this device does not appear to employ AI as a primary component.
Therefore, I cannot fully answer your request based solely on the provided text, as much of the requested information is absent.
Based on the provided document, here's what can be extracted, though it's incomplete for your specific questions:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Inferred from testing) | Reported Device Performance Summary (from text) |
|---|---|
| Overall design requirements | Met requirements |
| Sterilization | Met requirements (Ethylene oxide process validated per ISO 11135:2014) |
| Biocompatibility | Passed testing per ISO 10993-1:2018 |
| Sterile packaging integrity | Validated per ISO 11607:2019 and ASTM F 1980:2016 Standards |
| Shelf life | Validated per ISO 11607:2019 and ASTM F 1980:2016 Standards |
| Transportation | Passed testing per ISTA 3A:2018 and ISTA 3E:2017 |
| Electromagnetic Compatibility (EMC) | Passed testing per IEC 60601-1-2:2014 (4th Ed.) |
| Electrical safety | Passed testing per IEC 60601-1:2012 and IEC 60601-2-18:2009 |
| Software verification and validation | Passed testing per IEC 62304:2006/A1 & FDA Guidance |
| Compliance to Endoscope Standards | Compliant to ISO 8600-1:2015, ISO 8600-3:2019 and ISO 8600-4:2014 |
| Photobiological safety | Compliant per IEC 62471:2006 |
| Compatibility with endotherapy accessories | Demonstrated passage of instrument through endoscope and vice-versa |
| Image quality | Assessed same or better compared to predicate devices |
| Cleaning of display monitor | Met performance requirements |
| Functionality (conditions in use) | Image present and specified deflections up/down during 5 cycles |
| Climatic tests (transport and storage) | Met requirements |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the document for any specific clinical or comparative performance test. The non-clinical tests (e.g., biocompatibility, electrical safety) would have their own sample sizes, but these are not detailed.
- Data Provenance: Not specified for any comparative or clinical data. The submitter is Axess Vision Technology, located in Joué-lès-Tours, France.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document mentions "Image quality comparison image quality was assessed same or better compared to predicate devices" but does not detail how this assessment was done, by whom, or with what ground truth.
4. Adjudication method for the test set:
- Not specified.
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:
- Not mentioned. This device system (flexible bronchoscope and display monitor) is not described as having an AI component that would necessitate such a study. The focus is on physical and performance characteristics, and equivalence to existing predicate devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not mentioned. Again, an AI algorithm is not a described component of this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not specified for any comparative performance claims. For non-clinical tests, the "ground truth" would be the specified requirements and standards.
8. The sample size for the training set:
- Not applicable, as an AI component is not described.
9. How the ground truth for the training set was established:
- Not applicable, as an AI component is not described.
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.