(29 days)
BFlex™ 2 Slim 3.8 Single-Use Bronchoscope is 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 BFlex™ 2 Slim 3.8 Single-Use Bronchoscope is a component to the BFlex™ Single-Use Bronchoscope System. The BFlex™ Single-Use Bronchoscope system consists of a single-use flexible bronchoscope, a reusable monitor, and a reusable cable. The BFlex™ 2 Single-Use Bronchoscope System provides real time viewing and recording for a wide range of airway procedures.
The provided document describes a medical device called the BFlex™ 2 Slim 3.8 Single-Use Bronchoscope and its substantial equivalence to predicate devices. The information primarily focuses on performance testing and usability studies rather than a comparative effectiveness study with AI assistance.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document states that "All testing resulted in acceptance criteria passed" for comprehensive verification and validation testing, but it does not provide specific numerical acceptance criteria or detailed performance metrics for each test. Instead, it lists the types of tests performed.
| Acceptance Criteria Category (Implied) | Reported Device Performance |
|---|---|
| Full System Requirements | Passed |
| Electrical Safety (IEC 60601-1, IEC 60601-2-18) | Passed |
| Electromagnetic Compatibility (IEC 60601-1-2) | Passed |
| Optical testing (ISO 8600-1, ISO 8600-3, ISO 8600-4) | Passed |
| Biocompatibility (ISO 10993-1) | Passed |
| Sterile Packaging Integrity | Passed |
| Cleaning | Passed |
| Design Validation (Usability Testing) | Excellent with 99.97% task success rate; no patterns of crucial use error or unacceptable negative use-safety assessments for pediatric claims |
2. Sample size used for the test set and the data provenance
- Test Set (Usability Study):
- Sample Size: Thirty (30) representative end users.
- Data Provenance: The document does not explicitly state the country of origin. It indicates the study was conducted as part of validation testing for the BFlex 2 family and employed methods used for a previously cleared device (K211947). The study was "simulated use scenarios," implying a prospective study design conducted in a controlled environment as opposed to real-world patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Thirty (30) users were involved in the usability study. These users served as the test subjects, and their performance/feedback established the "ground truth" for usability.
- Qualifications of Experts:
- Fifteen (15) pediatric anesthesiologists.
- Fifteen (15) adult intensivists or pulmonologists.
4. Adjudication method for the test set
The document does not describe an explicit adjudication method for the usability study in the sense of resolving disagreements between multiple experts on a specific interpretation. The "ground truth" for the usability study was derived from observed participant performance and subjective assessments, suggesting direct measurement or user-reported feedback rather than a consensus process among reviewers.
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
- MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted.
- AI Assistance: The device described (BFlex™ 2 Slim 3.8 Single-Use Bronchoscope) is a physical medical instrument (a bronchoscope). There is no mention of AI assistance or an AI component in its functionality or "human readers" in the context of diagnostic interpretation. Therefore, there's no information on effect size related to AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. The device is a physical bronchoscope, not an algorithm. Its performance is inherent to the instrument's design and functionality, not an algorithmic output that could be tested in a standalone manner.
7. The type of ground truth used
- For Performance Testing (General): The ground truth for functional performance was established by compliance with recognized international and national standards (e.g., IEC, ISO) and internal design specifications. The document states, "All testing resulted in acceptance criteria passed," implying these standards and specifications defined the "truth."
- For Usability Testing: The ground truth was based on observed participant performance and subjective assessments during simulated use scenarios. The "task success rate" and absence of "crucial use error or unacceptable negative use-safety assessments" formed the basis of this ground truth for usability.
8. The sample size for the training set
This document does not describe a training set as the device is a hardware product, not a machine learning algorithm.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set for a machine learning model.
§ 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.