(44 days)
GlideScope® BFlex™ Single-Use Bronchoscope System are intended to work with the video monitor, in conjunction with non-powered endoscopic accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree in adult patients.
The GlideScope® BFlex™ Single-Use Bronchoscope System consists of a single-use flexible bronchoscope (5.0), a reusable monitor, and a reusable cable. The system is intended to provide real time viewing and recording for a wide range of airway procedures. The GlideScope® BFlex™ Single-Use Bronchoscope System is distributed sterile and is for single use only. The BFlex bronchoscope operates with a portable reusable GlideScope video monitor (GVM) for purposes of image display.
Here's an analysis of the provided text regarding the GlideScope® BFlex™ Single-Use Bronchoscope System, focusing on the acceptance criteria and study information:
Acceptance Criteria and Device Performance
The provided document describes a 510(k) premarket notification for the GlideScope® BFlex™ Single-Use Bronchoscope System. For this type of submission, the primary method of demonstrating safety and effectiveness is through substantial equivalence to a legally marketed predicate device. This often means demonstrating that the new device has similar technological characteristics and performs comparably to the predicate device, meeting established design specifications and relevant standards.
The document does not provide a direct table of specific numerical acceptance criteria and reported device performance values in the way one might expect for a standalone diagnostic algorithm with metrics like sensitivity, specificity, or AUC. Instead, the "acceptance criteria" are implied by successful completion of various engineering and performance tests against established standards and design specifications. The "reported device performance" is a general statement that these tests were passed.
Here's an interpretation based on the provided text:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meets System Requirements | All System Requirements Testing passed |
| Meets Hardware Verification standards | All Hardware Verification passed |
| Meets Software Verification standards | All Software Verification passed |
| Complies with AAMI / ANSI ES60601-1 (medical electrical equipment safety) | Testing resulted in acceptance criteria passed |
| Complies with IEC 60601-2-18 (endoscopic equipment safety) | Testing resulted in acceptance criteria passed |
| Complies with ANSI AAMI IEC 60601-1-2 (EMC for medical equipment) | Testing resulted in acceptance criteria passed |
| Complies with ISO 8600-1 (general endoscope requirements) | Testing resulted in acceptance criteria passed |
| Complies with ISO 8600-3 (field of view/direction of view) | Testing resulted in acceptance criteria passed |
| Complies with ISO 8600-4 (max width of insertion portion) | Testing resulted in acceptance criteria passed |
| Complies with ANSI AAMI ISO 10993-1 (biological evaluation) | Testing resulted in acceptance criteria passed |
| Maintains performance over time (Aging Performance) | Testing resulted in acceptance criteria passed |
| Maintains sterile barrier (Sterile Packaging Integrity) | Testing resulted in acceptance criteria passed |
| Effective cleaning procedures (Cleaning Testing) | Testing resulted in acceptance criteria passed |
| Meets design specifications and intended use (Design Validation) | Testing resulted in acceptance criteria passed |
Study Details
Based on the provided text, here are the answers to your specific questions:
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A table of acceptance criteria and the reported device performance:
- As detailed above, the document implies passing various engineering and performance tests against recognized standards and internal design specifications. A direct table of numerical "acceptance criteria" for metrics like sensitivity/specificity for a diagnostic AI is not present because this is a hardware device (bronchoscope) and a 510(k) submission, not an AI/diagnostic software submission. The overall reported performance is that "All testing resulted in acceptance criteria passed."
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document does not specify a "test set" in the context of clinical data or AI model evaluation. The performance testing refers to engineering verification and validation testing of the hardware device, not evaluation against a clinical dataset with ground truth. Therefore, information on sample size, data provenance (country, retrospective/prospective) for a clinical test set is not applicable or provided.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This information is not applicable and not provided. The "ground truth" here is compliance with engineering standards and design specifications, which is typically assessed by engineers and quality assurance personnel, not clinical experts for diagnostic accuracy.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable and not provided. Adjudication methods are relevant for ambiguous clinical cases in a diagnostic study, which is not what this document describes.
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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, an MRMC comparative effectiveness study was not done. The document explicitly states: "The GlideScope® BFlex™ Single-Use Bronchoscope System, subject of this submission, did not require clinical studies to support the determination of substantial equivalence." This device is a bronchoscope, not an AI-powered diagnostic tool, so a study of human readers with/without AI assistance is outside the scope of this submission.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This question is not applicable. The device is a bronchoscope, a hardware medical device with an imaging component, not a standalone algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" in this context is the successful demonstration of compliance with established engineering standards, design specifications, and regulatory requirements (e.g., ISO, IEC, AAMI standards for medical devices, biological evaluation, electrical safety, etc.). It's not clinical ground truth like pathology or expert consensus.
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The sample size for the training set:
- This information is not applicable and not provided. This device is a hardware bronchoscope, not an AI algorithm that undergoes "training" on a dataset.
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How the ground truth for the training set was established:
- This information is not applicable and not provided for the same reasons as point 8.
§ 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.