(302 days)
The Single-use Bronchoscopes have been designed to be used with the Monitor for Single-Use Endoscopy, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree. The Bronchoscope System is for use in a hospital environment.
The Single-use Bronchoscope is a disposable device designed for use in adults.
The Bronchoscope System consists of Single-use Bronchoscope (Model: BC12-1, BC12-2, BC20-1, BC20-2, BC22-1, BC22-2, BC22-3, BC28-1, BC28-2, BC28-3) to be introduced within the airways or tracheobronchial tree and Monitor for Single-Use Endoscopy (Model: P1-A, P1-C, P1-C, P1-D, P1-E, P2-A, P2-B, P2-C, P2-D, P2-E) for clinical image processing. The Single-use Bronchoscope is inserted through the airways and tracheobronchial tree during Bronchoscopy. The Monitor provides power and processes the images for medical electronic endoscope.
The Single-use Bronchoscope is a sterile single use flexible bronchoscope. The Monitor for Single-Use Endoscopy is a reusable monitor.
The light emitted by the LED cold light source at the distal tip of the disposable video Bronchoscope is irradiated into the body cavity, and the light reflected from the cavity enters the optical system and is captured by the CMOS image sensor. The CMOS acquisition image is controlled by the CMOS drive circuit, and the RGB video signal is output to the Monitor for Single-Use Endoscopy via the VI circuit. The Monitor receives video signals from the endoscope, processes the video signals and outputs the processed video signal. The Monitor also controls the brightness of the LEDs on the endoscope.
The provided document is a 510(k) Premarket Notification and primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report for a novel AI/ML-driven medical device. Therefore, it does not contain the specific information required to answer many of the questions about acceptance criteria, detailed study design, ground truth establishment, or human-in-the-loop performance.
This document describes a "Bronchoscope System," which includes a "Single-use Bronchoscope" and a "Monitor for Single-Use Endoscopy." The core technology described involves an optical system with a CMOS sensor to capture images for display, which is a common technology for endoscopes, not necessarily an AI/ML device in the sense of image analysis/decision support.
Here's an attempt to answer the questions based only on the provided text, highlighting what is not available:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of acceptance criteria with reported quantitative performance metrics in the format usually seen for AI/ML device studies (e.g., sensitivity, specificity, AUC). Instead, it relies on demonstrating equivalence through various non-clinical tests compared to a predicate device.
The "Summary of Testing" section lists the types of tests performed. The acceptance criteria are implicitly that the device performs "as well as" the predicate or meets established ISO standards.
| Test Category | Acceptance Criteria (Implicit/Standard) | Reported Device Performance |
|---|---|---|
| Electrical Safety & EMC | Compliance with IEC 60601-1, IEC 60601-2-18 (safety), IEC 60601-1-2 (EMC) | "The system complies with the IEC 60601-1 and IEC60601-2-18 for safety and the IEC 60601-1-2 for EMC." |
| Optical Performance | Compliance with ISO 8600 series standards. Performance comparable to predicate device. | "Optical performance testing according to ISO 8600 series." "The optical performance of the subject device was tested and the results met the ISO 8600 series..." |
| Mechanical Characteristics | Comparable to predicate device. | "Mechanical characteristics were performed compared with the predicate device." "All the performance was tested and the results met the standard requirements..." |
| Color/Photobiological Safety | Standard requirements met. | "Color feature separation and photobiological safety test." |
| Image Quality (Color, Res, DoF, SNR, Dynamic) | Comparable to predicate device. | "Color performance (color reproduction), optical performance (resolution, depth of view and image intensity uniformity), SNR and dynamic test compared with the predicate device." |
| Biocompatibility | Compliance with FDA guidance "Use of International Standard ISO 10993-1." No cytotoxicity, irritation, sensitization, pyrogen. | "Biocompatibility... was evaluated in accordance with the FDA guidance...", "No Cytotoxicity", "No Irritation to Skin", "No significant evidence of sensitization", "No pyrogen." |
| Sterilization & Shelf Life | Validated per ISO11135. Shelf life validated. | "Sterilization method has been validated according to ISO11135...", "The shelf life... is validated." |
| Software V&V | Compliance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software deemed "moderate" level of concern. | "Software verification and validation testing were conducted, and documentation was provided as recommended..." |
| Cybersecurity | Compliance with FDA's "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions." | "Cybersecurity was conducted according to FDA's Guidance..." |
| Package Validation | Compliance with ISO 11607-1:2019, ISO 11607-2:2019, ASTM F88/F88M-15, ASTM F 1929-15, ASTM D4169-16. | "Package validation was conducted according to ISO 11607-1:2019 and ISO 11607-2:2019, and ASTM F88/F88M-15, ASTM F 1929-15. Transport and shipping testing as per ASTM D4169-16." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states: "Based on the similarities of the device specifications, intended use, indications for use between the Bronchoscope System and its predicate device, no clinical studies were needed to support this 510(k) Premarket Notification."
This means there was no clinical test set in the traditional sense for evaluating something like diagnostic accuracy of an AI/ML model. The evaluation was done through non-clinical bench testing, electrical safety, biocompatibility, and software V&V. Therefore, information on sample size, data provenance (country, retrospective/prospective) for a clinical test set is not applicable to this submission.
3. 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)
Since no clinical studies were performed, no expert ground truth establishment for a clinical test set was required or conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable as no clinical test set using expert adjudication was conducted.
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 applicable, as this is not an AI-assisted diagnostic device submission requiring MRMC studies. The device is a bronchoscope system for visualization.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to an AI algorithm's performance. The Bronchoscope System is a hardware device for direct visualization, not an AI algorithm. Therefore, "standalone performance" in the AI sense is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" was established by engineering specifications, validated test methods (e.g., ISO standards), and comparisons against the predicate device's established performance parameters. For example:
- Electrical Safety/EMC: Compliance to IEC standards.
- Optical Performance: Measurement against ISO 8600 series specifications.
- Biocompatibility: Results of standard biological tests (e.g., cytotoxicity, sensitization) against established safe thresholds.
8. The sample size for the training set
The document does not mention a "training set" because it is not an AI/ML device that requires machine learning training.
9. How the ground truth for the training set was established
Not applicable, as no training set for an AI/ML model was used.
§ 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.