(166 days)
The LumiRex Bronchoscope is a single-use flexible endoscope designed to be used with Contra Healthcare Solutions video processors, endotherapy accessories, and ancillary equipment for endoscopy and endoscopic procedures within the airways and the tracheobronchial tree in a hospital environment.
The LumiRex Single-Use Bronchoscope is a flexible video-based medical device designed for insertion through the mouth or nose into the trachea and bronchial tubes. It comprises a long, thin tube equipped with a light source and a camera to provide real-time visualization of the airways. The bronchoscope also features a working channel that allows for the passage of various instruments, such as biopsy forceps, brushes, and suction devices, facilitating endoscopic procedures. The device is available in different diameters to accommodate a range of patient anatomies and clinical needs.
The Bronchoscope can be used wired or wireless through a Wired Scope Adapter or Wireless Scope Adapter. The adapters transmit images from the bronchoscope to the Video Processor Unit where the user can view the image from the bronchoscope, control the LED, and save and export images from the bronchoscope onto USB removable media.
The provided text is a 510(k) clearance letter and a 510(k) Summary for the LumiRex Bronchoscope. While it details numerous non-clinical validation tests (sterilization, biocompatibility, software, cybersecurity, electrical safety, wireless latency, and various bench tests related to mechanical and optical performance), it does not include information about an AI component or a study proving device performance against acceptance criteria for an AI algorithm.
The document focuses on the equivalence of the LumiRex Bronchoscope as a physical medical device (endoscope with camera) to a predicate device. It describes its mechanical and optical functions, wireless capabilities, and basic image display. There is no mention of an algorithm or AI specifically designed to interpret or analyze images for diagnostic or assistive purposes, which would typically be the focus of the "acceptance criteria and study" described in your prompt.
Therefore, I cannot create the table or answer the specific questions related to an AI algorithm's acceptance criteria and performance study based on the provided text. The information simply isn't present in this 510(k) submission summary.
If this was a misunderstanding and you were expecting information about the bronchoscope's general performance acceptance criteria, I can provide a general interpretation based on the bench testing listed, but it would not involve the AI-specific details you requested.
For example, if we were to infer "acceptance criteria" from the bench testing section without an AI component, it would look something like this:
Inferred Acceptance Criteria for LumiRex Bronchoscope (Non-AI)
| Acceptance Criteria Category | Reported Device Performance (Summary from text) |
|---|---|
| Sterilization & Shelf-Life | Evaluated to ISO 11135:2014 (Sterilization), ISO 11607-2:2019 and ASTM F1980 (Sterile Barrier), and validated for shelf-life. |
| Reprocessing | Evaluated per FDA Guidance, AAMI TIR12:2020, AAMI/ANSI/ISO 11737-1:2018, ANSI/AAMI ST79:2017, ANSI/AAMI/ISO 17665-1:2006/(R)2013, AAMI ST98:2022. |
| Biocompatibility | Evaluated to ISO 10993-1 (FDA Guidance), covering Cytotoxicity (10993-5:2009), Sensitization (10993-10:2021), Systemic Toxicity (10993-11:2017), Pyrogenicity (10993-11:2017), Irritation (10993-23:2021). |
| Software | Verification and validation testing conducted in compliance with IEC 62304, ANSI/AAMI/IEC ES60601-1, and FDA guidance documents ("General Principles of Software Validation," "Premarket Submissions for Device Software Functions"). |
| Cybersecurity | Evaluated in conformance to "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions." |
| Electrical Safety & EMC | Undergone testing complying with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18. |
| Wireless Performance (Latency) | Latency tested referring to "Radio Frequency Wireless Technology in Medical Devices – Guidance for Industry and Food and Drug Administration Staff." Latency comparable between wired and wireless modes and within acceptance range. |
| Mechanical Connectivity | Bench tested to ISO 80369-7:2021 (Small-bore Connectors). |
| General Endoscope Requirements | Bench tested to ISO 8600-1:2015 (General Requirements). |
| Optical - Field & Direction of View | Bench tested to ISO 8600-3:2019. Comparative testing showed wider field of view and larger depth of view than predicate. Results met standard requirements and showed substantial equivalence. |
| Mechanical - Insertion Portion Width | Bench tested to ISO 8600-4:2014. |
| Photobiological Safety | Bench tested to IEC 62471:2006. |
| Camera Image Quality | Spatial Resolution MTF (ISO 12233), Signal to Noise Ratio (ISO 15739), Dynamic Range, Depth of Field, Geometric Distortion, Image Intensity Uniformity, Color Performance. Comparative testing showed results met standard requirements and demonstrated substantial equivalence to predicate. |
| System Functional Testing | Leaking, irrigation, bending, articulating bending angle, endurance of bending section, instrument and accessory compatibility, bending section radius. Performance characteristics met defined requirements. |
| Maneuverability (Bending Performance) | Tested per ISO 8600-1:2015. Met specified requirements. (Smaller insertion tube bend radius than predicate.) |
| Image Controls | Automated White balance, no image enhancement control. Simplifies UI, no new risks. |
| Video Format Compatibility | Different input/output formats from predicate, but VPU processes and displays similarly to predicate. No new risks. |
Regarding the other questions:
- Sample size for the test set and data provenance: Not applicable or not specified for an AI algorithm evaluation. The document discusses bench testing of physical characteristics, not a clinical test set of patient data for algorithm performance.
- Number of experts used to establish ground truth: Not applicable, as there's no AI component or clinical ground truth established for an algorithm.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not mentioned and not typically performed for a purely hardware device without an AI interpretive component.
- Standalone (algorithm only) performance: Not applicable, as no algorithm is described.
- Type of ground truth used: Not applicable, as no AI algorithm requiring ground truth is described.
- Sample size for training set: Not applicable.
- How ground truth for training set was established: Not applicable.
In summary, the provided 510(k) documentation focuses on the substantial equivalence of "LumiRex Bronchoscope" as a medical device to a predicate based on its mechanical, electrical, software validation (for device operation, not AI), and optical characteristics, but does not contain information related to artificial intelligence performance studies.
§ 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.