(57 days)
The Ion™ Endoluminal System (Model IF1000) assists the user in navigating a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures. The Ion™ Endoluminal System enables fiducial marker placement. It does not make a diagnosis and is not for pediatric use.
The Flexision™ Biopsy Needle is used with the Ion™ Endoluminal System to biopsy tissue from a target area in the lung.
The PlanPoint™ Software uses patient CT scans to create a 3D plan of the lung and navigation pathways for use with the Ion™ Endoluminal System.
The Ion™ Endoluminal System (Model IF1000) is a software-controlled, electromechanical system designed to assist qualified physicians to navigate a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures. It consists of a Planning Laptop with PlanPoint™ Software, a System Cart with System Software, a Controller, Instruments, and Accessories. The Model IF1000 Instruments include the Ion™ Fully Articulating Catheter, the Ion™ Peripheral Vision Probe, and the Flexision™ Biopsy Needles. Accessories such as the Catheter Guide, Vision Probe Adapter, Suction Adapter, Swivel Connector, and Vision Probe Bag facilitate use of the Model IF1000 Instruments.
The provided document is a 510(k) summary for the Ion™ Endoluminal System (specifically the Ion™ Fully Articulating Catheter and the Ion™ Peripheral Vision Probe). The submission primarily focuses on changes to the reprocessing methods for these devices, introducing an alternative automated cleaning process and reducing rinsing steps for the existing manual cleaning process. It does not describe a study involving an AI algorithm in the traditional sense of diagnostic or predictive performance.
Therefore, the requested information regarding acceptance criteria and study details for AI performance (such as sample size for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set information) is largely not applicable to this document. The "device" in this context refers to the physical medical instruments, and the "performance" being evaluated is related to their reprocessability and safety after cleaning, not an AI's analytical capabilities.
However, I can extract the acceptance criteria and performance data related to the reprocessing validation and biocompatibility aspects, as these are the core performance assessments presented in this 510(k) summary.
Acceptance Criteria and Device Performance (Related to Reprocessing and Biocompatibility)
The device in question is the Ion™ Endoluminal System (Ion™ Fully Articulating Catheter and Ion™ Peripheral Vision Probe). The study described relates to validating new reprocessing methods (automated cleaning and reduced manual rinsing steps) for these devices.
Due to the nature of this 510(k) submission, which focuses on device reprocessing validation, many of the typical AI-related study components (like expert ground truth, MRMC, training sets) are not present.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Reference Standard) | Reported Device Performance |
|---|---|---|
| Reprocessing Validation | Cleaning Efficacy: | Passed: All testing passed the predetermined acceptance criteria. |
| - In accordance with AAMI TIR12:2010 | ||
| - In accordance with AAMI TIR30:2011/(R)2016 | ||
| Biocompatibility | Acceptable TOC Levels: | Acceptable: Results analyzed in accordance with ISO 10993-1:2018 deemed to result in acceptable TOC levels, comparable to predicate devices. |
| - In accordance with ISO 10993-1:2018 | ||
| Usability Testing | Successful User Performance: | Successful: Intended users can successfully understand and perform intended reprocessing procedure safely and effectively. |
| - In accordance with FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices" (Feb 3, 2016) | ||
| - In accordance with IEC 62366-1:2015/Amd1:2020 |
2. Sample Size Used for the Test Set and Data Provenance
- Reprocessing Validation (Cleaning Efficacy): The document does not specify the exact "sample size" in terms of number of devices tested for cleaning efficacy. It states that "AER equipment were validated" and "Testing was performed on the Model IF1000 devices subjected to the automated cleaning process."
- Biocompatibility (TOC Testing): Similar to reprocessing, the exact number of devices tested for TOC is not specified, but it was performed "on the Model IF1000 devices."
- Usability Testing: The document does not specify the number of users or sessions in the human factors study.
- Data Provenance: The studies described are prospective validation studies conducted by the manufacturer for the specific purpose of this submission. The origin of "data" in terms of patient information is not relevant here as these are laboratory and human factors studies, not clinical trials on patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the "test set" in this context refers to devices undergoing reprocessing and human factors testing, not an AI algorithm being evaluated against expert-annotated medical image data. The "ground truth" for cleaning validation is objective laboratory measurement against standards, and for usability, it's successful task completion by trained users.
4. Adjudication Method for the Test Set
This information is not applicable for the reasons stated above. Adjudication methods like 2+1 or 3+1 typically apply to resolving discrepancies in expert labeling for AI ground truth, which is not relevant here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document does not describe the evaluation of an AI algorithm assisting human readers. It focuses on the reprocessing of physical instruments.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This submission does not pertain to an AI algorithm.
7. The type of ground truth used
- Reprocessing Validation: The ground truth for cleaning efficacy was established through objective laboratory measurements of residual soil levels (e.g., proteins, hemoglobin) against pre-defined limits, as guided by AAMI standards (TIR12, TIR30).
- Biocompatibility: The ground truth for biocompatibility was established through objective laboratory measurements of Total Organic Carbon (TOC) residuals, evaluated against acceptable limits defined by ISO 10993-1.
- Usability Testing: The ground truth was based on participants successfully and safely completing the specified reprocessing tasks as described in the updated instructions.
8. The Sample Size for the Training Set
This information is not applicable. This document does not describe an AI system, and therefore there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there is no AI training set discussed in this document.
§ 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.