(206 days)
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XP190
This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree.
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190
This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree.
This EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190, OLYMPUS BF-P190) is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. The bronchovideoscope (BF-XP190, BF-P190) is indicated for use within the airways and tracheobronchial tree.
The bronchovideoscope (BF-XP190, BF-P190) is a video scope used for endoscopic diagnosis and treatment within the respiratory organs and modification of the BF-XT190 which was previously cleared under K183419.
The endoscope consists of three parts: the control section, the insertion section, and the connector section. The basic principle including user interface and operation for the procedure of the endoscope is identical to that of the predicate device, BF-XT190.
This appears to be a 510(k) summary for a bronchoscope, not an AI/ML device. Therefore, the typical acceptance criteria and study designs associated with AI/ML performance (e.g., accuracy, sensitivity, specificity, human-in-the-loop studies, multi-reader multi-case studies, ground truth establishment for AI/ML) are not directly applicable.
The document describes the device as a traditional medical device (a bronchoscope) and demonstrates substantial equivalence to a predicate device based on conventional performance testing, rather than AI/ML performance.
Therefore, I cannot provide an answer based on the requested format because the input document does not contain information about an AI/ML device's acceptance criteria or performance studies in the context of diagnostic or classification tasks.
However, I can summarize the types of performance data that were provided for this traditional medical device:
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide a direct table of acceptance criteria vs. specific reported numerical performance values for this bronchoscope in a diagnostic sense. Instead, it states that various tests were "conducted to ensure that the subject devices were carried out to demonstrate their safety and effectiveness" and that the "design verification tests and their acceptance criteria were identified and performed as a result of this risk management." The conclusion is that the device "raise no new issue of safety and effectiveness and are substantially equivalent to the predicate device."
The performance data listed are qualitative in nature, focusing on compliance with standards and successful completion of tests:
| Acceptance Criteria Category | Reported Device Performance Summary |
|---|---|
| Reprocessing Validation | Reprocessing instruction and reprocessing method validation testing was conducted and documentation provided as recommended by FDA Guidance "Reprocessing Medical Devices in Health Care Setting." |
| Biocompatibility Testing | Conducted in accordance with ISO 10993-1, including Cytotoxicity, Intracutaneous Study, Guinea Pig Maximization Sensitization Test, and Systemic Toxicity Study. |
| Software V&V Testing | Conducted and documentation provided as recommended by FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices." |
| Electrical Safety & EMC | Conducted in accordance with ANSI/AAMI ES 60601-1:2005/(R)2012 and A1:2012, IEC 60601-2-18:2009 (electrical safety), and IEC 60601-1-2:2014 (EMC). |
| Bench Performance Testing | Thermal Safety Test, Mechanical Durability Test, Photobiological Safety Test were conducted. |
| Risk Management | Performed in accordance with ISO 14971:2007, and human factors validation conducted in accordance with FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices." Design verification tests and their acceptance criteria were identified and performed as a result of this. |
2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/ML device that uses a test set of data samples in the way an algorithm would. Performance testing involved physical device testing and compliance with standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic AI/ML algorithms is not relevant for this device. Its performance is evaluated through engineering and biological safety tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Not an AI/ML diagnostic or classification device.
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. This is a standalone medical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm is being evaluated in this context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to this type of traditional medical device submission. Ground truth, in the context of this device, refers to meeting established engineering and safety standards, not diagnostic truth.
8. The sample size for the training set: Not applicable. This is not an AI/ML device with a training set.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device with a training set.
§ 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.