(14 days)
Indicated for use in aspiration in carinal, paratracheal and hilar lesions of the bronchial tree where biopsy forceps cannot obtain a submucosal sample.
The eXcelon™ Transbronchial Aspiration Needle is a needle catheter used for aspiration of tissue.
The provided document is a 510(k) Premarket Notification for a medical device, the eXcelon™ Transbronchial Aspiration Needle. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than conducting new clinical studies with defined acceptance criteria and detailed performance reporting.
Therefore, the document does not contain the information requested in several of your points. Specifically, it does not include:
- A table of acceptance criteria and reported device performance for clinical use.
- Details on sample size, data provenance, or ground truth establishment from clinical studies.
- Information on expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.
Here's a breakdown of what can be extracted from the document based on your request, and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria or reported device performance in the context of clinical outcomes or diagnostic accuracy. The submission is based on demonstrating substantial equivalence through:
- Comparison of Characteristics: "The modified device is substantially equivalent to the predicate device, as they have the same operating principal and intended use. In addition, the results of design control activities do not raise any new issues of safety or effectiveness."
- Performance Data: "FDA's "Guidance for the Content of Premarket Notifications", and the results of physical comparison and functional testing support a determination of substantial equivalence for the modified device when compared to the predicate device. The modified device is substantially equivalent to the currently marketed Boston Scientific Stifcor™ Transbronchial Aspiration Needle in terms of performance characteristics, biocompatibility, and intended use."
The "performance characteristics" mentioned here refer to bench testing and physical comparisons to ensure the new device functions similarly to the predicate, not clinical performance metrics.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This information would be relevant for a clinical study assessing a diagnostic or therapeutic outcome. The 510(k) focuses on a device (a needle) and its equivalence to a previously cleared device, not on diagnostic performance or clinical efficacy requiring a test set of patient data. The "functional testing" and "physical comparison" mentioned are likely bench or lab-based tests, not human studies.
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)
Not applicable. No clinical test set requiring expert ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set requiring adjudication is described.
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 device is a medical instrument (a needle), not an AI diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical instrument (a needle), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable for clinical ground truth. The "ground truth" for this 510(k) is essentially the established performance and safety profile of the predicate device (Boston Scientific Stifcor™ Transbronchial Aspiration Needle, K963252). The new device (eXcelon™) is compared against the predicate through physical comparison and functional testing to ensure it meets similar standards.
8. The sample size for the training set
Not applicable. No training set for a clinical algorithm or predictive model is described.
9. How the ground truth for the training set was established
Not applicable. No training set for a clinical algorithm or predictive model is described.
In summary:
This 510(k) clearance is for a medical device (a transbronchial aspiration needle) and relies on demonstrating substantial equivalence to an already legally marketed predicate device through engineering design control activities, physical comparison, and functional testing. It is not based on clinical studies involving patient cohorts, diagnostic accuracy assessments, or AI performance metrics, and therefore, the requested information related to such studies is not present 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.