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The Diagnostic Catheter System is intended for use as a sampling device by performing mini-bronchoalveolar lavage in adult patients undergoing mechanical ventilation in order to obtain lower respiratory tract samples for laboratory testing and diagnosis.

The Diagnostic Catheter System is a device that consists of an improved nonbronchoscopic Bronchoalveolar Lavage (BAL) catheter to be used for the blind retrieval of lower respiratory tract secretions (also know as mini-BAL).

The provided document is a 510(k) summary for the Cardinal Health Diagnostic Catheter System. It describes the device's intended use and the summary of technological characteristics compared to predicate devices. However, this document does not contain information on acceptance criteria for device performance, nor does it detail a study that proves the device meets specific performance criteria.

The document states:

• "Performance testing demonstrated that the proposed device is substantially equivalent to the currently marketed devices with regard to functional characteristics."
• "All materials used in the fabrication of the Diagnostic Catheter System were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 'Biological Evaluation of Medical Devices'. These materials also were tested in accordance with industry recognized test methods and were found to be acceptable for the intended use."

This indicates that testing was performed to demonstrate substantial equivalence and material safety, but it does not provide:

1. A table of explicit acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds).
2. Reported device performance metrics against such criteria.
3. Details of a clinical or analytical study proving the device meets performance criteria beyond substantial equivalence to predicate devices.
4. Sample sizes for test sets or training sets.
5. Data provenance (country, retrospective/prospective).
6. Number or qualifications of experts for ground truth.
7. Adjudication methods.
8. MRMC comparative effectiveness study details.
9. Standalone performance details.
10. Type of ground truth_ used (expert consensus, pathology, outcomes data).
11. How ground truth for training data was established.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy or meeting specific performance criteria through extensive clinical trials as might be required for a PMA (Premarket Approval). The information provided is typical for a 510(k) submission, confirming design similarity, material compatibility, and functional equivalence but not specific performance metrics or detailed study results relevant to the requested questions.

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