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Horizons ANSO Transbronchial Aspiration Needle is intended to be used in the flexible endescope for submucosal aspiration biopsy of the bronchial tree.

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The provided text is a 510(k) premarket notification letter from the FDA to Horizons International Corp. regarding their ANSO Transbronchial Aspiration Needle. This document determines substantial equivalence to a predicate device, allowing the manufacturer to market the device.

However, the provided document does not contain any information about acceptance criteria for the device's performance, nor does it describe any studies that prove the device meets such criteria.

The 510(k) process focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical trials to establish safety and effectiveness against specific performance criteria in the same way a PMA (Premarket Approval) would.

Therefore, I cannot provide the requested information from the provided text. The document does not include:

1. A table of acceptance criteria or reported device performance.
2. Sample sizes for test sets, data provenance, or study types (retrospective/prospective).
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. Information about MRMC comparative effectiveness studies or effect sizes.
6. Results of standalone algorithm performance studies.
7. The type of ground truth used.
8. Sample size for training sets.
9. How ground truth for training sets was established.

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