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These instruments have been designed to be used with an Olympus ultrasound endoscope for ultrasonically guided fine needle aspiration (FNA) of submucosal and extramural lesions within the gastrointestinal tract (i.e. pancreatic masses, mediastinal masses, perirectal masses and lymph nodes).

The Single Use Aspiration Needle NA U201H are single use aspiration needles to be used in conjunction with an Olympus ultrasound endoscope for ultrasonically guided fine needle aspiration (FNA) of submucosal and extramural lesions within the gastrointestinal tract (i.e. pancreatic masses, mediastinal masses, perirectal masses and lymph nodes).

The Single Use Aspiration Needle NA U201H consist of a handle section, needle section, and sheath section and needle sizes ranging from 19 to 25G will be available. The Single Use Aspiration Needle NA U201H are sterilized and packaged in a sterilization package. The Syringe (VACLOK Syringe and Stopcock), which is supplied by Merit Medical System and packaged in an individual sterilization package, is bundled. The Single Use Aspiration Needle NA U201H and the Syringe are put in one carton. When users use the device, the syringe is attached to the aspiration port on the handle section of the subject devices.

The provided document is a 510(k) summary for the Olympus Single Use Aspiration Needle NA-U201H. The key takeaway from this document is that no clinical studies or multi-reader multi-case (MRMC) comparative effectiveness studies were conducted involving human readers or AI. The submission relies on performance data from bench and animal testing to demonstrate substantial equivalence to a predicate device.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document mentions that "Risk analysis for the Single Use Aspiration Needle NA-U201H was conducted in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment." However, the specific quantitative acceptance criteria and detailed performance results for each test (e.g., insertion force, aspiration volume, etc.) are not explicitly provided in the summary. It only lists the categories of tests performed.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide details on sample sizes for the bench or animal testing. It also does not specify the provenance of any data (e.g., country of origin, retrospective or prospective), as the tests are described as internal performance evaluations.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as there were no clinical studies, and therefore no a ground truth established by medical experts for a test set. The performance evaluation was based on bench and animal testing, which would involve technical personnel.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as there were no clinical studies involving human interpretation or adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "This premarket notification does not rely on clinical study data to demonstrate substantial equivalence." Furthermore, this device is an aspiration needle and does not involve AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone performance study was not done, as this device is a physical medical instrument and does not involve an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the bench and animal testing, the "ground truth" would be defined by the measurement standards and specifications for each test (e.g., a specific force for insertion, a certain volume for aspiration, image quality metrics for visibility, etc.). There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this submission, as there were no clinical studies.

8. The sample size for the training set

This information is not applicable as there were no machine learning algorithms or AI components involved in this device, and thus no training set.

9. How the ground truth for the training set was established

This information is not applicable as there was no training set.

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