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The Clear-Tip EUS-FNA is used with an ultrasound endoscope for fine needle biopsy of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the gastrointestinal tract.

Clear-Tip EUS-FNA is used in conjunction with an ultrasound endoscope. It consists of a handle section and insertion. The handle section is connected to the endoscope's instrument channel port. The insertion is composed of the Catheter Tube, Needle, and Stylet. A Syringe is attached to the aspiration port on the handle section to aspirate that was punctured with the Needle. Syringe and Stopcock are accessories to provide and control the vacuum suction to aspirate the tissue specimen. They also can be used to expel the samples after the procedure. Clear-Tip EUS-FNA is offered in various needle gauges for insertion. The available needle gauge sizes of 19, 22 and 25 gauges. The Needle which is dimpled for ultrasonic visualization is advanced into the target site for aspiration. The device allows for adjustment of the Catheter Tube and Needle to enable the user to adjust for the working length of the endoscope and to control needle insertion depth. It is preloaded with a Stylet to aid in inserting the Needle which is removed for injection and aspiration. This device passes through the working channel of endoscope, and the average contact time with mucosa of the human digestive tract is less than 1 hour. This device is supplied sterile for single-patient use and shall be not reused or re-sterilized. This device is for Rx used only.

The provided text describes the 510(k) premarket notification for the "Clear-Tip EUS-FNA" device, focusing on its substantial equivalence to a predicate device. This type of regulatory submission primarily relies on comparing the new device's characteristics and performance to an already legally marketed device, rather than extensive clinical studies or acceptance criteria defined for a specific performance metric.

Therefore, the document does not contain information on acceptance criteria for a specific device performance metric (e.g., sensitivity, specificity for an AI algorithm) or a study proving the device meets such criteria.

The "acceptance criteria" mentioned in the document relate to non-clinical testing standards to demonstrate substantial equivalence, not to performance metrics like those for an AI algorithm. The study described is a non-clinical testing program to show that the device is as safe and effective as the predicate.

Here's a breakdown of the available information from the document with respect to your requested points:

Acceptance Criteria and Device Performance

Since this is a 510(k) submission for a physical medical device (biopsy needle) and not an AI/ML diagnostic tool, the "acceptance criteria" are not in the format of performance metrics like accuracy, sensitivity, or specificity. Instead, they are related to established international and FDA standards for medical device safety and functionality.

Study Details (Non-Clinical Testing for Substantial Equivalence)

The document describes a series of non-clinical tests to demonstrate substantial equivalence to the predicate device, not a study focused on a specific performance metric.

2. Sample size used for the test set and the data provenance: Not applicable in the context of an "AI test set." The "test set" here refers to physical samples of the Clear-Tip EUS-FNA device that underwent various laboratory tests (biocompatibility, mechanical properties, sterilization, etc.). The document does not specify the number of samples used for each test. The provenance is the manufacturer, FINEMEDIX CO., LTD., located in Republic of Korea. The testing is assumed to be prospective, laboratory-based testing of the manufactured device.

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 these non-clinical tests is established by adherence to recognized international standards (e.g., ISO, ASTM) and the results obtained from standardized laboratory procedures, not by expert consensus on clinical data.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods like 2+1 are typically used for clinical study endpoints, particularly when human readers are involved in disagreement resolution. These are laboratory tests against predefined standards.

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 physical biopsy needle, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical tests, the "ground truth" is adherence to the specified parameters and ranges defined by the international standards (e.g., ISO 10993 for biocompatibility, ASTM F1980 for shelf life, specific values for tensile strength, etc.).

8. The sample size for the training set: Not applicable. This is not an AI device that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

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