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The Expect™ Slimline (SL) Needle is designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.

The Expect™ Slimline (SL) Endoscopic Ultrasound Aspiration Needle is an endoscopic ultrasound aspiration needle that can be coupled to the biopsy channel of a Curvilinear Array (CLA) Echoendoscope with a standard luer connection and delivered into the digestive tract. The needle is used to acquire aspiration samples from lesions within and adjacent to the digestive system's major lumens that can be identified and targeted using the echoendoscope. An aspiration sample is obtained by penetrating the lesion with the needle while applying suction.

This 510(k) summary describes a medical device called the Expect™ Slimline (SL) Endoscopic Ultrasound Aspiration Needle. This submission is for a modified version of an already cleared device, focusing on a new handle design. Therefore, the performance data provided relates to the mechanical and physical characteristics of this new design rather than clinical performance (e.g., diagnostic accuracy or clinical outcomes). The document explicitly states that "Bench Testing has been performed... which demonstrates that the modified handle design met the required specifications for completed design verification tests." This indicates that the acceptance criteria are based on engineering specifications and the study is bench testing.

Here's the information extracted from the provided text, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not explicitly stated. The document refers to "Bench Testing" but does not provide details on the number of units tested for each criterion.
• Data Provenance: The study was "Bench Testing" conducted by Boston Scientific Corporation. This is a controlled laboratory environment, not human or animal data.

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. The ground truth for this type of bench testing is based on engineering specifications and objective measurements (e.g., force, length, durability tests) rather than expert interpretation.

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

• Not applicable. This is bench testing against objective engineering specifications, not a subjective assessment requiring 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:

• Not applicable. This device is a mechanical medical instrument (an aspiration needle), and the study described is bench testing of its mechanical characteristics. It does not involve AI or human readers for diagnostic interpretation.

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

• Not applicable. This device is a mechanical medical instrument, not an algorithm.

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

• The ground truth for the bench testing was engineering specifications and objective measurements. The device's performance was compared against predetermined design requirements for its mechanical functions.

8. The sample size for the training set:

• Not applicable. This device is a mechanical medical instrument, not a machine learning model requiring a training set. The "design verification tests" are likely derived from historical data and industry standards, but there isn't a "training set" in the AI sense.

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

• Not applicable. As noted above, there is no training set in the context of this device and study. The "ground truth" for the acceptance criteria (required specifications) would have been established through device design processes, engineering standards, and potentially regulatory benchmarks for similar devices.

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