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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. It can also be used for delivery of injectable materials (fluids) or fiducials into tissue or for passage of accessory devices.

The Expect™ Slimline (SL) Endoscopic Ultrasound Aspiration Needle is and 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 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. Per manufacturer's instructions, the Expect™ Slimline (SL) Endoscopic Ultrasound Aspiration Needle can also be used for delivery of injectable materials (fluids) or fiducials into tissue or for passage of accessory devices.

This looks like a 510(k) summary for a medical device (an aspiration needle), not an AI/ML algorithm. Therefore, many of the requested criteria related to AI/ML software validation (like MRMC studies, training/test set ground truth, expert adjudication, etc.) are not applicable and are not present in the provided text.

The document discusses substantial equivalence to a predicate device, focusing on "technological characteristics" and "performance data" that appear to be related to physical device performance rather than software performance.

Based on the provided text, here's what can be extracted:

• Device: Expect™ Slimline (SL) Endoscopic Ultrasound Aspiration Needle
• Purpose: To sample targeted submucosal and extramural gastrointestinal lesions through an echoendoscope, and for delivery of injectable materials (fluids) or fiducials, or passage of accessory devices.
• Key Change: The only change to the device is an increase in the allowable fiducial marker size that is compatible with the Expect Slimline 22ga Needle, from 0.35mm OD to 0.46mm OD. The physical device itself remains unchanged from its predicate.

Here's an attempt to answer your questions based only on the provided text, noting where information is not present or relevant to this type of device:

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

The document states that "additional performance testing was conducted to evaluate the ability of the device design to support the proposed change" (i.e., increased fiducial size). It also mentions "Bench Testing includes simulated use testing."

However, no specific acceptance criteria values or reported performance metrics (e.g., flow rates, force requirements, successful delivery rates, etc.) are detailed in the provided K173184 summary. The summary simply concludes that "Boston Scientific Corporation has demonstrated that the proposed Expect™ Slimline (SL) is substantially equivalent to the Expect™ Slimline (SL) Endoscopic Ultrasound Aspiration Needle (K163058)." This implies that the performance met the internal criteria used to establish substantial equivalence for the altered fiducial size, but the specifics are not disclosed in this summary.

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

• Sample Size: Not specified. The document only states "Bench testing has been performed on the proposed Expect™ Slimline (SL) device."
• Data Provenance: Not specified. "Bench testing" would typically be conducted in a lab setting, not on patient data from a specific country, and would be prospective in nature (designed and executed tests).

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

Not applicable. This is a physical medical device, not an AI/ML system requiring expert interpretation or ground truth establishment in the manner of medical imaging.

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

Not applicable. This is not a study involving human reader interpretation or clinical 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 is not an AI/ML device.

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

Not applicable. This is not an AI/ML algorithm.

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

Not applicable. For a physical device, "ground truth" would relate to its physical and functional performance specifications (e.g., successful passage of fiducials of a certain size, structural integrity, ability to aspirate, etc.), which would be verified by engineering tests and measurements, not clinical ground truth in the AI sense.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device.

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