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The Aspire Introducer Needle is intended to be used for guidewire introduction during percutaneous gastrointestinal procedures.

The Aspire Introducer Needle is a single use, sterile, non-pyrogenic, disposable product used to provide initial percutaneous access. It is comprised of a stainless steel needle with a plastic sheath to be used in guidewire placement during percutaneous endoscopic procedures. The needle is used once the stomach is insufflated and the site verified through trans-illumination and visualization of finger indentation through the endoscope. The introducer needle is similar in design to other needles currently on the market for the same intended purpose. The dimensions of this device fall within the range of currently marketed introducer needles with the same intended use, and the materials are similar in that the needle is made from stainless steel and the other components are plastics. The device also incorporates a female luer lock hub in the design, also provided in the predicate devices.

The Aspire Introducer Needle, a single-use, sterile, non-pyrogenic, disposable product, underwent testing to ensure its reliable design and performance. The device is intended for guidewire introduction during percutaneous gastrointestinal procedures.

Here's a breakdown of the acceptance criteria and the study information:

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

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

The document does not specify the exact sample size for each performance test (e.g., bond strength, biocompatibility). It generally states that "test articles" were used, implying a sample was taken for each test. The provenance of the data is from internal testing conducted by Aspire Bariatrics, Inc. and is likely prospective in nature as it is part of the premarket notification process for a new device.

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. The device is a physical medical instrument, and its performance is evaluated through engineering tests, sterilization validation, and biocompatibility testing, not through expert-established ground truth on a dataset. The "ground truth" here is the adherence to established engineering specifications and regulatory standards.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical study data where multiple experts interpret cases. For device performance testing, the results are typically objectively measured against predetermined acceptance criteria.

5. If a multi-reader multicase (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

This information is not applicable. The Aspire Introducer Needle is a physical medical device, not an AI-powered diagnostic or therapeutic tool that would involve human readers or AI assistance.

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

This information is not applicable. The device is a physical medical instrument and does not involve an algorithm.

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

The "ground truth" for the performance evaluation of this device is based on established engineering specifications, recognized industry standards (e.g., ISO 10993-1), and regulatory requirements for medical devices. This includes predefined strength limits for bond tests, successful sterilization, and documented biocompatibility.

8. The sample size for the training set

This information is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI.

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

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

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