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The Allerhope® Allergy Skin Tester is for the percutaneous administration of diagnostic allergenic extracts.

Allerhope Allergy skin tester is a sterile, disposable, multiple test head applicator used to administer skin test substances. When used to apply allergenic extracts it provides a quick, convenient, and standardized procedure.

The provided document is a 510(k) premarket notification for the Allerhope® Allergy Skin Tester. It aims to demonstrate substantial equivalence to a predicate device, the Multi-Test II by Lincoln Diagnostics, Inc. However, this document does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the study proving the device meets these criteria.

Specifically, the document focuses on non-clinical testing for biocompatibility, sterility, and some performance aspects (flexural properties, Izod impact strength). It explicitly states that a "comparison test over allergenic extracts delivery function has been conducted," but it does not provide the acceptance criteria for this test, the detailed results, or the methodology (e.g., sample size, ground truth establishment, expert involvement, MRMC study details).

Therefore, I can only provide information based on what is available in the document.

Here's an attempt to answer your questions based on the provided text, with clear indications where the information is not available in the document:

Device: Allerhope® Allergy Skin Tester

Study Objective (as implied by 510(k)): To demonstrate substantial equivalence of the Allerhope® Allergy Skin Tester to the predicate device (Multi-Test II by Lincoln Diagnostics, Inc.) for the percutaneous administration of diagnostic allergenic extracts.

1. Table of acceptance criteria and reported device performance:

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

• Sample Size: Not explicitly stated for any of the performance tests, including the "allergenic extracts delivery function" comparison.
• Data Provenance: The tests were conducted to support a submission from a company in China (Zhengzhou, Henan, China). It is implied these were prospective tests performed specifically for this 510(k) submission.

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

• Not Applicable / Not Provided. The document describes non-clinical engineering and laboratory tests, not a clinical study involving human patients or expert interpretation of medical images/data to establish ground truth in the typical sense of an AI/human reader study. For the "allergenic extracts delivery function" test, the document does not specify who conducted the comparison or how the "can carry extracts" conclusion was reached in terms of expert involvement.

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

• Not Applicable / Not Provided. This type of adjudication is relevant for studies involving human interpretation (e.g., radiology reads). The tests described are laboratory performance tests.

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. This document describes a 510(k) submission for a physical medical device (allergy skin tester), not an AI-powered diagnostic device. Therefore, an MRMC study comparing human reader performance with and without AI assistance was not performed and is not relevant to this submission.

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

• Not Applicable. Again, this is not an AI algorithm. The performance tests would be akin to "standalone" performance of the device in a laboratory setting, but not in the context of an AI algorithm.

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

• For the biocompatibility and sterility tests, the "ground truth" is adherence to established international standards (ISO, USP).
• For the physical performance tests (Flexural Properties, Izod Impact Strength), the "ground truth" is adherence to specific ISO standards.
• For the "allergenic extracts delivery function" comparison, the ground truth is simply whether the subject device performs as well as the predicate device in carrying extracts. The methodology for determining this "truth" (e.g., a quantitative measurement, visual assessment, etc.) and the specific criteria are not detailed in the document.

8. The sample size for the training set:

• Not Applicable. This is not an AI device, so there is no training set in the machine learning sense.

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

• Not Applicable. As above, no training set for an AI model.

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