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Tamper Evident Caps (Sterile) are indicated for use as a sterile tamper evident cap for IV syringes.

The International Medical Industries, Inc. Tamper Evident Cap consists of a polystyrene outer sleeve and bottom cover and a polypropylene tip cap held in place by a breakaway ring integrated into the sleeve. Evidence of access to the Luer lock cap is achieved by physically breaking the connection and removing the polystyrene outer sleeve exposing the Luer lock cap. Removal of the Luer Lock Cap is restricted by the presence of the sleeve. The restrictive sleeve and cap are available in multiple colors (cosmetic purposes only) in individual blister packs and trays of 10. The Luer Lock Caps are provided sterile to the end user. The sterilization method used is Ethylene Oxide.

The provided text is a 510(k) summary for a medical device called "Tamper Evident Cap." It details the device's characteristics and its comparison to a predicate device to establish substantial equivalence for FDA clearance.

**However, the document does not describe:

• An AI-powered device.
• Acceptance criteria related to AI performance metrics (e.g., sensitivity, specificity, AUC).
• A study that proves an AI device meets acceptance criteria.**

Instead, the document focuses on the physical and material properties of a non-AI medical device (Tamper Evident Cap) and its compliance with ISO 80369-7:2016 ("Small-bore connectors for liquids and gases in healthcare applications – Part 7 Connectors for intravascular or hypodermic applications") and ISO 80369-20:2015 ("Common test methods"), as well as biocompatibility testing standards.

Therefore, I cannot extract the information required by your prompt regarding AI device acceptance criteria and study details from the provided text. The questions about sample sizes for test and training sets, data provenance, expert panels, adjudication methods, MRMC studies, standalone performance, and ground truth types are not applicable to the non-AI device described in this 510(k) summary.

The only relevant information that can be extracted from the document regarding "acceptance criteria" and "study" is for the physical device:

Acceptance Criteria and Study for the Tamper Evident Cap (Non-AI Device)

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

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

• Sample Size: Not explicitly stated in the document, but standard medical device testing involves a sufficient number of samples to ensure statistical significance for the specific tests (e.g., multiple samples for each biocompatibility test, mechanical tests as per ISO standards).
• Data Provenance: The tests were conducted as part of the Design Control process, presumably by the manufacturer (International Medical Industries, Inc.) or contracted labs. The document does not specify country of origin for the data or if it was retrospective/prospective, but implies prospective testing for regulatory submission.

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 as this is a physical device being tested against established international standards (ISO, ASTM, USP). "Ground truth" in this context refers to the defined parameters and passing criteria of these standards, not expert interpretations of images or clinical outcomes.

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

• Not applicable. Testing is against objective, predefined criteria in established international 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 is a physical medical device, not an AI-powered diagnostic or assistive tool for human readers.

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

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

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

• The ground truth is based on the objective passing criteria defined by the relevant international standards (ISO 80369-7, ISO 80369-20, various ISO 10993 standards for biocompatibility, ASTM, USP) for mechanical performance and material safety.

8. The sample size for the training set:

• Not applicable. This is a physical device, not an AI model requiring a training set.

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

• Not applicable. This is a physical device.

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