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The Nexus Injection Site ("NIS") is a needle-less device intended as an intravascular administration set accessory for the delivery of drugs and fluids. The NIS device may aid in the prevention of needle stick injuries.

The Nexus Injection Site ("NIS") is a needle-less device intended as an intravascular administration set accessory for the delivery of drugs and fluids.

Here's an analysis of the provided text regarding the Nexus Injection Site (K024363), focusing on the requested acceptance criteria and study information.

Based on the provided document, the information available is extremely limited, as it is a 510(k) clearance letter and an "Indications for Use Statement." These types of documents do not typically contain detailed study data, acceptance criteria, or performance metrics in the way a clinical trial report or a comprehensive FDA review summary might.

Therefore, I will state what can be inferred and explicitly mention what information is not present in the provided text.

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

Unfortunately, the provided document does not contain any specific acceptance criteria or reported device performance metrics. This document is a 510(k) clearance letter, which confirms substantial equivalence to a predicate device, and an "Indications for Use Statement." These documents do not detail performance specifications or clinical study outcomes.

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

The provided document does not mention any test set, sample sizes, or data provenance. A 510(k) relies on demonstrating substantial equivalence, and while testing data (e.g., bench testing, biocompatibility, sterilization validation) is part of a 510(k) submission, the summary provided here does not include these details.

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)

The provided document does not mention any ground truth establishment, experts, or their qualifications.

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

The provided document does not mention any adjudication method.

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

The provided document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. Furthermore, this device (Nexus Injection Site, an intravascular administration set accessory) is a physical medical device, not an AI/software device, so the concepts of "human readers improve with AI" are not applicable.

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

This question is not applicable. The Nexus Injection Site is a physical medical device, not an algorithm.

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

The provided document does not mention any type of ground truth.

8. The sample size for the training set

The provided document does not mention any training set or sample size. This device is a physical product, not a machine learning model, so the concept of a "training set" in this context is not applicable.

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

This question is not applicable, as there is no mention of a training set or ground truth in the context of this device.

Summary of Inferred Information from the Document:

• Device Type: Nexus Injection Site, classified as an Intravascular Administration Set (Product Code FPA).
• Regulatory Pathway: 510(k) premarket notification (K024363).
• Regulatory Class: Class II.
• Key Aspect of 510(k): The FDA determined the device is "substantially equivalent" to legally marketed predicate devices. This means that the device has the same intended use as a predicate device and the same technological characteristics as the predicate device, or if it has different technological characteristics, the information submitted to FDA does not raise new questions of safety and effectiveness AND demonstrates that the device is as safe and effective as the legally marketed device.
• Intended Use: As a needle-less device and an intravascular administration set accessory for the delivery of drugs and fluids, with the potential to aid in the prevention of needle stick injuries.

Conclusion:

The provided K024363 FDA clearance letter and Indications for Use statement contain regulatory information and the intended use of the device but do not offer any details regarding specific acceptance criteria, study methodologies, performance metrics, sample sizes, or ground truth establishment that would typically be found in a detailed study report. The substantial equivalence determination of a 510(k) is based on a comparison to predicate devices, and the detailed data supporting that comparison is not part of these public summary documents.

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