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The Subcutaneous Infusion Set is designed specifically for the delivery of medication to the subcutaneous tissue

The subcutaneous needle infusion set consists of a sterile packaged kit including the infusion set and an adhesive dressing to hold the device in place. The unique Single, Bifurcated, Trifurcated, and Quadfurcated for the Sub-Q have a luer lock at one end and a 90 degree needle mounted to a butterfly stabilizer at the other end. The sets are convenient to use, associated with less trauma, and offer an opportunity to improve compliance cost-effectively through the use of a dedicated infusion set. The device is for single use only.

This 510(k) summary (K082818) for the Marcal Medical Subcutaneous Needle Infusion Set is very brief and primarily focuses on establishing substantial equivalence to predicate devices. It does not contain detailed information about specific acceptance criteria or a study proving the device meets those criteria, as would typically be found in a comprehensive clinical or performance study report.

The relevant section states:

"The Marcal Medical Subcutaneous Needle Infusion Set meets all established acceptance criteria for performance testing and design verification testing."

However, it does not list what those "established acceptance criteria" are or present any data from the "performance testing and design verification testing" themselves.

Therefore, I cannot fulfill all parts of your request with the provided text. Based on the information given, here's what can be extracted and what cannot:

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

This information is not provided in the document. The document only states that the device "meets all established acceptance criteria for performance testing and design verification testing" without specifying what those criteria or the actual performance results are.

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

This information is not provided in the document. No specific test set, its sample size, or data provenance (country, retrospective/prospective) is mentioned.

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)

This information is not provided in the document. This type of detail is typical for studies involving expert review for ground truth, which is not described here.

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

This information is not provided in the document. Adjudication methods are relevant when multiple experts are used to establish ground truth, which is not described.

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

There is no indication of a multi-reader multi-case (MRMC) comparative effectiveness study, nor is there any mention of AI assistance in the context of this device. This device is a physical medical device (infusion set), not a software or AI product.

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

There is no indication of a standalone algorithm performance study. This device is a physical medical device (infusion set), not an algorithm.

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

This information is not provided in the document. The document refers to "performance testing and design verification testing" but does not detail the methodology or what constituted "ground truth" for these tests, if applicable in the sense of clinical decision-making. For a physical device like an infusion set, "ground truth" might refer to engineering specifications or validated physical measurements rather than clinical diagnostic ground truth.

8. The sample size for the training set

This information is not provided in the document. The concept of a "training set" is typically associated with machine learning or AI models, which is not applicable to this physical medical device.

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

This information is not provided in the document. As with point 8, the concept of a "training set" for ground truth establishment is not relevant here.

Conclusion based on the provided text:

The provided 510(k) summary is extremely concise and focuses solely on stating that the device "meets all established acceptance criteria for performance testing and design verification testing" to demonstrate substantial equivalence. It does not disclose the specific acceptance criteria, the results of the performance testing, or any details about the methodologies used (e.g., sample sizes, expert involvement, ground truth establishment). For a physical medical device like an infusion set, performance testing typically involves engineering and bench testing (e.g., flow rate, tensile strength, sterility, biocompatibility) rather than clinical studies requiring expert consensus for ground truth or AI performance metrics. Such details would usually be found in the more comprehensive "performance data" or "test reports" section of the 510(k) submission, which is not included in this summary.

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