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The Aesculap Celsite®/Celsite® Concept™ Access Ports are indicated for intra-venous administration of drugs for chemotherapy, antibiotics and anti-viral drugs, and for parenteral nutrition, blood sampling or transfusions.

The Celsite®/ Celsite® Concept™ Access Ports are an implantable port and catheter system which allows safe, repeated access to the patient's bloodstream. The port chamber and catheter design can be used for the administration of medications and fluids.

The provided document is a 510(k) summary for the Celsite®/Celsite® Concept™ Access Ports. It describes the device, its intended use, and its substantial equivalence to previously marketed devices. However, it does not include information about specific acceptance criteria or a detailed study proving the device meets particular performance metrics beyond a general statement about biomechanical testing.

Therefore, many of the requested elements for describing acceptance criteria and a study cannot be extracted from this document.

Here's what can be inferred or stated based on the provided text:

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

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

• Sample Size: Not specified in the document. The document refers to "biomechanical testing results" but does not provide details on the number of devices or components tested.
• Data Provenance: Not specified in the document. It's likely that the testing was conducted by or for the manufacturer (Aesculap®, Inc.) based in the USA, but no explicit statement is given. The nature of the testing (e.g., in-vitro, ex-vivo, in-vivo) is also not detailed.

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 applicable to the type of device and study described. Biomechanical testing of medical devices typically relies on engineering and material science principles, not expert diagnostic interpretation to establish ground truth in the same way as, for example, an imaging AI study.

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

• This information is not applicable. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes, which is not the primary focus of the "biomechanical testing" mentioned for this device.

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, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done. This study type is irrelevant for an implantable access port and catheter system. The device is not an AI-assisted diagnostic tool.

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

• No, a standalone (algorithm-only) performance study was not done. This device is a physical medical device, not a software algorithm.

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

• The concept of "ground truth" as it applies to diagnostic or prognostic studies is not directly relevant here. For biomechanical testing, the "ground truth" would be established by standardized engineering measurements and established material properties, comparing the device's performance against predefined thresholds or established performance characteristics of the predicate devices. The document states that testing showed to be similar in performance to the previously cleared Aesculap® Access Ports. This implies that the predicate devices' performance serves as the "truth" for comparison.

8. The sample size for the training set

• This information is not applicable. The device is a physical medical device, not a machine learning model, so there is no "training set."

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

• This information is not applicable, as there is no training set for a physical medical device.

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