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A PORT-A-CATH® II Trans-Arterial Percutaneous System consists of a portal with a self-sealing silicone septum, accessible by percutaneous needle puncture, and single lumen catheter. The following accessories are provided with the portal and catheter: PORT-A-CATH® access needle, blunt needle, extra-thin wall introducer needle, dilator/sheath assembly, guidewire and syringe.

AI/ML Overview

The provided text describes a 510(k) submission for the PORT-A-CATH® II Trans-Arterial Percutaneous System. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than conducting new clinical trials with specific acceptance criteria as would be the case for novel devices.

Therefore, the requested information on acceptance criteria and a study proving those criteria are met for this specific device is largely not applicable in the traditional sense of a performance study. Instead, the submission argues that the device's similarity to existing, legally marketed devices implies its safety and effectiveness.

Here's how to address the request based on the provided text:

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

Since no specific performance acceptance criteria or direct performance data for the PORT-A-CATH® II Trans-Arterial Percutaneous System is reported for this 510(k), we can infer the "acceptance criteria" were related to demonstrating substantial equivalence.

Acceptance Criteria (Inferred for 510(k) Substantial Equivalence)	Reported Device Performance
Similarity in Materials	The PORT-A-CATH® II Trans-Arterial Percutaneous System uses Polysulfone/Titanium for the Portal, Silicone for the Septum, and Polyurethane for the Catheter, which are the same materials as the predicate PORT-A-CATH® II Low Profile™ System.
Similarity in Design	The submission states the device has "similarity in materials, design and function" to the predicate device. The dimensions (Height, Base, Septum Diameter for Portal; I.D., O.D., Length for Catheter) are identical or very similar to the predicate devices.
Similarity in Function	The submission states the device is "functionally the same as the PORT-A-CATH® II Low Profile™ Venous System."
Similarity in Intended Use (for relevant aspects)	The intended use ("A system is indicated when a patient requires prolonged or repeated intra-arterial infusion") is a variation of the predicate devices' broader "repeated vascular access for injection or infusion therapy and/or venous blood sampling."
Biocompatibility	Biocompatibility testing was conducted on the device, and the conclusion was that "the device materials were biocompatible," rendering the device "acceptable for human use."
No new safety/effectiveness concerns	The FDA's substantial equivalence determination implies that no new questions of safety or effectiveness were raised compared to the predicate devices.

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 for the test set: Not applicable. No clinical or functional performance test set was used for this device as part of the 510(k) submission. The submission relied on the established safety and effectiveness of the predicate devices and biocompatibility testing of the materials.
Data provenance: Not applicable.

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. No ground truth was established by experts for a test set for this device in this submission, as no new performance study was conducted.

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

Not applicable. No test set requiring adjudication was used.

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 medical device, not an AI-assisted diagnostic tool.

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

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

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

Not applicable for performance evaluation in this 510(k). The "ground truth" for the submission's approval was essentially the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not applicable. No training set was used for this device in this submission.

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

Not applicable. No training set was used.

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