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Lyka® PORT needle free access device is intended for use as an accessory to a vascular access device (catheter) used in Hemodialysis or as an accessory to an I.V. Set for the administration or withdraw of fluids to a patient through a cannula or needle placed in the vein or artery. The device may be used for patient populations including very low birth-weight infants, children, and adults for up to 7 days.

Lyka® PORT is a needle free accessory to a vascular access device (catheter) used in Hemodialysis or as an accessory to an IV set. It consists of a housing made from Polycarbonate and a Stem made from Silicone Rubber. The materials used in Lyka® PORT meet the requirements of ISO 10993-1 and have a long history of acceptable use with blood, blood-related products. The device will permit access to a catheter without the used in a closed position, it has a flat, smooth surface. When the male connector of a syringe or secondary line is engaged into the device, the silicone stem opens in the middle creating a straight fluid path. When the male connector is removed from the device, its body forces the stem shut and maintains a sealed fluid path. A cap is not required to seal Lyka® PORT or to maintain sterility. The device will be sold as a sterile, single use for up to seven (7) days.

The provided text describes the Lyka® PORT Needle Free Access Device (4170Y) and its substantial equivalence to a predicate device. However, it does not contain the level of detail requested for acceptance criteria, device performance results, sample sizes, expert qualifications, or ground truth establishment relevant to AI/ML device studies.

The document is a 510(k) summary for a medical device that appears to be a physical product (a needle-free access device), not an Artificial Intelligence/Machine Learning (AI/ML) software device. The acceptance criteria and performance data discussed are typical for a hardware device, focusing on physical properties and biocompatibility, not diagnostic or predictive performance metrics.

Therefore, I cannot fulfill the request to provide information about the acceptance criteria and study proving an AI/ML device meets them. The provided text is not about an AI/ML device.

To directly answer the questions based on the provided text, while acknowledging its irrelevance to AI/ML:

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

   Acceptance Criterion	Reported Device Performance
   Intended Use	Needle-free access to vascular devices for fluid administration/withdrawal. Suitable for very low birth-weight infants, children, and adults for up to 7 days.
   Design and Functionality	Needle-free, swabable, luer-activated, minimizes dead space, ensures sterile access.
   Flow Rate (Subject Device)	Not greater than 600 ml/min.
   Microbial Ingress	Effective barrier for seven days.
   Surface Disinfection	Achieved with 70% isopropyl alcohol in 30 seconds.
   Biocompatibility (ISO 10993-1)	Materials meet ISO 10993-1 requirements.
   Sterilization	Sterilized with ethylene oxide (EO) and packaged in Tyvek pouches.
   Shelf Life	3 years (supported by real-time and accelerated aging studies).
   Priming Volume (Subject Device)	~ 0.1 mL.
   Maximum Pressure (Subject Device)	1550 mmHg (30 psi).
   Valve Mechanism	Silicone valve mechanism with manual flushing (guided by IFU).
   Hemolysis & Biocompatibility (Specific)	Complies with ISO 10993-1 and ASTM F756; non-hemolytic.
   Ethylene Oxide Residuals (ISO 10993-7)	Complies with ISO 10993-7:2008 & AMD1:2019.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   The document does not specify sample sizes for test sets for any of the performance criteria. Data provenance for testing is not mentioned. The studies appear to be bench testing (non-clinical) rather than clinical studies with human subjects.

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 and not provided. The testing described is against engineering specifications and international standards, not against expert human interpretations of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable and not provided.

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. The document explicitly states, "No clinical testing was conducted on this device." This is a physical device, not an AI/ML diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. There is no algorithm mentioned.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   The "ground truth" used for this device's evaluation consists of established engineering specifications, international standards (like ISO 10993-1, ISO 10993-7, ASTM F756), and functional requirements for medical devices of this type (e.g., flow rate, pressure tolerance, microbial ingress prevention).

8. The sample size for the training set:
   Not applicable. There is no AI/ML model, and therefore no training set.

9. How the ground truth for the training set was established:
   Not applicable.

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