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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.
Celsite Discreet / Celsite Dual Venous / Celsite Brachial / Celsite Babyport / Celsite Babyport S Ports are recommended for use whenever patient therapy requires repeated I.V. Access for injection, drug therapy and/or blood sampling.

Device Description

The Celsite® Implantable Access Port Systems (Celsite port systems) are implantable port and catheter systems that allow safe, repeated access to the patient's bloodstream. The port chamber and catheter design can be used for the administration of medication and fluids. The Celsite system consists of an access port with a silicone septum, which is connected to a catheter using a connection ring. The triangular shaped access port has a low profile nose, finger stops on the side of the housing, and a round base. Celsite access ports have suture holes or suture zones to secure placement during implantation.
Celsite family infusion port product lines include: Celsite Discreet, and Celsite Concept. Celsite product lines are offered in 'standard' or 'small' sizes.

Celsite Access ports are manufactured with a low-profile design with titanium / polysulphone or titanium / epoxy materials. Catheters are available in either polyurethane or silicone materials. Some Celsite ports are available with pre-connected catheters.
Celsite Discreet ports are manufactured with a low-profile design with a left or right off-set exit cannula that permits a vertical incision and a 90 degree port/exit cannula. Celsite Discreet ports are manufactured with titanium / epoxy materials. Catheters are available in either polyurethane or silicone materials.
Celsite Concept ports are manufactured with a low-profile, light weight design and have three silicone suture areas, which provide the physician with flexibility in suturing. Celsite Concept ports are manufactured with titanium / polysulphone / silicone materials. Catheters are available in either polyurethane or silicone materials.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test/Evaluation	Acceptance Criteria	Reported Device Performance
Risk Assessment	No new potential risks were raised due to the new Winged Surecan needle versions.	"Results of risk assessment review showed no new potential risks were raised due to the new Winged Surecan needle versions."
Design Verification (New Winged Surecan Needle Versions)	`Met acceptance criteria.` (Implied: No specific quantitative criteria are listed, but the overall statement is that they met criteria)	"Design verification testing for the new needle versions, which included leakage, visual inspection, manual wing bending, strength test, check for exudation, detachment, and functional tests showed the test articles met acceptance criteria."
Biocompatibility Evaluation (New Winged Surecan Needle Versions)	`Biomaterial safety is supported.` (Implied: No specific criteria listed, but the conclusion is positive)	"Biocompatibility evaluations provide support for the biomaterial safety of the different material formulations used in the new Winged Surecan needle versions."
Overall Substantial Equivalence	No new questions of safety or effectiveness when compared to the currently marketed Celsite predicate system.	"The Celsite port systems with the new Winged Surecan needle accessories do not raise new questions of safety or effectiveness when compared to the currently marketed Celsite predicate system, and is, therefore, substantially equivalent."

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The evaluations mentioned are "design verification testing" and "biocompatibility evaluations," which typically involve laboratory or bench testing rather than clinical trials with human subjects.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not mention the use of experts to establish a "ground truth" for a test set in the context of human interpretation. The evaluations described are primarily engineering and material science tests.

4. Adjudication Method for the Test Set

Not applicable. The tests described are not subject to adjudication in the same way clinical image reviews or diagnoses would be. They are objective engineering and material tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. The study focuses on design verification and biocompatibility of device components for substantial equivalence, not on human reader performance with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is an implantable access port system, not an AI algorithm. Therefore, no standalone algorithm performance study was conducted.

7. The Type of Ground Truth Used

The "ground truth" for the tests appears to be defined by:

Engineering specifications and standards: For design verification tests like leakage, strength, etc.
Biocompatibility standards and accepted scientific principles: For biocompatibility evaluations.

These are objective measures and established scientific methods, rather than expert consensus, pathology, or outcomes data in the traditional sense of medical image analysis.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

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