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The Vaxcel™ w/ PASV® Port device is intended for use in patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. The device is also indicated for blood specimen withdrawal.

The Vaxcel™ w/ PASV® Port device is intended for use in patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. The device is also indicated for blood specimen withdrawal. The device is available in standard and mini port configurations made of either Titanium or Polysulfone materials.

The provided text describes a Special 510(k) submission for the Vaxcel™ with PASV® Port implantable port system, indicating that the new device is substantially equivalent to a previously cleared predicate device.

Crucially, this document does NOT contain information about acceptance criteria or a study that proves the device meets those criteria in the traditional sense of a clinical performance study with specific metrics (e.g., sensitivity, specificity, accuracy) for a diagnostic or AI-powered device.

Instead, the submission focuses on substantial equivalence to a predicate device. This means the device's safety and effectiveness are established by demonstrating that it is as safe and effective as a legally marketed device that FDA has already cleared.

Therefore, for your request, I will explain why most of the fields are not applicable in this context and what "acceptance criteria" and "study" mean in the context of a 510(k) for an implantable port system.

Summary of Device Acceptance Criteria and Performance (in the context of Substantial Equivalence):

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

Regarding the specific questions about "study" details, most are not applicable for this type of 510(k) submission, which relies on substantial equivalence rather than a de novo clinical performance study for a diagnostic AI device.

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

• Not Applicable (N/A): This type of information is pertinent to a clinical performance study or an AI/diagnostic software validation. For an implantable port system seeking 510(k) clearance via substantial equivalence, the "test set" would primarily refer to data, testing, and comparisons made to demonstrate equivalence to the predicate device, not a patient cohort in a diagnostic AI study. The document mentions "All data gathered," but specifics on sample size for these comparative tests are not provided. Biocompatibility testing often uses standardized methods and laboratory samples, not human clinical test sets in this context.

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 (N/A): This is relevant for diagnostic accuracy studies, particularly in AI. Ground truth for an implantable medical device's safety and effectiveness in a 510(k) context is typically established through engineering tests, material science evaluations, biocompatibility assessments, and comparison to the predicate device's known performance, rather than expert consensus on diagnostic interpretations.

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

• Not Applicable (N/A): Adjudication methods are used in diagnostic studies (especially in AI) to resolve disagreements among multiple expert readers establishing ground truth. This is not relevant for the type of safety and effectiveness evaluation described in this 510(k) summary.

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 (N/A): This device is an implantable port system, not an AI or diagnostic tool designed to assist human readers. Therefore, an MRMC study and AI assistance effect size are irrelevant.

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

• Not Applicable (N/A): Again, this question applies to AI algorithms or diagnostic software, not to an implantable medical device like a port system.

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

• Not Applicable (N/A) in the diagnostic sense: The "ground truth" for this device's safety and effectiveness in the 510(k) context would be established by:
  • Biocompatibility testing per ISO 10993 standards: Demonstrating that the materials are safe for implantation.
  • Engineering and functional testing: Verifying the device performs its intended functions (e.g., maintain patency, permit fluid flow, withdraw blood).
  • Comparison to predicate device: Evidence that the new device performs equivalently to the already legally marketed predicate in terms of safety and effectiveness.
    The document emphasizes that "All data demonstrate this device is biocompatible for its intended use" and that "All data gathered demonstrate this device as substantially equivalent" to the predicate.

8. The sample size for the training set

• Not Applicable (N/A): This is a term used in machine learning and AI development. This document describes an implantable medical device, not an AI model.

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

• Not Applicable (N/A): As with the training set itself, the concept of establishing ground truth for a training set is specific to AI/machine learning, not a medical device seeking clearance via substantial equivalence for its physical properties and intended use.

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