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Drainage of persistent ascites from the abdominal cavity into the venous system, for use in patients with: *chronic liver disease whose ascites has not responded to surgical correction of their portal hypertension nor to standard medical management *persistent ascites who are not considered candidates for portal-venous shunting *persistent ascites which is non-responsive to standard medical management *primary or metastatic intra-abdominal neoplasms with massive ascites to help relieve intra-abdominal pressure *persistent ascites with hepatorenal syndrome, chylous ascites, and idiopathic ascites

The devices have the same intended use, materials, configuration and dimensional specifications as the currently marketed Denver® Ascites Shunts (K894756) and Denver® Ascites Shunt Percutaneous Access Kits (K913728). The devices differ in that: The devices covered by this submission undergo a surface 1) treatment as part of the manufacturing process. No TDMAC-Heparin is applied to the devices covered by this 2) submission.

The provided text describes a 510(k) premarket notification for the Denver® Ascites Shunts and Denver® Ascites Shunt Percutaneous Access Kits. This document focuses on demonstrating substantial equivalence to existing devices, not on proving device performance through a clinical study with acceptance criteria in the manner typically associated with new AI/software devices.

Therefore, many of the requested fields cannot be directly answered from the provided text as it describes a different type of regulatory submission. The submission is for a medical device (a shunt) and focuses on manufacturing process changes rather than a new diagnostic or therapeutic algorithm.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated in the context of a clinical performance study. The "acceptance criteria" here implicitly revolve around demonstrating substantial equivalence to previously cleared devices (K894756 and K913728) based on having the "same intended use, materials, configuration and dimensional specifications," with the only differences being "a surface treatment as part of the manufacturing process" and "No TDMAC-Heparin is applied."
• Reported Device Performance: Not reported in terms of specific clinical metrics (e.g., sensitivity, specificity, accuracy). The submission asserts that the "manufacturing process changes... should not raise new issues of safety and/or effectiveness."

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

• Not applicable. The document does not describe a performance study with a test set. It focuses on comparison to a predicate device and manufacturing process changes.

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 test set or ground truth establishment by experts is described in this regulatory submission.

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

• Not applicable.

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 device is a physical shunt, not an AI software.

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

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

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

• Not applicable. Since no clinical performance study is described, no ground truth is created or used in the context of algorithm evaluation.

8. The sample size for the training set

• Not applicable. No training set for an AI algorithm is mentioned.

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

• Not applicable. No training set or ground truth establishment for a training set is mentioned.

Summary of what the document actually states regarding "acceptance criteria" (implicitly substantial equivalence) and "proof":

The document argues for the substantial equivalence of the Denver® Ascites Shunts and Denver® Ascites Shunt Percutaneous Access Kits to previously cleared devices (K894756 and K913728) based on the following:

• Acceptance Criteria (implicit for 510(k) pathway): The new device must have the same intended use, materials, configuration, and dimensional specifications as the predicate devices, and any differences (in this case, a surface treatment and absence of TDMAC-Heparin) should not raise new issues of safety and/or effectiveness.
• Study/Justification for Meeting Criteria: The "study" here is essentially the detailed comparison presented in the submission.
  • Comparison Basis: The devices have the "same intended use, materials, configuration and dimensional specifications" as the Denver® Ascites Shunts (K894756) and Denver® Ascites Shunt Percutaneous Access Kits (K913728).
  • Differences:
    1. "The devices covered by this submission undergo a surface treatment as part of the manufacturing process."
    2. "No TDMAC-Heparin is applied to the devices covered by this submission."
  • Proof of Equivalence despite differences: The submitter states, "The manufacturing process changes that are the subject of this submission should not raise new issues of safety and/or effectivenenss." They further support this by stating the devices are "substantially equivalent to Smith & Nephew Ventilation Tubes in that they both undergo this surface treatment as part of the manufacturing process," implying a precedent for the safety of the surface treatment itself.

In essence, the "study" is a regulatory comparison and justification rather than a typical clinical performance trial with predefined endpoints and statistical analyses.

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