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The Universa® Percutaneous Drainage Catheter Sets include introductory and exchange sets available with either a loop (6-14 Fr) or a Malecot catheter (8-24 Fr). Suprapubic sets are available with a Malecot catheter (8-16 Fr). Each set includes a drainage catheter and connecting tube, and may also include straightening stylets, trocar needle with obturator, hollow needle, wire guide, dilators, silicone retention disc with pull tie, or one-way stopcock. The devices will be supplied sterile and intended for one-time use.

AI/ML Overview

The provided text describes a 510(k) premarket notification for two medical devices: the Universa® Loop Drainage Catheter Set and the Universa® Malecot Drainage Catheter Set. It does not describe an AI/ML device or a study involving such a device. Therefore, many of the requested categories (such as sample sizes for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this document.

However, I can extract the information related to acceptance criteria and the studies performed for these physical medical devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test Performed	Predetermined Acceptance Criteria	Reported Device Performance
Mechanical Integrity	Tensile Strength Testing	Not explicitly stated but implied to ensure catheter materials/bonds do not fracture during proper clinical use.	The predetermined acceptance criteria were met.
Functional Retention	Loop and Malecot Retention Testing	Not explicitly stated but implied to ensure retention features resist dislodgement/removal.	The predetermined acceptance criterion was met.
Fluid Dynamics	Gravity Flow Rate, Lumen Blockage, and Leakage Testing	Not explicitly stated but implied to ensure consistent water flow without blockage or leakage.	The predetermined acceptance criteria were met.
Biocompatibility	Biocompatibility Testing	Conformance with ISO 10993-1.	The predetermined acceptance criteria were met.
Usability/Performance	Simulated Use Testing	Not explicitly stated but implied to ensure compatibility and performance according to instructions for use.	The results of the study are acceptable for clinical practice.

2. Sample size used for the test set and the data provenance

Sample size: Not specified in the provided document.
Data provenance: Not applicable. These are physical device tests, not data-driven studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of experts: Not applicable. Ground truth for these physical device tests is established through engineering and biological standards, not expert consensus on data interpretation.
Qualifications of experts: Not applicable.

4. Adjudication method for the test set

Adjudication method: Not applicable. Performance is measured against physical test standards.

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

MRMC study: No. This is not an AI/ML device.

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

Standalone study: No. This is not an AI/ML device.

7. The type of ground truth used

The "ground truth" for these physical device tests is based on:
- Engineering specifications and material properties (for tensile strength, flow rates).
- Functional design requirements (for retention).
- International standards (ISO 10993-1 for biocompatibility).
- Instructions for use for simulated clinical performance.

8. The sample size for the training set

Sample size: Not applicable. This is not an AI/ML device, so there is no training set in that context.

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

Ground truth establishment: Not applicable. No training set for an AI/ML context.

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