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The Valved Safety Centesis Catheter is indicated for the therapeutic aspiration of fluids from body cavities.

The Valved Safety Centesis Catheter is a drainage, centesis catheter with a self sealing valve and a passive safety needle-shielding feature. The catheter is designed with drainage holes located around the distal tip of the catheter to facilitate the drainage of fluid. The catheter surface and tapered end is designed for smooth transition through the tissue, while the inner surface is designed for easy retraction of the insertion needle. The insertion needle comes with a vent plug that allows air to exit and does not allow fluid to exit. The echogenic needle tip provides a guidance for proper catheter placement using ultrasound. The needle hub is clear and locks within the catheter hub. The catheter is radiopaque and can be visualized using fluoroscopy. The hub of the catheter contains a luer adapter to facilitate attachment of drainage collection devices and a bevel indicator for needle bevel orientation reference. The device is provided individually packaged sterile.

The provided text is a 510(k) summary for a medical device called the "Valved Safety Centesis Catheter." It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the information required to answer your specific questions related to acceptance criteria, a study proving performance against acceptance criteria, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, or MRMC studies.

This document focuses on demonstrating substantial equivalence through performance testing (functional and biocompatibility) and comparing technical characteristics to a predicate device, rather than a clinical study establishing performance against predefined acceptance criteria for AI or diagnostic purposes.

Here's why the requested information isn't present in this document:

• Device Type: This is a physical medical device (a catheter), not a software or AI-driven diagnostic tool. The questions you've asked (e.g., sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance) are typically relevant for AI/ML-driven diagnostic devices or software that provides interpretations.
• Regulatory Focus: The 510(k) process for this type of device primarily aims to show that the new device is "substantially equivalent" to a legally marketed predicate device, meaning it's as safe and effective. This is often achieved through bench testing (functional and biocompatibility) and comparing design features, not clinical trials requiring human reader analysis or complex ground truth establishment for diagnostic accuracy.
• Lack of AI/Diagnostic Component: There is no mention of any AI component, image analysis, or diagnostic output from this catheter that would necessitate the kind of rigorous validation against human expert performance or established ground truth that your questions imply.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a study proving device meets acceptance criteria, as the provided document does not contain this type of information for a device like the Valved Safety Centesis Catheter.

The document does mention "Performance Testing" which includes flow rate, tensile strength, pressure testing, and safety feature verification. These are functional performance criteria for a physical device, not diagnostic performance criteria.

To be absolutely clear, here's what the document does say about testing:

• Performance Testing Areas: Visual Inspection, Radio-detectability, Echogenicity, Flow rate, Occlusion, Tensile strength, Pressure testing, Penetration force, Safety feature verification.
• Biocompatibility Testing: Completed considering ISO 10993-1 recommendations.
• Clinical Testing: "No clinical testing was performed as this device does not require clinical studies to demonstrate substantial equivalence with the predicate device."

This explicitly states that no clinical studies were performed, which further confirms why information on human readers, ground truth establishment by experts, or MRMC studies would not be present.

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The paracentesis catheter is a device used for the therapeutic or diagnostic aspiration of fluid or air from the abdominal cavity.

The paracentesis "catheter over the needle" is comprised of a Radiopague Polyurethane Catheter over a needle with stopcock, self-sealing valve and 5 cc syringe attached.

This document is a 510(k) summary for a Paracentesis Catheter and does not contain detailed information about specific acceptance criteria or an efficacy study in the manner typically expected for AI/ML device submissions. Instead, it focuses on substantial equivalence to a predicate device and biocompatibility testing.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• The document does not describe an efficacy or performance study with a "test set" in the context of an AI/ML device.
• For biocompatibility, the "sample size" is implied to be of the materials used in the device. The provenance is internal to Allegiance Healthcare Corporation (manufacturer). The testing is described as "biological qualification safety tests," which are typically laboratory-based tests on material samples, not a clinical study on a patient population.

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

• This information is not applicable as there is no "test set" and "ground truth" establishment in the context of clinical interpretation by experts for this type of device submission. The evaluation focused on material safety and equivalence to an existing device.

4. Adjudication Method for the Test Set:

• Not applicable. There was no "test set" requiring adjudication by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, an MRMC study was not done. This submission is for a physical medical device (catheter) and not an AI/ML diagnostic or assistive device that would involve human readers interpreting cases.

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

• Not applicable. This is not an algorithm-based device.

7. The Type of Ground Truth Used:

• For biocompatibility: The "ground truth" was established by standardized laboratory tests and recognized safety criteria for cytotoxicity, sensitization, irritation, systemic toxicity, and hemocompatibility, as applied to the device materials.
• For substantial equivalence: The "ground truth" was the characteristics (intended use, performance attributes) of the predicate device (K870704).

8. The Sample Size for the Training Set:

• Not applicable. There is no "training set" in the context of AI/ML for this device.

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

• Not applicable. No training set was involved.

Summary of the Study that Proves the Device Meets the Acceptance Criteria:

The "study" or rather, the evidence provided to prove the device meets acceptance criteria, focuses on two main aspects:

1. Substantial Equivalence Demonstration: The manufacturer asserted that the proposed Paracentesis Catheter is substantially equivalent to a legally marketed predicate device (K870704, also owned by Allegiance Healthcare Corporation). This was "proved" by demonstrating that its intended use and performance attributes are the same as the predicate device. This is a foundational regulatory pathway for many medical devices.
2. Biocompatibility Testing: The materials used in the fabrication of the paracentesis device underwent a battery of biological qualification safety tests. These tests covered:
   • Cytotoxicity
   • Sensitization
   • Irritation or intracutaneous reactivity
   • Systemic toxicity (acute)
   • Hemocompatibility
     The document states that these materials met the testing requirements and were found to be acceptable for the intended use. This indicates internal lab testing against established biocompatibility standards.

In essence, the "study" for this 510(k) submission primarily consisted of a comparison to a predicate device and laboratory-based material safety testing, rather than a clinical performance study with human subjects, which is common for physical devices demonstrating substantial equivalence.

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