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Single-Loop Snare Retrieval Kit and Triple-Loop Snare Retrieval Kit are intended for the percutaneous removal of retrievable inferior vena cava (IVC) filters that are no longer medically required, via jugular approach.

The Single-Loop Snare Retrieval Kit and Triple-Loop Snare Retrieval Kit are single use devices. The disposable system consists of: [A] 9F (ID) Inner Sheath, [B] 11F (ID) Outer Sheath, [C] 8F (OD) Dilator, [D] Hemostasis Valve with Sideport, [E] High Pressure Stopcock, [F] 7F [2.4mm] (OD) x 76cm Snare Catheter with Tuohy-Borst Y-Port Adapter, 20mm x 93cm Single-Loop Snare (fully expanded) or 30mm x 93cm Triple-Loop Snare (fully expanded) with Torque Handle. The snares have radiopaque loops and are preloaded in the snare catheter. The snare catheter, inner sheath, and outer sheath have a radiopaque marker band at the distal tip for enhanced fluoroscopic visualization.

The provided text describes a 510(k) premarket notification for a medical device, specifically retrieval kits for inferior vena cava (IVC) filters. The submission focuses on a modification to an existing device.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission for a modification to an existing device, the "acceptance criteria" are not explicitly stated as numerical targets in a table. Instead, the acceptance criteria are implicit in meeting the performance standards of the predicate device and ensuring the modification doesn't negatively impact safety or effectiveness. The reported device performance is that all tests met their respective acceptance criteria.

The document explicitly states: "Test results demonstrate that all acceptance criteria were met; therefore, the device meets the established product specifications."

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

The document does not specify the exact sample sizes used for each individual non-clinical test. It only lists the types of tests performed. The data provenance is not explicitly mentioned in terms of country of origin, but it is implied to be from the manufacturer's internal testing. The tests are non-clinical (bench testing, biocompatibility) rather than human subject studies, so the terms "retrospective or prospective" are not applicable in this context.

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

This information is not applicable to this submission. The tests performed are non-clinical (mechanical, materials, biocompatibility) and do not involve expert interpretation or ground truth establishment in the way clinical studies with AI algorithms would. The "ground truth" for these tests is based on objective measurements against established engineering and biocompatibility standards (e.g., ISO and ASTM standards).

4. Adjudication Method for the Test Set

This is not applicable as the tests are non-clinical and do not involve human interpretation or adjudication.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission is for a physical medical device (retrieval kit) with a material modification, not an AI-powered diagnostic or interpretive device. The document explicitly states: "Clinical testing was not required for the determination of substantial equivalence."

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

A standalone performance study was not done. This is not an AI device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical tests is based on:

• Engineering specifications and standards: For mechanical and dimensional tests (e.g., tensile strength, leak test, burst test, radiopacity, Luer testing, flexural modulus, radial force).
• Biocompatibility standards: For biocompatibility tests (e.g., ISO 10993 series for cytotoxicity, sensitization, irritation, pyrogenicity, systemic toxicity, hemocompatibility).
• Simulated use conditions: For tests like simulated use and design validation.

8. The Sample Size for the Training Set

This is not applicable as this is not an AI device and therefore has no "training set."

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

This is not applicable as this is not an AI device and therefore has no "training set" or associated ground truth establishment process.

Ask a specific question about this device

Single-Loop Snare Retrieval Kit and Triple-Loop Snare Retrieval Kit are intended for the percutaneous removal of retrievable inferior vena cava (IVC) filters that are no longer medically required, via jugular approach.

The Single-Loop Snare Retrieval Kit and Triple-Loop Snare Retrieval Kit consist of a 9F inner sheath, 11F outer sheath, 8F dilator, hemostasis valve with sideport, high pressure stop-cock, 20mm single-loop snare (fully expanded) or 30mm triple-loop snare (fully expanded), 7F snare catheter, Tuohy-Borst Y-port adapter, and torque handle. The snares have radiopaque loops and are preloaded in the snare catheter. The snare catheter, inner sheath, and outer sheath have a radiopaque marker band at the distal tip for enhanced fluoroscopic visualization. This product does not contain natural rubber latex. The maximum recommended infusion rate is 15mL/sec for power injection of contrast.

The provided text describes the 510(k) premarket notification for the "Single-Loop Snare Retrieval Kit" and "Triple-Loop Snare Retrieval Kit." This document focuses on demonstrating substantial equivalence to predicate devices for these medical devices, which are physical instruments used for retrieving IVC filters.

The information requested in the prompt (acceptance criteria and study details for an AI/software device) is not present in the provided text. The document details non-clinical performance tests for the physical retrieval kits, such as tensile strength, liquid leakage, and biocompatibility, but it does not describe any AI system, its performance metrics, or clinical studies involving human readers or ground truth establishment relevant to an AI/software product.

Therefore, I cannot provide the requested information based on the given input. The document is about physical medical devices, not AI/software.

Ask a specific question about this device