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The Angel® Catheter is intended to provide the combined functions of an inferior vena cava (IVC) filter and a multilumen central venous catheter.

The Angel® Catheter is intended for short term use for the prevention of clinically significant pulmonary embolism (PE) in critically ill patients at high risk for PE or recognized contraindications to standard pharmacological thromboprophylaxis therapy.

The Angel® Catheter is also intended to provide access to the central venous system.

The Angel® Catheter is a retrievable vena cava filter permanently attached to a central venous access catheter. The conical, self-expanding, Nitinol filter has wide proximal openings that allow the capture of clots in the distal end of the filter. The filter is 50 mm long at its maximum expanded/unconstrained diameter of 30 mm. The distal end of the filter is free floating on the central venous catheter so that the filter can expand to the diameter of the vena cava.

The catheter is designed to constrain the IVC filter component in an unexpanded state for delivery to the IVC and to function as the sheath for retrieval of the IVC filter. It has '1 cm' depth markers indicating the depth the catheter has been inserted into the patient. For ease of placement, the catheter has a hydrophilic coating applied to the outer diameter up to the 24 cm depth marker.

The filter is permanently attached to the multi-lumen catheter to ensure secure positioning, while simultaneously providing access to the central venous system for administration of medications, fluids, or blood products; blood sampling; and monitoring of central venous pressure. The multi-lumen catheter and sheath connections are standard color-coded luer fittings, compatible with current ICU pressure monitoring equipment and other accessories. The Distal Tip Port and Proximal Sheath Port may be used for power injection of contrast media, and these luers contain specific pad printing indicating the maximum power injection rates.

The provided text describes the Angel® Catheter, a device integrating an inferior vena cava (IVC) filter and a multi-lumen central venous catheter. The document summarizes the performance data, including biocompatibility testing, bench testing, animal studies, and clinical studies, to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a structured table for all performance measures. However, it indicates that the device met "applicable design and performance requirements" and that "performance bench testing for the Angel® Catheter conformed to the product specifications and met the applicable acceptance criteria."

Based on the clinical study results, the primary effectiveness endpoint was:

For secondary safety endpoints, the document reports incidence rates:

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

The "test set" in this context refers to the subjects in the Pivotal Study.

• Sample Size: 163 eligible subjects (intention-to-treat (ITT) population). 151 subjects had the device in place for at least 48 hours (per-protocol (PP) population). The study had a goal of 150 evaluable subjects.
• Data Provenance: The document states "Multiple clinical studies were performed with the Angel® Catheter including a First in Man (FIM) Pilot Study, a European Post-Market Registry Study, an Early Feasibility Study under FDA's Early Feasibility Program (EFP), and a Pivotal Study." This indicates that the data comes from prospective clinical studies involving human subjects. The locations are not explicitly detailed as "country of origin" for the Pivotal Study, but mention of a "European Post-Market Registry Study" suggests international data, while the Early Feasibility Study under FDA's EFP points to US data.

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

The document mentions that the primary endpoint (freedom from clinically significant PE or fatal PE) was "determined by the CEC" (Clinical Events Committee). However, it does not specify:

• The exact number of experts on the CEC.
• The qualifications of those experts (e.g., "radiologist with 10 years of experience").

4. Adjudication method for the test set

The document mentions a "Clinical Events Committee (CEC)" determined the primary effectiveness endpoint. This implies an adjudication process was in place. However, the specific adjudication method (e.g., 2+1, 3+1, none) is not detailed.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on human readers improving with or without AI assistance was not described in this document. The device is a physical medical device (catheter with filter), not an AI-based diagnostic or assistive technology.

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

No, this question is not applicable. The Angel® Catheter is a physical medical device. It is not an algorithm, and the concept of "standalone" performance for an algorithm without human involvement does not apply here. The device's performance is inherently tied to its use by medical professionals.

7. The type of ground truth used

For the safety and effectiveness endpoints in the clinical study, the ground truth was established by clinical observation and assessment by a Clinical Events Committee (CEC). This involves diagnosis of conditions like PE, DVT, infections, and bleeding events based on clinical guidelines and diagnostic procedures. The document mentions "clinically significant PE or fatal PE... as determined by the CEC."

8. The sample size for the training set

The document does not mention a training set as this device is a physical medical device, not a machine learning model that typically requires a training set. The "training" of the device is through its design, manufacturing processes, and rigorous pre-clinical (biocompatibility, bench, animal studies) and clinical testing.

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

Not applicable, as there is no mention of a "training set" in the context of a machine learning model. For the pre-clinical studies, "ground truth" refers to the established scientific methods and accepted standards for biocompatibility, mechanical performance, and animal responses.

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