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The FlowCardia MicroSheath LP a single lumen catheter, 123 cm in length, with a standard luer fitting at the proximal end. The catheter is available in two tip shapes, straight and angled. The distal tip is atraumatic to help facilitate vessel navigation. A single radiopaque marker on the straight version of the MicroSheath LP and five radiopaque markers on the angled version aid in fluoroscopic visualization. The MicroSheath LP is 6F Sheath/7Fr Guide compatible.

AI/ML Overview

The provided text describes a 510(k) summary for the FlowCardia MicroSheath LP Catheters, comparing it to a predicate device, the VP Sheath. The text focuses on establishing substantial equivalence rather than a clinical study with human readers or AI. Therefore, much of the requested information (e.g., sample sizes for training/test sets, expert qualifications, MRMC studies, human reader improvement with AI) is not applicable or cannot be extracted from this document.

Here's the information that can be extracted or deduced from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test Performed	Acceptance Criteria (Implied)	Reported Device Performance
Dimensional Verification	Met specifications (implied by "dimensional verification")	Performed similarly to predicate devices
Tensile Strength	Similar to predicate device	Performed similarly to predicate devices
Tip Flexibility	Similar to predicate device	Performed similarly to predicate devices
Access and Navigation Bench Modeling	Successful creation of a pathway for other devices (implied)	Performed similarly to predicate devices
Critical Bend Testing	Similar to predicate device	Performed similarly to predicate devices
Leak and Pressure Testing	Met safety/performance standards (implied)	Performed similarly to predicate devices
Torque Strength	Similar to predicate device	Performed similarly to predicate devices
Biocompatibility	Met relevant guidance documents	Testing conducted according to relevant guidance documents. Assumed to meet.
Materials	Equivalent to predicate device	Equivalent to predicate device
Manufacturing Methods	Equivalent to predicate device	Equivalent to predicate device
Sterilization	Equivalent to predicate device	Equivalent to predicate device
Catheter Stiffness	Substantially equivalent to predicate device	Substantially equivalent to predicate device

Note: The document primarily states that the device "met the acceptance criteria and performed similarly to the predicate devices" without explicitly listing numerical acceptance criteria for each test. The acceptance criteria are largely implied as being "similar to" or "equivalent to" the predicate device and meeting relevant guidance documents for safety and efficacy.

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

Sample Size for Test Set: Not applicable or not specified. The study involved bench testing and design analysis, not a clinical test set with patient data.
Data Provenance: Not applicable, as no human data or clinical study is described. The tests are physical and bench-based.

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

Number of Experts & Qualifications: Not applicable. The ground truth for engineering and material performance tests is established through objective measurements and accepted engineering standards, not expert consensus on interpretations.

4. Adjudication method for the test set

Adjudication method: Not applicable. There was no clinical test set requiring adjudication. The evaluation was based on objective physical and mechanical testing.

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 document describes the 510(k) clearance process for a physical medical device (catheter), not an AI-powered diagnostic or imaging device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

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

Standalone Study: No. This is not an algorithm or AI device.

7. The type of ground truth used

Ground Truth Type: For the physical tests, the "ground truth" would be the objective measurements of the device's physical properties (e.g., tensile strength in Newtons, precise dimensions, flexibility measurements) and their comparison to established engineering standards, regulatory requirements, and the characteristics of the predicate device. For biocompatibility, it would be compliance with biological safety standards.

8. The sample size for the training set

Training Set Sample Size: Not applicable. There is no AI or machine learning component described, so no training set was used.

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

Training Set Ground Truth: Not applicable, as there was no training set.

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