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The Micro Catheter is a sterile, single-use, single lumen, variable stiffness, composite catheter. The Micro Catheter is available in three inner diameters (0.017″, 0.021″ and 0.027″), and two working lengths (150cm and 155cm). All models are designed with a straight tip, and are steam shapeable by the user. Single or dual radiopaque markers at the distal end facilitate fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic coating to increase lubricity. The proximal end of Micro Catheter incorporates a standard luer adapter to facilitate the attachment of accessories. The catheter body has a semi-rigid proximal end which transitions into the flexible distal end to facilitate the advancement of the catheter in the tortuous vasculature. The Micro Catheter is compatible with ≤ 0.014″ guidewires and 5F or larger guide catheters.

AI/ML Overview

The provided 510(k) clearance letter pertains to a Micro Catheter and describes its performance and testing to demonstrate substantial equivalence to a predicate device. This document does not discuss an AI/ML powered device, nor does it present data from a study involving human readers or the establishment of ground truth for AI model training or testing. Therefore, I cannot address most of your specific questions related to AI device evaluation.

However, I can extract the acceptance criteria and performance data for the Micro Catheter based on the provided text.

Acceptance Criteria and Device Performance for Micro Catheter

The document describes the testing performed on the Micro Catheter to demonstrate its substantial equivalence to a predicate device. The "acceptance criteria" are implied by the "Results" column in the tables, indicating whether the device met the required performance standards for each test.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The FDA 510(k) summary for a medical device like a micro catheter focuses on engineering and biocompatibility performance rather than AI-specific metrics. The "acceptance criteria" are implicitly met if the "Results" indicate compliance, comparability to a predicate, or "met the acceptance criteria."

Test (Category)	Specific Test Method Summary	Acceptance Criteria (Implied by Results)	Reported Device Performance
Bench Performance Testing
Dimensional Verification	Measured inner/outer diameter, effective length.	Met specified dimensions.	Micro Catheter and accessories met the acceptance criteria.
Radiopacity	Visualized under fluoroscopy.	Equivalent to predicate device.	Micro Catheter and the predicate device were imaged showing equivalence in terms of radiopacity.
Surface Inspection	Visual inspection under microscopy.	Met visual quality standards.	Micro Catheter met the acceptance criteria.
Corrosion Resistance	ISO 10555-1, Annex A.	No signs of corrosion.	Micro Catheter showed no signs of corrosion.
Peak Tensile Force/Bond Strength	Evaluated full system tensile force/bond strength.	Met minimum tensile strength requirement.	Micro Catheter met the acceptance criteria.
Liquid Leakage	ISO 10555-1, Annex C.	No leakage.	Micro Catheter showed no leakage.
Air Leakage	ISO 10555-1, Annex I.	No leakage.	Micro Catheter showed no leakage.
Hub Testing	ISO 80369-20.	Met hub standards.	Micro Catheter hub met the acceptance criteria.
Flowrate at Maximum Rated Infusion Pressure	Measured flow rate with saline, saline:contrast, contrast.	Met flow rate criteria; comparable to predicate.	Micro Catheter met the acceptance criteria. The mean flow rate values for the subject device and predicate device are comparable for the injectate media tested.
Dynamic Burst Pressure	ISO 10555-1, Annex G.	Met burst pressure criteria.	Micro Catheter met the acceptance criteria.
Static Burst Pressure	ISO 10555-1, Annex F.	Met burst pressure criteria.	Micro Catheter met the acceptance criteria.
Simulated Use	Evaluated in anatomical model for preparation, assembly, compatibility, trackability, lubricity, durability, kink resistance.	Met performance in simulated use.	Micro Catheter met the acceptance criteria.
Flexibility and Kink Test	Evaluated resistance to kinking in bends.	Met kink resistance criteria.	Micro Catheter met the acceptance criteria.
Torque Strength	Rotated in anatomical model with distal tip fixed; recorded rotations to failure.	Similar rotations to failure as cleared comparator.	Micro Catheter and a cleared comparator showed a similar number of rotations to failure.
Coating Integrity	Inspected pre- and post-simulated use.	Met coating integrity standards.	Micro Catheter met the acceptance criteria.
Coating Lubricity	Evaluated frictional forces on universal testing machine.	Similar frictional forces to predicate.	Micro Catheter and the predicate showed similar frictional forces.
Particulate Evaluation	Evaluated particulate generation during simulated use.	Similar particle numbers to predicate.	Micro Catheter and the predicate showed similar particle numbers.
Tip Stiffness	Distal tip deflected on universal testing machine.	Similar tip stiffness to cleared comparator.	Micro Catheter and a cleared comparator showed a similar tip stiffness.
Distal Tip Inspection	Inspected for defects.	Met defect criteria.	Distal tip met the acceptance criteria.
Tip Shapeability	Shaped using shaping mandrel.	Met shapeability criteria.	Distal tip met the acceptance criteria.
Lumen Collapse	Measured force to collapse catheter.	Similar forces to collapse catheter as predicate.	Micro Catheter and the predicate showed similar forces to collapse the catheter.
Compatibility tests	Inspected for damage post-simulated use with compatible interventional devices.	Met compatibility criteria.	Micro Catheter met the acceptance criteria.
Biocompatibility Testing
ISO MEM Elution Test	ISO 10993-5	Reactivity grade ≤2.	Non-cytotoxic (reactivity grade of ≤2).
ISO Guinea Pig Maximization Sensitization Test	ISO 10993-10	No evidence of delayed dermal contact sensitization.	Non-sensitizer.
Intracutaneous Reactivity Test in Rabbits	ISO 10993-23	Differences between test and control mean scores < 1.0.	Non-irritant.
Acute Systemic Toxicity Study in Mice	ISO 10993-11	No mortality or evidence of acute systemic toxicity.	No evidence of acute systemic toxicity.
Material-Mediated Pyrogenicity Test in Rabbits	ISO 10993-11	No temperature rise ≥0.5°C.	Non-pyrogenic.
ASTM Hemolysis Test	ISO 10993-4	Hemolytic index < 2%.	Non-hemolytic.
Complement Activation SC5b-9 Assay	ISO 10993-4	SC5b-9 concentration statistically lower than negative reference and comparator.	Not an activator.
Non-anticoagulated Venous Implant Study	ISO 10993-4	Extent of thrombus formation not greater than comparator.	Non-thrombogenic.
Sterilization & Shelf Life
Sterilization	Ethylene Oxide.	Sterility Assurance Level (SAL) of 10⁻⁶.	Verified SAL of 10⁻⁶ in accordance with ISO 11135.
Shelf-Life	Aging studies.	Demonstrated 2-year shelf life.	Demonstrated a 2-year shelf-life.
Packaging Aging Tests	N/A	All acceptance criteria met.	Results met all acceptance criteria.
Packaging
Sterile Barrier System (SBS) Validation	ISO 11607-2.	Met requirements.	SBS validation conducted per ISO 11607-2.

Based on the provided text, the following questions cannot be answered as they are relevant to AI/ML or image analysis devices, not the physical Micro Catheter:

Sample sizes used for the test set and the data provenance: Not applicable. Performance is based on physical bench and biocompatibility testing, not a "test set" of data for an AI model.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no "ground truth" establishment in the context of an AI model. Testing involves objective measurements and compliance with standards.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is a physical device, not an AI assistance tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" in this context is compliance with engineering standards and physiological responses (e.g., non-toxic, non-pyrogenic).
The sample size for the training set: Not applicable. There is no AI model or "training set."
How the ground truth for the training set was established: Not applicable.

This 510(k) clearance is for a conventional Class II medical device, and therefore the evaluation and acceptance criteria are based on established engineering, material science, and biological safety standards, not AI/ML performance metrics.

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