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The InNeuroCo Zenith product consists of a catheter, a hemostasis valve, two split sheath introducers, and a Scout introducer. The Zenith catheter is a single lumen, variable stiffness catheter that has an outer polymer shaft and is reinforced with a Stainless Steel cross coil. The Zenith catheter has a radiopaque Platinum/lridium marker band on the distal end. The Zenith product line is available in two internal diameters: 0.065 inches and 0.074 inches. The 0.065 catheter has a tapered design and is 0.079 inches outer diameter in the distal end and a 0.081 inches outer diameter in the proximal end. The 0.074 catheter has a nominal outer diameter of 0.086 inches. There are three working lengths available: 115 cm, 125 cm, and 132 cm in either diameter. The Zenith catheter has a PTFE-lined lumen throughout the catheter shaft. The catheter is flexible and has a hydrophilic coating. The Zenith catheter is inserted through a quide catheter or vascular sheath, provides access to the target site, and once in place, provides a reinforcing conduit for other intravascular devices. Accessories included with the device are a Tuohy-Borst hemostasis valve with an extension luer and two split sheath introducers. There is another introducer, named Scout, which provides support to the Zenith catheter while tracking to target site. The Zenith product line is supplied sterile, nonpyrogenic, and intended for single use only.

AI/ML Overview

The provided text describes the regulatory clearance (510(k)) of a medical device, the "Zenith" percutaneous catheter, and a summary of non-clinical data supporting its substantial equivalence to predicate devices. The document does not describe an AI/ML-enabled device or a study involving human readers or comparative effectiveness with AI. Therefore, several aspects of your request (e.g., sample sizes for test set/training set, number of experts, adjudication method, MRMC study, standalone performance, provenance of data) are not applicable to this document.

However, I can extract the acceptance criteria and study conclusions for the non-clinical performance and biocompatibility tests described.

Here's the information derived from the document, focusing on the available details:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance (Conclusion)
Biocompatibility - Material Mediated Pyrogen	The test article extracts must not cause a febrile reaction greater than 0.5°C in any individual subject.	Zenith test samples met the acceptance criteria for Material Mediated Pyrogen to demonstrate that the Zenith is substantially equivalent to the predicate device.
Biocompatibility - Cytotoxicity MEM Elution	The cultures treated with the test article must not have a reactivity grade greater than 2.	Zenith test samples met the acceptance criteria for Cytotoxicity MEM Elution to demonstrate that the Zenith is substantially equivalent to the predicate device.
Biocompatibility - Hemolysis ASTM Method, extract human blood	The hemolytic index above the negative control article must be less than 5%.	Zenith test samples met the acceptance criteria for Hemolysis ASTM Method, extract human blood to demonstrate that the Zenith is substantially equivalent to the predicate device.
Biocompatibility - Hemolysis, ASTM method, direct contact (human blood)	The hemolytic index above the negative control article must be less than 5%.	Zenith test samples met the acceptance criteria for Hemolysis, ASTM method, direct contact (human blood) to demonstrate that the Zenith is substantially equivalent to the predicate device.
Biocompatibility - Unactivated Partial Thromboplastin Time	There must be no statistical decrease between the UPTT of plasma exposed to the test article and to the negative or untreated control.	Zenith test samples met the acceptance criteria for Unactivated Partial Thromboplastin Time to demonstrate that the Zenith is substantially equivalent to the predicate device.
Biocompatibility - Complement Activation	There must be no statistical increase between either the C3a or SC5b-9 concentrations in plasma exposed to the test article as compared to the negative and untreated controls.	Zenith test samples met the acceptance criteria for Complement Activation to demonstrate that the Zenith is substantially equivalent to the predicate device.
Biocompatibility - Dog Thromboresistance	The test articles must receive a thrombus formation score less than or equal to that of the control.	Zenith test samples met the acceptance criteria for Dog Thromboresistance to demonstrate that the Zenith is substantially equivalent to the predicate device.
Biocompatibility - Maximization Sensitization	The test article must elicit a positive response in less than 10% of the test animals.	Zenith test samples met the acceptance criteria for Maximization Sensitization to demonstrate that the Zenith is substantially equivalent to the predicate device.
Biocompatibility - Intracutaneous Toxicity/Reactivity	The test article extracts must not induce a significantly greater biological reaction than the control.	Zenith test samples met the acceptance criteria for Intracutaneous Toxicity/Reactivity to demonstrate that the Zenith is substantially equivalent to the predicate device.
Biocompatibility - Acute Systemic Toxicity Test	The test article extracts must not induce a significantly greater biological reaction than the control.	Zenith test samples met the acceptance criteria for Acute Systemic Toxicity Test to demonstrate that the Zenith is substantially equivalent to the predicate device.
Animal Testing - Angiographic Evaluation	No units tested can cause vessel injury.	Zenith test samples met the acceptance criteria for Animal Testing- Angiographic Evaluation to demonstrate that the Zenith is substantially equivalent to the predicate device.
Chemical Compatibility	Chemicals have no negative effect on the catheter or accessories.	Zenith test samples met the acceptance criteria for Chemical Compatibility to demonstrate that the Zenith is substantially equivalent to the predicate device.
Radiographic Detectability	Product shall be visible under fluoro imaging.	Zenith test samples met the acceptance criteria for Radiographic Detectability to demonstrate that the Zenith is substantially equivalent to the predicate device.
Visual Inspection	Catheter shall appear free from damage, including a rounded tip and smooth transition points.	Zenith test samples met the acceptance criteria for Visual Inspection to demonstrate that the Zenith is substantially equivalent to the predicate device.
Working Length	Test samples should be within existing working length specification.	Zenith test samples met the acceptance criteria for Working Length to demonstrate that the Zenith is substantially equivalent to the predicate device.
Hub compatibility	Hub shall meet existing Luer specifications.	Zenith test samples met the acceptance criteria for Hub compatibility to demonstrate that the Zenith is substantially equivalent to the predicate device.
Outside diameter	Test samples should be within existing outside diameter specification.	Zenith test samples met the acceptance criteria for Outside diameter to demonstrate that the Zenith is substantially equivalent to the predicate device.
Leak – Air	Test samples should be within existing Air – Leak specifications.	Zenith test samples met the acceptance criteria for Leak – Air to demonstrate that the Zenith is substantially equivalent to the predicate device.
Leak – Liquid	Test samples should be within existing Leak – Liquid specifications.	Zenith test samples met the acceptance criteria for Leak – Liquid to demonstrate that the Zenith is substantially equivalent to the predicate device.
Particulates	Test samples should be within existing Particulate specifications.	Zenith test samples met the acceptance criteria for Particulates to demonstrate that the Zenith is substantially equivalent to the predicate device.
Simulated Use - Bench	Test samples must meet predetermined user needs.	Zenith test samples met the acceptance criteria for Simulated Use - Bench to demonstrate that the Zenith is substantially equivalent to the predicate device.
Catheter Burst	Test sample burst pressures must meet or exceed existing minimum burst pressure specification.	Zenith test samples met the acceptance criteria for Catheter Burst to demonstrate that the Zenith is substantially equivalent to the predicate device.
Tensile	Test sample ultimate tensile strength must meet or exceed existing tensile strength specifications.	Zenith test samples met the acceptance criteria for Tensile to demonstrate that the Zenith is substantially equivalent to the predicate device.
Corrosion	Test samples shall exhibit no evidence of corrosion.	Test results for the predicate device were leveraged for the Zenith as the materials and manufacturing processes are equivalent. (Implies Zenith is expected to meet this, based on predicate data.)
Packaging - Dye Leak	Test sample shall not exhibit any visual leaks or channels.	Zenith test samples met the acceptance criteria for Packaging - Dye Leak to demonstrate that the Zenith is substantially equivalent to the predicate device.
Packaging - Peel	Test sample tensile strength must meet or exceed existing tensile strength specifications.	Zenith test samples met the acceptance criteria for Packaging - Peel to demonstrate that the Zenith is substantially equivalent to the predicate device.
Kink Resistance	Test sample kink resistance must meet or exceed existing Kink Resistance specifications.	Zenith test samples met the acceptance criteria for Kink Resistance to demonstrate that the Zenith is substantially equivalent to the predicate device.
Torque	Test sample torque results must meet or exceed existing torque specifications.	Zenith test samples met the acceptance criteria for Torque to demonstrate that the Zenith is substantially equivalent to the predicate device.
PTFE Liner inspection	Test sample liner adhesion must meet or exceed existing PTFE Liner inspection specifications.	Zenith test samples met the acceptance criteria for PTFE Liner inspection to demonstrate that the Zenith is substantially equivalent to the predicate device.
Hydrophilic Coating Integrity	Test sample results must meet or exceed existing Hydrophilic Coating Integrity specifications.	Zenith test samples met the acceptance criteria for Hydrophilic Coating Integrity to demonstrate that the Zenith is substantially equivalent to the predicate device.
Labeling Legibility	Test samples shall demonstrate text legibility.	Zenith test samples met the acceptance criteria for labeling legibility to demonstrate that the Zenith is substantially equivalent to the predicate device.
Barcode	Test samples shall demonstrate readily readable barcodes.	Zenith test samples met the acceptance criteria for barcode testing to demonstrate that the Zenith is substantially equivalent to the predicate device.
Sterilization	Sterilization load shall pose an equal or lesser challenge to sterilize than existing sterile product loads.	Zenith sterilization load met the acceptance criteria for sterilization to demonstrate that the Zenith is substantially equivalent to the predicate device.
Shelf Life	Aged test samples must meet or exceed existing specifications.	Zenith test samples met the acceptance criteria for shelf life to demonstrate that the Zenith is substantially equivalent to the predicate device.

Regarding the specific requested points that are relevant to this type of device clearance:

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

The document does not explicitly state the sample sizes for each non-clinical test performed (e.g., how many catheters were burst-tested, how many animals in the angiographic evaluation). It refers to "test samples" or "units tested."
The data provenance is from non-clinical laboratory and animal studies (e.g., ISO standards, ASTM standards, porcine model). It is not human subject data, so concepts like "country of origin" or "retrospective/prospective" as they apply to clinical studies are not applicable.
- For biocompatibility tests, it mentions "extract human blood" for some hemolysis tests.
- For the Angiographic Evaluation, it explicitly states it was a "porcine model."

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

This is not applicable as the studies described are non-clinical (laboratory and animal testing). The "ground truth" for these tests comes from adherence to established scientific and regulatory standards (e.g., ISO 10993, ASTM, USP) and predefined physical/chemical limits.
For "Simulated Use - Bench," it mentions "by a physician," implying one or more physicians were involved in the benchtop evaluation, but their number and specific qualifications are not detailed beyond "physician."

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable to non-clinical laboratory or animal studies. Ground truth is determined by test results against defined acceptance criteria.

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:

Not applicable. This device is a percutaneous catheter, not an AI/ML diagnostic or assistive device.

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

Not applicable. This is not an algorithm/AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For non-clinical tests, the "ground truth" is determined by meeting predefined technical specifications, industry standards (e.g., ISO, ASTM), and biological safety parameters. For example, a burst pressure test's ground truth is a numerical value compared to a specification. For biocompatibility, it's the absence of adverse biological reactions per standard protocols. For the animal study, it's the absence of "clinically significant injury."

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires training data.

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

Not applicable. This is not an AI/ML device that requires a training set or its associated ground truth establishment.

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