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The proposed (7F, 8F) VIKING OPTIMATM Guiding Catheter has a standard working length of 100 cm and a standard overall length of 107 cm, but can be produced in lengths from 40 to 160 cm depending upon physician preference and patient size.

The proposed (7F, 8F) VIKING OPTIMATM Guiding Catheter has a radiopaque shaft, which varies in stiffness at the distal end to accommodate customer preference and give optimal support in each tip shape. The stiffness of the shaft is determined by the durometer of the segment of polymer along the axial length. The lower the durometer of polymer (or polymer blend of Nylon 12 and/or Pebax), the more flexible the guiding catheter. The Pebax raw material durometers vary from 25D to 72D. The guiding catheter also has a radiopaque soft tip at the most distal section.

The proposed (7F, 8F) VIKING OPTIMATM Guiding Catheter is manufactured in varying tip shapes. Each shape is specific for patient anatomy and physician preference, and therefore a wide range of shapes is available with and without sideholes.

AI/ML Overview

The document provided is a 510(k) premarket notification for a medical device, the VIKING OPTIMA™ Guiding Catheter. It describes the device, its intended use, and states that substantial equivalence has been demonstrated through non-clinical bench tests and analyses. However, it does not contain specific acceptance criteria, reported device performance metrics, or details of a study that proves the device meets specific acceptance criteria.

Therefore, I cannot fulfill your request for the detailed table and study information. The provided text is primarily a regulatory submission for substantial equivalence based on bench testing, and not a detailed performance study with quantifiable acceptance criteria for a new AI/software-based device.

Here's how I can address your request based on the information provided:

1. A table of acceptance criteria and the reported device performance

Not applicable / Information not provided. The document states that "The substantial equivalence of the proposed (7F, 8F) VIKING OPTIMATM Guiding Catheter has been demonstrated through data collected from non-clinical bench tests and analyses." However, it does not specify the exact acceptance criteria for these bench tests nor the quantitative results of those tests. The submission focuses on showing similarity to a predicate device (K001435) rather than meeting predefined performance metrics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable / Information not provided. The study referenced is "non-clinical bench tests and analyses." There is no mention of a "test set" in the context of patient data or clinical imaging.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable / Information not provided. As this was a non-clinical bench test, there was no ground truth requiring expert consensus in the clinical sense.

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

Not applicable / Information not provided. This refers to clinical data review, which was not part of the described evaluation.

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 document describes a physical medical device (guiding catheter), not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance would not be relevant.

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

Not applicable. This document describes a physical medical device, not an algorithm.

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

Not applicable / Information not provided. The "performance data" mentioned refers to non-clinical bench tests, likely measuring physical attributes of the catheter against engineering specifications or predicate device characteristics, rather than clinical ground truth like pathology or outcomes.

8. The sample size for the training set

Not applicable / Information not provided. There is no mention of a "training set" as this is not a machine learning or AI device.

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

Not applicable / Information not provided. Not applicable to this type of device and study.

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K Number

K012002

Device Name

VIKING OPTIMA GUIDING CATHETER

Manufacturer

GUIDANT CORP.

Date Cleared

2001-07-26

(29 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K001435

Intended Use

The guiding catheter is designed to provide a pathway through which therapeutic and diagnostic devices are introduced.

Device Description

The proposed (6F) VIKING OPTIMA™ Guiding Catheter has a standard working length of 100 cm and a standard overall length of 107 cm, but can be produced in lengths from 40 to 160 cm depending upon physician preference and patient size.

The proposed (6F) VIKING OPTIMA™ Guiding Catheter has a radiopaque shaft, which varies in stiffness at the distal end to accommodate customer preference and give optimal support in each tip shape. The stiffness of the shaft is determined by the durometer of the segment of polymer along the axial length. The lower the durometer of polymer (or polymer blend of Nylon 12 and/or Pebax), the more flexible the guiding catheter. The Pebax raw material durometers vary from 25 to 72D. The guiding catheter also has a radiopaque soft tip at the most distal section.

The proposed (6F) VIKING OPTIMA™ Guiding Catheter is manufactured in varying tip shapes. Each shape is specific for patient anatomy and physician preference, and therefore a wide range of shapes is available with and without sideholes.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the VIKING OPTIMA™ Guiding Catheter. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance data as would be found in an AI/software device submission.

Therefore, most of the requested information regarding acceptance criteria and a study proving their fulfillment is not present in this document. This document is for a physical medical catheter, not an AI or software-based device.

Here's an assessment based on the information provided, highlighting what is and isn't available:

Acceptance Criteria and Device Performance

1. A table of acceptance criteria and the reported device performance

This information is not provided in the document. The document states: "The substantial equivalence of the proposed (6F) VIKING OPTIMA™ Guiding Catheter has been demonstrated through data collected from nonclinical bench tests and analyses." However, it does not specify what those bench tests entailed, what the acceptance criteria for those tests were, or what the reported performance outcomes were.

Study Details (Applicable to AI/Software Devices, Not This Submission)

For the following points (2-9), the information is not applicable or not present because this is a 510(k) for a physical medical device (a catheter) and not an AI or software-based device requiring detailed clinical performance studies with ground truth.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable / Not Provided. This type of data is common for AI/software evaluations, not for a physical catheter 510(k).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable / Not Provided. Ground truth establishment by experts is relevant for diagnostic AI systems, not for a physical catheter.

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

Not Applicable / Not Provided.

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 / Not Provided. MRMC studies are for evaluating diagnostic accuracy with or without AI assistance, which is not relevant for this physical device.

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