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Vista Brite Tip - The guiding catheter is intended for use for intravascular introduction of interventional / diagnostic devices into the coronary or peripheral vascular systems.
Envoy – The Envoy guiding catheter is intended for use in the peripheral, coronary, and neurovasculature for the intravascular introduction of interventional / diagnostic devices.

• 6 French (ID 0.070");
• Single lumen catheter with a reinforced body (tightly wound stainless steel braid wire);
• Catheter body transitions provide a gradual decrease in material stiffness (varying durometers) from the body to the tip; and,
• Polycarbonate hub.

This document describes a 510(k) premarket notification for the Cordis Vista Brite Tip® and Envoy® Guiding Catheters. The study conducted for this submission does not involve an AI device, and therefore the standard acceptance criteria, performance metrics, and study design relevant to AI devices (such as sample size for test/training sets, ground truth establishment, expert adjudication, or MRMC studies) are not applicable.

The submission is for a medical device (catheter) that demonstrates substantial equivalence to previously cleared predicate devices rather than proving performance against specific acceptance criteria for an AI algorithm.

Here's the information derived from the provided text, adapted to clarify its non-AI nature:

1. Table of Acceptance Criteria and Reported Device Performance

• Vista Brite Tip: Intravascular introduction of interventional/diagnostic devices into coronary or peripheral vascular systems.
• Envoy: Intravascular introduction of interventional/diagnostic devices into peripheral, coronary, and neurovasculature. | Confirmed: The device's intended use is identical to the predicate Cordis Vista Brite Tip® and Envoy® Guiding Catheters. |
  | Device Description:
• 6 French (ID 0.070");
• Single lumen catheter with reinforced body (tightly wound stainless steel braid wire);
• Catheter body transitions for gradual decrease in material stiffness (varying durometers) from body to tip;
• Polycarbonate hub. | Confirmed: The device description (size, materials, construction) is substantially equivalent to the predicate devices. |
  | Material Biocompatibility: All materials used in the devices are biocompatible. | Confirmed: All materials used are biocompatible, consistent with the predicate devices. |
  | Performance Standards: No specific performance standards established under Section 514 of the Food, Drug and Cosmetic Act for Percutaneous Catheters. | No specific performance standards to meet; substantial equivalence determination relies on comparison to predicate. |

2. Sample Size Used for the Test Set and Data Provenance

• Not applicable. This submission is for a medical device (catheter) demonstrating substantial equivalence to a predicate, not for an AI algorithm evaluated with a test set of data. There is no "test set" of data in the context of an AI device. The equivalence is established through comparison of design, materials, and intended use.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Not applicable. As this is not an AI device, there is no "ground truth" establishment by experts for a test set of data. The regulatory review process primarily involves FDA reviewers assessing the device specifications against predicate devices.

4. Adjudication Method for the Test Set

• Not applicable. There is no "test set" or adjudication method in the context of an AI device's performance evaluation. The "adjudication" is the FDA's regulatory review and determination of substantial equivalence.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. An MRMC study is relevant for evaluating the impact of AI assistance on human reader performance. This submission is for a physical medical device (catheter), not an AI algorithm, so an MRMC study was not performed.

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

• No. This is not an AI algorithm, so the concept of standalone algorithmic performance is not applicable.

7. The Type of Ground Truth Used

• Not applicable. For this type of medical device submission, "ground truth" in the context of AI (e.g., pathology, expert consensus on images) is not relevant. The "truth" established is that the new device is "substantially equivalent" to predicate devices based on its design, materials, and intended use, reviewed against regulatory requirements.

8. The Sample Size for the Training Set

• Not applicable. This submission is for a medical device (catheter), not an AI algorithm. There is no "training set."

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As there is no AI algorithm or training set, this question is not relevant.

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The VISTA BRITE TIP and ENVOY Guiding Catheters are intended for use for intravascular introduction of interventional/diagnostic devices into the coronary, peripheral, and neuro vasculature.

• 6 French
• Single lumen catheter featuring a nylon body reinforced with a tightly wound stainless steel braid wire
• The transition segment is designed with nylons of different durometers (stiffness) to provide a gradual decrease in material stiffness from the catheter body to the tip.

This document describes safety and effectiveness for VISTA BRITE TIP and ENVOY Guiding Catheters. However, this submission to the FDA (K982632) is for a medical device, not an AI/ML algorithm. Therefore, many of the requested criteria for AI/ML validation studies, such as sample size for test/training sets, experts for ground truth, adjudication methods, and MRMC studies, are not applicable to this type of submission.

The primary focus of this document is to establish substantial equivalence to previously cleared predicate devices, an approach common for medical device clearances that are not software algorithms.

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

1. Table of Acceptance Criteria (Inferred from Substantial Equivalence) and Reported Device Performance

Since this is a substantial equivalence claim for guiding catheters, the "acceptance criteria" are implicitly met by demonstrating that the new devices perform as intended and are as safe and effective as the predicate devices. The document does not describe a formal study with quantitative performance metrics against pre-defined acceptance criteria in the way an AI/ML study would. Instead, it relies on the comparison to established predicate devices.

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

• Not Applicable. This is a medical device submission, not an AI/ML algorithm study involving a "test set" of data in the computational sense. The "test" is more about demonstrating that the physical device's characteristics (materials, design, function) are equivalent to existing cleared devices.

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

• Not Applicable. See point 2. Ground truth in this context would implicitly be the established safety and effectiveness of the predicate devices based on their prior clearance and clinical use, rather than expert annotation of a dataset.

4. Adjudication method

• Not Applicable. See point 2.

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 is not an AI-assisted device.

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

• Not Applicable. This is not an artificial intelligence algorithm.

7. The type of ground truth used

• Predicate Device Performance/Clearance: The "ground truth" for this submission is essentially the established safety, effectiveness, and intended use of the predicate devices (Cordis Corporation VISTA BRITE TIP Guiding Catheter and Cordis Endovascular Systems, Inc. ENVOY Guiding Catheter). The submission aims to prove the new device is "substantially equivalent" to these already cleared devices, meaning it performs as well and is as safe as those established devices.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML algorithm that requires a "training set" of data.

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

• Not Applicable. See point 8.

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