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The intended use of the Modified Device is to provide stability and directional control during transcatheter ablation of endocardial tissue.

PREFACE Braided Guiding Sheath - The intended use of the percutaneous Braided Guiding Sheath is for the introduction of intravascular electrophysiology catheters into any cardiac chamber.

PERRY Exchange Dilator - The intended use of the PERRY Exchange Dilator is for the transseptal exchange of Cordis Webster PREFACE Braided Guiding Sheaths which are used for the introduction of intravascular electrophysiology catheters. The exchange dilator permits exchange of the guiding sheaths while maintaining transseptal left heart access and control of sheath location.

The components of the Predicate Device (K970264) consists of 1) a Guiding Sheath with posterior, anterior or multipurpose shaped distal tip section, 2) a conventional sheath vessel dilator (vessel dilator), 3) a dual-tapered long vessel dilator (exchange dilator), 4) a .032", 260cm guidewire, and 5) a guidewire funnel. The components of the Predicate Device are packaged in four configurations: 1) Guiding Sheath w/ posterior curve and vessel dilator, 2) Guiding Sheath w/ anterior curve and vessel dilator, 3) Guiding Sheath w/ multipurpose curve, vessel dilator, exchange dilator, .032", 260cm guidewire and guidewire funnel, and 4) Posterior, Anterior and Multipurpose Guiding Sheaths, vessel dilator, exchange dilator, .032", 260cm guidewire and guidewire funnel.

The packaging configuration of the Predicate Device has been modified to offer the Guiding Sheath and Exchange System in two separate packages. The Guiding Sheath (PREFACE Braided Guiding Sheath) with posterior, anterior or multipurpose shaped distal tip sections is packaged with a vessel dilator and a short .032", 150cm guidewire. The Exchange System includes the exchange dilator (PERRY Exchange Dilator), .032", 260cm guidewire, and guidewire funnel. The distal end of the vessel dilator and both ends of the PERRY Exchange Dilator were modified by adding radiopaque tips with tungsten to improve visibility under fluoroscopy. The function and intended use of the Modified Device as compared to the Predicate Device are identical, as are all component materials with the exception of the tungsten dilator material. The addition of the tungsten material does not affect safety or effectiveness as demonstrated in the Verification Test Data provided in Appendix I.

The PREFACE Braided Guiding Sheaths are intended to provide stability and directional control during catheter ablation. The PREFACE Braided Guiding Sheath is packaged with a vessel dilator with a radiopaque distal tip, and a .032", 150cm guidewire. The PERRY Exchange Dilator will be utilized by the physician to exchange the existing PREFACE Braided Guiding Sheath for an alternate PREFACE Braided Guiding Sheath without losing the established intracardiac position. The PERRY Exchange Dilator with radiopaque ends is packaged with a .032", 260cm guidewire and guidewire funnel.

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:

The document (K982740) describes a Special 510(k) for a "Device Modification Cordis Webster Braided Guiding Sheath Exchange System." This is a modification of an existing device (Predicate Device K970264). The core of this submission is to demonstrate that the modified device is substantially equivalent to the predicate device, particularly because of changes made to the dilators (adding radiopaque tips with tungsten for improved visibility).

Key Finding: This submission does not detail a study with specific acceptance criteria related to a diagnostic or AI-based performance. Instead, it focuses on verification testing to demonstrate that the modification (the addition of tungsten to the dilators) does not adversely affect the device's safety or effectiveness compared to the predicate device.

Therefore, many of the requested categories (like performance metrics, sample size for test sets/training sets, expert qualifications, adjudication methods, MRMC studies, standalone AI performance, and AI-specific ground truth) are not applicable to this type of device modification submission.

Acceptance Criteria and Study Details (Based on Provided Text)

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

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

• Sample Size: Not specified in the provided summary. The submission refers to "Verification Test Data provided in Appendix I," which is not included. These types of tests typically involve a limited number of physical samples (e.g., a few units of each size/component for mechanical testing).
• Data Provenance: Not specified, but generally, such verification testing is conducted in a controlled lab environment by the device manufacturer.

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. This is not a diagnostic device or an AI-algorithm requiring expert ground truth in that sense. The "ground truth" for mechanical properties would be derived from standard engineering measurement techniques and comparison to established benchmarks (e.g., the predicate device or a standard sheath).

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

• Not Applicable. See point 3.

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

• No. This is not a diagnostic device, and no AI component is described.

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

• No. This is not an AI-enabled device.

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

• The ground truth for the mechanical properties (stiffness, insertion force) would likely be quantitative physical measurements obtained through standard engineering testing methods. The "ground truth" for safety and effectiveness relative to the modification is the comparison against the predicate device's established performance and relevant material standards.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not a machine learning device.

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

• Not Applicable. See point 8.

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