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The Pre-Formed Blue guidewire is intended to facilitate the introduction and placement of interventional devices within the chambers of the heart, including those used during transcatheter aortic valve procedures.

The Pre-Formed Blue guidewire is designed to facilitate device placement during TAVR procedures and has a unique pre-shaped spiral distal tip to ensure placement within the heart. The guidewire is intended for single use. The guidewire has a 0.035" diameter and is 275cm in length. The guidewire composed of two primary components: a core, and a coil. Both components are made of stainless steel. The core wire component is a piece of stainless-steel wire which is ground on the distal end to fit into the coil and provide flexibility. The coil component is fitted over the distal end of the core and is a stainless-steel coiled wire coated with blue PTFE coating. The coil and core components are secured together using a weld on the distal end, forming the guidewire. The pre-shaped distal end of the guidewire is available in two sizes (extra-small and small). The Pre-Formed Blue guidewire is sterilized using ethylene oxide. There are no accessories packaged with the Pre-Formed Blue guidewire.

The provided text describes the regulatory clearance of a medical device, the "Pre-Formed Blue" guidewire, and the testing conducted to demonstrate its substantial equivalence to a predicate device. However, it does not contain the level of detail requested for a comprehensive acceptance criteria and study description for an AI device.

Specifically, the document pertains to a physical medical device (a guidewire), not an AI device. Therefore, many of the requested elements, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone (algorithm only) performance," "sample size for the training set," and "how the ground truth for the training set was established," are not applicable and are not present in the provided text.

The closest information available related to "acceptance criteria" and "study" is the summary of non-clinical (bench) performance testing and an animal study comparing the new device to its predicate.

Here's an attempt to extract and present the information in the requested format, clearly indicating where information is not applicable (N/A) for a physical device or not provided in the text.

Device: Pre-Formed Blue Guidewire
Type of Device: Catheter Guide Wire (Physical Medical Device)

1. Table of Acceptance Criteria and Reported Device Performance

The document states that for all listed tests, "The predetermined acceptance criteria were met." However, the specific quantitative acceptance criteria values for each test are not provided. The table below summarizes the tests conducted and the reported outcome.

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

• Sample Size for Test Set:
  • For non-clinical (bench) tests: Not explicitly stated how many units were tested for each specific bench test. The document refers to "samples were analyzed."
  • For the animal study: Not explicitly stated how many animals were used.
• Data Provenance:
  • For non-clinical (bench) tests: Data generated from internal laboratory testing according to established procedures and FDA guidance.
  • For the animal study: Conducted according to 21 CFR Part 58 for Good Laboratory Practice (GLP) for Non-Clinical Laboratory studies. The geographic origin of the study is not specified. It is a prospective study in the context of device development and substantial equivalence demonstration.

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

N/A. This information is relevant for AI devices where experts establish ground truth for image interpretation or diagnosis. For a physical guidewire, "ground truth" is established by direct measurement and performance against engineering specifications and accepted standards. The document does not refer to experts establishing ground truth in this sense.

4. Adjudication method for the test set

N/A. Adjudication methods like 2+1 or 3+1 are used to resolve disagreements in expert interpretations, typically for AI model ground truth establishment. This is not applicable to the bench and animal testing of a physical guidewire.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, an effect size of how much human readers improve with AI vs without AI assistance

N/A. This is a physical guidewire, not an AI device. Therefore, no MRMC study or AI assistance evaluation was conducted.

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

N/A. This is a physical guidewire, not an AI device.

7. The type of ground truth used

• For non-clinical (bench) tests: Ground truth is based on predetermined acceptance criteria derived from engineering specifications, industry standards (e.g., ASTM, ISO, EN ISO), and FDA guidance for guidewire performance.
• For the animal study: Ground truth is based on safety and performance objectives and Customer Requirement Specifications as measured by post-procedure feedback forms, with comparison to the predicate device.

8. The sample size for the training set

N/A. This is a physical medical device, not an AI model that requires a training set.

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

N/A. This is a physical medical device, not an AI model that requires a training set.

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