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The Prelude Small O.D. Introducer Guide Wire is intended to facilitate the placement of introducer sheaths during diagnostic and interventional procedures.
The Prelude Small O.D. Introducer Guide Wire is indicated for use in the peripheral vasculature only.

The Prelude® Small O.D. Introducer Guide Wire is composed of a stainless-steel core wire inside a stainless-steel coil. The guide wire is welded at the distal and proximal tips and has a polished weld finish. The stainless-steel construction provides radiopacity and visibility to the user under X-ray. The wires are available in outer diameters 0.018", 0.021" and 0.025", lengths from 45 cm to 80 cm, straight and double-ended J 3mm / straight tip shapes, Standard and Firm body wire stiffness profiles, with a flexible atraumatic tip.

The provided text is a 510(k) summary for a medical device called the "Prelude Small O.D. Introducer Guide Wire." It details the device's characteristics, intended use, and a comparison to a predicate device, along with a list of non-clinical performance and biocompatibility tests conducted.

However, the request asks for specific information regarding acceptance criteria and a study that proves the device meets the acceptance criteria, particularly in the context of an AI-powered device or a study involving human readers and AI assistance.

The provided document does not describe an AI-powered device, a study involving human readers, a test set with expert ground truth, or an MRMC comparative effectiveness study. The tests listed are for a physical medical guide wire, focusing on its mechanical properties, material integrity, and biocompatibility.

Therefore, I cannot fulfill the request for information on acceptance criteria and study proving device meets the criteria for an AI device or a study involving human readers and AI assistance, as the provided text pertains to a traditional, non-AI medical device.

Here's a breakdown of why I cannot answer the specific questions based on the provided text:

• 1. A table of acceptance criteria and the reported device performance: While the document states "The subject Prelude Small O.D. Introducer Guide Wire met the predetermined acceptance criteria," it does not list the specific numerical or qualitative acceptance criteria for each test (e.g., "Tensile strength must be >X Newtons"). It also does not report the exact performance results (e.g., "Tensile strength was Y Newtons"). It only confirms that the criteria were met.
• 2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to the physical guide wires tested, not a dataset of images or clinical cases. Sample sizes for each mechanical and biocompatibility test are not provided. Data provenance (country of origin, retrospective/prospective) is irrelevant for this type of device testing.
• 3. Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth as typically defined for AI/imaging studies (e.g., expert radiological reads) is not relevant for the physical testing of a guide wire.
• 4. Adjudication method for the test set: Not applicable. There's no "adjudication" for mechanical and biocompatibility tests in the way there would be for expert interpretations of medical images.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done... effect size: Not applicable. This type of study involves human readers interpreting medical images, usually with and without AI assistance. The device in question is a physical guide wire, not an AI algorithm for imaging.
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device is not an algorithm.
• 7. The type of ground truth used: Not applicable. Ground truth in the context of AI/imaging studies (expert consensus, pathology, outcomes data) is not relevant here. The "ground truth" for this device's performance is derived from standardized physical and chemical tests (e.g., measuring tensile strength against a specification).
• 8. The sample size for the training set: Not applicable. This device does not involve a training set as it's not an AI model.
• 9. How the ground truth for the training set was established: Not applicable, as there's no training set.

In summary, the provided document is for a conventional medical device (a guide wire) and does not contain the information requested regarding AI device performance studies.

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To facilitate the placement of devices during diagnostic or interventional procedures.

NeoMetrics guidewires are constructed using stainless steel and nickel titanium alloys. Configurations include a single tip or dual tip, retracted core or fixed core, and straight or J-tipped. The guidewire is packaged in a spiral hoop fitted with a "J"-Straightener, where applicable to aid in insertion of the guidewire into the puncture needle.

This document is a 510(k) Summary for the Neometrics Spring Coil Guidewire (K143135). It demonstrates substantial equivalence to a predicate device, focusing on bench testing rather than clinical study data relevant to AI/algorithm performance. Therefore, I cannot provide a detailed answer to your request as it pertains to AI/algorithm acceptance criteria and studies.

Based on the provided document, here's what can be extracted and why the rest cannot be answered:

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

Explanation: The document states, "To verify that device design met functional and performance requirements, representative samples of the device underwent bench testing in accordance to applicable standards and guidances." It then lists the types of performance tests conducted. While specific numerical acceptance criteria and detailed performance results are not provided in this summary, the conclusion states that "These data demonstrates that the Spring Coil Guidewire is equivalent to the predicate." implying all tests met their respective acceptance criteria.

The following questions cannot be answered from the provided document because it describes a traditional medical device (a guidewire) and its premarket notification, which relies on bench testing and substantial equivalence to a predicate, not an AI/algorithm-based device and its associated clinical/performance studies.

• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective) - Not applicable, as this is bench testing of physical device properties, not a study on an algorithm with a test set of data.
• 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. Ground truth for a physical guidewire is established through objective measurements and material science standards during bench testing.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set - Not applicable for bench testing.
• 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 as this is not an AI-assisted device or an imaging/diagnostic device involving human readers.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done - Not applicable as this is not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc) - For bench testing, ground truth is based on engineering specifications, material standards, and physical measurements.
• 8. The sample size for the training set - Not applicable, as there is no AI algorithm being trained.
• 9. How the ground truth for the training set was established - Not applicable, as there is no AI algorithm being trained.

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TFX Medical Guidewires are intended to fit inside a percutaneous catheter for the purpose of directing it through a blood vessel or other natural channel excluding use in coronary arteries and in the neurovasculature.

TFX Medical will supply a standard range of guidewires as sterile, packed finished products, and will also supply in bulk to other manufacturer to their specific size requirements (for example: for inclusion in a kit).

The kev features of the TFX Medical Guidewire are:

• O Core Wire
• O Ribbon Wire (where fitted)
• O Spring Wire
• O Welds
• Coating (p.t.f.e. coating or uncoated stainless steel)
• Tips (available straight and "J" forms, one or two tips)

Guidewires will be manufactured of grade 302/304 stainless steel and be available:

• . with and without a ribbon wire
• ♥ in fixed and moveable core designs
• . uncoated and p.t.f.e. coated
• with straight and "J" formed end(s)
• with and without a length marking

I am sorry, but the provided text does not contain the detailed information required to fulfill your request. The document is a 510(k) summary for a medical guidewire and mentions "Test data in the premarket notification demonstrates TFX Medical Guidewires meeting the requirements of the appropriate parts of British Standard BS 7174: 1990: Part 4." However, it does not provide the specific acceptance criteria, reported device performance in a table, details about the study (sample size, data provenance, ground truth, experts, adjudication, MRMC, or standalone performance), or information about the training set.

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