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This product is intended for use in conjunction with catheters or other devices, which require the aid of a stylet to render it stiff for placement.

The TFX Medical Hydrophilic Coated or Uncoated Stylet consists of a hub which is bonded to the flexible stainless steel shaft.

This 510(k) submission (K992664) for the TFX Medical Coated Catheter Stylet focuses on demonstrating substantial equivalence to a predicate device rather than providing a study with acceptance criteria and measured performance.

Therefore, this document does not contain the requested information regarding acceptance criteria and a study that proves the device meets those criteria.

The submission is for a Class II medical device, and the FDA's clearance is based on the finding of "substantial equivalence" to a legally marketed predicate device (Lake Region Stylet), meaning the basic features, designs, and intended uses are the same, and the differences raise no new issues of safety and effectiveness.

To directly answer your request based on the provided text, the following information is NOT available:

1. A table of acceptance criteria and the reported device performance: Not present.
2. Sample size used for the test set and the data provenance: No test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No test set or ground truth described.
4. Adjudication method: Not applicable as no test set is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not performed or reported.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device, not an algorithm.
7. The type of ground truth used: Not applicable as no study data is presented.
8. The sample size for the training set: Not applicable as no study data is presented.
9. How the ground truth for the training set was established: Not applicable as no study data is presented.

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This product is to assist in the percutaneous introduction of diagnostic or therapeutic devices into a vessel.

The TFX Medical Introducer Kit consists of a Sheath/Dilator Assembly, Needle with indicator, Syringe, Guide-wire Tray

The provided text is a 510(k) summary for the TFX Medical Introducer Kit. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than providing extensive clinical study data with acceptance criteria for device performance in the way a novel AI or diagnostic device might.

Therefore, many of the requested data points (acceptance criteria, specific study details, sample sizes, ground truth establishment, MRMC studies, standalone performance) are not typically included in a 510(k) summary for a device like an introducer kit. The evaluation is based on comparison to existing devices with established safety and effectiveness.

Here's an analysis based on the provided text, addressing the points where information is available or explaining why it's not present:

Acceptance Criteria and Study for TFX Medical Introducer Kit (K991647)

This 510(k) summary for the TFX Medical Introducer Kit does not report specific quantitative acceptance criteria or a detailed study designed to measure the device's performance against such criteria. Instead, the submission relies on demonstrating substantial equivalence to existing legally marketed predicate devices. The "acceptance criteria" in this context are implicitly met if the device has "basic features, designs and intended uses" that are the same as the predicate and the "differences... raise no new issues of safety and effectiveness."

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. This 510(k) summary does not describe a clinical "test set" or a study involving human subjects or data collection for performance measurement. The submission is a comparison to predicate devices, focusing on design and intended use specifications.

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

Not applicable. No "ground truth" establishment by experts for a test set is described, as the submission relies on substantial equivalence.

4. Adjudication method for the test set

Not applicable. No test set or adjudication method is described.

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 device is an introducer kit, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study, human readers, or AI assistance is relevant or discussed in this submission.

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

Not applicable. This device is an introducer kit, not an algorithm, and does not have a "standalone" or "human-in-the-loop" performance component.

7. The type of ground truth used

Not applicable. As discussed, the submission relies on demonstrating substantial equivalence to predicate devices, not on proving performance against a specific "ground truth" derived from pathology, outcomes data, or expert consensus for the TFX Medical Introducer Kit itself. The "ground truth" is effectively the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not applicable. This submission does not involve machine learning or AI models, so there is no concept of a "training set."

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

Not applicable. As there is no training set, there is no corresponding ground truth to establish.

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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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