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The TAD / TAD II Guide Wire is intended for use in angiographic procedures to introduce and position diagnostic and interventional devices within the peripheral vasculature during percutaneous procedures. The wire can be torqued to facilitate navigation through tortuous vessels.

The TAD / TAD II Guide Wire is not intended for use in coronary or neurovasculature.

The TAD/TAD II Tapered Guide Wire is a shaping ribbon designed wire that is 0.018" nominal at the distal end and is 0.035" nominal on the proximal end. The core is tapered from the tip over 40 cm in three successive steps in diameter until it reaches its full diameter for the TAD Guide Wire and is tapered from the tip over 23 cm in two successive steps in diameter until it reaches its full diameter for the TAD II Guide Wire.

The distal portion of the wire incorporates a stainless shaping ribbon inside a platinum nickel wound coil that is attached with solder at the very distal portion. The stainless steel intermediate coil tapers from 0.018" to 0.035" over a distance of 15 cm for the TAD guide wire and 10 cm for the TAD II guide wire. The proximal coil is a 0.035" PTFE coated stainless steel coil. The coils are attached to the core by solder.

Polyethylene (PE) coating covers the proximal end and is attached to the proximal coil with a medical grade glue (Cyanoacrylate Ester) to ensure a smooth transition from coil to coating. Silicon is used to coat the entire length of the polyethylene tubing. Microglide® coating covers from the distal end of the proximal coil to the distal tip. TAD/TAD II Tapered Guide Wires come in lengths of 145 cm, 200 cm, 260 cm, and 300 cm. The wires that are 145 cm, 200 cm, and 300 cm (TAD only) in length are extendible using the Loc Guide Wire Extension. Each TAD/TAD II Tapered Guide Wire comes with a 0.025"- 0.038" Torque Device.

I'm sorry, but the provided text does not contain the information required to describe acceptance criteria and a study proving a device meets them. The document is a 510(k) summary for a guide wire, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing performance studies against specific acceptance criteria.

The document discusses:

• The device's trade name and classification.
• A summary of substantial equivalence, highlighting that the device is the same as a previously marketed one, implying that a new performance study to establish acceptance criteria is not necessary for this 510(k) submission.
• Device description and technological characteristics.
• Intended use.
• Changes made (which are primarily branding, packaging, and labeling, with no impact on product performance).
• The FDA's letter regarding the substantial equivalence determination.

There is no mention of:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for any test sets.
3. Number or qualifications of experts used for ground truth.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for a training set.
9. How ground truth for a training set was established.

This document is a regulatory submission for substantial equivalence based on a comparison to an already cleared device, not a report on a new performance study.

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