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The TechDevice Guidewire facilitates placement and exchange of catheters and other instruments in the peripheral vasculature. This device is not indicated for neuro, or cardiac use.

The Guidewire is constructed of a stainless steel core wire and a stainless steel or platinum coil welded/brazed in place over the core wire. The coil may cover the entire or just the floppy distal portion. The exposed core wire and or the coil may be uncoated stainless steel or coated with a PTFE spray or a PTFE jacket. Platinum marker bands may be placed under the coil to aid in visualization. Exit markers may be printed on the proximal section of the guidewire to aid the physician in determining the depth of insertion.

The provided text is a 510(k) Premarket Notification for a vascular guidewire, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through clinical studies or extensive performance testing with acceptance criteria.

Therefore, the document does not contain the information requested for acceptance criteria and a study proving a device meets them in the context of typical AI/software device evaluation.

Here's a breakdown of why the specific questions cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: Not present. The submission focuses on comparison to predicate devices and bench testing results, not predefined acceptance criteria for a novel performance metric.
2. Sample size used for the test set and the data provenance: Not applicable. There is no "test set" in the sense of clinical data or image data for an AI algorithm. The testing described is bench testing in a lab.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth, as this is not an AI/diagnostic device.
4. Adjudication method for the test set: Not applicable.
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 is a physical medical device (guidewire), not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary of Device Performance (from the document):

The device's safety and performance were established through:

• Comparison of labeling, physical, and performance design characteristics to predicate devices.
• Results of comparative bench testing, which included:
  • Tensile Strength
  • Torque Strength
  • Torqueability
  • Tip Flexibility
  • Coating Integrity

The document concludes that "Based on the indications for use, technological characteristics, and comparison to predicate devices, the TechDevice Guidewire has been shown to be safe and effective for its intended use." This statement is based on the substantial equivalence argument and the bench test results against the predicate, not a defined set of quantitative acceptance criteria for clinical performance that would typically be associated with an AI study.

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The TechDevice Guidewire facilitates placement and exchange of catheters and other instruments in the alimentary tract. This device is not indicated for neuro or cardiac use.

The Guidewire is constructed of a stainless steel core wire and a stainless steel or platinum coil welded/brazed in place over the core wire. The coll may cover the entire core wire or just the floppy distal portion. The exposed core wire and or the coil may be uncoated stainless steel or coated with a PTFE spray or a PTFE jacket. Platinum iridium marker bands may be placed under the coil to aid in visualization. Exit markers may be printed on the proximal section of the guidewire to aid the physician in determining the depth of insertion.

This 510(k) summary describes a medical device called the TechDevice Guidewire. The device is intended to facilitate the placement and exchange of catheters and other instruments in the alimentary tract, but not for neuro or cardiac use. The submission states that substantial equivalence was based on a comparison of labeling, physical and performance design characteristics to predicate devices, as well as the results of comparative bench testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The document does not specify the sample sizes used for the comparative bench testing (test set sizes). It also does not mention the country of origin of the data or whether the data was retrospective or prospective. It only states "comparative bench testing."

3. Number of Experts and Qualifications

This information is not provided in the document. Bench testing typically does not involve human expert review in the same way clinical studies do.

4. Adjudication Method

This information is not provided in the document. Adjudication methods are typically associated with clinical studies involving human interpretation, not bench testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was done. The document describes bench testing of physical and performance characteristics, not a clinical study involving human readers or AI.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a physical guidewire, not an algorithm or software. The performance described is for the physical device itself.

7. Type of Ground Truth Used

The ground truth for the performance tests would be the established engineering standards or specifications for each of the measured characteristics (Tensile Strength, Torque Strength, Torqueability, Tip Flexibility, Coating Integrity). The document implies that the "ground truth" was the performance of the predicate devices. The phrase "comparative bench testing" suggests that the TechDevice Guidewire's performance was compared directly against the predicate devices for these characteristics.

8. Sample Size for the Training Set

Not applicable. This device is a physical guidewire, not an AI or software device that uses a training set. The "training" in the context of device development would refer to the design and engineering process, not a data-driven training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" in the context of this device. The design and manufacturing process would be guided by engineering principles and comparison to predicate devices, rather than a data-driven ground truth.

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