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The VascuPuncture PICC Guidewire is indicated for percutaneous entry of peripheral vessels using the Seldinger Technique. The device is not intended for use in the coronary or cerebral vasculature.

The VascuPuncture™ PICC Guidewires are guidewires constructed of stainless steel and nickel titanium alloy with or without lubricious coatings. Devices are available in diameters of 0.014 to 0.018 inches and in lengths ranging from 40 to 145 cm. with a variety of coil material options available.

This document describes the VascuPuncture™ PICC Guidewire by NeoMetrics, Inc. and its 510(k) premarket notification. However, it does not contain the detailed acceptance criteria or results from a study proving the device meets those criteria in the format explicitly requested for AI/medical device performance evaluation.

The provided text focuses on the device's substantial equivalence to predicate devices based on:

• Functional and performance characteristics demonstrated through equivalence with the predicate device and testing of representative device samples as part of Design Verification Testing.
• Biocompatibility demonstrated through successful completion of Biocompatibility Testing in accordance with ISO 10993.
• Shelf Life demonstrated through successful completion of accelerated aging studies and subsequent testing in accordance with ISO 11070.

This information is typical for a 510(k) submission for a conventional medical device like a guidewire, which relies on demonstrating equivalence to an already legally marketed predicate device rather than on clinical AI performance metrics.

Therefore, I cannot populate the requested table and study details as they are not present in the provided text.

Specifically, the following information is NOT present in the provided document:

1. A table of acceptance criteria and the reported device performance: While general areas of testing (functional, performance, biocompatibility, shelf life) are mentioned, specific acceptance criteria (e.g., tensile strength minimum, kink resistance maximum) and their corresponding reported values are absent.
2. Sample size used for the test set and the data provenance: No information on the number of guidewires tested or where the test data was generated (e.g., country, retrospective/prospective).
3. Number of experts used to establish the ground truth and their qualifications: Not applicable, as this is not an AI device relying on expert-annotated ground truth.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone (algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable, as this is a physical medical device, not an AI model requiring ground truth for diagnosis/detection.
8. The sample size for the training set: Not applicable, as there is no AI model or "training set" for this device.
9. How the ground truth for the training set was established: Not applicable.

The document states that the conclusion of substantial equivalence is based upon "functional design, indications for use, principles of operation, risk analysis, and performance characteristics." The "performance characteristics" are demonstrated through "testing of representative device samples as part of Design Verification Testing" and compliance with ISO standards for biocompatibility and shelf life. This indicates that bench testing was performed for mechanical and material properties, rather than clinical studies with human participants for diagnostic performance.

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The VascuPuncture PICC Guidewire is indicated for percutaneous entry of peripheral vessels using the Seldinger Technique. VascuPuncture Guidewires are not indicated for use in the coronary or cerebral vasculature.

The VascuPuncture™ PICC Guidewires are guidewires constructed of stainless steel and nickel titanium alloy with a lubricious coating. Devices are available in diameters of 0.014 to 0.018 inches and in lengths ranging from 45 to 135 cm.

The provided document is a 510(k) summary for the VascuPuncture™ PICC Guidewire, which is a medical device. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in the manner one would see for a novel AI/software medical device.

Therefore, much of the requested information cannot be extracted directly from this document. However, I will fill in what can be inferred or stated based on the nature of a 510(k) submission for a guidewire.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (guidewire), acceptance criteria and performance are typically related to physical and functional characteristics demonstrating equivalence to existing, legally marketed predicate devices. The document explicitly states:

"Functional and performance characteristics are demonstrated through equivalence with the predicate device and testing of representative device samples."

However, specific quantitative acceptance criteria (e.g., tensile strength > X, lubricity

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The VascuPuncture PICC Guidewire is indicated for percutaneous entry of peripheral vessies using the Seldinger technique. VascuPuncture Guidewires are not indicated for use in the coronary or cerebral vasculature.

The VascuPuncture™ PICC Guidewires are guidewires constructed of stainless steel and nickel titanium alloy with a lubricious coating. Devices are available in diameters of 0.014 and 0.018 inches and in lengths ranging from 45 to 145 cm.

The provided text describes a 510(k) premarket notification for the VascuPuncture™ PICC Guidewire with Hydro-Silk Coating. This is a medical device submission seeking clearance to market a new device by demonstrating its substantial equivalence to a legally marketed predicate device.

The study presented here is a substantial equivalence comparison, not a clinical study designed to test diagnostic or treatment efficacy. Therefore, many of the typical acceptance criteria and study design elements found in a clinical study (like multi-reader multi-case studies, ground truth establishment for a test set of patient data, training set information, etc.) are not applicable in this context.

Here's the breakdown based on the provided document:

1. Table of Acceptance Criteria and the Reported Device Performance

2. Sample Size Used for the Test Set and the Data Provenance

For a 510(k) submission like this, the "test set" typically refers to the physical devices manufactured and subjected to bench testing or material characterization. It does not refer to patient-level data.

• Sample Size for Bench/Performance Testing: The document states "testing of representative device samples." The exact number is not specified in the provided text.
• Data Provenance: The data comes from internal testing conducted by NeoMetrics, Inc. The location of the testing is not specified, but it would have been performed by the manufacturer or a contract laboratory. This is retrospective in the sense that the test results are generated for the purpose of the submission after product development. It is not patient data, so "country of origin of the data" in a clinical sense is not applicable.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable for this type of submission. "Ground truth" in the context of patient data adjudicated by experts is not relevant here. The "ground truth" for demonstrating substantial equivalence rests on objective engineering and scientific testing to prove that the device performs as intended and is safe, similar to the predicate. The FDA (specifically the Division of Cardiovascular Devices) evaluates the submitted data to determine if substantial equivalence has been met.

4. Adjudication Method for the Test Set

Not applicable in the sense of expert adjudication of clinical outcomes or images. The "adjudication" for this submission is the FDA's review process, where their experts evaluate the provided test data and comparisons to the predicate to determine substantial equivalence.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic devices where human readers interpret patient data (e.g., radiology images). This submission is for a guidewire, a physical interventional device, and the clearance is based on substantial equivalence to an existing device, not on comparative clinical effectiveness with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This submission is for a physical medical device (a guidewire), not a software algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on:

• Objective Engineering Standards and Bench Test Results: Performance characteristics (e.g., lubricity, tensile strength, kink resistance, coating integrity) are measured against established engineering standards and specifications.
• Biocompatibility Testing Results: Data from tests conducted according to recognized standards (e.g., ISO 10993 series) to confirm the new material's safety in contact with the body.
• Comparison to the Predicate Device: The established performance and safety profile of the legally marketed predicate device (VascuPuncture PICC Guidewire, K031652) serves as the primary benchmark.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of machine learning or AI algorithms for this type of physical device submission.

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

Not applicable. As a mechanical device, there is no training set for an algorithm described in this submission.

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The VascuPuncture PICC Guidewire is intended for percutaneous entry of peripheral vessels using the Seldinger Technique. VascuPuncture Guidewires are not intended for use in the coronary or cerebral vasculature.

The VascuPuncture PICC Guidewires are guidewires constructed of stainless steel and nickel titanium alloy with a lubricious coating. Devices are available in diameters of 0.014 and 0.018 inches and in lengths ranging from 45 to 145 cm.

The provided text describes a 510(k) submission for the VascuPuncture PICC Guidewire, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed acceptance criteria and a study demonstrating performance against those criteria in the same way a clinical trial for a new drug or novel device might.

Based on the provided text, the specific information requested in your prompt is not present for the following reasons:

• No detailed acceptance criteria or performance metrics are explicitly stated in the provided text. The submission aims to show substantial equivalence, implying that the device performs similarly to predicate devices rather than meeting a specific set of quantitative criteria.
• The "study" refers to bench testing, not a clinical trial with human subjects. Clinical studies, sample sizes for test/training sets, expert involvement, and ground truth establishment are not described.
• The document explicitly states "Functional and Safety Testing: Representative samples of the device underwent bench testing to demonstrate appropriate functional and performance characteristics compared to the predicate device." This indicates bench testing (in-vitro) was performed, not an in-vivo study involving human subjects or clinical data in the manner typically associated with the questions asked.

Therefore, I cannot provide a table of acceptance criteria and reported device performance using the information given, nor can I answer the questions regarding sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details because this type of information is simply not included in this 510(k) summary.

The conclusion of the 510(k) summary states: "The VascuPuncture PICC Guidewire modified as proposed in this submission, is substantially equivalent to the predicate devices. This conclusion is based upon the similarity in design, principles of operation, materials, and performance and of the modified device compared to the originally, cleared device."

This heavily implies that the "acceptance criteria" were met by demonstrating that the device's functional and safety characteristics (as evaluated through bench testing) were comparable to the predicate devices, thereby ensuring it met the same safety and effectiveness standards.

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