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An intravascular diagnostic catheter is a device used to record intracardiac pressure, to sample blood, and to introduce substances into the heart and vessels.

The 4F SiteSeer (II) catheter is an intravascular diagnostic catheter for use in the cardiovascular system.

The provided text is a 510(k) summary for the AVE 4F SiteSeer (II) Cardiovascular Angiographic Catheter. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel performance against specific acceptance criteria in a clinical study for an AI-powered device. Therefore, much of the requested information regarding AI device evaluation (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies) is not applicable or present in this document.

However, I can extract information related to the device's technical performance and the studies conducted to show substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" in the way an AI device might have for diagnostic accuracy. Instead, it details performance testing done to show substantial equivalence to predicate devices. The "reported device performance" are the results demonstrating this equivalence.

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

This information is not applicable as this is a traditional medical device (catheter) submission, not an AI/ML device, and no "test set" of patient data was used in the context of an AI study. The "testing" referred to are engineering and biocompatibility tests on the physical catheter.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as ground truth in the context of diagnostic accuracy is not relevant for this type of device submission. Expert judgment might have been involved in establishing test protocols or assessing results for mechanical properties, but this is not detailed as "ground truth" for a test set.

4. Adjudication Method for the Test Set

This information is not applicable. See Point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

This information is not applicable. This is not an AI-assisted diagnostic device, so no MRMC study was conducted.

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

This information is not applicable. This is not an AI algorithm.

7. The Type of Ground Truth Used

This information is not applicable in the context of diagnostic performance. The "ground truth" for the device's performance would be the objective measurements from the engineering and biocompatibility tests compared against established standards or predicate device performance.

8. The Sample Size for the Training Set

This information is not applicable. This is a physical device, not an AI/ML algorithm requiring a training set.

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

This information is not applicable. See Point 8.

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AVE guide wires are steerable guide wires that are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion. AVE guide wires are not intended for use in the cerebral vasculature. AVE steerable exchange wires are used to facilitate the substitution of one diagnostic or interventional device for another.

The GT1 Floppy, GT1 Hi-Per Flex, and GT1 Light Support Guide Wires are steerable guide wires that are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion. The GT1 Floppy, GT1 Hi-Per Flex, and GT1 Light Support Guide Wires are not intended for use in the cerebral vasculature.

The provided text describes a 510(k) submission for the GT1 Guide Wires, comparing them to the predicate Commander Series guide wires. The submission focuses on demonstrating substantial equivalence, primarily through material changes and subsequent bench testing and biocompatibility assessments, rather than clinical studies or evaluations of diagnostic accuracy typically associated with AI/ML devices. Therefore, much of the requested information (e.g., sample size for test set, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable here.

Here's an analysis of the provided text based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a formal table of specific acceptance criteria with numerical targets and corresponding performance values in the way one might expect for a diagnostic or AI device. Instead, it states that the GT1 guide wires were evaluated against the "performance requirements" of their Commander Series counterparts and that their performance was either:

• Statistically equivalent to
• Better than
• Between the performances of the currently sold Commander Series guide wire counterparts
• Or was found to meet specification (i.e. the performance was clinically acceptable) in every case.

For biocompatibility, the acceptance criterion was "biocompatible."

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

The document mentions "bench testing" was conducted on the GT1 Floppy and GT1 Hi-Per Flex guide wires as "representative samples." It does not specify the exact sample size (number of guide wires tested, or number of tests performed per guide wire) used for this bench testing.

• Data Provenance: The testing was "bench testing," meaning it was conducted in a laboratory setting, not with human or animal subjects. The origin of the data is internal to the manufacturer (Arterial Vascular Engineering Massachusetts, Inc.). The data is prospective in the sense that the tests were conducted specifically for this submission, but it's not a clinical trial.

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

This information is not applicable as the study was not a clinical or diagnostic study involving human subjects or expert interpretations. The "ground truth" for mechanical properties would be defined by the physical measurements and established engineering standards, rather than expert consensus on medical images or diagnoses. Biocompatibility assessment relies on standardized laboratory tests.

4. Adjudication Method for the Test Set:

This information is not applicable as the study was not a clinical or diagnostic study requiring adjudication of expert opinions.

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:

This information is not applicable as the device is a guide wire, not an AI/ML diagnostic or assistive tool, and no MRMC study was conducted.

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

This information is not applicable as the device is a guide wire, not an AI algorithm. Its performance is inherently "standalone" in its mechanical function, but this is not the context of AI standalone performance.

7. The Type of Ground Truth Used:

• Mechanical Performance: The ground truth for mechanical performance was based on established performance requirements and specifications for guide wires, and comparative measurements against the predicate Commander Series guide wires. This is analogous to engineering specifications and comparative testing.
• Biocompatibility: The ground truth for biocompatibility was established through standardized biocompatibility testing conducted according to recognized protocols (mentioned in NAMSA reports in Appendix 1, though not detailed in the provided text). This is based on scientific assay results.

8. The Sample Size for the Training Set:

This information is not applicable as the device is a guide wire and does not involve AI/ML requiring a training set.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable as the device does not involve AI/ML requiring a training set.

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The AVE Bridge™ Stent System is intended for use in patients to maintain patency of a biliary duct which is occluded by tumor. The AVE Bridge™ Stent System is indicated for palliative treatment of biliary duct strictures caused by malignant tumors. This device is not intended for intravascular use.

The AVE Bridge™ Stent System consists of a balloon-expandable intraluminal stent premounted onto the balloon of an over-the-wire delivery catherer. The AVE Bridge™ Stent System has two radiopaque platinum markers imbedded in the inner shaft (at each end of the stent) to aid in the placement of the stent during fluoroscopy. The delivery system is compatible with 0.035" guidewires and has a useable length of 75 cm to 90 cm. The AVE Bridge™ Stent System is provided enclosed in a sterile package.

The provided text describes a 510(k) premarket notification for the AVE Bridge™ Stent System, focusing on demonstrating substantial equivalence to a predicate device, the PALMAZ™ Balloon-Expandable Stent. The document details performance testing conducted to support this claim, rather than establishing new acceptance criteria or proving the device meets those criteria in a de novo fashion.

Here's an analysis of the provided information relative to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define acceptance criteria in terms of specific thresholds for the AVE Bridge™ Stent. Instead, the "acceptance criteria" for the studies were to demonstrate substantial equivalence to the predicate device (PALMAZ™ Balloon-Expandable Stent). The reported device performance is presented as a comparison to this predicate.

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

The document does not specify the sample sizes used for any of the non-clinical performance tests (Balloon Performance, Two Plane Crush Strength, Dimensional Verification).
The data provenance is industrial testing conducted by Arterial Vascular Engineering, Inc. and is retrospective to the submission date. There is no mention of country of origin for data; it's implied to be from the manufacturer's testing in the USA.

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

This information is not provided in the document. The studies are non-clinical, mechanical performance tests, not studies requiring expert interpretation or ground truth establishment in the medical sense (e.g., diagnosis from imaging).

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided, as the tests are non-clinical mechanical performance tests, not clinical studies requiring adjudication of outcomes or interpretations.

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

This information is not applicable and therefore not provided. The submission is for a medical device (stent) based on non-clinical performance testing for substantial equivalence, not an AI or imaging diagnostic device that would typically involve MRMC studies.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable and therefore not provided. The AVE Bridge™ Stent System is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

For the Balloon Performance Study and Two Plane Crush Strength Study, the "ground truth" was essentially the performance of the predicate device (PALMAZ™ Balloon-Expandable Stent), against which the AVE Bridge™ Stent was compared for substantial equivalence in mechanical properties.
For the Dimensional Verification and Stent Uniformity at Nominal Deployment study, the "ground truth" was the labeled specifications for stent diameter and stent length.

8. Sample Size for the Training Set

This information is not applicable and therefore not provided. As noted, this is a physical medical device, not an AI model, and therefore does not have a "training set" in the context of machine learning. The non-clinical performance studies are akin to validation/test sets for mechanical properties.

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

This information is not applicable and therefore not provided, as there is no "training set" in this context.

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