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The ValvuloPro® Valvuloplasty Balloon Catheter is indicated for balloon aortic valvuloplasty.

The ValvuloPro® Valvuloplasty Balloon Catheters are indicated for balvoon aortic valvuloplasty. It consists of an inflatable balloon on a catheter shaft with multiple lumens for inflation. The effective length of the catheter is 130cm. The y-connector consists of a balloon inflation port and a guidewire lumen. Two radiopaque tantalum marker bands are positioned within the balloon shoulders to provide visual reference points fluoroscopically for balloon positioning within the stricture. The balloon catheter is supplied sterilized by ethylene oxide (EO) for single use.

The provided document is a 510(k) Summary for the ValvuloPro Valvuloplasty Balloon Catheter. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing rather than clinical studies or AI/software performance. Therefore, many of the requested categories related to AI/software performance, clinical studies, and ground truth establishment are not applicable.

Here's the breakdown of the information available in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists various non-clinical tests conducted and states that "All tests were passed" for each category. It does not provide specific numerical acceptance criteria or detailed performance metrics. Instead, it refers to compliance with established standards (e.g., ISO, internal technical requirements).

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

• Test set sample size: Not explicitly stated for each test. The document mentions "Relevant testing was conducted on samples before and after aging to establish device shelf life," indicating multiple samples were used for performance tests.
• Data provenance: Not explicitly stated, but the tests are non-clinical, likely conducted in a controlled lab environment by the manufacturer (Dongguan TT Medical, Inc.) or their contracted labs. It is all prospective testing of the manufactured device.

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

• Not applicable. This section pertains to clinical studies or expert review of data for AI/software validation. The document describes non-clinical performance and biocompatibility testing against defined standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable. This is relevant for clinical studies or expert consensus on clinical data. Non-clinical tests follow defined protocols and yield objective results.

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 a physical medical device (balloon catheter), not an AI/software product that assists human readers.

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

• Not applicable. This device is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not applicable. For this type of device, "ground truth" refers to established engineering standards, material properties, and biological safety parameters defined in international standards (e.g., ISO 10993, ISO 11135, ISO 11607) and internal technical specifications. The device's performance is measured against these objective criteria rather than expert consensus on clinical cases.

8. The sample size for the training set:

• Not applicable. This refers to machine learning models.

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

• Not applicable. This refers to machine learning models.

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The VesPenetrator®, VesTraveler® Coronary Dilatation Balloon Catheters are indicated for:
· balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion
· balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction

The VexPander® Coronary Dilatation Balloon Catheters are indicated for:
· balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion
· balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction
· in-stent restenosis
· post-delivery expansion of balloon expandable coronary stents

The Coronary Dilatation Balloon Catheter (VesPenetrator®, VesTraveler® and VexPander®) is a percutaneous transluminal coronary angioplasty (PTCA) is indicated for balloon dilatation of the stenotic portion of a coronary artery. Balloon diameters ranged from 1.5mm to 4.0mm. The balloon is made of Nylon material with a rated burst pressure of 16 atmospheres (atm) for both VesPenetrator and VesTraveler, and 18atm for VexPander. The proximal shaft of the catheter is composed of a female luer connector bonded to a PTFE coated stainless steel tube. The proximal shaft joins with a smooth transition to a distal shaft composed of an outer tube of nylon or Pebax and a tri-extrusion inner tube with a balloon welded to both tubes at the distal tip. Two radiopaque platinum marker bands are positioned within the balloon shoulders. The inner tube accepts a standard 0.014 inch guidewire. The guide wire enters the catheter's tip and advances coaxially out the distal Rx port, thereby allowing both coaxial guidance and rapid exchange of catheter with a single standard length guide wire. Two marked sections of 5mm length each located on the proximal shaft indicate catheter position relative to the tip of the brachial artery or the guide tube of the femoral artery.

The provided text is a 510(k) Summary for a medical device (Coronary Dilatation Balloon Catheters). It describes the device, its intended use, comparison to predicate devices, and the performance data that supports its substantial equivalence. However, this document does not contain information about an AI-based device or a study that involves human readers, ground truth establishment by experts, or MRMC studies.

The "Performance Data" section (Page 5 and 6) lists various non-clinical engineering tests performed on the balloon catheters (e.g., balloon inflation/deflation time, bond strength, flexibility, etc.) and biocompatibility testing. These are physical tests to ensure the device performs as expected and is safe for use in the human body.

Therefore, I cannot provide the requested information regarding AI device acceptance criteria, expert ground truth, MRMC studies, or training/test set details because this document does not pertain to an AI/ML medical device.

Here's why the requested information cannot be extracted from the provided text:

• No AI Device: The device described (Coronary Dilatation Balloon Catheter) is a physical medical instrument, not a software or AI-driven diagnostic/assistive tool.
• No AI-Specific Acceptance Criteria: The acceptance criteria mentioned relate to the physical and functional performance of the catheter (e.g., burst pressure, flexibility), not AI performance metrics like sensitivity, specificity, AUC, or concordance with human readers.
• No Human Readers/Experts: There is no mention of a study involving human readers (e.g., radiologists, cardiologists) or experts establishing ground truth for diagnostic purposes. The "experts" in this context would likely be engineers or quality control personnel evaluating the physical device.
• No MRMC Study: An MRMC (Multi-Reader Multi-Case) study is specific to evaluating the impact of AI on human diagnostic performance. This is not applicable here.
• No Training/Test Sets: The concepts of training sets and test sets are relevant to machine learning model development and evaluation, which is not described. The "testing" mentioned is laboratory testing of the physical catheter.
• No Ground Truth for AI: The "ground truth" for a physical device is its engineered specifications and performance under defined conditions, not "expert consensus" or "pathology" in the context of an AI-driven diagnosis.

In summary, the provided document relates to the regulatory clearance of a physical medical device (coronary balloon catheter) through substantial equivalence, based on engineering and biocompatibility testing, not an AI/ML device.

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The MultiStage Balloon Dilatation Catheters are indicated for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract. Also indicated in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy.

The MultiStage Balloon Dilatation Catheters are indicated for use to endoscopically dilate strictures of the alimentary tract and the Sphincter of Oddi with or without prior sphincterotomy. It consists of an inflatable balloon on a catheter shaft with multiple lumens for inflation and passage of a guidewire. The MultiStage balloon is designed with three-in-one technology and provides successive, gradual dilation of strictures. The balloon is made of Pebax material. The MultiStage Balloon Dilatation is designed to pass over a 0.035in (0.89mm) guidewire through its guidewire lumen or through an minimum working channel of a 2.8mm alimentary tract, or a 3.7mm biliary tract. The hub is made of polycarbonate (PC). Two radiopaque tantalum marker bands are positioned within the balloon shoulders to provide visual reference points fluoroscopically for balloon positioning within the stricture. Accordingly, product models, are divided into those with a wireguided (MSW) and non-wireguided (MSO) component. The MSW model allows the guidewire and catheter to be introduced into the endoscope together. The MSO model as a traditional operation method, the guidewire is first inserted into the endoscope for positioning and then the catheter is inserted through the guidewire for good passability. The physician can choose the model as needed.

The provided text is a 510(k) summary for a medical device called the "MultiStage Balloon Dilatation Catheter." This document describes the device, its intended use, and its comparison to a predicate device to establish substantial equivalence for regulatory clearance. It does not contain information about an AI/ML algorithm or a study proving that an AI/ML device meets acceptance criteria.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance for an AI/ML device.
2. Sample sizes or data provenance for an AI/ML test set.
3. Number of experts or their qualifications for establishing ground truth for an AI/ML test set.
4. Adjudication method for an AI/ML test set.
5. MRMC comparative effectiveness study results for an AI/ML device.
6. Standalone performance of an AI/ML algorithm.
7. Type of ground truth used for an AI/ML study.
8. Sample size for the training set of an AI/ML algorithm.
9. How the ground truth for an AI/ML training set was established.

The document focuses on the non-clinical testing of a physical medical device (balloon catheter), which includes:

• Biocompatibility testing (Cytotoxicity, Sensitization, Intracutaneous reactivity test)
• Shelf life testing
• Sterilization validation
• Performance characteristics (Visual Inspection, Bacteriostasis performance of pouch, Dye penetration, Tension test, Guidewire compatibility, Channel compatibility, Product Dimensional Inspection, Compliance, Balloon fatigue, Balloon rated burst pressure (RBP), Peak tensile, Kink resistance, Leakage Test, Hydratability, Hub Corrosion resistance, X-ray detectability, Chemical properties).

All of these non-clinical tests were reported to have "passed." The document explicitly states: "No clinical study is included in this submission."

For an AI/ML-based medical device, the information you requested would typically be found in sections detailing performance studies, often referred to as "clinical performance" or "algorithm performance" studies, which are absent here.

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MultiStage balloon dilatation catheter is intended to be used to dilate strictures located in the airway tree.

The MultiStage Balloon Dilatation Catheter is intended to be used endoscopically to dilate strictures of the airway tree. Balloons designed with three-in-one technology and provides successive, gradual dilation of strictures. The balloon material is made of Pebax material. The MultiStage Balloon Dilatation Catheter designed to pass over a 0.035in (0.89mm) guidewire through its guidewire lumen or through a minimum 2.8mm working channel bronchoscope. The Catheter hub is made of polycarbonate (PC). Two radiopaque tantalum marker bands are positioned within the balloon shoulders to provide visual reference points fluoroscopically for balloon positioning within the stricture.

This document is a 510(k) Summary for a medical device called the "MultiStage Balloon Dilatation Catheter." It is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. As such, it does not describe specific acceptance criteria and a study proving the device meets those criteria in the way one might expect for a novel AI/software device.

Instead, the document focuses on demonstrating that the proposed device is "substantially equivalent" to a predicate device. This is achieved by showing similar intended use, technological characteristics, and principles of operation, and by performing non-clinical tests to ensure safety and effectiveness.

Here's an attempt to extract the requested information, understanding that it will be framed within the context of substantial equivalence rather than a direct performance study against defined acceptance criteria for, for example, a diagnostic accuracy claim:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly state "acceptance criteria" in terms of specific quantitative thresholds to be met for diagnostic performance (as would be typical for an AI/software device making a diagnostic claim). Instead, the "acceptance criteria" are implied by the standards and performance characteristics tested for a physical medical device, and the "reported device performance" is that the device passed these tests and is considered "safe and effective."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document lists "non-clinical tests" which include physical, chemical, and biological performance testing of the device and its components. The sample sizes for these specific engineering and biocompatibility tests are not disclosed in this summary. The data provenance is primarily from laboratory testing of the manufactured device. There is no mention of patient data or its origin.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to this type of submission. The device is a physical medical instrument, not a diagnostic AI/software that requires expert-established ground truth from clinical data. The "ground truth" for the non-clinical tests is established by adherence to recognized international standards (e.g., ISO, ASTM) and engineering principles.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human readers/interpreters to establish a consensus ground truth for diagnostic decisions. This submission focuses on non-clinical performance and substantial equivalence to a predicate device.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices, not for a physical balloon dilatation catheter.

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

This refers to AI/software performance. The device is a physical catheter, so a "standalone" algorithm performance study is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests, the "ground truth" is defined by the specifications, requirements, and methods outlined in the referenced international standards (e.g., ISO 10993-1 for biocompatibility, ASTM F1980 for shelf life, ISO 11135 and ISO 11607-1 for sterilization). There is no clinical ground truth involving patient outcomes or expert consensus for this type of submission.

8. The sample size for the training set

This is not applicable. The device is a physical medical instrument, not an AI/software device that requires a training set for model development.

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

This is not applicable as there is no training set for a physical medical device.

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