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The COREPASS FLEX/CONTROL microcatheters are indicated for:
· supporting and facilitating the placement of guidewires in the coronary and peripheral vasculature (not intended for neurovasculature).
· exchanging guidewires in the coronary and peripheral vasculature.
· the delivery of contrast media into the coronary, peripheral, and abdominal vasculature.

The COREPASS FLEX/ CONTROL microcatheters are singe lumen catheters, offered in two shaft sizes (2.2F and 2.5F) with working lengths of 135cm or 150cm, designed for use in coronary, peripheral, and abdominal vasculature. The COREPASS FLEX/CONTROL share identical shaft profile 2.5F (0.032'') but different distal profile, including 2.2F (0.028'') for the 2.2F configuration (COREPASS FLEX) and 2.5F (0.032'') for the 2.5F configuration (COREPASS CONTROL). The catheter consists of five sections: hub with a female luer connector, catheter body shaft, proximal section, distal section, and tip. The distal most 60cm of the outer surface is coated with a hydrophilic polymer to increase lubricity and the lumen of catheter is lined with a fluoropolymer to facilitate movement of the guidewire. The catheter is compatible with a standard 0.014 inch (0.36mm) guidewire.

The provided text is a summary of a 510(k) premarket notification for a medical device (COREPASS Modular Microcatheter) and does not contain information about a study that proves the device meets specific acceptance criteria in the context of an AI-powered diagnostic tool. The document focuses on the regulatory clearance process for a physical medical catheter device.

Therefore, I cannot extract the requested information regarding:

1. A table of acceptance criteria and the reported device performance (in the context of an AI device)
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth
4. Adjudication method
5. Multi-reader multi-case (MRMC) comparative effectiveness study
6. Standalone performance
7. Type of ground truth used
8. Sample size for the training set
9. How the ground truth for the training set was established

The "Performance Data" section in the document lists various physical and material-related tests conducted on the microcatheter (e.g., Sterilization, Shelf-Life Performance, Particulate Evaluation, Dimension Inspection, Media Flow Rate, Shaft Burst Pressure, Guidewire Compatibility, Coating Integrity, Flexibility and Kinking, Corrosion Resistance, Torque Strength, Tensile Strength, Radiopacity, and a range of Biocompatibility tests). It simply states:

"The test results of COREPASS Modular Microcatheter met all acceptance criteria, which are same or similar to the predicate device and reference device. It ensures that the design and construction of COREPASS Modular Microcatheter are suitable for its intended use."

This confirms that acceptance criteria exist for these physical properties and that the device met them, but the document does not elaborate on what those specific criteria are nor does it describe a study design in the way one would for an AI/software as a medical device (SaMD).

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The Sapphire NC ULTRA Coronary Dilatation Catheter is 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 Sapphire NC ULTRA Coronary Dilatation Catheter is designed to allow easy exchange of the catheter using a standard length 0.014 inch guidewire. Balloon diameters range from 1.75mm to 5.0mm. The balloon material is made of a minimally compliant material, 1.75mm to 4.0mm balloons have a rated burst pressure of 20 atmospheres, and 4.5mm to 5.0mm balloons have a rated burst pressure of 18 atmospheres. The minimally compliant balloon material allows high pressure dilatation while maintaining precise control of the balloon diameter and length. The proximal shaft of the catheter is composed of a female luer connector connected to a PTFE coated stainless steel tube. The proximal shaft allows superior proximal pushability and trackability with a smooth transition to a distal shaft. Two radiopaque platinum/iridium marker bands are located within the balloon segment. The guidewire enters the catheter tip and advances coaxially out the distal Rx port, thereby allowing both coaxial guidance and rapid exchange of catheter with a single standard-length guidewire. Two marked sections of 5mm length each located on the proximal shaft indicate catheter position relative to the tip of either a brachial or femoral guiding catheter.

The provided text is a 510(k) summary for the Sapphire NC ULTRA Coronary Dilatation Catheter. It outlines various performance tests conducted to establish substantial equivalence to a predicate device. However, it does not contain the specific level of detail required to fully answer all aspects of your request, particularly regarding clinical study design, expert qualifications, or detailed performance metrics against acceptance criteria.

Here's an attempt to answer your questions based on the available information:

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

The document states: "The test results met all acceptance criteria, which are the same or similar to the predicate device and ensure that the Sapphire NC ULTRA Coronary Dilatation Catheter design and construction are suitable for their intended use."

While it lists the types of tests performed, it does not provide a table with specific acceptance criteria or quantitative performance results for each test. For example, it lists "Balloon Rated Burst Pressure (in-stent)" as a test, but doesn't state what the accepted pressure was or what the device achieved.

Here's a generalized table based on the types of tests mentioned, but without specific numerical criteria or performance data:

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

The document describes in vitro performance tests and biocompatibility tests. This means the "test set" refers to material samples (e.g., catheter units, material extracts) used for these laboratory tests, not a clinical patient dataset.

• Sample Size: The document does not specify the sample size for the in vitro or biocompatibility tests.
• Data Provenance: Not applicable in the context of in vitro and biocompatibility testing. These are laboratory tests conducted on device components or finished products.

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 question is geared towards clinical studies involving human interpretation or pathology. Since the provided text only details in vitro and biocompatibility testing, there is no information about experts or their qualifications for establishing ground truth as would be required in a clinical setting. These tests typically follow standardized protocols and are evaluated by lab personnel, not medical experts establishing clinical ground truth.

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

Again, this question is relevant for clinical studies with human assessors. For the in vitro and biocompatibility testing described, adjudication methods like N+1 are not applicable. The results are typically quantitative measurements or observations against predefined pass/fail criteria according to established standards (e.g., ISO, FDA guidance).

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The device is an angioplasty catheter, not an AI software or a device that assists human readers in interpreting images. Therefore, this question is not applicable to the information provided.

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

This question is also not applicable. The Sapphire NC ULTRA Coronary Dilatation Catheter is a physical medical device, not an algorithm or software requiring standalone performance testing in that context.

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

For the in vitro performance tests, the "ground truth" is established by adherence to predefined engineering specifications, material properties, and performance benchmarks derived from industry standards (e.g., those in the "Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters").

For biocompatibility testing, the "ground truth" is established by compliance with international standards like ISO 10993-1, which define acceptable biological responses and safety profiles for medical device materials.

8. The sample size for the training set

This question is applicable to machine learning or AI models. Since the device is a physical medical catheter and the testing described is primarily in vitro and biocompatibility, there is no concept of a "training set" in this context.

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

As there is no training set for a physical medical device, this question is not applicable.

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The Sapphire ULTRA Coronary Dilatation Catheter (1.0-1.25mm configurations) is indicated for: balloon pre-dilatation of a stenotic portion of a coronary artery or bypass graft stenosis (≥70% stenosis) for the purpose of improving myocardial perfusion.

The Sapphire ULTRA Coronary Dilatation Catheter (1.5-4.0mm configurations) is 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 Sapphire ULTRA Coronary Dilatation Catheter is designed to allow easy exchange of the catheter using a standard length 0.014 inch guidewire. Balloon diameters range from 1.0mm to 4.0mm. The balloon material is made of the semi-compliant material with a rated burst pressure of 14 atmospheres. The proximal shaft of the catheter is composed of a female luer connector connected to a PTFE coated stainless steel tube. The proximal shaft allows superior proximal pushability with a smooth transition to a distal shaft composed of an outer tube and an inner tube with a balloon laser welded to both tubes at the distal tip. Two radiopaque platinum marker bands are located within the balloon segment (there is only one centrally located marker band for Ø1.0-1.5mm configurations). The guidewire enters the catheter tip and advances coaxially out the distal Rx port, thereby allowing both coaxial guidance and rapid exchange of catheter with a single standard length guidewire. Two marked sections, 5mm length each, located on the proximal shaft indicate catheter position relative to the tip of either a brachial or femoral guiding catheter.

The provided text is a 510(k) summary for the Sapphire ULTRA Coronary Dilatation Catheter. It outlines the device's description, indications for use, technological characteristics, and performance tests conducted to demonstrate substantial equivalence to predicate devices.

However, the provided document DOES NOT contain information regarding:

• Acceptance criteria for an AI/ML device. This document describes a medical device (a catheter), not an AI/ML diagnostic or prognostic tool. Therefore, there are no AI/ML specific acceptance criteria, study designs (like MRMC), or details about ground truth establishment as would be typically required for such devices.
• Study that proves the device meets AI/ML acceptance criteria. The performance tests listed are for the physical properties and biocompatibility of a medical catheter, not for the performance of an AI/ML algorithm.

Therefore, I cannot provide the requested information regarding AI/ML acceptance criteria and proof of performance. The document focuses on the physical and biological safety and efficacy of a coronary dilatation catheter, which is a hardware medical device.

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The JADE PLUS PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for postdilation of balloon expandable and self-expanding stents in the peripheral vasculature.

The JADE PLUS Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheters are designed for peripheral indications with Over-The-Wire (OTW) structure. The overthe-wire design permits the use of standard 0.014 inch, 0.018 inch and 0.035 inch guidewires respectively.

This document is a 510(k) summary for the JADE PLUS PTA Balloon Dilatation Catheter. It does not describe an AI/ML powered device, therefore the requested information for acceptance criteria and studies are not applicable in the context of an AI/ML device.

The document discusses the substantial equivalence of the JADE PLUS PTA Balloon Dilatation Catheter to a predicate device, based on in vitro performance tests. The acceptance criteria and reported device performance mentioned relate to physical properties and functionality of the catheter, not to an AI algorithm's performance or accuracy.

The relevant information from the document is related to the device's physical performance testing:

Acceptance Criteria and Reported Device Performance:

The document states that "The test results met all acceptance criteria, which are the same or similar to the predicate device and ensure that the JADE PLUS PTA Balloon Dilatation Catheter design and construction are suitable for their intended use."

The specific performance tests conducted and the general nature of their acceptance criteria are listed:

The study that proves the device meets acceptance criteria is an in vitro performance test study conducted on the subject device in accordance with FDA guidance "Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters" issued on April 14, 2023.

Given that this is a 510(k) summary for a physical medical device (balloon dilatation catheter) and not an AI/ML powered device, the following points are not applicable and therefore cannot be extracted from the provided text:

2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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The Teleport XT microcatheters are indicated for:

• supporting and facilitating the placement of guidewires in the coronary and peripheral vasculature.
• exchanging guidewires in the coronary and peripheral vasculature.
• the delivery of contrast media into the coronary, peripheral, and abdominal vasculature.

Teleport XT Microcatheter is a single lumen OTW catheter offered in one size (2.1F, distal OD) with working lengths of 90cm, 135cm or 150cm, designed for use in the coronary and peripheral vasculature. The shaft profile gradually changes from 2.8F (0.0370") to 2.1F (0.0280"). The catheter consists of five primary sections: hub, body shaft, proximal section, distal section, and a radiopaque tip. The distal most 60cm of the outer surface is coated with hydrophilic polymer to increase lubricity and the lumen of the catheter is lined with fluoropolymer to facilitate movement of the guidewire. The catheter is compatible with a standard 0.014-inch (0.36mm) guidewire.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "Teleport XT Microcatheter." This document does not contain information about acceptance criteria and study results for an AI/ML device. Instead, it outlines the regulatory approval process for a physical medical device.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and study details for an AI/ML device based on the provided text. The document discusses performance data for a microcatheter, which includes physical tests such as:

• Sterilization
• Shelf-Life Performance Testing
• Particulate Evaluation
• Visual Inspection
• Dimension Inspection
• Media Flow Rate
• Simulated Use
• Vacuum Leakage
• Shaft Burst Pressure
• Guidewire Compatibility
• Coating Integrity
• Flexibility and Kinking
• Corrosion Resistance
• Torque Strength
• Tensile
• Radiopacity
• Pouch Integrity
• Pouch Burst
• Seal Strength

The document states: "The Teleport XT microcatheter test results met all acceptance criteria and were similar to the predicate and reference devices." However, it does not detail what those specific acceptance criteria were or provide the reported performance values. It also does not discuss any of the AI/ML specific criteria you requested (sample sizes for test/training sets, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance).

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The Sapphire NC 24 Coronary Dilatation Catheter is 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 Sapphire NC 24 Coronary Dilatation Catheter is designed to allow easy exchange of the catheter using a standard length 0.014 inch guidewire. Balloon diameters range from 1.5mm to 5.0mm. The balloon material is made of a minimally compliant material, 1.5mm to 3.5mm balloons have a rated burst pressure of 24 atmospheres, 3.75mm to 4.0mm balloons have a rated burst pressure of 22 atmospheres and 4.5mm to 5.0mm balloons have a rated burst pressure of 20 atmospheres. The minimally compliant balloon material allows high pressure dilatation while maintaining precise control of the balloon diameter and length. The proximal shaft of the catheter is composed of a female luer connector bonded to a PTFE coated stainless steel tube. The proximal shaft allows for superior pushability and trackability with a smooth transition to a distal shaft. Two radiopaque platinum/iridium marker bands are located within the balloon segment with the exception of 1.5mm balloon diameter which incorporate a centrally positioned single marker band. The guidewire enters the catheter tip and advances coaxially out the distal Rx port, thereby allowing both coaxial guidance and rapid exchange of catheter with a single standard length guidewire. Two marker sections of 5mm length each located on the proximal shaft indicate catheter position relative to the tip of either a brachial or femoral guiding catheter.

The Sapphire NC 24 Coronary Dilatation Catheter demonstrated substantial equivalence to its predicate devices through various performance tests. Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

• 1.5mm to 3.5mm balloons: 24 atmospheres
• 3.75mm to 4.0mm balloons: 22 atmospheres
• 4.5mm to 5.0mm balloons: 20 atmospheres | All acceptance criteria met. |
  | Balloon Fatigue | Not explicitly stated, but implied to withstand repeated inflations/deflations. | All acceptance criteria met. |
  | Balloon Compliance | Not explicitly stated, but implied to maintain precise control of balloon diameter and length under high pressure. | All acceptance criteria met. |
  | Balloon Inflation and Deflation Time | Not explicitly stated, but implied to be within acceptable clinical limits. | All acceptance criteria met. |
  | Catheter Bond Strength | Not explicitly stated, but implied to ensure structural integrity. | All acceptance criteria met. |
  | Tip Pull Strength | Not explicitly stated, but implied to ensure secure attachment of the tip. | All acceptance criteria met. |
  | Flexibility and Kink | Not explicitly stated, but implied to allow for smooth navigation through coronary arteries without kinking. | All acceptance criteria met. |
  | Torque Strength | Not explicitly stated, but implied to allow for effective manipulation by the user. | All acceptance criteria met. |
  | Marker Band Radiopacity | Not explicitly stated, but implied to allow for clear visualization under fluoroscopy. | All acceptance criteria met. |
  | Coating Integrity | Not explicitly stated, but implied to ensure smooth passage and minimize friction. | All acceptance criteria met. |
  | Particulate Evaluation | Not explicitly stated, but implied to be below harmful levels. | All acceptance criteria met. |
  | Balloon Rated Burst Pressure (in-stent) | Not explicitly stated, but implied to perform as expected within a stent. | All acceptance criteria met. |
  | Balloon Fatigue (in-stent) | Not explicitly stated, but implied to maintain integrity within a stent. | All acceptance criteria met. |
  | Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute systemic toxicity, Hemocompatibility, Pyrogenicity, Genotoxicity) | Per ISO 10993-1 standards for biological evaluation of medical devices. | All acceptance criteria met. |
  | Packaging and Sterilization Validation | Not explicitly stated, but implied to maintain sterility and device integrity throughout shelf life. | All acceptance criteria met. |
  | Shelf Life | Not explicitly stated, but implied to maintain device performance over a specified period. | All acceptance criteria met. |

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

The document does not explicitly state the specific sample sizes used for each individual performance test. The tests were conducted on the "subject device," implying representative samples of the Sapphire NC 24 Coronary Dilatation Catheter.

The data provenance is not specified, but given that OrbusNeich Medical (Shenzhen) Co., Ltd is located in China, it is highly probable that the testing was conducted in laboratories within China. The study appears to be retrospective in the sense that these tests were performed on finished devices to demonstrate their compliance with pre-defined standards.

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

This information is not applicable to this type of device and study. The testing described is primarily physical, chemical, and biological performance testing of a medical device, not a diagnostic or AI-driven system that would require expert-established ground truth. The acceptance criteria for these tests are typically based on engineering standards, regulatory guidelines (like FDA guidance and ISO standards), and internal design specifications, not expert consensus on interpretations of data.

4. Adjudication Method for the Test Set

This information is not applicable as the study involves objective performance testing against predefined criteria, not subjective interpretations requiring adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially those involving image interpretation or clinical decision support AI), but not for a physical medical device like a coronary dilatation catheter.

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

No, a standalone algorithm performance study was not done. This study is focused on the physical and biological performance of a medical catheter, not an algorithm.

7. The type of Ground Truth Used

The "ground truth" for this study is established through:

• Engineering and Design Specifications: The device is designed to meet specific physical dimensions, pressures, and other performance characteristics.
• Regulatory Guidance: Adherence to FDA guidance documents (e.g., "Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters") dictates many of the required performance tests and implied acceptance criteria.
• International Standards: Compliance with ISO standards (e.g., ISO 10993-1 for biocompatibility) provides the framework and acceptance criteria for biological safety.
• Predicate Device Performance: The subject device's performance is compared against the known performance characteristics of the predicate device (Sapphire NC Plus Coronary Dilatation Catheter) and reference device (Sapphire II Pro Coronary Dilatation Catheter) to establish substantial equivalence.

8. The Sample Size for the Training Set

There is no training set for this study. This is not a machine learning or AI-driven device. The term "training set" is not applicable to the performance testing of a physical medical device.

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

As there is no training set, this question is not applicable.

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The JADE PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilation of balloon expandable and self-expanding stents in the peripheral vasculature.

The JADE Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheters are designed for peripheral indications and include both Rapid Exchange (RX) and Over-The-Wire (OTW) designs. The over-the-wire design permits the use of standard 0.018 inch and 0.035 inch guidewires respectively (hereafter referred to as 18 OTW version and 35 OTW version), and the rapid exchange design permits the use of standard 0.018 inch guidewires (hereafter referred to as 18 RX version) as shown in Table 1 below. The JADE PTA balloon dilatation catheter is made of a minimally compliant material with a rated burst pressure of 16 atmospheres for 7.0mm diameters, 18 atmospheres for 4.5-6.0mm diameters and 20 atmospheres for 1.5-4.0mm diameter. Two radiopaque marker bands (Platinum/Iridium) are positioned within the balloon shoulder, and for balloons of working length 180-240mm, two more marker bands (four marker bands in total) are positioned in the middle of the balloon. A hydrophilic lubricious coating is applied to the outside surface of distal section of the catheter. A Silicone coating is applied to wire lumen surface.

The provided text describes a 510(k) submission for a medical device, the JADE PTA Balloon Dilatation Catheter, and its performance testing to demonstrate substantial equivalence to a predicate device. However, it does not pertain to an Artificial Intelligence/Machine Learning (AI/ML) device.

Therefore, the information required to answer the question about the acceptance criteria and study proving an AI/ML device meets those criteria, specifically concerning data provenance, expert ground truth, MRMC studies, or standalone algorithm performance, is not present in the provided document.

The document focuses on in vitro performance tests and biocompatibility tests for a physical medical device (a balloon catheter), not a software-driven diagnostic or AI-assisted system.

Specifically, the document lists performance tests such as:

• Visual Inspection
• Dimensional Verification
• Balloon Preparation, Deployment, and Retraction
• Balloon Rated Burst Pressure (including in-stent)
• Balloon Fatigue (including in-stent)
• Balloon Compliance
• Balloon Inflation and Deflation Time
• Catheter Bond Strength
• Tip Pull Strength
• Flexibility and Kink
• Torque Strength
• Marker Band Radiopacity
• Coating Integrity
• Particulate Evaluation

And biocompatibility tests:

• Cytotoxicity
• Intracutaneous reactivity
• Sensitization
• Acute systemic toxicity
• Hemocompatibility (Hemolysis, Complement activation, Partial thromboplastin time, Platelet and leukocyte counts, In vivo thromboresistance)
• Pyrogenicity
• Genotoxicity (bacterial mutagenicity test, in vitro mouse lymphoma Assay)

It concludes that "The test results met all acceptance criteria," but it does not specify what those numerical criteria were, only the types of tests performed. It certainly does not provide any details related to AI/ML device validation.

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The Jade PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, poplited, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilation of balloon expandable and self-expanding stents in the peripheral vasculature.

The JADE PTA Balloon Dilatation Catheters is now also available as an over-the-wire balloon catheter for peripheral indications. The balloon diameters range from 1.5mm to 6.0mm and balloon lengths range from 20mm to 240mm, with 90cm, 150cm and 200cm catheter lengths. The balloon material is made of a minimally compliant material with a rated burst pressure of 18 atmospheres for 5.0-6.0mm and 20atm for 1.5-4.0mm. Hydrophilic lubricious coatings are applied to the distal section of the catheter. The shaft of the catheter is composed of a proximal shaft and a distal shaft. The distal shaft is composed of a distal outer tube and tri-extrusion inner tube with a balloon welded to both tubes at the distal tip to aid in tracking through vasculature. The proximal shaft is composed of a proximal outer tube and tri-extrusion inner tube that are bonded to a female luer connector, with the proximal outer tube allowing for proximal pushability with a smooth transition to the distal shaft. The inner lumen of the catheter accepts a maximum 0.014 inch (0.36mm) guidewire. The guidewire enters the catheter tip and advances coaxially out the hub guidewire lumen. Two radiopaque marker bands are positioned within the balloon shoulder, and for balloons of working length 180-240mm, two more marker bands (four marker bands in total) are positioned in the middle of the balloon. One marked section, for the 90cm catheter working length, or two marked sections, for the 150cm and 200cm catheter working lengths, are located on the proximal shaft to indicate catheter position relative to the tip of the guiding catheter or introducer sheath. The Y-type hub is bonded on the proximal end of the catheter at the entrance to the inflation lumen and the guidewire lumen. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.

The provided text describes the 510(k) summary for the Jade PTA Balloon Dilatation Catheter, which is a medical device. This type of submission is for proving "substantial equivalence" to a legally marketed predicate device, rather than proving that an AI/algorithm-based device meets specific performance criteria.

Therefore, the document does not contain the information requested regarding acceptance criteria and the study that proves an AI/algorithm device meets those criteria. The provided text details performance testing for a physical medical device (a balloon catheter) to demonstrate its safety and effectiveness, and its equivalence to a predicate catheter.

Specifically, the document does not address any of the following points relevant to an AI/algorithm-based device study:

• 1. A table of acceptance criteria and the reported device performance (for an AI/algorithm)
• 2. Sample sized used for the test set and the data provenance
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
• 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
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
• 8. The sample size for the training set
• 9. How the ground truth for the training set was established

The performance data mentioned in the document (Visual Inspection, Marker Band Radiopacity, Dimensional Verification, etc.) are all related to the physical characteristics and functionality of the balloon catheter, not an AI algorithm.

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