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The PTA balloon dilatation catheter is indicated for the percutaneous transluminal angioplasty (PTA) of the peripheral vascular system, including the iliac, femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The 0.0180" PTA balloon dilatation catheter is mainly composed of tip tube, inner tube, balloon, marker bands, outer tube, stress release tube and hub. Among them the balloon is the most important part of the catheter. In order to dilate different stenosis, the balloon should be dilated to difference dimension by inflating different pressure. The soft tip at the end of the balloon is to make the balloon catheter more easily to push to the stenosis position. The inner tubing which connects to the tip tubing is for guide wire passage and the pushing road. The two marker bands which wrapping on the inner tubing are for positioning the balloon location by cooperating in vitro monitoring equipment. The distal of the outer tube is connected with the balloon by a variable-diameter stretching structure, which can make the balloon get smaller winding diameter. The proximal of the outer tube is connected with the hub as the inflation passage and the pushing shaft. The hub is for connecting the outer pressure filling equipment. The stress release tubing is for protecting the outer tube from bending. The outer surface of the catheter is coated with a hydrophilic coating that ranges 400mm in length from the tip tube to the proximal end of the balloon, including part of the outer tube.

The provided text describes a 510(k) premarket notification for a PTA Balloon Dilatation Catheter. It outlines the device's characteristics, its comparison to a predicate device, and the performance data used to demonstrate substantial equivalence. However, it does not involve an AI/ML powered device, therefore no information about AI/ML specific aspects likes performance data, sample sizes for training/testing, ground truth establishment, or expert involvement for ground truth creation.

Here's the information based on the provided text, with "N/A" for criteria not applicable to this type of device submission:

Acceptance Criteria and Device Performance Study

The submission demonstrates substantial equivalence for the PTA Balloon Dilatation Catheter to a legally marketed predicate device (SABER .018 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter, K133843). The acceptance criteria are based on meeting performance standards primarily through bench testing and biocompatibility assessments, ensuring the device is suitable for its intended use and does not raise new questions of safety or effectiveness compared to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

The general acceptance criteria are that the device's design and construction are suitable for its intended use, and its performance is equivalent to the predicate device, as recommended by the draft Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions (FDA; January 13, 2020). Specific acceptance criteria were applied to each bench test listed below.

Specific Bench Tests Conducted:

• Visual inspection
• Dimensional verification
• Hydration test
• Leakage test
• Balloon inflation and deflation time
• Balloon fatigue
• Radiopacity
• Simulated use test/guidewire and introducer sheath compatibility test
• Tip pull strength
• Catheter bond strength
• Torque strength
• Balloon rated burst pressure
• Balloon compliance
• Catheter body burst pressure
• Flexibility and kinking
• Coating integrity
• Particulate evaluation
• Infusion flow rate
• Corrosion resistance test
• Packaging performance Test (Visual inspection, Sealing strength, Sealing integrity, Sterility)
• Shelf life testing

Specific Biocompatibility Tests Conducted:

• Cytotoxicity
• Sensitization
• Intracutaneous reactivity
• Acute systemic toxicity
• Hemocompatibility (hemolysis, partial thromboplastin time, complement activation, and in vivo thromboresistance)
• Material-mediated pyrogenicity

All these tests "met all acceptance criteria."

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

The document indicates that bench testing and biocompatibility testing were performed. However, it does not specify the exact sample sizes used for each of these tests.

Data Provenance: Not explicitly stated, but typically, these tests are conducted under controlled laboratory conditions by the manufacturer or a contracted testing facility.

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

N/A. This is a medical device (PTA Balloon Dilatation Catheter) submission, not an AI/ML device. Ground truth is established through physical and chemical testing against engineering specifications and industry standards, not expert annotation of data.

4. Adjudication method for the test set

N/A. This is a medical device (PTA Balloon Dilatation Catheter) submission, not an AI/ML device. The "acceptance criteria" are based on quantitative measurements from bench and biocompatibility tests.

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

N/A. This is a medical device (PTA Balloon Dilatation Catheter) submission, not an AI/ML device. Therefore, no MRMC study or AI assistance evaluation was conducted.

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

N/A. This is a medical device (PTA Balloon Dilatation Catheter) submission, not an AI/ML device.

7. The type of ground truth used

The "ground truth" for this device is based on established engineering specifications, industry standards (e.g., ISO 10993-1 for biocompatibility), and performance benchmarks derived from the predicate device and relevant FDA guidance documents. This is determined through physical measurements, chemical analyses, and simulated use tests.

8. The sample size for the training set

N/A. This is a medical device (PTA Balloon Dilatation Catheter) submission, not an AI/ML device. There is no concept of a "training set" in this context.

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

N/A. This is a medical device (PTA Balloon Dilatation Catheter) submission, not an AI/ML device.

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The Selebrek PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

The Selebrek PTCA Balloon Dilatation Catheter is a rapid exchange (RX) PTCA Balloon Dilatation Catheter used for the purpose of dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

The Selebrek is a sterile, single-use, intravascular medical device with a working length of 142cm. The proximal shaft is PTFE coated stainless steel tube, which allows for exceptional push ability and a smooth transition to the distal shaft, which is composed of an outer tube, an inner tube, and a balloon. A hydrophilic coating is applied to the distal section. The semicompliant balloons are available in diameters of 1.5mm and lengths from 6-30mm, and have a rated burst pressure of 14 atm.

The proximal shaft of the catheter has two marker sections of 5mm length that aid in gauging dilatation catheter position relative to the guiding catheter located closest to the dilatation catheter adaptor is for femoral guiding catheters and the other marker is for brachial guiding catheters).

The distal shaft of the catheter has an integrated shaft system. The shaft has a combination of single lumen and dual lumen tubing. One lumen is used for inflation of the balloon with contrast medium. The other lumen, in the distal shaft, permits the use of a quide wire to facilitate advancement of the dilatation catheter to and through the stenosis to be dilated.

The guidewire enters the catheter tip and advances coaxially out the distal Rx port, thereby allowing both coaxial quidance and rapid exchange of the catheter with a single standard length guidewire.

One radiopaque Platinum/lridium marker band is located within the balloon segment to aid in positioning the balloon in the stenosis, and are designed to provide an expandable segment of known diameter and length at a specific pressure. The design of this dilatation catheter does not incorporate a lumen for distal dye injections and distal pressure measurements.

The provided document is a 510(k) Summary for a medical device (Selebrek PTCA Balloon Dilatation Catheter). It details the device's comparison to a predicate device and non-clinical testing performed to establish substantial equivalence.

However, the document does NOT contain information about AI/ML device performance or acceptance criteria related to AI/ML. There is no mention of an algorithm, AI assistance, human readers, ground truth establishment for AI, or any of the metrics typically associated with AI/ML model evaluation (e.g., sensitivity, specificity, AUC).

Therefore, I cannot provide the requested information regarding AI/ML acceptance criteria and studies. The document only describes a traditional medical device (balloon catheter) and its non-clinical bench testing for mechanical, physical, and biocompatibility properties.

If you are looking for an example of a 510(k) submission that does include AI/ML performance data, you would need to refer to a different type of device, such as an AI-powered diagnostic imaging tool.

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The Selethru™ NC PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

The SelethruTM NC PTCA Balloon Dilatation Catheter is a rapid exchange (RX) PTCA Balloon Catheter used for the purpose of dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
And it is a sterile, single-use, intravascular medical device with a working length of 142cm. The non-compliant balloons are available in diameters 2.0 and 5.0mm and lengths from 6-30mm, and have a rated burst pressure of 22 atm for φ2.0 mm and 20 atm for φ5.0mm.
The proximal shaft is PTFE coated stainless steel tube, which allows for exceptional push ability and a smooth transition to the distal shaft, which is composed of an outer tube, an inner tube, and a balloon. A hydrophilic coating is applied to the distal section. Moreover, the proximal shaft of the catheter has two marker sections of 5mm length that aid in gauging dilatation catheter position relative to the guiding catheter tip (marker located closest to the dilatation catheter adaptor is for femoral guiding catheters and the other marker is for brachial guiding catheters).
The distal shaft of the catheter has an integrated shaft system. The shaft has a combination of single lumen and dual lumen tubing. One lumen is used for inflation of the balloon with contrast medium. The other lumen, in the distal shaft, permits the use of a guide wire to facilitate advancement of the dilatation catheter to and through the stenosis to be dilated. The guidewire enters the catheter tip and advances coaxially out the distal Rx port, thereby allowing both coaxial guidance and rapid exchange of the catheter with a single standard length guidewire
Two radiopaque Platinum/Iridium marker bands are located within the balloon segment to aid in positioning the balloon in the stenosis, and are designed to provide an expandable segment of known diameter and length at a specific pressure. The design of this dilatation catheter does not incorporate a lumen for distal dye injections and distal pressure measurements.

This document is an FDA 510(K) Premarket Notification summary for a medical device (Selethru™ NC PTCA Balloon Dilatation Catheter). The information provided focuses on the device's technical specifications, safety, and substantial equivalence to predicate devices, rather than an AI-powered diagnostic tool.

Therefore, the requested information about acceptance criteria, study details (sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance), and ground truth establishment is not applicable to this document. These categories are typically relevant for AI/ML device submissions, which involve clinical performance metrics and validation against a reference standard.

The document states that:

• Acceptance Criteria and Device Performance: "The test results met all acceptance criteria and ensure that the Selethru™ NC Catheter design and construction are suitable for its intended use as recommended by the Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (FDA; September 8, 2010)."
• Study Types: Both "in vitro performance tests" and "biocompatibility tests" were conducted.

Specific results for each test against acceptance criteria are not detailed in this summary. The summary lists the types of tests performed:

• In vitro performance tests: dimensional verification, balloon rated burst pressure, balloon fatigue, balloon compliance, balloon inflation and deflation time, catheter bond strength, tip pull strength, flexibility and kinking, torque strength, radiopacity, coating integrity, and particulate evaluation.
• Biocompatibility tests: cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemocompatibility (hemolysis, complement activation, and in vivo thromboresistance), and pyrogenicity.

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The Selethru PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

The Selethru PTCA Balloon Dilatation Catheter is a rapid exchange (RX) PTCA Balloon Catheter used for the purpose of dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The Selethru is a sterile, single-use, intravascular medical device with a working length of 142cm. The proximal shaft is PTFE coated stainless steel tube, which allows for exceptional pushability and a smooth transition to the distal shaft, which is composed of an outer tube, an inner tube, and a balloon. A hydrophilic coating is applied to the distal section. The semi-compliant balloons are available in diameters ranging from 1.5-4.0mm and lengths from 10-30mm, and have a rated burst pressure of 16 atm. The proximal shaft of the catheter has two marker sections of 5mm length that aid in gauging dilatation catheter position relative to the guiding catheter tip (marker located closest to the dilatation catheter adaptor is for femoral guiding catheters and the other marker is for brachial guiding catheters). The distal shaft of the catheter has an integrated shaft system. The shaft has a combination of single lumen and dual lumen tubing. One lumen is used for inflation of the balloon with contrast medium. The other lumen, in the distal shaft, permits the use of a guide wire to facilitate advancement of the dilatation catheter to and through the stenosis to be dilated. The guidewire enters the catheter tip and advances coaxially out the distal Rx port, thereby allowing both coaxial guidance and rapid exchange of the catheter with a single standard length guidewire. Two radiopaque Platinum/Iridium marker bands are located within the balloon segment to aid in positioning the balloon in the stenosis, and are designed to provide an expandable segment of known diameter and length at a specific pressure. The design of this dilatation catheter does not incorporate a lumen for distal dye injections and distal pressure measurements.

This is a medical device submission, not an AI/ML product. The document describes a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Catheter (Selethru PTCA Balloon Dilatation Catheter). Therefore, the requested information regarding AI/ML device performance, such as sample sizes for test/training sets, ground truth establishment by experts, adjudication methods, or MRMC studies, is not applicable.

The document does, however, provide information about the acceptance criteria and performance of this traditional medical device.

Here's an analysis of the provided text, focusing on the device's performance and acceptance criteria:

1. Table of acceptance criteria and the reported device performance:

The document states that both in vitro performance tests and biocompatibility tests were conducted. The crucial summary statement is: "The test results met all acceptance criteria and ensure that the Selethru Catheter design and construction are suitable for its intended use as recommended by the Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (FDA; September 8, 2010)."

While specific numerical acceptance criteria values are not provided in this summary, the types of tests performed indicate the areas where performance was assessed against established criteria.

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

This information is not provided in the given text. For in vitro and biocompatibility tests, sample sizes would typically be determined by relevant ISO standards or FDA guidance documents for medical devices. The data provenance would be laboratory testing data.

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 information is not applicable as this is a physical medical device, not an AI/ML product requiring expert ground truth for image interpretation or diagnosis. Biocompatibility and in vitro test results are evaluated against established scientific and engineering standards by qualified laboratory personnel.

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

This information is not applicable for the same reasons as point 3.

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 this is not an AI/ML device designed to assist human readers.

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

This information is not applicable as this is a physical medical device, not an algorithm.

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

For the in vitro tests, the "ground truth" is defined by engineering specifications and performance standards (e.g., burst pressure measured by a transducer, dimensional measurements validated against design drawings). For biocompatibility tests, the "ground truth" is defined by biological response measurements against established safety thresholds (e.g., cell viability in cytotoxicity tests, hemolysis rates, pyrogenicity assays) based on recognized standards (e.g., ISO 10993 series).

8. The sample size for the training set

This information is not applicable as this is a physical medical device, not an AI/ML product that undergoes a "training" phase.

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

This information is not applicable as this is a physical medical device, not an AI/ML product.

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