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The Artimes pro Balloon Dilatation Catheter is indicated for initial balloon dilatation of the stenotic portion of a coronary artery in patients with myocardial ischemia.

The Artimes pro (Rx type) device is a coronary dilatation catheter designed for easy guidewire exchange. The catheter working length is 140cm. Lubricious coatings are applied to the distal section. Balloon diameters range from 1.0mm to 1.25mm. The balloon material is made of a semi-compliant material for diameter 1.0mm to 1.25mm with a rated burst pressure of 14 atmospheres. The proximal shaft of the catheter is composed of a female luer connector bonded to a PTFE coated stainless steel tube with a wire. The proximal shaft joins with a smooth transition to a distal shaft composed of an outer tube and a tri-extrusion inner tube with a balloon laser welded to both tubes at the distal tip. The catheter has one radiopaque platinum/iridium marker band. The inner tube accepts a standard 0.014 inch PTCA guidewire. The guide wire 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 guide wire. 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 design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.

The provided text is a 510(k) clearance letter for a medical device, specifically the Artimes pro Balloon Dilatation Catheter. It outlines the regulatory approval process and states that the device has been found substantially equivalent to predicate devices. However, this document does not contain the specific details about the acceptance criteria and the comprehensive study results as typically required for an AI/ML-based device.

The "study" mentioned in the document is a Good Clinical Practice (GCP) clinical study for the physical medical device (catheter), not a study assessing the performance of an AI/ML algorithm. Therefore, many of the requested points related to AI/ML device evaluation (like ground truth establishment, expert adjudication, MRMC studies, etc.) are not applicable to the information contained within this document.

Here's a breakdown of the information that can be extracted, and where the requested information is not present in this document:

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

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

• Sample Size (Clinical Study): Sixty (60) study subjects and sixty-one (61) target lesions.
• Data Provenance: Not specified in this document (e.g., country of origin, retrospective/prospective). However, the mention of "GCP clinical study" implies it was prospective data collected under Good Clinical Practice guidelines.

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)

• Not applicable / Not present in the document. This document describes a physical medical device, not an AI/ML system requiring expert-established ground truth for a test set. This type of information would be relevant for devices that use AI to interpret medical images or data.

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

• Not applicable / Not present in the document. Adjudication methods are typically used when multiple experts review data for the purpose of establishing ground truth for AI algorithms. This document doesn't pertain to an AI algorithm.

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 / Not present in the document. MRMC studies are specific to evaluating AI/ML systems that assist human readers in tasks like image interpretation. This document is about a physical catheter.

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

• Not applicable / Not present in the document. This document is for a physical medical device, not an AI algorithm.

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

• For the clinical study: The "effectiveness" of the catheter would likely be assessed based on clinical outcomes relevant to balloon dilatation, such as successful dilatation of the stenotic portion of a coronary artery and improved myocardial perfusion, which would be observed during the procedure and in follow-up. This is a form of outcomes data or clinical assessment rather than expert consensus on images.

8. The sample size for the training set

• Not applicable / Not present in the document. There is no mention of a "training set" as this is not an AI/ML device. The "training set" concept is relevant for machine learning model development.

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

• Not applicable / Not present in the document. As above, no AI/ML training set is mentioned or implied.

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The Sapphire® II PRO balloon 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® II PRO Balloon Dilatation Catheter (Ø1.5-4.0mm 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® II PRO Balloon Dilatation Catheter is also indicated for:
• percutaneous transluminal angioplasty in the peripheral vasculature, including renal, femoral, popliteal, infra-popliteal, tibial, and peroneal arteries.

The Sapphire II PRO Balloon Dilatation Catheter is now also available as an over-the-wire balloon catheter with a working length of 150cm. The semi-compliant balloons are available in diameters from 1.0-1.25mm and lengths from 5-15mm with a rated burst pressure of 14 atmospheres. The catheter consists of proximal section with a Y-type hub and distal section with a balloon near the distal tip. The straight port of the hub is the guidewire entrance and the side port is used to inflate and deflate the balloon. The external lumen provides for inflation of the balloon with dilute contrast media solution. The internal lumen permits the use of a standard 0.014 inch guidewire to facilitate advancement of the catheter to and through the stenosis to be dilated. Hydrophilic lubricious coatings are applied to the distal section. One radiopaque platinum marker band is located within the balloon segment. The catheter is compatible with 5F or larger guiding catheters and 4F or larger guiding sheaths. Two marked sections (3mm in length) are located on the proximal shaft to indicate catheter position relative to the tip of either guiding catheter or guiding sheath. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.

The provided document is a 510(k) summary for the Sapphire II PRO Balloon Dilatation Catheter. It outlines the device's indications for use, technological characteristics, and performance data used to establish substantial equivalence to a predicate device.

However, the document does not contain the specific type of acceptance criteria and study detailed in the request, which typically pertains to the performance evaluation of a diagnostic or AI-driven medical device (e.g., accuracy, sensitivity, specificity, human reader study data). This document describes performance testing for a physical medical device (balloon catheter), focusing on mechanical properties, sterilization, and biocompatibility.

Therefore, I cannot extract the information to fill out the requested table and answer questions 2-9 from the provided text. The document does not describe a study that proves a diagnostic algorithm meets acceptance criteria.

Based on the provided text, here's what can be inferred about the "acceptance criteria" and "study" for this device, though it doesn't align with the template for diagnostic or AI device evaluation:

• Acceptance Criteria (Implied): The acceptance criteria are related to the physical and functional performance of the balloon dilatation catheter. The statement "The Sapphire II PRO balloon dilatation catheter test results met all acceptance criteria and were similar to the predicate device" implies that the device had to pass certain predefined thresholds for parameters such as:

  • Balloon Rated Burst Pressure
  • Balloon Fatigue
  • Balloon Compliance
  • Catheter Bond Strength
  • Tip Pull Strength
  • Radiopacity
  • Coating Integrity
  • Dimensional Verification
  • Shaft Burst
  • Balloon Inflation and Deflation Time
  • Flexibility and Kinking
  • Torque Strength
  • Particulate Evaluation
  • Biocompatibility (Cytotoxicity, Intracutaneous Reactivity, Sensitization, Acute Systemic Toxicity, Pyrogenicity, Hemocompatibility, Genotoxicity)
  • Sterilization
  • Visual Inspection
  • Balloon Preparation, Deployment, and Retraction

• Study That Proves the Device Meets Acceptance Criteria: The study described is a series of bench tests and laboratory evaluations to demonstrate the physical, mechanical, and biological compatibility of the Sapphire II PRO Balloon Dilatation Catheter. The primary objective was to show that the new over-the-wire design meets the same performance standards as its predicate device (OrbusNeich Sapphire II PRO, K180921) and other reference devices, and that it is safe and effective for its intended use.

Therefore, the requested table and answers to questions 2-9 cannot be fully provided as the information is not present in the supplied text.

Here is what can be extracted or stated based on the provided document in the context of the user's request, acknowledging the mismatch in the type of device and study:

Table of Acceptance Criteria and Reported Device Performance:

(Note: The table above reiterates that all listed tests for the subject device "met all acceptance criteria and were similar to the predicate device." Specific numerical performance values are not provided in this summary.)

Answers to Specific Questions (based on the provided text's context of a physical device, not a diagnostic/AI device):

1. Sample sizes used for the test set and the data provenance:

   • Sample sizes: Not specified in the provided text. The text only lists the types of tests performed.
   • Data provenance: Not explicitly stated (e.g., country of origin) but implied to be from laboratory testing performed by or for OrbusNeich Medical Trading Inc. The text mentions "Testing was leveraged from the predicate device (K180921) when applicable" and "Additional testing was performed to support the use of the Sapphire II PRO balloon dilatation catheter over-the-wire shaft design," indicating these are laboratory/bench studies, not clinical (retrospective or prospective) patient data.

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

   • Not applicable (N/A) in this context. This question refers to human assessment for ground truth in diagnostic studies. For a physical device, ground truth established by standard testing methods (e.g., measuring dimensions, burst pressure, biocompatibility assays) does not involve human expert consensus in the same way.

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

   • N/A. This refers to adjudication in human reader studies for diagnostic accuracy.

4. 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 device is a physical balloon catheter, not an AI-assisted diagnostic tool.

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

   • N/A. This is a physical device, not an algorithm.

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

   • For a physical device, "ground truth" is established by objective, quantitative measurements and standardized laboratory test results based on engineering specifications and regulatory standards (e.g., ISO, ASTM). For example, the "ground truth" for balloon burst pressure is the measured pressure at which the balloon ruptures, compared against a specified acceptance limit. For biocompatibility, it's the results of verified biological assays.

7. The sample size for the training set:

   • N/A. This device is not an AI model requiring a training set.

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

   • N/A. No training set is used for this type of device.

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