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The NC ROCKSTAR™ Non-Compliant PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilatation of the stenotic portion of a native coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion in patients with atherosclerosis. The NC ROCKSTAR™ Non-Compliant PTCA Balloon Dilatation Catheter is also indicated for the postdelivery expansion of balloon expandable stents (bare metal and drug-eluting).

The NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is a rapid exchange catheter, including a low compliance balloon close to the distal tip. The catheter's distal portion is dual lumen and coaxial. The dual lumen includes an outer lumen for balloon inflation, and an inner lumen to allow a ≤0.014 in (0.36 mm) guidewire to facilitate catheter advancement to and through the stenosis or stent that is to be dilated. The proximal portion of the catheter is a sinqle-lumen, stainless steel hypotube that includes a sinqle luer hub for balloon inflation/deflation. The balloon design provides for an inflatable segment of both known diameter and length at recommended pressures. A balloon protective sheath placed over the balloon maintains a low profile. A mandrel is positioned inside the inner lumen to protect catheter patency. The catheter's tapered tip is aids advancement to and through the stenosis or stent. The effective length of the catheter is 145 cm. Radiopaque marker bands, in conjunction with fluoroscopy, are aids for the placement of the catheter's balloon. The entire balloon has a hydrophobic coating. The shaft has a hydrophilic coating from the guidewire port to just proximal of the balloon.

The provided document is a 510(k) summary for a medical device (NC ROCKSTAR™ Non-Compliant PTCA Balloon Dilatation Catheter), which focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not contain information about studies involving human subjects, AI assistance, or expert readers, which are typically found in submissions for diagnostic or AI-driven devices.

Therefore, many of the requested details regarding acceptance criteria, study design for AI models, human expert involvement, and ground truth establishment are not applicable or derivable from this document. The document primarily describes bench and biocompatibility testing.

Here's an attempt to answer the questions based only on the provided text, noting where information is not available:

Acceptance Criteria and Device Performance

The document states: "The in vitro bench tests demonstrated that the NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter met all acceptance criteria and performed similarly to the predicate device." However, the exact quantitative acceptance criteria for each test (e.g., specific limits for balloon inflation/deflation time, flexibility, or burst pressure) are not explicitly listed in a table within the provided text. The performance data is summarized qualitatively as "met all acceptance criteria" and "performed similarly to the predicate device."

Since the document does not provide a quantitative table of acceptance criteria and reported device performance values, I cannot generate the requested table.

Study Details

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

   • Not provided in the document. The document states that the device "met all acceptance criteria" and "performed similarly to the predicate device" for various non-clinical tests, but the specific numerical acceptance criteria and the quantitative performance results are not detailed.

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

   • Sample Size: Not specified for each non-clinical test.
   • Data Provenance: The tests are described as "Non-clinical laboratory testing" and "in vitro bench tests." The location (e.g., country of origin) of these labs is not specified. They are inherently retrospective in nature, as they evaluate the manufactured device's characteristics against predefined specifications.

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

   • Not applicable. This document describes non-clinical engineering and biocompatibility testing, not studies involving human image interpretation or AI. Therefore, there are no "experts" in the sense of radiologists or other clinicians establishing ground truth for a test set. The "ground truth" for these tests would be objective measurements and predefined engineering specifications.

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

   • Not applicable. See 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:

   • No. This was not an MRMC study and does not involve AI assistance or human readers.

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

   • No. This document describes a medical device (balloon catheter), not an algorithm or AI system.

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

   • For the non-clinical tests, the "ground truth" is based on objective engineering measurements (e.g., dimensions, pressure resistance, flexibility) and standardized laboratory testing protocols for biocompatibility as per ISO standards (though specific standards aren't cited for each test, the list of biocompatibility tests performed is standard). There is no "expert consensus" in the clinical sense, pathology, or outcomes data mentioned.

8. The sample size for the training set:

   • Not applicable. There is no "training set" as this is not an AI/ML device.

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

   • Not applicable. There is no "training set" as this is not an AI/ML device.

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The NC TREK NEO™ Coronary Dilatation Catheters are indicated for:
a) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion
b) Balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with STsegment elevation myocardial infarction
c) Balloon dilatation of a stent after implantation (balloon models 2.00 mm - 5.00 mm only)

NC TREK NEO is a Non-Compliant (NC), Rapid Exchange (RX), Coronary Dilatation Catheter (CDC). The catheter is a rapid exchange co-axial design with a balloon at the distal tip. The proximal lumen provides for inflation of the balloon with contrast medium. The central distal lumen permits the guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The outside diameter (OD) of the distal end of the device, including the distal shaft, tip, and the balloon are coated with Hydrophilic Coating.
Radiopaque markers are positioned on the inner member underneath the balloon to provide accurate positioning of the balloon in the artery. The balloon is designed to provide an expandable segment of known diameter and length at specified pressures. Proximal shaft markers located on the outer shaft aid in gauging the dilatation catheter position relative to the guiding catheter tip when introducing the catheter through the guiding catheter. The Single arm on proximal end of the device provides access to the inflation lumen. It is designed with a Luer-lock fitting to facilitate connection to an inflation device.
The NC TREK NEO™ Coronary Dilatation Catheter will be available in select combinations of 1.50-6.00mm diameters and 6-25mm lengths.

This document concerns the 510(k) premarket notification for the NC TREK NEO™ Coronary Dilatation Catheter (K220634). The information provided does not contain details about acceptance criteria, device performance, and study design typically found in reports for AI/ML-driven medical devices. Instead, it describes a conventional medical device (a PTCA catheter) and establishes substantial equivalence to a predicate device through a comparison of design, materials, manufacturing, sterilization, and non-clinical performance data.

Therefore, many of the requested fields cannot be filled as they are explicitly related to studies and acceptance criteria for AI/ML devices, which are not applicable here.

Here's a breakdown of the available information and what cannot be provided:

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

The document lists various performance tests conducted on the device. However, it does not provide a table with specific quantitative acceptance criteria or the reported device performance values for these tests. It only states that the tests supported a determination of substantial equivalence and raised no new safety or performance issues.

Performance Tests Completed (no specific acceptance criteria or reported values provided in this document):

• Tip dimensions
• Crossing Profile
• Guidewire Lumen
• Shaft Dimensions
• Proximal Shaft Marker Location
• Catheter Length
• Catheter Preparation
• Balloon Inflation/Deflation Time
• Balloon Rated Burst Pressure (RBP)
• Maximum Compliance Label
• Balloon Compliance
• Balloon RBP (In-Stent)
• Proximal Seal Tensile Strength
• Outer Member to Hypotube Seal Tensile Strength (Notch-Seal Tensile Strength)
• Proximal Adaption Tensile Strength
• Catheter Tip Tensile Strength
• Inner Member Lumen Collapse
• Balloon Fatigue Resistance
• Balloon Fatigue Resistance (In-Stent)
• Hydrophilic Coating- Dry Adhesion of Coating
• Hydrophilic Coating- Coefficient of Friction
• Kink/Flex
• Torque
• Particulates
• Finished Good Sheath Removal
• Balloon Preparation, Deployment and Retraction

Biocompatibility and Chemical Characterization Tests Completed:

• Cytotoxicity
• Sensitization
• Irritation
• Acute Systemic & Pyrogenicity
• Hemocompatibility

2. Sample size used for the test set and the data provenance:
Not applicable. This is a conventional medical device, not an AI/ML device relying on a test set of data. The "test set" here refers to the physical devices manufactured for bench and biocompatibility testing. The exact number of devices or components used for each test is not specified in this summary, nor is data provenance in the context of clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth and expert consensus are concepts for AI/ML device validation, which is not relevant for this conventional catheter.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable for this type of device and study.

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 not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. The "truth" for this device's performance is determined by established engineering standards, material properties, and biological compatibility testing, not by expert consensus on clinical data or pathology in the context of an AI/ML algorithm.

8. The sample size for the training set:
Not applicable. This device does not involve a training set for an AI/ML algorithm.

9. How the ground truth for the training set was established:
Not applicable. This device does not involve a training set for an AI/ML algorithm.

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The Emerge Over-The-Wire and Emerge Monorail PTCA Dilatation Catheters (1.20 mm balloon models) are indicated as pre-dilatation catheters in the stenotic portion of a coronary artery or bypass graft stenosis (≥70% stenosis).

The Emerge Over-The-Wire and Emerge Monorail PTCA Dilatation Catheters (balloon models 1.50-4.00 mm) are indicated for the balloon catheter dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

The Emerge Over-The-Wire and Emerge Monorail PTCA Dilatation Catheters (balloon models 2.00 - 4.00 mm) are also indicated for the post-delivery expansion of balloon expandable stents (bare metal and drug-eluting).

The Boston Scientific Emerge™ PTCA Dilatation Catheter is a sterile (EO), single-use, intravascular medical device for use in coronary angioplasty procedures. The catheter consists of a dual-lumen polymeric shaft with a balloon near the distal tip. The outer lumen is used for inflation of the balloon, and the inner lumen permits the use of a guidewire to facilitate advancement of the catheter to the appropriate location. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. The Emerge™ PTCA Dilatation Catheter is offered in both Monorail (MR) and Over-The- Wire (OTW) platforms. Marks on the proximal portion of the catheter shaft (at 90 cm and 100 cm) indicate the exit of the balloon catheter tip out of the guide catheter. Radiopaque marker bands located under the balloon aid in positioning the system during the procedure. Hydrophilic and hydrophobic coatings are applied to the balloon and catheter to enhance insertion and withdrawal performance. The Emerge™ PTCA Dilatation Catheters (1.20 mm and 1.50 mm balloon models) are available in balloon lengths from 8 mm to 20 mm. The Emerge™ PTCA Dilatation Catheters (2.00 - 4.00 mm balloon models) are available in balloon lengths from 8 mm to 30 mm.

Here's a breakdown of the acceptance criteria and study information for the Emerge PTCA Dilatation Catheter based on the provided document:

This document is a 510(k) summary for a medical device submitted to the FDA, which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive clinical study report for a new AI-powered diagnostic. Therefore, the information provided primarily relates to device performance testing (bench testing and biocompatibility) and does not include details about acceptance criteria or studies involving human readers, AI assistance, or complex ground truth establishment in the way typically seen for AI/ML-based diagnostic devices.

The "device" in this context is a physical medical device (a PTCA Dilatation Catheter), not an AI algorithm. As such, many of the requested points related to AI studies are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various performance tests and biocompatibility tests conducted to demonstrate substantial equivalence. It does not provide specific numerical acceptance criteria or detailed quantitative results in this summary. Instead, it states that the tests provide "reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use."

Specific Performance Tests (Bench Testing):

• Corrosion Resistance
• Proximal Mark Abrasion Resistance
• Proximal Shaft Marks
• Repeat Inflation
• Midshaft Bond Tensile
• Shaft and Bond Burst Pressure

Specific Biocompatibility and Chemical Characterization Tests:

• Cytotoxicity
• Partial Thromboplastin Time
• Sensitization
• In Vitro Hemocompatibility
• Intracutaneous Reactivity
• Complement Activation
• Acute Systemic Injection
• USP Physicochemical
• Materials Mediated Pyrogenicity
• Latex Assay
• Mutagenicity
• Nonvolatile Residue
• Hemolysis
• SEM

Regarding AI-Specific Criteria (Not Applicable to this Device):

• 2. Sample size used for the test set and the data provenance: Not applicable. This is a physical device, not an AI model evaluated on a data test set.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI-based diagnostic model is not relevant here. The "ground truth" for this catheter is its ability to perform its mechanical and biological functions safely.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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 not an AI for human reader assistance.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For a physical medical device like this, "ground truth" relates to engineering specifications, material properties, and biological safety standards (e.g., ISO standards, FDA guidance documents). There isn't a "ground truth" in the diagnostic sense.
• 8. The sample size for the training set: Not applicable. This is a physical device; there is no "training set" in the AI sense.
• 9. How the ground truth for the training set was established: Not applicable.

Clarification:

The provided document is an FDA 510(k) clearance letter and summary for a PTCA Dilatation Catheter, which is a physical medical device used in coronary angioplasty. It is not an AI/ML-based diagnostic system. Therefore, the questions related to AI studies, test sets, training sets, ground truth establishment by experts, and reader studies are not relevant to the information presented in this document. The "study" described is a series of non-clinical bench tests and biocompatibility evaluations confirming the physical and biological properties of the catheter.

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NC Quantum Apex™ PTCA Dilatation Catheters are indicated for the balloon catheter dilatation of the stenotic portion of a native coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion NC Quantum Apex™ PTCA Dilatation Catheters are also indicated for the post-delivery expansion of balloon expandable stents (bare metal and drugeluting).

Not Found

This document is a 510(k) premarket notification for a medical device called the NC Quantum Apex™ PTCA Dilatation Catheter. It is not an AI/ML device, therefore the requested information regarding AI/ML studies is not applicable.

However, I can provide available information regarding the non-clinical testing performed to demonstrate substantial equivalence for this device.

1. Table of Acceptance Criteria and Reported Device Performance

The document summarizes a range of non-clinical bench tests and biocompatibility tests. While specific acceptance criteria for each test (e.g., a specific numerical threshold for corrosion resistance or burst pressure) are not explicitly stated in this high-level summary, the general acceptance criterion is that the device demonstrates performance equivalent to the predicate device and is safe and effective for its intended use. The reported performance is that the device met these tests, providing reasonable assurance of conformance.

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

The document does not specify the exact sample sizes for each non-clinical bench test or biocompatibility test. These are typically described in detail in the full test reports submitted to the FDA, but not in the 510(k) summary. The data provenance is from internal Boston Scientific Corporation testing, which is standard for premarket submissions. These are prospective tests conducted on manufactured device samples.

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

This information is not applicable. This is a medical device for physical intervention, not an AI/ML diagnostic device requiring expert interpretation of outputs for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable. The tests are bench tests or laboratory assays, not requiring human adjudication in the context of diagnostic interpretation.

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

Not applicable. This is not an AI/ML device.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is not an AI/ML device.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests is based on established engineering principles, industry standards (e.g., ISO standards for medical devices, USP for physicochemical tests, ASTM for material properties), and regulatory requirements. For example:

• Bench tests: Performance metrics (like burst pressure, tensile strength, corrosion resistance) are compared against predetermined functional specifications derived from the predicate device's performance or engineering requirements.
• Biocompatibility tests: Compliance with standards like ISO 10993 (Biological evaluation of medical devices) is the "ground truth" to ensure the materials are safe for human contact.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device and therefore does not have a "training set" in the context of machine learning.

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

Not applicable. As above, this is not an AI/ML device.

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This catheter is intended for ultrasound examination of coronary intravascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

OptiCross™ 6 is a short-rail 40 MHz IVUS imaging catheter. It is compatible with a 0.014" guidewire, and at a minimum, a 6F guide catheter (≥ 0.064" ID). OptiCross 6 is intended for use with Boston Scientific's (BSC)'s iLab™ equipment and BSC's latest motor drive unit, MDU5 PLUS™. When used together, the catheter, motor drive unit (MDU), and iLab equipment form a complete imaging system that allows for ultrasonic examination of coronary intravascular pathology. The catheter consists of two main components: the catheter body and the imaging core. The catheter body consists of four sections: the telescope assembly, proximal shaft, distal shaft, and the distal guidewire lumen. The proximal shaft, distal shaft, and distal guidewire lumen comprise the usable length of the catheter (135 cm). The proximal telescoping section remains outside of the guide catheter. The distal guidewire lumen (1.6 cm) is used to track the catheter along the guidewire and incorporates a radiopaque marker band (0.5 cm from the distal tip). The distal shaft serves as a flexible and acoustically transparent imaging window. The proximal shaft provides pushability to the catheter and serves as a lumen to the imaging core. Two insertion markers are located on the proximal shaft (90 and 100 cm from the distal tip). These markers facilitate estimation of catheter position relative to the distal tip of the guide catheter. The telescope assembly allows the imaging core to be advanced and retracted up to 15 cm. The corresponding movement of the transducer occurs within the imaging window from 2 to 17 cm from the distal tip of the catheter. The telescoping shaft includes 16 incremental markers (1 cm apart) for lesion length assessment; the 5-cm, 10-cm, and 15- cm markers are distinct. The outer surface of the catheter body also employs a hydrophilic coating to enhance lubricity and promote deliverability (distal 23 cm). The imaging core consists of a proximal hub assembly and a rotating drive cable that houses a piezoelectric (PZT) transducer at the distal imaging window. The hub assembly (1) provides an electro-mechanical interface between the catheter and the motor drive unit and (2) incorporates a one- way check valve that is used to flush the interior of the catheter body. The catheter must be flushed with heparinized saline prior to use, as this provides the acoustic coupling media required for ultrasonic imaging. The drive cable and PZT transducer rotate independently of the sheath to provide 360° image resolution. The transducer converts electrical impulses sent by the motor drive in to transmittable acoustic energy. Reflected ultrasound signals are converted back to electrical impulses, returned to the motor drive unit, and are ultimately processed by the iLab equipment for visualization.

The provided text describes a 510(k) premarket notification for the OptiCross™ 6 40 MHz Coronary Imaging Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving novel effectiveness through extensive clinical trials. Therefore, much of the requested information regarding clinical studies, human readers, and detailed ground truth for AI algorithms is not applicable to this document.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a table of acceptance criteria with specific numerical targets (e.g., "measurement accuracy > 95%") alongside reported performance values. Instead, it lists the types of tests performed and states that the device met the requirements, indicating successful performance in each area.

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

• Sample Size: Not specified in terms of number of devices or data points. Bench testing involves a representative number of devices to assess performance.
• Data Provenance: Not applicable in the context of clinical data for an AI device. The data for bench and safety testing would be generated in a lab setting by the manufacturer (Boston Scientific Corporation). All testing is non-clinical.

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

Not applicable. This is not an AI-enabled device requiring expert ground truth for image interpretation. The testing focuses on the physical and functional performance of the catheter.

4. Adjudication method for the test set

Not applicable. This is not an AI-enabled 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

Not applicable. This is not an AI-enabled device and no MRMC study was conducted. The determination of substantial equivalence is based on non-clinical performance data.

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

Not applicable. This is a medical device (intravascular imaging catheter), not an AI algorithm.

7. The type of ground truth used

For bench testing, the "ground truth" is the established engineering specifications, performance standards, and regulatory requirements (e.g., dimensional tolerances, image quality parameters, safety limits). For biological safety, it's compliance with ISO standards and successful completion of specific biological assessments.

8. The sample size for the training set

Not applicable. This is a medical device, not an AI algorithm requiring a training set.

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

Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study described is a non-clinical performance evaluation to demonstrate substantial equivalence to a predicate device (OptiCross™ K123621). This means the focus is on proving that the new device, OptiCross™ 6, is as safe and effective as a previously cleared device, not necessarily on proving novel clinical efficacy.

The study included:

• Bench Testing: Extensive tests to evaluate the physical integrity, functionality, and performance of the catheter across various aspects such as deliverability, image resolution, measurement accuracy, and structural integrity.
• Biological Safety Testing: Assessments for biocompatibility (in accordance with ISO 10993-1), bioburden, endotoxin, pyrogenicity, and sterility assurance.
• Electrical and Mechanical Safety Testing: Evaluation of acoustic output against FDA guidance and electromagnetic compatibility testing to ensure compliance with IEC 60601-1-2.
• Packaging Validation: Testing the integrity of the packaging configutation according to ISO 11607-1 and ISO 11607-2.

The document explicitly states: "Non-clinical performance evaluations, as described above, indicate that the subject device is substantially equivalent to, and at least as safe and effective as the predicate device, OptiCross™ (K123621)." It also notes "Clinical Performance Data: Not applicable; determination of substantial equivalence is based on an assessment of non-clinical performance data."

The "acceptance criteria" were implied by the successful completion and compliance with the various tests and standards mentioned (e.g., "Acoustic Output test results for the OptiCross™ 6 are below the FDA Track 1 limits," and "demonstrating compliance to IEC 60601-1-2"). The report concludes that based on these non-clinical data, the device meets the safety and effectiveness requirements for substantial equivalence.

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