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The NC Emerge Over-The-Wire (OTW) and NC Emerge Monorail (MR) 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 in patients with atherosclerosis.
NC Emerge Over-The-Wire and NC Emerge Monorail PTCA Dilatation Catheters (balloon models 2.00-5.00 mm) are also indicated for the post-delivery expansion of balloon expandable stents (bare metal and drug-eluting).

The NC Emerge PTCA Dilatation Catheters are sterile, single-use, intravascular medical devices. The catheter consists of a shaft with a balloon near the distal tip. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. The NC Emerge PTCA Dilatation Catheter is offered in both Monorail (MR) and Over-The-Wire (OTW) platforms. There are two (2) radiopaque marker bands located under the balloon to aid in positioning the system during the procedure. Coatings are applied to the balloon and catheter to enhance insertion and withdrawal performance.

The provided text describes a 510(k) premarket notification for the NC Emerge™ PTCA Dilatation Catheter. It focuses on demonstrating substantial equivalence to existing predicate devices through bench testing and biocompatibility testing. The document explicitly states "No new safety or performance issues were raised during the testing and, therefore, these devices may be considered substantially equivalent to the predicate devices."

However, the provided text does not contain the specific acceptance criteria, reported performance values, or detailed study results (like sample sizes, ground truth establishment, or expert information) that would typically be found in a comprehensive study report. The "Performance Data" section lists the types of tests performed but does not provide quantitative results or explicit acceptance criteria for those tests.

Therefore, many of the requested details cannot be extracted from this document.

Here's a breakdown of what can and cannot be provided based on the input:

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

• Cannot be provided definitively from the text. The document lists the types of performance tests conducted (e.g., Effective Length, Rated Burst Pressure, Balloon Fatigue), but it does not specify the acceptance criteria or quantitative reported performance values for these tests. For example, it doesn't state what the accepted range for "Effective Length" is or what the measured effective length was. It only concludes that the tests supported substantial equivalence.

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

• Cannot be provided from the text. The document mentions "bench testing and biocompatibility testing were performed" but does not specify the sample sizes used for these tests. It also does not provide information on data provenance (country of origin, retrospective/prospective). This is common for 510(k) summaries, which often abstract away detailed test reports.

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 / Cannot be provided from the text. This type of information is relevant for studies involving human physiological data or image interpretation where expert consensus forms the ground truth. The tests described are "bench testing" and "biocompatibility testing," which are laboratory tests performed on the device itself, not human subjects. Therefore, the concept of "experts establishing ground truth" in the way described does not apply here.

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

• Not applicable / Cannot be provided from the text. Similar to point 3, adjudication methods are typically used for expert review of subjective data (like medical images or clinical outcomes). The described tests are objective laboratory measurements, so adjudication by experts is not relevant.

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 device is a PTCA Dilatation Catheter, a physical medical device used in interventional cardiology. It is not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this device.

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

• No. This device is a physical medical device, not an algorithm or AI system. Therefore, a standalone algorithm performance study is not relevant.

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

• Not applicable / Cannot be provided directly as "ground truth" in the requested sense. For the bench and biocompatibility tests, the "ground truth" would be established by physical measurement standards, internationally recognized test methods (e.g., ISO standards), and internal Boston Scientific specifications for device performance. It's not "expert consensus" on an image, for example, but rather adherence to predefined engineering specifications and biological safety standards.

8. The sample size for the training set

• Not applicable / Cannot be provided from the text. Training sets are relevant for machine learning or AI models. This device is a physical medical device, not an AI system. Therefore, there is no "training set" in this context.

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

• Not applicable / Cannot be provided from the text. As explained in point 8, there is no training set for this type of device.

Summary of available information from the text regarding acceptance criteria and study:

The document outlines that the device was subjected to:

• "bench testing"
• "biocompatibility testing"

These tests were performed "according to the requirements of Guidance for Industry and FDA Staff – Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, 08 September 2010."

The types of tests completed are listed under "Performance Data":

Biocompatibility and Chemical Characterization Tests:

• Cytotoxicity
• Sensitization
• Intracutaneous Reactivity
• Acute Systemic Toxicity
• Materials Mediated Pyrogenicity
• USP Physicochemical
• Hemolysis (Direct Contact)
• Hemolysis (Extract Method)
• Complement Activation
• Coagulation
• In Vitro Hemocompatibility

In-vitro Performance Tests:

• Effective Length
• Shaft Inner and Outer Diameter
• Crossing Profile
• Balloon Preparation, Deployment, and Retraction
• Withdrawal into a Guide Catheter
• Rated Burst Pressure
• Balloon Fatigue (Repeat Inflations)
• Balloon Compliance
• Balloon Inflation/Deflation Time
• Catheter Bond Strength Tensile
• Tip Pull Test
• Flexibility and Kink
• Torque Strength
• Radiopacity
• Coating Integrity
• Particulate Evaluation
• Rated Burst Pressure in a Stent
• Balloon Fatigue (in Stent)
• Kissing Balloon Compatibility

Conclusion: "The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing and, therefore, these devices may be considered substantially equivalent to the predicate devices."

In essence, the "study" is a series of laboratory tests demonstrating that the NC Emerge PTCA Dilatation Catheter performs comparably to its predicate devices in accordance with regulatory guidance and relevant standards, ensuring its safety and effectiveness. The specific quantitative acceptance criteria and detailed performance values are not disclosed in this summary document.

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The NC Quantum Apex™ Monorail™ PTCA Dilatation Catheter is intended for dilatation of stenosis in coronary arteries or bypass grafts and for post-delivery expansion of balloon expandable stents (bare metal and drug-eluting.)
The NC Quantum Apex™ Monorail™ 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 Monorail PTCA Dilatation Catheters are also indicated for the post-delivery expansion of balloon expandable stents (bare metal and drug-eluting).

The Boston Scientific NC Quantum Apex™ Monorail™ PTCA Dilatation Catheter is a sterile, single-use, intravascular medical device. The catheter consists of a shaft with a balloon near the distal tip. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. There are radiopaque marker bands located under the balloon to aid in positioning the system during the procedure. Coatings are applied to the balloon and catheter to enhance insertion and withdrawal performance. The NC Quantum Apex Monorail PTCA Dilatation Catheter is available with balloon diameters of 2.00 mm to 5.00 mm and balloon lengths of 6 mm to 30 mm.

The provided text describes a 510(k) premarket notification for a medical device, the NC Quantum Apex™ Monorail™ PTCA Dilatation Catheter. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria and performance metrics typically seen for AI/ML devices. Therefore, much of the requested information regarding AI/ML study components (sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance) is not applicable or cannot be extracted from this document.

However, I can extract information related to the device's technical specifications and the non-clinical performance testing conducted to support its substantial equivalence.

Device Acceptance Criteria and Reported Performance (Non-Clinical Testing)

The acceptance criteria for this device are implicitly tied to demonstrating "substantial equivalence" to the predicate device, meaning its performance should be comparable to or within acceptable limits of the predicate. The document lists various non-clinical tests performed. While specific numeric acceptance criteria and reported performance values are not provided in the summary, the successful completion of these tests suggests the device met the pre-defined criteria for substantial equivalence.

Information Regarding AI/ML Study Components (Not applicable to this 510(k))

As this submission is for a physical medical device (PTCA Dilatation Catheter) and not an AI/ML algorithm, the following sections are not relevant and the requested information cannot be found in the provided text:

2. Sample sizes used for the test set and the data provenance: Not applicable. This is not an AI/ML study.
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 AI/ML analysis is not relevant here.
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.
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): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Nature of the Study and Device

The K121667 submission describes a PTCA Dilatation Catheter, which is a physical, invasive medical device used in coronary angioplasty. The "study" referenced in the document is a non-clinical design verification testing program aimed at demonstrating substantial equivalence to an existing predicate device (NC Quantum Apex™ PTCA Dilatation Catheter) and reference devices (Emerge™ PTCA Dilatation Catheter and Quantum™ Maverick™ PTCA Dilatation Catheter).

The document explicitly states: "Design verification testing was performed to demonstrate that the performance of the modified NC Quantum Apex Monorail PTCA Dilatation Catheter remains substantially equivalent to the predicate device." This means the purpose of the testing was to confirm that the minor modifications to the device (related to the hypotube, midshaft component, proximal shaft marks, and removal of accessory kit components) did not negatively impact its safety and effectiveness compared to the already approved devices.

The tests conducted are typical for mechanical and material aspects of a catheter: Effective Length, Proximal Shaft Profile, Shaft and Bond Burst Pressure, Catheter Bond Strength, Flexibility and Kink, Balloon Deflation Time, Corrosion Resistance, Torque Strength, Particulate Evaluation, and Biocompatibility. The successful completion of these tests formed the basis for the FDA's determination of substantial equivalence.

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