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The SC HONK YTONK PTCA Balloon Dilatation Catheter is 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 SC HONKYTONK™ PTCA Balloon Dilatation Catheter is a rapid exchange catheter, including a semi-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) quidewire to facilitate catheter advancement to and through the stenosis that is to be dilated. The proximal portion of the catheter is a single-lumen, stainless steel hypotube that includes a single 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 aids advancement to and through the stenosis. The effective length of the catheter is 145 cm. Radiopaque marker bands, in conjunction with fluoroscopy, are aid for the placement of the catheter's balloon. The 1.50 mm device size has one radiopaque marker band, while all other sizes have two radiopaque marker bands. The entire balloon has a hydrophobic coating. The shaft has a hydrophilic coating from the guidewire port to just distal of the balloon.

This document is a 510(k) Premarket Notification for the SC HONKYTONK™ PTCA Dilatation Catheter. It focuses on demonstrating substantial equivalence to a predicate device, the Emerge™ Monorail PTCA Dilatation Catheter (K163174), through non-clinical testing. This type of submission generally relies on bench testing and does not typically involve clinical studies with human participants or AI performance evaluations as described in your prompt.

Therefore, many of the requested categories are not applicable to this type of regulatory submission and the provided document.

Here's an breakdown based on the information provided and standard 510(k) practices for this type of device:

Acceptance Criteria and Device Performance for SC HONKYTONK™ PTCA Dilatation Catheter

This submission relies on non-clinical (bench) testing to demonstrate substantial equivalence to a predicate device. The "acceptance criteria" are implied by the successful completion and meeting of specifications for each test. The "reported device performance" refers to the outcomes of these non-clinical tests.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a number of "patients" or "images" since this is a non-clinical bench study. The "sample size" refers to the number of devices or components tested for each specific bench test (e.g., a certain number of balloons for burst pressure, a certain number of catheters for simulated use). These numbers are not detailed in the summary document but would be part of the full testing report submitted to the FDA.
• Data Provenance: Non-clinical (bench) laboratory testing performed by the manufacturer, Sino Medical Sciences Technology Inc. The data is generated in a controlled laboratory environment, not from human subjects.

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

• Not Applicable (N/A). This is a non-clinical bench study for a PTCA catheter. "Ground truth" in the clinical sense (e.g., expert diagnosis of an image) is not established. The "truth" is based on engineering specifications and validated test methods.

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

• Not Applicable (N/A). Adjudication methods like 2+1 or 3+1 are used for clinical studies involving multiple readers (typically human experts reviewing images/data). This submission is based on automated or semi-automated bench test results against predefined criteria.

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 is a non-clinical 510(k) submission for a medical device (catheter), not an AI/CADe/CADx device that would involve human reader performance.

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

• No. This is a non-clinical 510(k) submission for a medical device (catheter) with no AI component.

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

• Engineering Specifications and Industry Standards: The "ground truth" for non-clinical testing is based on the device's design specifications, relevant ISO/ASTM standards (e.g., for material properties, biocompatibility), and comparison to the predicate device's established performance parameters. For example, a balloon's rated burst pressure is a design specification, and the test verifies it meets that "ground truth."

8. The sample size for the training set

• Not Applicable (N/A). There is no "training set" as this is not an AI/machine learning device. The device itself is manufactured, and specific units are selected for verification and validation (V&V) testing.

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

• Not Applicable (N/A). As there is no training set.

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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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