(121 days)
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
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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.
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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.
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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.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. See point 3.
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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.
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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.
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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.
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The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/ML device.
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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.
§ 870.5100 Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.
(a)
Standard PTCA Catheter —(1)Identification. A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end. A PTCA balloon catheter has a single or double lumen shaft. The catheter features a balloon of appropriate compliance for the clinical application, constructed from a polymer. The balloon is designed to uniformly expand to a specified diameter and length at a specific pressure as labeled, with well characterized rates of inflation and deflation and a defined burst pressure. The device generally features a type of radiographic marker to facilitate fluoroscopic visualization of the balloon during use. A PTCA catheter is intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. A PTCA catheter may also be intended for the treatment of acute myocardial infarction; treatment of in-stent restenosis (ISR) and/or post-deployment stent expansion.(2)
Classification. Class II (special controls). The special control for this device is “Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.” See § 870.1(e) for the availability of this guidance document.(b)
Cutting/scoring PTCA Catheter —(1)Identification. A cutting/scoring PTCA catheter is a balloon-tipped catheter with cutting/scoring elements attached, which is used in those circumstances where a high pressure balloon resistant lesion is encountered. A cutting/scoring PTCA catheter is intended for the treatment of hemodynamically significant coronary artery stenosis for the purpose of improving myocardial perfusion. A cutting/scoring PTCA catheter may also be indicated for use in complex type C lesions or for the treatment of in-stent restenosis.(2)
Classification. Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 870.3.