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The balloon dilatation catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

This balloon dilatation catheter is not intended for the expansion or delivery of a stent.

Hoper Rapid Exchange (LPRX) Balloon Dilatation Catheter is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System. The proximal shaft is a polymer coated stainless steel tube. The steel construction is designed to optimize proximal pushability with a smooth transition to a distal shaft specifically designed to be highly trackable. The semi-compliant balloon material allows dilatation with precise control of balloon diameter and length. Two radiopaque platinum marker bands are located within the balloon segment. The catheter is compatible with 5F or larger guiding catheters. The internal lumen of the catheter accepts a standard 0.014 inch PTCA guide wire. The proximal part of the guide wire enters the catheter's tip and advances coaxially out the catheter's proximal port, thereby allowing both coaxial guidance and rapid exchange of catheters with a single standard length guide wire.

Two marked sections are located on the hypo tube shaft to 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 product can be used to expand stenotic coronary vessel, and improve myocardial bleeding. This kind of balloon catheter possesses such merits as moderate compliance, high pressure resistance, minor diameter, etc.

The provided text describes a medical device, the Hoper™ PTCA Balloon Dilatation Catheter, and its 510(k) summary for FDA clearance. However, it does not include information about acceptance criteria or a study proving the device meets those criteria in the context of clinical performance or a comparative effectiveness study with human readers.

The "Performance Testing" section lists various in vitro performance tests and biocompatibility tests. It states that "The test results met all acceptance criterions, were similar to predicate devices, and ensured that the Hoper™ PTCA Balloon Dilatation Catheter design and construction are suitable for its intended use as recommended by the Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (FDA, September 8, 2010)."

This indicates that acceptance criteria were met for these technical and biological safety aspects, but the specific numerical acceptance criteria and detailed study results for each test are not provided in the summary.

Based on the provided text, I cannot answer the specific questions about clinical acceptance criteria and related studies, as the document focuses on regulatory clearance based on substantial equivalence to predicate devices through technical performance and biocompatibility testing, rather than a clinical trial or AI performance evaluation.

Therefore, for the requested information, the answer is:

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

   • The document states that "The test results met all acceptance criterions" for the listed in vitro performance tests and biocompatibility tests.
   • However, specific numerical acceptance criteria or detailed quantitative performance data for each test (e.g., maximum allowable balloon inflation/deflation time, minimum bond strength, specific cytotoxicity results) are not provided in this summary. The summary only confirms compliance without detailing the criteria or results.

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

   • This information is not provided for the in vitro performance tests or biocompatibility tests. No clinical test set is described.

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):

   • This is not applicable, as no clinical test set or ground truth established by experts is mentioned in the provided text.

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

   • This is not applicable, as no clinical test set requiring adjudication is mentioned.

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:

   • This is not applicable. The device is a PTCA Balloon Dilatation Catheter, not an AI imaging analysis tool, and no MRMC study or AI assistance is mentioned.

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

   • This is not applicable, as the device is not an algorithm or AI system.

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

   • For the in vitro tests, the "ground truth" would be the engineering specifications and recognized standards (e.g., ISO, ASTM, FDA guidance documents) against which the device performance was measured. For biocompatibility, it's about meeting established safety limits for chemical and biological interactions. No clinical ground truth (like pathology or outcomes data) is mentioned as being used for these tests.

8. The sample size for the training set:

   • This is not applicable, as the device is not an AI system that requires a training set.

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

   • This is not applicable, as the device is not an AI system.

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