Search Results

The Gallant PTCA 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;
• Post-deployment stent expansion.

The Gallant is a sterile, single-use, intravascular medical device. The Gallant is a combination of single lumen and dual lumen catheter comprising an expandable semi-compliant (SC) coronary balloon on a rapid exchange (RX) catheter.

The provided text is a 510(k) summary for the Gallant PTCA Dilatation Catheter. It outlines the device's indications for use, its comparison to a predicate device, and the performance data used to demonstrate substantial equivalence. However, it does not contain the detailed acceptance criteria or the specific results of a study as typically required for AI/ML device evaluations.

Instead, this document describes a traditional medical device (a PTCA dilatation catheter) and the engineering and biocompatibility tests performed on it. The performance data section lists various types of tests conducted:

• Bench Testing: Includes visual and handling performance, dimensional verification, crossing profile, simulated use, kissing balloon technique (KBT), balloon rated burst pressure, balloon fatigue, various balloon diameter and length measurements, non-uniformity markers positioning, catheter bond strength, tip pull test, flexibility and kink resistance, torque strength, catheter radiopacity, particulate evaluation, coating integrity, balloon rated burst pressure (in stent), balloon fatigue (in stent), catheter corrosion resistance, packaging integrity, and environmental & shipping & accelerated shelf-life.
• Biocompatibility Testing: Cytotoxicity, sensitization, intracutaneous toxicity, material mediated pyrogenicity, in vitro hemolysis, SC5b-9 complement activation assay.
• Chemical Characterization: Performed.
• Pre-clinical Studies: A GLP Acute Performance Study of Novel Gallant PTCA Balloons in a Porcine Model.

The document states that 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, September 8, 2010." It concludes that "No new safety or performance issues were raised during the testing and, therefore, the Gallant may be considered substantially equivalent to the predicate device."

Based on the provided text, I cannot complete most of the requested fields because they relate to the evaluation of AI/ML-based devices and clinical performance studies with specific statistical outcomes, which are not present in this 510(k) summary for a catheter.

Here's an attempt to answer what can be extracted or inferred, and explicitly state what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with specific quantitative acceptance criteria or detailed numerical performance results for the various tests. It only lists the types of tests performed. The acceptance criteria would be defined by the "Guidance for Industry and FDA Staff – Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010" and Medinol's internal specifications, but these are not enumerated in the summary. The "reported device performance" is summarized qualitatively as "No new safety or performance issues were raised during the testing."

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

• Test Set Sample Size: Not specified in the document. For bench and biocompatibility tests, sample sizes would vary per test type (e.g., number of catheters, number of test articles). For the porcine model, the number of animals or procedures is not stated.
• Data Provenance: The preclinical "GLP Acute Performance Study... in a Porcine Model" implies animal data. Bench testing and biocompatibility testing are laboratory-based. The country of origin for the studies is not explicitly stated, but the submitter's address is Israel.

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

Not applicable, as this is not an AI/ML device with ground truth established by human experts for image or data interpretation. The "ground truth" for the performance of a PTCA catheter would be the physical properties and functional performance against engineering standards.

4. Adjudication method for the test set

Not applicable. This concept pertains to resolving discrepancies in expert opinions for AI/ML ground truth, which is not relevant here.

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/ML device that assists human readers.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is based on engineering specifications and biological safety standards. This includes:

• Physical measurements and properties (e.g., balloon diameter, burst pressure, tensile strength).
• Functional performance in simulated use models (e.g., crossing profile, kink resistance).
• Biological responses (biocompatibility tests).
• Acute physiological response in an animal model (porcine study).

8. The sample size for the training set

Not applicable, as this is not an AI/ML device that requires a training set.

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

Not applicable, as this is not an AI/ML device that requires a training set.

Ask a specific question about this device