(77 days)
The Opta5 PTA balloon catheters is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal infra popliteal and renal arteries, and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulac
The Cordis Opta5 PTA balloon catherer is a coaxial design with a distal inflatable balloon. Two radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement.
The working pressure range for the balloon is between the nominal size pressure and the rated burst pressure. All balloons distend to sizes above the nommal size at pressures greater than the nominal pressure.
The balloon lumen is used to milate and deflate the ballown - The nommal balloon size is printed on the hub.
The injectate lumen is used to track the catheter over a prepositioned guidewire or to inject contrast medium and/or saline. The maximum injection pressure is 500 psi. The compatible guidewire size, catheter shaft French size and catheter length are printed on the hub. The radiopaque marker bands indicate the stated nominal length of the balloon. The tip length of the long tip version is approximately 10cm and is provided with side holes.
This document describes a PTA Balloon Catheter (Opta5 ™ PTA Balloon Catheter) seeking 510(k) clearance. The provided text is a summary of safety and effectiveness, focusing heavily on comparing the device to existing predicate devices to establish substantial equivalence.
Based on the provided text, there is no study described related to acceptance criteria and device performance in the context of AI/ML or diagnostic performance. This document pertains to a medical device's physical and functional characteristics for regulatory clearance, not an AI/ML diagnostic system.
Therefore, many of the requested fields cannot be answered as they are applicable to AI/ML diagnostic studies, not a PTA balloon catheter's regulatory submission.
Here's an attempt to answer the questions based only on the provided text, highlighting what is missing or not applicable:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative or tabular format, nor does it provide a study with reported performance data against specific criteria like sensitivity, specificity, or AUC, which are common for diagnostic devices. Instead, it relies on demonstrating substantial equivalence to predicate devices.
The "performance" discussed is primarily related to mechanical aspects and intended use, not diagnostic accuracy.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is not a study involving a test set of data for diagnostic performance.
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. This is not a diagnostic device submission requiring ground truth establishment by experts for a test set.
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. This is not an AI/ML device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this device's approval would be its physical properties, biocompatibility, and functional performance (e.g., burst pressure, inflation/deflation, trackability) and comparison to predicate devices, not diagnostic outcomes.
8. The sample size for the training set
Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
Summary regarding the provided text and the requested information:
The provided document is a 510(k) summary for a PTA Balloon Catheter. Its purpose is to demonstrate that the new device is substantially equivalent to legally marketed predicate devices. The "performance" discussed relates to its physical and functional characteristics (e.g., working pressure range, material biocompatibility, and intended use), not diagnostic accuracy or AI/ML performance. Therefore, the questions related to AI/ML studies, test sets, ground truth, experts, and reader studies are not applicable to this specific regulatory submission document.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).