(99 days)
The Cordis AMIIA PTA Balloon Dilatation catheter is intended for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, ilio-femoral, popliteal, infra popliteal, renal, and carotid arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloonexpandable and self-expanding stents in the peripheral vasculature.
The Cordis AMIIA PTA Balloon Dilatation Catheter is a catheter with a distal DURALYN™ inflatable balloon. The catheter utilizes a Rapid Exchange design, consisting of a single inflation lumen and a distal guide wire lumen. The guide wire lumen begins at the distal tip and terminates at the guide wire exit port. The guide wire exit port (hole) is approximately 25 cm from the distal tip. The maximum guide wire diameter that may be used is printed on the package label. The catheter tip is tapered to facilitate crossing of tight lesions. The proximal hub is used as a balloon inflation port. The balloon is inflated by injecting diluted contrast medium through this hub. Two radiopaque marker bands within the balloon indicate the dilating section of the balloon and aid in balloon placement. The nominal balloon diameter and length are printed on the identification band near the hub. The working pressure range for the balloon is between the nominal pressure and the rated burst pressure. All balloons distend to sizes above the nominal size at pressures greater than the nominal pressure. Consult the compliance table incorporated with the product, for diameters of the balloon at given pressures. The design of this catheter does not incorporate a lumen for distal dye injection. The balloon catheter with a usable shaft length of 142 cm has two proximal shaft markers (90 cm and 100 cm from the distal tip). Both indicate the relative position of the catheter tip to the distal end of the guiding catheter. An additional marker is located at the distal port exit notch and aids in locating the guide wire exit.
The provided text describes the Cordis AMIIA PTA Balloon Dilatation Catheter and its substantial equivalence to predicate devices, focusing on its intended use and safety. It does not contain information about specific acceptance criteria, device performance metrics, or a formal study with a test set, ground truth, or statistical analysis (like MRMC studies) as requested in the prompt. The document explicitly states that "No biocompatibility test was required, as the original device has not changed and there was no change in the vascular application of the device" and that safety and effectiveness were demonstrated via "non-clinical design verification tests and analyses." This suggests that the approval was based on engineering and design verification rather than a clinical performance study with human subjects.
Therefore, many of the requested details cannot be extracted from the provided text.
Here is an attempt to answer the questions based only on the provided information, noting where information is absent:
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A table of acceptance criteria and the reported device performance
The document does not explicitly list quantitative acceptance criteria or reported device performance metrics from a formal study. It broadly states that safety and effectiveness were demonstrated through "non-clinical design verification tests and analyses." -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable (N/A). The document indicates that safety and effectiveness were demonstrated via "non-clinical design verification tests and analyses" rather than a clinical test set. No sample size for a test set or data provenance is mentioned. -
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 (N/A). There is no mention of experts or ground truth establishment for a test set. The approval is based on substantial equivalence and non-clinical design verification. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable (N/A). No test set requiring adjudication is mentioned. -
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 (N/A). The device is a physical medical catheter, not an AI-assisted diagnostic tool. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable (N/A). The device is a physical medical catheter, not an algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable (N/A). The document refers to "non-clinical design verification tests and analyses" for safety and effectiveness, implying engineering and performance specifications rather than clinical ground truth like pathology or outcomes data. The basis for approval is substantial equivalence to predicate devices. -
The sample size for the training set
Not applicable (N/A). No training set is mentioned as this is a physical medical device. -
How the ground truth for the training set was established
Not applicable (N/A). No training set or associated ground truth establishment is mentioned.
§ 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).