(28 days)
The Chameleon PTA Balloon Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The Chameleon enables the infusion of diagnostic or therapeutic fluids. This catheter is not for use in coronary arteries or cerebral vasculature.
The Chameleon Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter is an over-the-wire, multi-lumen balloon catheter. The Chameleon enables the injection of diagnostic fluids, such as contrast medium or therapeutics fluids through a dedicated opening proximal to the balloon. The multi-lumen shaft incorporates a balloon inflation/deflation lumen and a Guide Wire (GW) lumen which also serves as the infusion lumen.
This document is a 510(k) premarket notification for a medical device (Chameleon PTA Balloon Catheter), not a study for an AI/ML medical device. Therefore, it does not contain the specific information requested in your prompt regarding acceptance criteria and performance data for an AI/ML-driven diagnostic or assistive technology.
The document primarily focuses on establishing "substantial equivalence" of a new version of the existing Chameleon PTA Balloon Catheter (with new balloon sizes) to a legally marketed predicate device. This type of submission relies heavily on bench testing and simulated use to demonstrate that the physical and functional characteristics of the device remain safe and effective for its intended purpose.
Here's why the requested information cannot be extracted from the provided text:
- No AI/ML Component: The device is a physical medical instrument (a balloon catheter used in angioplasty), not a software or AI/ML algorithm that interprets medical images or data.
- No Diagnostic Performance: The "performance data" mentioned (Section 13) refers to mechanical and physical properties of the catheter (e.g., balloon compliance, burst pressure, fatigue, leakage), not diagnostic accuracy (e.g., sensitivity, specificity) of an AI system.
- No Human Readers/Experts for Interpretation: The context of "human readers" assisting with AI or "expert consensus" for ground truth isn't relevant to a physical catheter's mechanical performance.
However, I can extract what is relevant to the document about its "acceptance criteria" and "study" (bench testing):
Acceptance Criteria and Reported Device Performance (as pertains to this physical device)
The document states: "All test results demonstrate that the Chameleon PTA Balloon Catheter met the established specifications necessary for consistent performance during its intended use." And "The Chameleon PTA Balloon Catheter met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, and test protocols."
While specific numerical targets or thresholds for each bench test are not provided in this summary document, the general categories of acceptance criteria and the finding that they were met are clear.
| Acceptance Criteria Category (Related to Bench Testing) | Reported Device Performance |
|---|---|
| Dimensional Inspection | Met established specifications |
| Balloon Compliance | Met established specifications |
| Balloon Burst Pressure | Met established specifications |
| Fatigue Resistance | Met established specifications |
| Leakage | Met established specifications |
| Overall Performance for Intended Use | Met all predetermined acceptance criteria of design verification and validation |
Regarding the specific questions in your prompt, here's why they are largely unanswerable from this document:
- A table of acceptance criteria and the reported device performance: Partially addressed above for mechanical properties, but no diagnostic performance like an AI would have.
- Sample sizes used for the test set and the data provenance: Sample sizes for bench tests (e.g., N=X catheters tested for burst pressure) are not detailed. Data provenance is "bench testing and simulated use," implying lab conditions. No patient data is involved for this type of device submission.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical catheter's mechanical properties is derived from engineering specifications and testing methods, not expert human interpretation of medical images.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is for AI/ML diagnostic studies, not device mechanical testing.
- 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 for AI/ML diagnostic studies.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this mechanical device, the "ground truth" for its performance is adherence to engineering specifications and performance benchmarks (e.g., it must not burst below X pressure, it must meet Y compliance).
- The sample size for the training set: Not applicable. There is no AI/ML model to train.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is for a traditional medical device (catheter) and illustrates a "substantial equivalence" pathway, not a submission for an AI/ML-driven medical device requiring clinical performance evaluation of diagnostic accuracy.
§ 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).