(175 days)
The AngioSculpt Scoring Balloon Catheter is intended for balloon dilatation of lesions in infrapopliteal arteries. Not for use in the coronary or neuro-vasculature.
The AngioSculpt Scoring Balloon Catheter is a standard two-lumen catheter with a scoring balloon near the distal tip. One lumen is used for inflation with contrast medium; the other lumen permits the use of a guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated.
The balloon has radiopaque markers to aid in positioning the balloon in the stenosis, and is designed to provide an expandable segment of known diameter and length at a specific pressure.
The provided text is a 510(k) summary for the AngioSculpt Scoring Balloon Catheter, seeking substantial equivalence to predicate devices. It does not contain information about a study proving the device meets acceptance criteria. The document states that "Performance testing demonstrated that the AngioSculpt catheter reliably achieves the desired affect and is safe for its intended use" but does not detail the specifics of such testing, acceptance criteria, or the study design.
Therefore, I cannot provide the requested information from the given text.
The information not found in the document includes:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs without AI assistance.
- If a standalone performance study (algorithm only without human-in-the loop performance) was done. (This device is a physical medical device, not an AI algorithm, so this question is not applicable in its current form.)
- The type of ground truth used.
- The sample size for the training set. (This device is a physical medical device, not an AI algorithm, so this question is not applicable in its current form.)
- How the ground truth for the training set was established. (This device is a physical medical device, not an AI algorithm, so this question is not applicable in its current form.)
§ 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).