(62 days)
The PolarCath™ Peripheral Dilatation System is indicated to dilate stenoses in the peripheral vasculature (iliac, femoral, popliteal, infrapopliteal, renal and subclavian arteries) and for the treatment of obstructive lesions of polytetrafluoroethylene (PTFE) access grafts or arteriovenous dialysis fistulae. The PolarCath™ Peripheral Dilatation System is also indicated for post-deployed stent expansion of self-expanding peripheral vascular stents.
The PolarCath™ Peripheral Dilatation System consists of a Catheter, Inflation Unit, connecting cable and a rechargeable battery pack with recharging unit and battery receptacle. The inflation medium (liquid nitrous oxide) is provided in a disposable 14 gram cartridge.
The provided text describes a 510(k) premarket notification for a modification to the PolarCath™ Peripheral Dilatation System, specifically focusing on changes to the Inflation Unit's circuit board. This filing is for a device modification and does not involve a study to establish the diagnostic or predictive performance of an AI/ML algorithm. Therefore, many of the requested elements pertaining to such studies are not applicable.
Here's an analysis of the provided information in the context of the requested questions:
1. A table of acceptance criteria and the reported device performance
Since this is a submission for a modification to an existing device, the "acceptance criteria" are related to ensuring the modified device performs equivalently to the predicate device. The performance reported here relates to the safety and functionality of the changed component.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Maintain equivalent function of inflation units and circuitry | Successful completion of verification testing which assessed the function of inflation units and their circuitry through 12 sequential runs, or inflations, of the balloon. The changes "have been proven not to adversely affect the function of the device." |
| No adverse effect on overall design, function, material, intended use, labeling, or directions for use compared to the predicate device | No adverse effects reported. The changes only affect the Inflation Unit circuit board and not other aspects of the device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The information states "12 sequential runs, or inflations, of the balloon" were performed during verification testing. This implies a sample size of 12 tests on the modified inflation units. There is no information provided about the country of origin or whether the data was retrospective or prospective. This type of testing is typically prospective, performed in a controlled lab setting, rather than on patient data.
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)
This is not applicable. The "ground truth" for this type of engineering verification testing would be the pre-defined functional specifications of the device, assessed by engineers or technicians, not clinical experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as there's no clinical "ground truth" being established by experts through adjudication for this type of engineering verification. The assessment would likely involve comparing device output/functionality against engineering specifications.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for a physical device modification, not an AI/ML algorithm that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This submission is for a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this verification testing would be the functional specifications and performance parameters of the device's inflation unit and circuitry. It would be measured against engineering benchmarks, not clinical outcomes or expert consensus.
8. The sample size for the training set
This is not applicable. There is no "training set" as this is a physical device modification, not a machine learning model.
9. How the ground truth for the training set was established
This is not applicable for the same reason as above.
§ 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).