(25 days)
Balloon dilatation of the femoral, popliteal and infra-popliteal arteries. These catheters are not designed to be used in the coronary arteries.
The LitePAC PTA Catheter is a standard rapid exchange PTA catheter. The proximal end provides a mono luer hub connector which allows the attachment of an inflation device used to inflate and deflate the balloon through the outer lumen. The rapid exchange port is positioned at the transition area between the stiffer hypotube and the more flexible distal portion and facilitates single operator use for insertion into a 0.014" guidewire.
This response is based on the provided text, which details a 510(k) submission for a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing, rather than clinical studies with human subjects or AI algorithms. Therefore, many of the requested categories related to clinical study design (sample size for test/training sets, expert ground truth, adjudication, MRMC studies, standalone performance) are not applicable to this document.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Criterion) | Reported Device Performance (Demonstrated by) |
|---|---|
| Visual and functional testing | In vitro testing (results demonstrated comparability to predicate devices) |
| Catheter body diameter | In vitro testing (results demonstrated comparability to predicate devices) |
| Measurement of balloon working surface | In vitro testing (results demonstrated comparability to predicate devices) |
| Inflation/deflation testing | In vitro testing (results demonstrated comparability to predicate devices) |
| Pull back testing | In vitro testing (results demonstrated comparability to predicate devices) |
| Balloon Compliance | In vitro testing (results demonstrated comparability to predicate devices) |
| Average burst pressure | In vitro testing (results demonstrated comparability to predicate devices) |
| Tensile testing of proximal bond | In vitro testing (results demonstrated comparability to predicate devices) |
| Compliance with ISO 10555-1 and ISO 10555-4 | Testing performed in compliance with these standards (results demonstrated comparability to predicate devices) |
| Substantial Equivalence to Predicate Device | Comparison of technological characteristics and performance criterion, demonstrated through in vitro testing and numerous device similarities. |
Study Proving Acceptance Criteria Met:
The study that proves the device meets the acceptance criteria is a non-clinical design verification and design validation testing and analysis. This involved a series of in vitro tests performed in accordance with FDA guidance documents on non-clinical testing of medical devices, as well as ISO 10555-1 and ISO 10555-4 standards.
The conclusion drawn from this testing is that "the technological characteristics and performance criteria of the LitePAC PTA catheter are comparable to the predicate devices and that it can perform in a manner equivalent to devices currently on the market for the same intended use." This demonstrates substantial equivalence, which is the primary criterion for 510(k) clearance.
Detailed Information as Requested (where applicable):
Since this is a 510(k) submission for a physical medical device (catheter) and not an AI/software device, many of the requested items related to study design for AI are not applicable.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: The document does not specify the exact number of units or samples tested for each in vitro test. It refers to "in vitro testing" without providing specific sample numbers.
- Data Provenance: The testing was conducted by ClearStream Technologies Ltd. The data is retrospective in the sense that it's generated for submission after device design, but it's not retrospective clinical data. It is laboratory-generated test data. The country of origin for the testing itself is not explicitly stated, but the applicant's address is Moyne Upper, Enniscorthy, Co.Wexford, Ireland.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as the "ground truth" for a physical device's performance in in vitro testing is determined by engineering specifications, validated test methods, and measurement accuracy, not by expert human interpretation in the way it would be for medical image analysis or similar AI applications.
4. Adjudication method for the test set:
- Not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human experts when establishing ground truth from subjective data. In vitro physical testing relies on objective measurements and established pass/fail criteria.
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 device is a physical medical instrument, not an AI software intended to assist human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a catheter, not an algorithm.
7. The type of ground truth used:
- The "ground truth" in this context is defined by engineering specifications, industry standards (ISO 10555-1 and ISO 10555-4), and FDA guidance documents for non-clinical testing of medical devices. The device's performance is measured against these established criteria.
8. The sample size for the training set:
- Not applicable. There is no "training set" in the context of a physical device's non-clinical safety and performance testing. Training sets are relevant for machine learning algorithms.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set, there is no ground truth to be established for it.
§ 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).