(124 days)
The Atrion Medical QL® Locking Syringe Device is intended for single use to inject fluid into and aspirate fluid from a balloon interventional device having a recommended balloon inflation volume.
The Atrion Medical QL® Locking Syringe Device consists of a plastic syringe with a screw-type plunger and a locking mechanism.
The provided text is a 510(k) summary for the Atrion Medical QL® Locking Syringe Device. It describes the device, its intended use, and states that it has been found substantially equivalent to predicate devices. However, the document does not contain specific acceptance criteria, a detailed study report comparing the device to these criteria, or any information related to AI/ML device performance metrics.
Therefore, I cannot fulfill most of the requested information points, as they pertain to performance testing and evaluation metrics typically associated with AI/ML devices or more extensive clinical or bench testing beyond what is summarized here.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot provide. The document states "The materials of the device which contact the solution in use have been tested using USP guidelines and the results of these studies indicate that the product is safe for its intended use." However, it does not specify what the acceptance criteria were (e.g., specific thresholds for extractables, biocompatibility, etc.) nor does it report detailed performance results against those criteria.
2. Sample sized used for the test set and the data provenance
- Cannot provide. The document mentions "results of these studies" but gives no details on sample sizes or data provenance for any testing conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable / Cannot provide. This information is relevant for studies involving human interpretation (e.g., medical imaging devices evaluated by radiologists). The Atrion Medical QL® Locking Syringe Device is a mechanical device, and its testing would not involve "experts establishing ground truth" in this context.
4. Adjudication method for the test set
- Not applicable / Cannot provide. See point 3.
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. This is a mechanical device, not an AI/ML diagnostic tool. An MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used
- Cannot provide specific details. The document states testing used "USP guidelines." For a mechanical medical device, "ground truth" would typically refer to validated measurement standards or established performance benchmarks defined by those USP guidelines (e.g., material compliance, dimensional accuracy, leak integrity, pressure handling, etc.). However, these specific ground truths are not detailed in the summary.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device.
Summary:
The document emphasizes "substantial equivalence" to predicate devices (Atrion Medical Products, Inc. QL® Inflation Device, K032840, and Merit Medical Systems, Inc. Viceroy™ Inflation device, K040138) rather than presenting a detailed performance study against specific acceptance criteria. The only testing mentioned is related to materials conforming to USP guidelines for safety for intended use, without providing specifics on methodology or results.
§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.