(37 days)
The Arrow StimuCath™ Continuous Nerve Block Set permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.
The StimuCath™ Continuous Nerve Block Device is an anesthesia conduction catheter that is electrically conductive. Using peripheral nerve stimulation, the clinician can locate specific nerves or nerve plexuses for continuous nerve block anesthesia or analgesia. The StimuCath™ is available sterile in a kit with the necessary accessories required to perform the procedure and fix the catheter in place.
The provided text describes a 510(k) premarket notification for the "StimuCath Continuous Nerve Block Set." It lists performance tests, including a clinical study, that demonstrate substantial equivalence to predicate devices. However, the document does not provide detailed acceptance criteria or specific results of the clinical study beyond stating that it was performed and contributed to the conclusion of substantial equivalence.
Therefore, many of the requested details cannot be extracted from this document.
Here's what can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document lists performance tests but does not explicitly define acceptance criteria or specific quantitative results for the StimuCath Continuous Nerve Block Set within the provided text. It concludes that the "results of the laboratory tests, calculations and the clinical study demonstrate that the device is substantially equivalent to the legally marketed predicate devices."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Holding strength of Snap-Lock™ adapter to catheter | Performed, concluded substantial equivalence. |
| Snap force of Snap-Lock™ | Performed, concluded substantial equivalence. |
| Leak test (positive pressure) | Performed, concluded substantial equivalence. |
| Flow rate | Performed, concluded substantial equivalence. |
| Biocompatibility tests | Performed, concluded substantial equivalence. |
| Power and current density calculations | Performed, concluded substantial equivalence. |
| Clinical study | Performed, concluded substantial equivalence. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions a "clinical study" but does not provide any details regarding the sample size, country of origin, or whether it was retrospective or prospective.
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)
The document mentions a "clinical study" but does not provide any details regarding experts used for ground truth or their qualifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document mentions a "clinical study" but does not provide any details regarding an adjudication method.
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
The document describes a medical device (a catheter and needle for nerve blocks), not an AI diagnostic or assistance system. Therefore, an MRMC comparative effectiveness study involving AI assistance would not be applicable, and none was done in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document mentions a "clinical study" but does not specify the type of ground truth used. Given the nature of a nerve block set, it's likely related to successful nerve localization and analgesia/anesthesia outcomes, but this is not explicitly stated.
8. The sample size for the training set
The document mentions a "clinical study" for performance testing but does not mention a separate training set or its sample size. This is common for traditional medical devices where performance is evaluated through design verification, validation, and clinical studies rather than machine learning model training.
9. How the ground truth for the training set was established
As no training set is indicated, this information is not applicable.
§ 868.5140 Anesthesia conduction kit.
(a)
Identification. An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.(b)
Classification. Class II (performance standards).