(70 days)
To administer to a patient conduction, regional, or local anesthesia.
The Epidural Catheter and accessories consists of an epidural, a stylet, a threading aid and a connector. The components are packaged in a tray. The tray is placed in a paperboard box with an outer box.
This document describes a 510(k) summary for an Epidural Catheter and accessories, specifically K983125. The document is a premarket notification for a medical device and thus does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria. The 510(k) summary outlines the device's substantial equivalence to a legally marketed predicate device (Aries K840201), rather than presenting performance criteria and study results.
Here's why none of the requested information can be extracted from the provided text:
- 1. A table of acceptance criteria and the reported device performance: This document is a regulatory submission for substantial equivalence, not a performance study report. It does not contain acceptance criteria for device performance or reported performance metrics.
- 2. Sample size used for the test set and the data provenance: Not applicable. No test set data or study details are provided.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment or expert involvement in a study is described.
- 4. Adjudication method for the test set: Not applicable. No test set or adjudication process is mentioned.
- 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 an Epidural Catheter, a physical medical device, not an AI or imaging diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and not present.
- 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No performance study requiring ground truth is described.
- 8. The sample size for the training set: Not applicable. This document does not describe the development of an AI model or a training set.
- 9. How the ground truth for the training set was established: Not applicable. No training set or ground truth establishment for a training set is discussed.
In summary, the provided text is a 510(k) submission for an epidural catheter, focusing on its substantial equivalence to a predicate device for regulatory approval. It does not include information about clinical studies, performance criteria, or AI model development that would address the questions posed.
§ 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).