(44 days)
The Atrion Epidural Anesthesia Kit is intended for use in the administration of anesthetic agents into the epidural space. It is recommended that the epidural catheter be removed or replaced every 72 hours.
The NeedleVISE™ sharps securing system is intended for use in sterile anesthesiology procedure trays as a sharps securing device for the contaminated specialized needles that do not have integral engineered sharps safety devices.
The Atrion Epidural Anesthesia Kit with NeedleVISE™ Sharps Securing System consists of components necessary for conducting repeated administration of anesthetic agents in the epidural space. The kit also contains the NeedleVISE™ sharps securing system which is a opidural opade, single patient procedure use, disposable device used for securing the specialized needles found in sterile anesthesiology procedural trays.
As provided to the user, the NeedleV/SE™ sharps securing system is retained in an upright position in the sterile procedure tray to allow for stability and one-hand insertion of sharps during a procedure. The healthcare professional using only one hand can render the sharps harmless while remaining with the patient in the sterile field. The purpose of the NeedleVISE™ sharps while rounsvitem is to provide a means to make engineered sharps control protection available within the sterile field, for all instances in which introduction of contaminated sharps containers is not acceptable.
The provided text is a 510(k) premarket notification for the Atrion Epidural Anesthesia Kit with NeedleVISE™ sharps securing system. It is a submission to the FDA for a medical device and therefore does not include acceptance criteria or a detailed study plan/results for AI-powered devices. The information provided is for a traditional medical device, not an AI/ML diagnostic tool.
Therefore, many of the requested fields cannot be extracted from the given text.
Here's an attempt to answer the questions based on the provided text, flagging where information is not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Property Testing: Assessed impact, stability, puncture, and leak resistance for the NeedleVISE™ sharps securing system. | The results showed the NeedleVISE™ device to be substantially equivalent to the predicate sharps securing devices. |
| Clinical Utility: Evaluated ease of use in field trials for the NeedleVISE™ sharps securing system. | (Specific performance metrics for ease of use are not detailed, but the device gained 510(k) clearance implying satisfactory performance). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text. The term "field trials" suggests prospective data collection in a clinical setting, but no details are given.
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 information is not applicable and not provided. The testing described focuses on mechanical properties and ease of use of a physical medical device, not diagnostic accuracy requiring expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. The testing described focuses on mechanical properties and ease of use of a physical medical device, not diagnostic accuracy requiring adjudication.
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
This information is not applicable. The device is a physical epidural anesthesia kit with a sharps securing system, not an AI-powered diagnostic tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical epidural anesthesia kit with a sharps securing system, not an AI-powered algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable. The testing described for the NeedleVISE™ sharps securing system involved mechanical property testing (impact, stability, puncture, leak resistance) and "field trials designed to assess ease of use." Ground truth in the sense of diagnostic accuracy is not relevant here. The "ground truth" would be the direct measurements of these mechanical properties and subjective user feedback on ease of use.
8. The sample size for the training set
This information is not applicable. The device is a physical medical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable. The device is a physical medical device, not an AI/ML model that requires a training set.
§ 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).