(146 days)
The Patil Cricothyroid Catheter is used for emergency airway access when conventional endotracheal intubation cannot be performed. It is provided in peel-open packages and is intended for one-time use.
Used for emergency airway access when conventional endotracheal intubation and ventilation cannot be performed.
The Patil Cricothyroid Catheter consists of a connector on the proximal end connected to tubing with an inner diameter. Through the catheter lumen is a dilator. The dilator over a needle is used for insertion. The catheter will be included in a set consisting of appropriately sized components.
This document (K013252) does not contain detailed information about specific acceptance criteria or a dedicated study proving that the device meets those criteria. Instead, it seems to be a 510(k) premarket notification for a medical device (Patil Cricothyrotomy Catheter), which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive performance studies with predefined acceptance criteria.
The phrase "The results of the tests performed provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a cricothyrotomy catheter" (from {1}) indicates that some testing was done, but the specifics of those tests, the acceptance criteria, and the detailed results are not included in this document.
Therefore, most of the information requested in your prompt cannot be extracted from this document. However, I can provide what is available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this document. | The document states, "The results of the tests performed provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a cricothyrotomy catheter." No specific performance metrics or values are provided. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified.
- Data Provenance: Not specified.
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)
- Not applicable/Not specified, as no study with a test set requiring expert-established ground truth is detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified.
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 MRMC comparative effectiveness study is mentioned in this document. The device is a physical catheter, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a physical catheter.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not specified, as no study with a ground truth determination process is detailed.
8. The sample size for the training set
- Not applicable, as this device is a physical component, not an AI/algorithmic system that typically involves training sets.
9. How the ground truth for the training set was established
- Not applicable.
§ 868.5090 Emergency airway needle.
(a)
Identification. An emergency airway needle is a device intended to puncture a patient's cricothyroid membrane to provide an emergency airway during upper airway obstruction.(b)
Classification. Class II (performance standards).