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The Melker Emergency Cricothyrotomy Catheter Set is used for emergency airway access.
. In patients whom conventional endotracheal intubation and ventilation cannot be performed.
The device will be supplied sterile and is intended for one-time use.

Used for emergency airway access when conventional endotracheal intubation and ventilation cannot be performed.

Device Description

The Melker Emergency Cricothyrotomy Catheter with a standard inner diameter of 3.5, 4, or 6 mm and a length of either 3.8, 4.2, 7.5 cm with a proximal fitting and a coaxial dilator tapered to a 0.038-inch wire guide.

AI/ML Overview

This 510(k) premarket notification for the Melker Emergency Cricothyrotomy Catheter Set (K013916) does not contain the detailed information necessary to fully address all aspects of your request. The submission is primarily focused on demonstrating substantial equivalence to a predicate device (K010016) based on indications for use, material, and physical characteristics, and adherence to quality system procedures.

Here's an analysis based on the provided text, highlighting what is available and what is missing:

Acceptance Criteria and Study for K013916: Melker Emergency Cricothyrotomy Catheter Set

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Reported Device Performance	Comments
Specific Performance Criteria	Not explicitly stated in terms of measurable thresholds or pass/fail criteria.	The document states "Specific performance of the device subject of this submission is assured through adherence to the firm's quality system procedures for device quality. Various device design specifications and quality specifications are used to produce a device that meets predetermined acceptance criteria." However, the specific acceptance criteria themselves and the performance metrics against those criteria are not detailed in this 510(k) summary.
Substantial Equivalence	"This device is the same with respect to indications for use, material and physical characteristics to the Melker Cuffed Cricothyrotomy Catheter Set cleared under K010016 on 10/09/01."	This is the primary "performance" being demonstrated for regulatory clearance. The device is deemed to perform acceptably because it is equivalent to a previously cleared device.
Sterility	"The Melker Emergency Cricothyrotomy Catheter Set will be sterilized using an Ethylene Oxide (ETO) gas cycle validated to assure a 10⁻⁶ sterility assurance level."	This is a specific performance criterion and the reported result (validation to 10⁻⁶ SAL) meets the industry standard for sterile medical devices.
Packaging Integrity	"Each unit is packaged and sealed within a Tyvek-Poly pouch and properly labeled."	Implies that packaging integrity is a criterion, though specific test results (e.g., seal strength, barrier properties) are not provided.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not describe a specific "test set" in the context of a clinical or performance study with human or simulated cases for K013916.
The comparison is based on the characteristics of the device being "the same" as a predicate device (K010016).
Therefore, no sample size for a test set is provided, and data provenance for such a test set is not applicable in this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

Not applicable. As no specific "test set" or clinical study requiring ground truth establishment is described for K013916, there is no mention of experts or their qualifications for this purpose.

4. Adjudication Method for the Test Set:

Not applicable. No test set requiring an adjudication method is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was done or reported in this submission. The submission relies on substantial equivalence to the predicate device, not on demonstrating improved human reader performance with or without AI.

6. Standalone Performance Study (Algorithm Only):

Not applicable. This device is a catheter set, not an algorithm or AI-driven system. Therefore, a standalone (algorithm only) performance study is not relevant.

7. Type of Ground Truth Used:

Not applicable. As there is no described test set or study involving diagnostic performance, the concept of "ground truth" (e.g., pathology, outcomes data) is not relevant to this 510(k) submission for K013916. The "ground truth" for the clearance is essentially the established performance and safety profile of the predicate device (K010016).

8. Sample Size for the Training Set:

Not applicable. As this is a physical medical device (catheter set) and not an AI/ML algorithm requiring a training set, the concept of a "training set" is not relevant to this submission.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As there is no training set mentioned, the establishment of its ground truth is also not applicable.

Summary of Study (as presented in the 510(k) for K013916):

The "study" for K013916 is a substantial equivalence comparison to a predicate device (Melker Cuffed Cricothyrotomy Catheter Set, K010016). The manufacturer asserts that the new device is "the same with respect to indications for use, material and physical characteristics" as the predicate device. Therefore, the "acceptance criteria" in this context are that the new device replicates the key attributes of the cleared predicate device. The "study" largely involves documentation of device design, materials, manufacturing processes, and sterilization validation, aligning them with those of the predicate device and the firm's quality system.

The submission does not involve clinical trials, comparative studies against human performance, or studies typically associated with AI/ML devices that would require test sets, ground truth, or statistical power calculations for diagnostic accuracy.

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