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The Nutrisafe 2 is a complete system of feeding tubes and accessories. The feeding tubes are available in several configurations and in three materials: DEHP-free PVC, Polyurethane, and Silicone. One of the benefits of the Nutrisafe 2 is that the connection does not incorporate a luer, and thus eliminating the risk of inadvertently connecting the system to an IV system. The Nutrisafe 2 feeding tube features a locking connection which eliminates the risk of involuntary disconnection; voluntary disconnection is achieved by simply unscrewing the hub connections.

AI/ML Overview

The provided 510(k) summary for the Nutrisafe 2 describes a medical device, not a software algorithm or AI device. Therefore, many of the requested categories related to acceptance criteria, ground truth, and studies for AI/algorithm performance are not applicable.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Biocompatibility: Non-irritant and non-toxic	"Biocompatibility testing of the material demonstrates that it is non-irritant and non-toxic."
Performance: No adverse effect on safety/efficacy due to changes	"Performance testing demonstrates that the changes do not affect safety or efficacy."
Risk Assessment (ISO 14971 compliance)	"Risk Assessment was conducted in compliance with ISO 14971."
Elimination of risk of IV administration through feeding tube	The device's design "does not incorporate a luer, and thus eliminating the risk of inadvertently connecting the system to an IV system." This is a fundamental design characteristic and the basis for its intended use and a key benefit over predicate devices.
Elimination of risk of involuntary disconnection	The device features "a locking connection which eliminates the risk of involuntary disconnection; voluntary disconnection is achieved by simply unscrewing the hub connections." This is a fundamental design characteristic.
No change in end-user technique; no special training required	"Another benefit of the Nutrisafe 2 is that it does not change the technique of the end-user, and therefore it does not require any special training." This is a claim made about user interaction with the device.
Meets manufacturers specifications	"Biocompatibility testing, performance testing and risk assessment demonstrate that the Nutrisafe 2 meets manufacturers specifications." While this is a general statement, it implies various internal specifications were met. This is a common umbrella acceptance criterion for medical devices.

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

This information is not applicable as the device is a physical feeding tube system, not an algorithm or AI device that relies on a test set of data. The studies conducted were physical materials and performance tests.

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

This information is not applicable for a physical medical device. "Ground truth" in the context of AI refers to verified labels on data. For the Nutrisafe 2, evaluations would involve standard engineering and biological testing methods.

4. Adjudication Method for the Test Set

This information is not applicable for a physical medical device. Adjudication methods like 2+1 or 3+1 are used in studies involving expert review of data, typically for AI performance evaluation.

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 as the device is a physical feeding tube system, not an AI-assisted diagnostic or therapeutic tool.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

This information is not applicable as the device is a physical feeding tube system, not a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the Nutrisafe 2 is derived from physical and biological testing standards and requirements, interpreted as meeting manufacturer specifications and safety/efficacy goals. This includes:

Biocompatibility standards: Demonstrating non-irritant and non-toxic properties.
Performance standards: Verifying the functional aspects like the locking connection and prevention of incorrect luer connections.
Risk assessment standards: Compliance with ISO 14971.

8. The Sample Size for the Training Set

This information is not applicable as the device is a physical feeding tube system, not an AI algorithm that requires a training set. Material and design choices are based on engineering principles and existing medical knowledge, not machine learning training.

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

This information is not applicable for the same reasons as above.

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