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The enFlow IV Fluid Warmer System is indicated for warming blood, blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.

Device Description

The Insulated Strap is an accessory to the enFlow IV Fluid Warmer which is used to secure the warmer component of the enFlow IV Fluid Warmer System to the patient during transport. The Insulated strap consists of a silicone strap, an insulating element and a mounting plate, into which the user can secure the enFlow IV Fluid Warmer.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the enFlow IV Fluid Warmer Insulated Strap:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document (510(k) Summary for K130867) does not list specific numerical acceptance criteria or performance metrics for the enFlow IV Fluid Warmer Insulated Strap. Instead, it focuses on qualitative compliance and equivalence.

Acceptance Criteria Category	Reported Device Performance (Qualitative)
Material Biocompatibility	Meets biocompatibility requirements per ISO 10993.
Design & Performance Verification	Verified that the enFlow IV Fluid Warmer IV System meets the defined specifications. Includes functional, packaging, and labeling evaluations.
Risk Analysis	Risk Management employed throughout development and implementation.
User Validation Testing	User testing performed to validate the enFlow IV Fluid Warmer Insulated Strap against its intended use.
Equivalence to Predicate Device	Equivalent in performance to the predicate strap, but introduces new materials in the insulating element and mounting plate.
Safety and Effectiveness	Considered as safe, as effective, and to perform in a substantially equivalent manner to the current enFlow IV Fluid Warmer System and the predicate device.
Compliance with Voluntary Standards	Accessories comply with voluntary standards.
Clinical Studies	Did not require clinical studies.

2. Sample Size for Test Set and Data Provenance:

Sample Size: Not explicitly stated. The document mentions "User Validation Testing" and "Design & Performance Verification Testing" but does not quantify the number of units or tests involved.
Data Provenance: Not explicitly stated. Given it's a 510(k) submission from a US company (GE Healthcare, Totowa, NJ), the testing was likely conducted in the US, but this is not confirmed. The testing appears to be retrospective in the sense that it's evaluating a developed accessory against established standards and a predicate device, rather than a prospective clinical trial.

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

Number of Experts: Not explicitly stated. The section mentions "User Validation Testing" but does not specify how many users were involved or if they were considered "experts" for establishing ground truth, and if so, their qualifications. The other tests (biocompatibility, design/performance verification, risk analysis) would involve qualified engineers and scientists, but these are not referred to as "experts establishing ground truth" in the context of clinical or diagnostic performance.
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set:

Adjudication Method: Not specified. For non-clinical tests like material biocompatibility, functional verification, and risk analysis, formal adjudication methods like 2+1 or 3+1 are typically not applied in the same way they would be for expert review of images in a diagnostic AI study. Decisions would be based on test results meeting predefined specifications or standards.

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

MRMC Study Done? No. The document explicitly states: "The subject of this premarket submission, enFlow IV Fluid Warmer Insulated Strap, did not require clinical studies to support substantial equivalence." This means no comparative effectiveness study with human readers was conducted, as the device is an IV fluid warmer accessory, not a diagnostic imaging device.
Effect Size of Human Readers with AI vs. Without AI Assistance: Not applicable, as there was no MRMC study or AI component in this device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Standalone Study Done? Not applicable. This device is an IV fluid warmer accessory and does not involve an algorithm or AI for diagnostic or predictive purposes. Its performance is related to warming fluids and material properties.

7. Type of Ground Truth Used:

The concept of "ground truth" as typically used in AI/diagnostic studies (e.g., expert consensus for disease presence or absence) is not directly applicable here. For this device, the "ground truth" or reference for evaluating its performance comes from:

Defined Specifications: For functional, packaging, and labeling evaluations.
Voluntary Standards: For overall compliance.
ISO 10993: For biocompatibility requirements.
Intended Use: For user validation testing.
Predicate Device Performance: For establishing substantial equivalence.

8. Sample Size for the Training Set:

Sample Size: Not applicable. This device is a hardware accessory and does not involve a "training set" in the context of machine learning or AI models.
How Ground Truth for Training Set was Established: Not applicable.

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