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DJF Intravascular Administration Sets are intended for use with Curlin (Moog) Infusion Pump, for the delivery of fluids from a container or bag to the patient's vascular system

DJF Administration Sets are sterile/non-pyrogenic, single use, non-DEHP PVC tubing with a Universal Spike, Slide Clamp, Luer Lock (male) with integral anti-free flow valve (AFF) {optional, separately provided}, 0.2 micron or 1.2 micron filters, Yellow Cassette and Blue key (locator pin) for use with the Curlin IV pump. Three (3) new sets are: 1. DJFCUR001: Administration set compatible with Curlin Pump 2. DJFCUR002: Administration set with 0.2 micron filter compatible with Curlin Pump 3. DJFCUR003: Administration set with 1.2 micron filter compatible with Curlin Pump

This document is a 510(k) summary for the DJF Intravascular Administration Set. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than specifically outlining acceptance criteria for a new device's performance and the detailed studies proving it.

Therefore, much of the requested information regarding detailed acceptance criteria, specific performance metrics, sample sizes, ground truth establishment for AI/ML models, and comparative effectiveness studies (MRMC) for an AI device is not present in this document. This document describes a traditional medical device, not an AI/ML powered one.

However, based on the provided text, I can extract information related to the device's testing and safety/effectiveness for its intended use. I will adapt the requested table to reflect the information available.

Description of the Device:
The DJF Intravascular Administration Set is a sterile, single-use, non-pyrogenic set of PVC tubing designed for the delivery of fluids from a container or bag to a patient's vascular system. It is specifically intended for use with the Curlin (Moog) Infusion Pump. It includes features like a Universal Spike, Slide Clamp, Luer Lock (male) with optional anti-free flow valve, 0.2 or 1.2 micron filters, a Yellow Cassette, and a Blue key (locator pin) for compatibility with the Curlin pump.

I will provide the table of acceptance criteria and reported device performance based on the standards and tests mentioned, even though explicit "acceptance criteria" values are not quantified in this summary.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the following information is NOT available or NOT applicable (N/A) as this is a traditional medical device, not an AI/ML product:

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 for any of the performance tests. The document simply states "testing data" or "functional testing was conducted."
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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)

• N/A. This information pertains to studies where expert opinion is used to define a 'ground truth', typically in diagnostic or interpretative devices, especially AI/ML. For a physical administration set, ground truth is established through adherence to physical and biological standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• N/A. This is relevant for studies involving human interpretation or decisions, often in AI contexts.

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

• N/A. This device is an intravenous administration set, not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• N/A. This device does not involve an algorithm. Performance is assessed through physical, chemical, and biological testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For physical/biological characteristics: Standardized test methods/protocols (e.g., ISO, ASTM standards) and functional performance with the Curlin (Moog) pump serve as the "ground truth" or benchmark for acceptable performance. The predicate device (K121803) and reference device (K981816) also serve as benchmarks for substantial equivalence.

8. The sample size for the training set

• N/A. This device does not use an AI/ML model that requires a training set.

9. How the ground truth for the training set was established

• N/A. This device does not use an AI/ML model that requires a training set.

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