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The InviroBlunt and InviroBlunt w/EZ Wings Cannulas are used in conjunction with a syringe as an additive device for aspiration from multi-dose medicine vials or injection into I.V. Systems and pre-slit septums covering injection sites.

The InviroBlunt/InviroBlunt Cannula were designed to replace hypodermic needles currently for withdrawal of medication from rubber-stoppered vials or injection into I.V. Systems and pre-slit septums covering injection sites. The family of InviroBlunt Plastic Cannulas are 18 gauge stainless steel blunt cannulas for penetrating medicine vials and dispensing medications or for injection into I.V. Systems and for use in pre-slit septums covering injection sites. The InviroBlunt Cannulas are used in conjunction with a syringe to penetrate rubber-stopered medicine vials and pre-slit septums covering injection sites. The cannula is pre-lubricated to reduce septum insertion forces. The devices are individually packaged and are provided sterile and are labeled as single use.

Here's an analysis of the provided text regarding the InviroBlunt/InviroBlunt w/EZ Wings Cannula, focusing on acceptance criteria and supporting studies:

This document is a 510(k) summary for a medical device (K083851). It focuses on demonstrating substantial equivalence to a predicate device, not on presenting a comprehensive study of device performance to specific clinical acceptance criteria in the way a novel AI algorithm might. Therefore, many of the requested data points (e.g., sample size for test set, number of experts, MRMC studies, training set details) are not applicable or not present in this type of FDA submission summary for a physical medical device.

1. Table of Acceptance Criteria and Reported Device Performance

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

This document does not specify the sample size for any "test set" in the context of clinical or performance studies. For a physical device like a cannula, "test set" would typically refer to a number of units tested. The information provided is a summary of non-clinical tests.

• Sample Size: Not specified.
• Data Provenance: The tests described are non-clinical performance requirements, likely conducted internally by the manufacturer (Inviro Medical) in a controlled laboratory environment. No country of origin for clinical data is provided as no clinical data is referenced in this summary.

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

Not applicable. The "ground truth" for the performance criteria listed (e.g., smooth surface, dimensional accuracy, force requirements) would be established by engineering specifications and objective measurements, not by expert medical opinion in the way clinical ground truth is established for diagnostic AI.

4. Adjudication Method for the Test Set

Not applicable. As described above, the acceptance criteria are based on objective, non-clinical engineering and performance metrics, not on human interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This is a physical medical device (cannula), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to readers or AI assistance is irrelevant.

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

Not applicable. This is a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for the acceptance criteria are:

• Engineering Specifications: Dimensional requirements, force measurements (Cap Pull off, penetration, bending, tip breaking), flow rate.
• Visual Inspection Criteria: Smoothness, absence of contamination/defects/flash/burrs, invisible lubricant, correct color.
• Pressure Resistance Standards: Ability to withstand 330 kPa for 30 seconds without leakage.

8. The Sample Size for the Training Set

Not applicable. This is for a physical device, not an AI algorithm, so there is no "training set."

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

Not applicable. There is no training set for a physical device.

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