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The Insignis™ Syringe Infusion System is specifically indicated for the subcutaneous infusion of the following human plasma-derived immunoglobulins when used according to the FDA approved biologic labeling: Cuvitru®, Immune Globulin Infusion (Human) 20% (manufactured by Takeda®); Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®); and Xembify®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by Grifols®) in the home, hospital, or ambulatory settings when administered according to the approved biologic or drug product labeling. The system is intended for use by clinicians and lay users. It is intended for use in adults and in adolescents ages 13-21. For adolescents, it is to be operated under the supervision of an adult after instruction is provided by a healthcare provider.

The Insignis TM Syringe Infusion System with the Insignis Syringe Driver and Intravenous Controller, is specifically indicated for the intravenous infusion of fluids such as 0.9% Sodium Chloride (normal saline) and dextrose solutions, and the following antibiotics when used according to the FDA approved drug product labeling: vancomycin, ertapenem, meropenem, oxacillin, and tobramycin.

The Insignis™ Syringe Infusion System is a portable mechanical infusion system that operates without electricity. The Insignis system is intended to deliver indicated fluids subcutaneously or intravenously, depending on the prescribed medicine type, route of administration, and dose. The Insignis system incorporates into its design, a means to maintain a constant nominal pressure (13.5 psi), a controlled flowrate within a restrictive tubing circuit and needles to ensure the desired flowrate of medication to the patient is achieved. The spring-loaded Insignis™ Syringe Driver a constant mechanical force to the plunger of a BD 50 mL syringe (ref. #309653), that dispenses fluid through a restricted flowrate tubing and / or needle set. The Insignis system can infuse the rated BD syringe volume of 0 - 50 mL. Through a selection of IHS products total flowrates of 8 mL/hr -250 mL/hr are available: application specific.

• A. For subcutaneous immunoglobulin (SCIg) administrations, the Insignis system includes the OneSett™ Subcutaneous Administration Set, which consists of a selectable rate flow controller connected in-line to an administration set comprised of 1 - 4 needle set configurations (6mm, 9mm, 12 mm, and 14mm lengths). The OneSett is dedicated to deliver 20% concentrate SCIg drugs at specific flowrates which meet the drug manufacturer's package inserts recommended flowrate limitations. The selectable rate flow controller controls the flowrate delivered to each subcutaneous needle site.

• B. For intravenous administrations, the Insignis system includes the Intravenous Controller, which consists of a selectable rate flow controller connected in-line to a tubing set. The Intravenous Controller is dedicated to delivering select antibiotics, and saline and dextrose solutions. Again, the selectable rate flow controller allows for selectable and controllable flowrates.
  For administering the prescribed medications, the Insignis system requires that the user fill the syringe with the prescribed medications, connect the infusion set to the syringe, eliminate air from the fluid line, secure the syringe into the Insignis™ Syringe Driver, connect to the infusion set to the patient, and load the syringe driver to begin the infusion.

The system is comprised of the Insignis™ Syringe Driver, a syringe, and either intravenous or subcutaneous infusion sets. To elaborate:

• a. The Insignis™ Syringe Driver provides the constant driving force to dispense fluids.
• b. The syringe is the reservoir that holds the fluids (manufactured by Becton & Dickinson).
• c. The infusion sets (intravenous or subcutaneous) form the fluid path and delivers the fluid to the patient at controlled flowrates.

This document is a 510(k) Summary for the Insignis™ Syringe Infusion System, a medical device. It focuses on demonstrating substantial equivalence to a predicate device, not on proving clinical efficacy via a multi-reader multi-case (MRMC) study or complex AI-driven ground truth establishment. Therefore, many of the requested points regarding AI model performance, expert adjudication, and training/test set details are not applicable as this is a traditional medical device submission, not an AI/ML product submission.

The document primarily details the results of non-clinical performance testing (bench testing) to verify the device meets its intended use and design requirements. The "acceptance criteria" can be inferred from the performance data presented, particularly the acceptable flow rate ranges and deviations.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides tables of flow rate performance for different configurations and medications. The "acceptance criteria" are implied by the ranges and percentage deviations provided for each labeled flowrate. The reported device performance is these very ranges and deviations. There isn't a separate, explicit table of acceptance criteria before the results, but the results themselves define the product's performance specifications.

Intravenous Controller (for 0.9% NaCl, Vancomycin, Ertapenem, Meropenem, Oxacillin, Tobramycin):

*KVO for saline and dextrose only.

Subcutaneous IgG Infusion - Hizentra® for Primary Immunodeficiency (PI):
Throughout the infusion, the measured flow rate may vary ±36% from the flow rate labeled on the dial.

*Subsequent infusion after initial infusion.
= Outside of drug's prescribing information recommended minimum - maximum flowrate.

Subcutaneous IgG Infusion - Hizentra® for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP):
Throughout the infusion, the measured flow rate may vary ±36% from the flow rate labeled on the dial.

*Subsequent infusion after initial infusion.
= Outside of drug's prescribing information recommended minimum - maximum flowrate.

Subcutaneous IgG Infusion - Xembify® for Primary Immunodeficiency (PI):
Throughout the infusion, the measured flow rate may vary -48.4%, +9% from the flow rate labeled on the dial.

= Outside of drug's prescribing information recommended minimum - maximum flowrate.

Subcutaneous IgG Infusion - Cuvitru® for Primary Immunodeficiency (PI):
Throughout the infusion, the measured flow rate may vary from the flow rate labeled on the dial.

*Subsequent infusion after first two infusions.
*Subsequent infusion after first two information recommended minimum - maximum flowrate.

2. Sample size used for the test set and the data provenance:

• Sample Size: The document states, "Flow rate was measured by visually assessing the change in volume in a graduated cylinder every 30 seconds." It does not specify the number of individual tests, number of devices, or number of runs for each configuration. It only describes the method of measurement and the resulting performance ranges.
• Data Provenance: The data is from "bench testing conditions," which generally implies a controlled laboratory environment. The country of origin is not explicitly stated, but the submission is to the U.S. FDA by a U.S.-based company (Innovative Health Sciences, LLC, Chester, NY), implying the testing was likely conducted in the US. The data is prospective, generated specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. This is a mechanical/fluid dynamics device, not an AI/ML diagnostic device requiring expert interpretation of medical images or data for ground truth. The "ground truth" for flow rate performance is established through direct, objective physical measurements using calibrated equipment (graduated cylinder, timing device, etc.), as described in the "Flowrate Performance" section: "Flow rate was measured by visually assessing the change in volume in a graduated cylinder every 30 seconds, when using the Insignis™ Syringe Infusion System as intended."

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

• Not Applicable. There is no expert adjudication for this type of performance testing.

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:

• Not Applicable. This is not an AI-assisted diagnostic device. No MRMC study was conducted or is relevant for this type of submission.

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

• Not Applicable. This is a mechanical infusion system, not an algorithm. Bench testing evaluates the device's standalone physical performance parameters.

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

• The ground truth for flow rate performance is based on direct, objective physical measurements (volume over time) under controlled bench testing conditions, as described.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device that requires a training set.

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

• Not Applicable. No training set was used.

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