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The SCIg60 Infusion System is intended for the subcutaneous infusion of the following immunoglobulin liquid medications:

• · Hizentra, Immune Globulin Subcutaneous (Human) 20% (manufactured by CSL Behring),
  • Gammagard Liquid, Immune Globulin Infusion (Human) 10% (manufactured by Takeda Pharmaceutical Company, formerly Baxalta).

· Cuvitru Immune Globulin Infusion (Human) 20% (manufactured by Takeda Pharmaceutical Company, formerly Baxalta)

• · Gamunex-C Immune Globulin Subcutaneous (Human), 10% (manufactured by Grifols Therapeutics, Inc.),
• · Gammaked Immune Globulin Subcutaneous (Human), 10% (manufactured by Grifols Therapeutics, Inc.)
• · Xembify Immune Globulin Subcutaneous (Human), 20% (manufactured by Grifols Therapeutics, Inc.), and
• · Cutaquig Immune Globulin Subcutaneous (Human), 16.5% (manufactured by Octapharma AG)

with the BD 50 ml syringe (model no. 309653) in the home or hospital environment.

The EMED SCIg60 Infusion System consists of the SCIg60 Infuser Pump, a flow rate controller (Infuset fixed rate flow control extension set. VersaRate variable flow rate controller, or VersaRate Plus variable flow rate controller), and can be used with commercially available SUB-Q administration sets that utilize a standard Luer Lock style connector. The SCIg60 Infuser Pump must be used with the BD 50 mL syringe (model no. 309653 manufactured by Becton Dickinson (BD)), which was formerly labeled as a 60 mL syringe.

The SCIg60 Infuser pump is a reusable mechanical, non-electronic ambulatory infusion pump that does not require batteries or any electrical source. The SCIg60 Infuser Pump uses a spring as a source of energy to provide pressure for the subcutaneous infusion of the indicated human plasma-derived immunoglobulin solutions. The SCIg60 Infuser Pump is provided with a carrying case and User Manual.

The Infuset flow rate controller is an individually packaged, sterile, single use device. It is assembled from standard Luer components and specified lengths of PVC microbore tubing. The length and diameter of the tubing results in fixed flow rates when used with the SCIg60 Infuser Pump, and include side-clamps for stopping the flow of fluid. The SCIg60 Infusion System User Manual includes information to guide users in the selection of Infuset flow rate controller and SUB-Q patient administration sets to achieve the desired infusion rates.

The VersaRate or VersaRate Plus variable flow rate controllers are individually packaged, sterile, single use devices. They may be used with the SCIg60 Infuser Pump to provide convenient control of the flow rate without having to select specific Infuset flow rate controller. The barrel-shaped dial (VersaRate) or flat dial (VersaRate Plus) can be adjusted by turning a barrel or dial in order to set an appropriate flow rate of immune globulin solution, or stop the fluid flow entirely. The SCIg60 Infusion System User Manual includes information to guide users in the selection of VersaRate (or VersaRate Plus) settings and SUB-Q patient administration sets to achieve the desired infusion rates.

The document provided is a 510(k) premarket notification for a medical device called the SCIg60 Infusion System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive de novo studies with specific acceptance criteria and detailed performance metrics as one might find for novel AI/ML devices or pharmaceutical trials.

Based on the provided text, the acceptance criteria and study information are presented in terms of equivalence to the predicate device and verification of performance with additional biologics. It does not describe an AI/ML device, nor does it contain information typically found in studies involving AI/ML performance metrics such as sample size for test sets, data provenance, expert ground truth, MRMC studies, or standalone algorithm performance.

Here's an analysis of the available information in the context of the requested parameters, highlighting what is present and what is absent:

Acceptance Criteria and Device Performance (Analogous to)

The document frames "acceptance criteria" and "device performance" in terms of demonstrating that the modified SCIg60 Infusion System (with expanded biologics and the VersaRate Plus controller) performs equivalently to the predicate device (K161906) and within the recommendations of the immunoglobulin manufacturers.

Regarding AI/ML Specific Information (NOT APPLICABLE)

The provided text describes a mechanical infusion pump and its accessories. There is no indication that this device uses artificial intelligence or machine learning. Therefore, the following requested points are not relevant to this document and cannot be extracted:

2. Sample size used for the test set and the data provenance: Not an AI/ML device. Performance testing on the infusion system itself was conducted, but details like sample sizes of units tested are not provided, nor is data provenance for an AI model.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not an AI/ML device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not an AI/ML device.
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 an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not an AI/ML device. The "ground truth" for this device would be its own mechanical performance (e.g., flow rate accuracy, material compatibility) and comparison to established predicate properties and drug manufacturer guidelines.
8. The sample size for the training set: Not an AI/ML device.
9. How the ground truth for the training set was established: Not an AI/ML device.

Summary of the Study (Non-Clinical Performance Testing)

The "study" described in the document is a series of non-clinical performance tests and analyses to demonstrate the substantial equivalence of the modified SCIg60 Infusion System to its predicate (K161906). This involved:

• Comparison of Device Characteristics: Detailed comparison of the infuser components (materials, dimensions, principle of action) and flow controllers (materials, design, settings, flow rates) to the predicate.
• Assessment of Biologic Compatibility: Evaluation of the physiochemical properties (protein concentration, pH, osmolarity, viscosity, density) of the newly indicated immunoglobulin solutions to determine similarity to previously approved ones and ensure no adverse interactions with the device.
• Flow Rate Performance Testing: Bench testing to characterize the flow rates provided by the SCIg60 Infusion System when used with the additional immunoglobulin solutions, various flow controllers (Infuset, VersaRate, VersaRate Plus), and SUB-Q administration sets. This testing strategy was identical to that used for the predicate.
• Material Compatibility and Sterilization Validation: Assessment of new materials in the VersaRate Plus for compliance with chemical requirements (ISO 8536-9:2015) and confirmation that sterilization processes and residual levels meet ISO 11135:2014 and ISO 10993-7:2008/Amd 1:2019 standards.
• Risk Management and Labeling Review: Updates to risk management matrices and labeling/instructions for use to incorporate the expanded indications and the new VersaRate Plus controller.

Conclusion stated in the document:
"The data generated by the performance tests demonstrates that the EMED Technologies Corporation SCIg60 Infusion System... is substantially equivalent to the predicate devices and provides infusion rates consistent with the FDA approved human plasma-derived immunoglobulin labeling, when used as directed." (Page 9)

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