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The SCIg60 Infusion System is intended for use in the home or hospital environment for the subcutaneous infusion of Hizentra, Immune Globulin Subcutaneous (Human), 20% Liquid (manufactured by CSL Behring), Gammagard Liquid, Immune Globulin Infusion (Human) 10% (manufactured by Baxalta), and Cuvitru Immune Globulin Infusion (Human) 20% (manufactured by Baxalta) with the BD 60 ml syringe (model no. 309653).

The EMED SCIg60 Infusion System consists of the SCIg60 Infuser, the Infuset™ flow control extension set and SUB-Q patient administration set. The SCIg60 Infuser must be used with the BD 60 ml syringe (model no. 309653). The Infuset™ flow control extension sets and SUB-Q patient administration sets are also manufactured by EMED Technologies.

The SCIg60 Infuser is a reusable mechanical. non-electronic ambulatory infusion pump that does not require batteries or any electrical source. The EMED SCIg60 Infuser uses a spring as a source of pressure for the subcutaneous infusion of indicated human plasma-derived immunoglobulin solutions.

The Infuset™ flow control extension sets are assembled from standard luer lock components and specified lengths of PVC microbore tubing. The length and diameter of the tubing results in predetermined flow rates when used with the SCIg60 Infuser, and include slide-clamps for stopping the flow of fluid. The SCIg60 Infuser user manual includes information to guide users in the selection of Infuset™ flow control extension sets and SUB-Q patient administration sets users to achieve the desired infusion rates.

SCIg60 Infusion System should be used in accordance with its directions for use.

The provided text describes a 510(k) submission for the SCIg60 Infusion System, primarily to expand its indications for use to include Gammagard and Cuvitru in addition to Hizentra. The document focuses on demonstrating that the device's performance with these new indications is substantially equivalent to its performance with the predicate indication (Hizentra) and aligns with the drug manufacturers' recommended infusion rates.

The acceptance criteria for this device are implicitly tied to maintaining the safety and effectiveness of the infusion system, specifically its ability to deliver the indicated human plasma-derived immunoglobulin solutions at appropriate flow rates. The study proving the device meets these criteria is a performance testing study, summarized within the "Summary of Performance Testing" section.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are not explicitly stated as quantitative thresholds (e.g., "flow rate must be within +/- X% of target"). Instead, the acceptance is based on the device's ability to achieve flow rates that are consistent with the FDA approved human plasma-derived immunoglobulin labeling, when used as directed.

The reported device performance is demonstrated through tables that specify:

• Needle Gauge
• Number of needles
• Total Flow Rate (ml/hr)
• Approx. Per Site Flow Rate (ml/hr)
• Infuset™ Reorder Number
• SUB-Q Set

These tables are provided for:

• Hizentra (First Infusion and Standard Infusions)
• Gammagard (Initial Infusion for patients =40kg; Maintenance Infusions for patients =40kg)
• Cuvitru (First 2 Infusions and Subsequent Infusions)

The "reported device performance" is the achievement of these specific flow rates for various configurations, which are then stated to be consistent with the respective drug manufacturers' recommendations.

Example Excerpt for Hizentra (Standard Infusions) as an illustration of reported performance:

The general acceptance criterion is that the device, when used with the specified Infuset and SUB-Q sets, delivers flow rates that fall within the ranges published by the drug manufacturers for the given immunoglobulin solutions. The full set of tables across pages 6-10 represents the reported performance data that meets this criterion.

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

The document does not explicitly state the sample sizes (e.g., number of tests, number of devices tested) for the infusion flow rate testing. It mentions "Infusion flow rate testing with SCIg60 Infusion System and indicated human plasma-derived immunoglobulin solutions" and "Infusion flow rate testing with combinations of SCIg60 Infuser. Infuset 100 extension sets, and . SUB-Q patient administration sets with simulated test fluid."

Given this is a 510(k) submission, the data provenance is likely from laboratory testing conducted by the manufacturer (EMED Technologies Corporation) in the USA, and it would be prospective for the specific tests performed to support this submission. However, some data (e.g., reliability, biocompatibility, sterility, shelf life) were "incorporated by reference to data from K142319," which means they were likely established during the predicate device's clearance and are thus retrospective in the context of this specific submission.

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

This type of information (number and qualifications of experts) is typically relevant for studies involving human interpretation (e.g., image reading). For this device, which performs a mechanical function (fluid infusion), the "ground truth" is based on engineering specifications and established fluid dynamics principles (Poiseuille equation) along with the manufacturer-recommended infusion rates for the pharmaceutical products. There is no indication of "experts" in the sense of human adjudicators for the test set results; rather, the "ground truth" is adherence to known physical laws and pharmaceutical labeling.

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

No human adjudication method is mentioned or relevant for this type of performance testing. The "adjudication" is based on direct measurement of flow rates and comparison against established product specifications.

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

An MRMC study is not relevant to this device. This is a medical device (infusion pump), not an AI-assisted diagnostic tool requiring human reader studies.

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

This refers to the performance of the infusion system itself (the "algorithm" in this context is the mechanical and fluid dynamic operation), without direct human-in-the-loop performance influencing the measurement of its function. The "Infusion flow rate testing" described is indeed a standalone performance test of the device.

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

The ground truth for this performance study is based on:

• Engineering principles and physical laws: The flow control properties follow the Poiseuille equation.
• Manufacturer specifications for the device: The design, materials, and functionality of the SCIg60 Infuser, Infuset, and SUB-Q sets.
• Pharmaceutical product labeling: The "manufacturer-recommended total flow rates of the additional indicated immunoglobulin biologics" (Hizentra, Gammagard, Cuvitru) serve as the target "ground truth" for the flow rate performance.

8. The sample size for the training set

This concept (training set) is typically applicable to machine learning or AI models. The SCIg60 Infusion System is a mechanical device, not an AI. Therefore, there is no "training set" in the context of artificial intelligence. Its design and performance are based on engineering principles and testing.

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

As there is no training set for an AI model, this question is not applicable. The "ground truth" for the device's design and expected performance (as mentioned in point 7) is derived from established scientific and engineering principles, and the specific requirements of the drug products it is designed to administer.

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The SCIg60 Infusion System is intended for use in the home or hospital environment for the subcutaneous infusion of Hizentra, Immune Globulin Subcutaneous (Human), 20% Liquid (manufactured by CSL Behring) with the BD 60 ml syringe (model no. 309653).

The EMED SCIg60 Infusion System consists of the SCIg60 Infuser, the Infuset™ flow control extension set and SUB-Q patient administration set. The SCIg60 Infuser must be used with the BD 60 ml syringe (model no. 309653). The Infuset™ flow control extension sets and SUB-Q patient administration sets are also manufactured by EMED Technologies (see K140133 and K140131).

The SCIg60 Infuser is a reusable mechanical, non-electronic ambulatory infusion pump that does not require batteries or any electrical source. The EMED SCIg60 Infuser uses a spring as a source of pressure for the subcutaneous infusion of Hizentra, Immune Globulin Subcutaneous (Human), 20% Liquid (manufactured by CSL Behring).

The Infuset™ flow control extension sets are assembled from standard luer lock components and specified lengths of PVC microbore tubing. The length and diameter of the tubing results in predetermined flow rates when used with the SCIg60 Infuser, and include slide-clamps for stopping the flow of fluid. The SCIg60 Infuser user manual includes information to guide users in the selection of Infuset™ flow control extension sets and SUB-Q patient administration sets users to achieve the desired infusion rates.

SCIg60 Infusion System should be used in accordance with its directions for use.

Please find the requested information regarding the acceptance criteria and study details for the SCIg60 Infusion System below.

Acceptance Criteria and Reported Device Performance

• Account for the characteristics of Hizentra in flow rate accuracy. | Performance data demonstrated that the SCIg60 Infusion System provides infusion rates consistent with the FDA-approved Hizentra labeling when used as directed. The study included:
  • Infusion accuracy testing with SCIg60 Infusion System and Hizentra.
  • Infusion accuracy testing with combinations of SCIg60 Infuser, Infuset™ extension sets, and SUB-Q patient administration sets and Hizentra simulated test fluid.
  • Validation of simulated Hizentra test fluid. |
    | Influence of Elevation | - Demonstrate consistent flow rates across varying elevations. | Influence of elevation on flow rate was tested. The document does not explicitly state the acceptance criteria for this test, but the overall conclusion of substantial equivalence suggests satisfactory performance. |
    | Residual Volume | - Minimize residual volume of Hizentra at the end of infusion. | Residual volume of Hizentra remaining at the end of infusion was measured. The document does not explicitly state the acceptance criteria for this test, but the overall conclusion of substantial equivalence suggests satisfactory performance. |
    | Reliability | - Maintain performance over the labeled shelf life (accelerated aging). | Reliability testing of SCIg60 Infuser devices that were aged (accelerated aging) to the labeled shelf life was conducted. The document does not explicitly state the acceptance criteria for this test, but the overall conclusion of substantial equivalence suggests satisfactory performance. |
    | Biocompatibility | - Be biocompatible for components in contact with the patient. | Biocompatibility data was incorporated by reference for the Infuset™ flow control extension sets and SUB-Q patient administration sets (K140131 and K140133). The specific acceptance criteria are not detailed in this document but are assumed to meet regulatory standards. |
    | Sterility | - Ensure sterility of relevant components. | Sterility data was incorporated by reference for the Infuset™ flow control extension sets and SUB-Q patient administration sets (K140131 and K140133). The specific acceptance criteria are not detailed in this document but are assumed to meet regulatory standards. |
    | Shelf Life | - Maintain integrity and function over the specified shelf life. | Shelf life data was incorporated by reference for the Infuset™ flow control extension sets and SUB-Q patient administration sets (K140131 and K140133). The specific acceptance criteria are not detailed in this document but are assumed to meet regulatory standards. |
    | Human Factors | - Ensure safe and effective use by intended users. | Human factors testing was conducted to validate the SCIg60 Infusion System, implying that the device was found to be safe and effective for its intended users. The specific acceptance criteria are not detailed. |
    | Hizentra Compatibility | - Demonstrate no adverse effects on Hizentra after infusion through the system regarding appearance, particulates, protein concentration, IgG fragments/polymers/aggregates, anti-complementary activity (ACA), density, and Fc-function. | Compatibility of Hizentra with the SCIg60 Infusion System was conducted. The characteristics of Hizentra (appearance, particulates, protein concentration, amount of IgG fragments, polymers or aggregates, anti-complementary activity (ACA), density, and Fc-function) were evaluated after being infused through the SCIg60 Infusion System and compared to a control. The document does not explicitly state quantitative acceptance criteria, but the overall conclusion of substantial equivalence suggests the device did not adversely affect Hizentra. |
    | Safety Assurance | - Provide a safety assurance case as recommended by FDA guidance. | A safety assurance case for the SCIg60 Infusion System was provided, as recommended by the FDA guidance document, Infusion Pumps Total Product Life Cycle. This indicates that a comprehensive assessment of potential risks and their mitigation was performed to ensure the safety of the device. The explicit acceptance criteria for this case are not detailed. |

Study Details:

1. Sample Size used for the test set and the data provenance:
   The document does not specify the exact sample sizes for each performance test (e.g., number of infusers, sets, or Hizentra samples tested).
   The data provenance is implied to be from laboratory testing conducted by EMED Technologies Corporation, likely within the United States. The data is retrospective in the sense that it was collected as part of the 510(k) submission process, not as a prospective clinical trial on human subjects.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not provided in the document. Given that the testing involves technical performance characteristics of an infusion pump, the "ground truth" would generally be established through calibrated laboratory measurements and validated test methods, rather than expert consensus on clinical findings. For the Hizentra compatibility testing, the "ground truth" would be the known properties of Hizentra before infusion and comparison to a control, likely measured by qualified laboratory personnel.

3. Adjudication method for the test set:
   Not applicable. The testing primarily involves objective measurements of device performance characteristics (flow rate, residual volume, material properties, etc.) against pre-defined technical specifications. These types of tests do not typically require adjudication by multiple experts in the way clinical diagnostic studies might.

4. 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. The SCIg60 Infusion System is an infusion pump, a mechanical device for drug delivery, not a diagnostic imaging device or an AI-powered system that assists human readers in interpreting medical data. Therefore, an MRMC study related to AI assistance for human readers is not relevant to this device.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   Not applicable. The SCIg60 Infusion System is a mechanical infusion pump. It does not contain algorithms for diagnostic interpretation or decision-making that would require a "standalone" algorithm performance study. Its performance is inherent in its mechanical design and function.

6. The type of ground truth used:
   The ground truth for the performance testing was based on:

   • Objective Laboratory Measurements: Calibrated instruments and established test methods to measure flow rates, residual volumes, and material properties.
   • Predicate Device Performance: Comparison to the performance and characteristics of legally marketed predicate infusion systems.
   • Hizentra Labeling and Properties: The known and approved properties of Hizentra, Immune Globulin Subcutaneous (Human), 20% Liquid directly from the manufacturer and its FDA-approved labeling.
   • FDA Guidance Documents: Compliance with recommendations from relevant FDA guidance, such as "Infusion Pumps Total Product Life Cycle," for the safety assurance case.

7. The sample size for the training set:
   Not applicable. This device is a mechanical infusion pump and does not involve AI or machine learning algorithms that require a "training set" of data.

8. How the ground truth for the training set was established:
   Not applicable, as no training set was used.

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