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The MEDRAD Continuum MR Infusion System with Wireless Remote Accessory is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

The MEDRAD Continuum MR Infusion System with Wireless Remote Accessory is a modification of the MEDRAD Continuum MR Compatible Infusion System (3T Proximity) predicate device described in 510(k) submission K061128. Similar to the MEDRAD predicate device, the system is designed for patients requiring medications and other fluids during an MR imaging procedure. Both are designed for use in MR environments up to the 2000 Gauss line in magnet strengths up to and including 3T and are not intended to provide long-term patient care. Both systems connect to the existing patient administration line by the addition of a proprietary disposable and replace the bedside pump during the MR procedure. The proposed device and the predicate device are intended to be used by trained healthcare professionals, medical physicians, and critical care, emergency room, and radiology nursing staff. Neither is intended for the delivery of blood, blood products or nitroglycerine.

The MEDRAD Continuum MR Infusion System included in the proposed device has a similar design, similar materials of construction, similar components and similar infusion pump technology as the MEDRAD Continuum MR Compatible Infusion System (3T Proximity) predicate device. The primary difference between the two MEDRAD devices is the addition of the remote accessory and wireless radio technology.

The document provided is a 510(k) Pre-market Submission for the MEDRAD Continuum MR Infusion System with Wireless Remote Accessory. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing extensive clinical trials as would be required for a PMA (Pre-Market Approval). Therefore, the study described is primarily for bench testing and verification/validation against established standards and to confirm design specifications, rather than a clinical study evaluating device performance in humans or against a true "ground truth" derived from patient data.

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

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present specific acceptance criteria in a quantified table with corresponding performance results. Instead, it states that testing will be conducted against applicable standards, and satisfactory test results are required prior to release of the product. The implicit acceptance criterion is successful compliance with the listed standards and internal design specifications.

The document does provide a comparative table (Table 2 and 3) that lists various parameters of the proposed device against predicate devices. While this isn't "acceptance criteria" in the traditional sense of a performance study, it highlights how the proposed device aims to meet or exceed the predicate's specifications.

Study Proving Acceptance Criteria:

The study described is a performance testing program against applicable industry standards.

• Standards: IEC 60601-2-24, IEC 60601-1, UL 60601-1, and IEC 60601-1-2. These standards address safety and performance for medical electrical equipment, particularly infusion pumps.
• Testing Conducted by: Third-party certified test labs.
• Outcome: "Satisfactory test results required prior to release of the product."
• Purpose: To confirm that design specifications have been met and that the device meets the applicable requirements of the cited safety and performance standards. This also serves to confirm substantial equivalence to predicate devices.

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

This is a device performance study (bench testing), not an AI or clinical study with patient data. Therefore, there is no "test set" in the context of patient data. The "test set" would refer to the physical devices or components subjected to testing. The sample size for these engineering tests is not specified in the document, but it typically involves a representative number of units to ensure manufacturing consistency and reliability, as governed by engineering and quality assurance protocols.

Data provenance (country of origin, retrospective/prospective) is not applicable here as it pertains to patient or clinical data, which is not the focus of this 510(k) submission's described study.

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

Not applicable. "Ground truth" typically refers to verified diagnoses or outcomes in clinical studies, often established by expert consensus or pathology. For this device, the "ground truth" equivalent is compliance with engineering specifications and regulatory standards. The "experts" involved are the engineers, regulatory specialists, and third-party testers who verify adherence to these standards. Their specific number and qualifications (e.g., years of experience) are not detailed in this submission but would be internal to the device manufacturer and the testing labs.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 typically apply to clinical studies where human reviewers assess cases and discrepancies are resolved by a tie-breaker or consensus. For engineering bench testing, "adjudication" is the process of comparing test results against predefined functional and safety specifications, with clear pass/fail criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This is not an MRMC or comparative effectiveness study. It's a technical verification and validation of a medical device against safety and performance standards and comparison to predicate devices, not an AI or diagnostic imaging product comparison.

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

Not applicable. This is not an algorithm or AI device. It is an infusion pump system. The "performance" being evaluated is the physical and functional operation of the pump, not an algorithm's diagnostic output.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance study is adherence to predefined engineering specifications, safety standards (e.g., IEC 60601 series, UL 60601-1), and functional requirements for an infusion pump. This is confirmed through bench testing and verification/validation activities. It does not involve expert consensus on clinical cases, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable. This is a medical device (infusion pump), not an AI algorithm that requires a "training set" of data.

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

Not applicable, as there is no "training set" for this type of device.

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The Medrad Continuum MR Compatible Infusion System is designed for patients who require maintenance medications and fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during, and immediately after the MR procedure, functioning while either stationary or mobile. It is not intended to provide long-term patient care outside of the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

The Medrad Continuum MR Compatible Infusion System has been modified to include two new programming options, and to remove two previous programming options. None of the modifications required changes to the system hardware, labeling, or disposable administration sets. The following two programs have been added as features to the Continuum MR Infusion System:

1. Dose Program The Dose Program enables the administration of a weight-based dose in either micrograms/kg/min or milligrams/kg/min. This program is designed for use in procedures that require special dosing and infusion based on the patient's weight. The program calculates a flow rate in ml/hr based on the input parameters programmed by the user. The require parameters are:
   Patient Weight (kg) t
   Drug Concentration (mg/ml) ●
   Dose (ug/kg/min or mg/kg/min) ●
   . Volume (ml)
2. Bolus Program The Bolus Program chables the Continuum MR Infusion System to administer a bolus to the patient. This program removes the need for an cxternal syringe connection to the Continuum Administration Set for a bolus administration. The Bolus Program feature is available in both the Dose program and the Rate Over Volume mode of the Continuous Program. The Bolus Program prompts the user for the bolus volume and then administers the bolus at the user's command. The following parameters are available for the Bolus Program:
   Bolus Flow Rate (programmable in the Adjust Settings Menu) .
   a. 10 99.9 ml/hr in 0.1 ml increments
   b. 100 500 ml/hr in 1.0 ml increments
   Bolus Volume (0.1 100 ml in 0.1 ml increments)
   In addition to the inclusion of the two programs above, two of the existing programs, the Intermittent Program and the 25-steps Protocol, have been removed from the modified Continuum MR Infusion System.

The Medrad Continuum MR Infusion System is a peristaltic pump system designed for administering maintenance medications and fluids to patients during MR procedures. The system has been modified to include new "Dose Program" and "Bolus Program" options while removing the existing "Intermittent Program" and "25-steps Protocol". The modifications did not require changes to the system hardware, labeling, or disposable administration sets.

Acceptance Criteria and Device Performance

The provided document does not explicitly state acceptance criteria in a quantitative format for the new Dose and Bolus programs, nor does it detail a specific study that quantitatively proves the device meets such criteria. However, the submission is a Special 510(k) for device modifications, implying that the modified device's performance is considered substantially equivalent to the predicate device (Medrad Continuum MR Infusion System, K021988), particularly since no hardware changes were made. The "System Accuracy" for flow rate remains the same as the predicate device: ± 10%. This can be inferred as the primary performance criterion for fluid delivery.

The comparison table provided in the document highlights the parameters that are "Same" as the predicate device, implying that their performance and safety characteristics remain unchanged and meet the previously established standards for the predicate device.

Table 1: Acceptance Criteria and Reported Device Performance

Note: The document is a 510(k) summary, which typically presents a high-level overview. Detailed test reports with specific acceptance criteria and performance data for the new software functions (Dose and Bolus Programs) are not included in this summary but would have been part of the full 510(k) submission. The "Same" entries in the performance column imply that the modified device's performance for those parameters continues to meet the predicate device's established performance.

Study Details and Ground Truth Establishment

The provided document does not describe a detailed "study" in the sense of a clinical trial or a formal quantitative performance study tailored to prove the device meets specific acceptance criteria for the new features. Instead, this is a Special 510(k) submission for device modifications. This type of submission relies on the concept of substantial equivalence to a predicate device, particularly when the modifications do not affect fundamental safety or effectiveness.

Given the nature of a Special 510(k), the "study" would primarily involve verification and validation (V&V) testing to ensure the new software functionality (Dose and Bolus Programs) operates as intended and does not negatively impact existing safety and performance features. This V&V testing would compare the modified device's performance against its own design specifications and the predicate device's established performance characteristics.

Based on the information provided, here's an analysis of the requested points:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   The document does not specify a "test set" in terms of patient data or clinical cases. The V&V testing would likely involve bench testing using a representative number of infusion scenarios and parameters for the Dose and Bolus programs to confirm accurate calculation and delivery. The data provenance would be from internal Medrad, Inc. testing. The testing would be prospective in the sense that the new software features are tested against their design specifications.

2. 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):
   Not applicable in this context. For an infusion pump, "ground truth" relates to the accurate delivery of fluids based on programmed parameters, which is verified through physical measurements and engineering standards, not expert consensus on interpretations. The "experts" would be the engineers and quality assurance personnel conducting the V&V testing, ensuring the device performs according to its design and regulatory requirements.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable. Adjudication methods are typically used in studies involving subjective interpretations (e.g., image analysis by multiple radiologists) to establish a consensus ground truth. For an infusion pump, performance is objectively measured.

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. This device is an infusion pump, not an AI-powered diagnostic tool. MRMC studies are used for evaluating AI performance in diagnostic imaging.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   The "standalone" performance for the infusion pump refers to its ability to accurately deliver fluids as programmed. The V&V testing for the new Dose and Bolus programs would assess this. For example, testing would confirm that if a user programs a specific dose (micrograms/kg/min) and concentration, the pump correctly calculates and delivers the corresponding flow rate (ml/hr) with the specified accuracy (± 10%). Similarly, for the Bolus program, the accuracy of delivering the programmed bolus volume and rate would be tested.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   For an infusion pump, the "ground truth" for V&V testing is based on engineering specifications and metrology. For instance, the ground truth for flow rate accuracy would be the precisely measured volume of fluid delivered over time, compared to the calculated and programmed rate. This is established using calibration equipment and standard test methods for infusion devices.

7. The sample size for the training set:
   Not applicable. Infusion pumps are not typically developed using machine learning or AI models that require "training sets." The device's functionality is based on deterministic algorithms and software logic.

8. How the ground truth for the training set was established:
   Not applicable, as there is no "training set" in the context of this device.

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